While waiting for a state health-records exchange, medical society launches one

Frustrated that after 10 years of effort the state of Connecticut has yet to launch a functioning health information exchange (HIE) allowing physicians, hospitals and other health care providers to share patient medical records, the Connecticut Medical Society is offering one of its own.
Available to all clinicians in the state and called CTHealthLink, it is based on a system currently used in Kansas.

Part of the motivation was the threat that clinicians would miss out on Medicare and Medicaid incentives given for participating in a health information exchange and would instead be subject to penalties, said Matthew Katz, executive vice president and chief executive officer of the Connecticut State Medical Society (CSMS).

“The Connecticut medical society decided to go ahead and try to do it because our members are missing out on the opportunity for financial benefits,” and many have to pay penalties for not participating, Katz said.

For the 2017-18 federal fiscal year, only 800 of the eligible medical professionals and none of the eligible hospitals are expected to receive Medicaid incentive payments, according to planning documents for the state health information exchange.

In 2007, Connecticut first attempted to create a health information exchange (HIE) specifically for Medicaid with a $5 million grant, before most physicians had switched to electronic health records. It was cutting edge, but the state’s medical professionals weren’t ready for it, said Dr. Thomas Agresta, a professor and director of medical informatics in family medicine at UConn Health, who has been involved in HIE efforts since the beginning.

Between 2007 and 2016 the state tried twice more to design and implement an HIE for all providers. Neither attempt produced a functioning system despite extensive planning and $18 million in funding.

“Everybody was hyped up and interested in the potential for health, but not aware of changes that needed to occur,” Agresta said. “Most people were a little naïve in terms of complexity.”

Before deciding to join CTHealthLink, all providers — hospital systems, like Yale New Haven Health, private practices and physician groups — are facing this decision: Is it worthwhile to sign on with CTHealthLink or should they wait for a fourth attempt at a state HIE system to pan out?
A health information exchange allows any participating clinician to see the procedures, tests, lab results and medical histories ordered for their patients by other participating clinicians, preventing repetition that wastes time and money.

CTHealthLink also provides a portal that allows patients to see their own records, something providers have expressed interest in having at state-held planning discussions for attempt four.
Yale New Haven Health says it will need to make sure the CTHealthLink system would truly benefit patients and be cost-effective before signing up, said Lisa Stump, chief information officer for the hospital system.

“There are a few questions that need to be answered before I’m confident in submitting our data,” Stump said. “Is there good structure around opting in and out, so that patients get a choice” of whether to have their medical information shared?

Stump said Yale New Haven Health also would want to be sure CTHealthLink would improve care enough to make a subscription worth the cost. When the state system begins operating all hospitals will be required to join, whether they are part of CTHealthLink or not.

CTHealthLink will cost between $50 and $120 per physician per month, depending on when a facility joins, whether the physicians are CSMS members, and whether the provider is a very large practice or a hospital system, Katz said. There is also a set-up cost based on the internal records system a practice or hospital uses.

“If we do the math, even at the lowest rate of $50, for a medical practice of 1,200 physicians, it is $720,000 per year…and at $120 it’s $1.7 million,” Stump said.

For an organization the size of Yale New Haven Health, which includes five hospitals and 3,500 to 4,000 physicians, it would be two or three times more.

“The benefit of any HIE is how robust the data are in the HIE. We are a large health exchange and have good sharing within our system” and with the Veterans Administration’s Healtheway system, Stump said. “Is that cost (of CTHealthLink) going to bring us a value more than the means we already have.”
And more than the state system will in the coming years.

Incentives for participation in an HIE are available to all physicians and many other clinicians through the Medicare quality payment program (MIPS). Eligible clinicians who don’t participate in MIPS by the end of 2017 would see a 4 percent reduction in their Medicare reimbursement in 2019.
“Even though it is starting late (in the year), it is more than enough time to get the federal benefits,” Katz said.

CTHealthLink expected to sign contracts in July and to begin sharing data between medical practices beginning in August and September. But as of August 15, none of the contracts had been finalized.
According to CSMS, the process has been delayed because determining the set-up cost each hospital or practice’s electronic health record vendor is going to charge is taking longer than expected.

The goal is to include at least 80 percent of the state’s 9,600 physicians in fewer than five years, Katz said.

Connecticut Hospital Association spokeswoman Michelle Sharp said the association “is pleased that CSMS is seeking a solution for its physician practice members who may need additional support to elevate their health IT infrastructure.”

CTHealthLink is set up like a central data warehouse that allows doctors and patients to view all their patients’ health records in one place, Katz said, with only a three-minute delay from the time an electronic health record is posted.

Katz said the model is much less expensive than others in use, and wouldn’t require any state or federal funding to operate. However, the state’s health information technology officer, Allan Hackney, said there are cheaper ways to do it.

“Whenever you bring data to the center, it is automatically a more expensive undertaking, because you have to curate the data, store it, secure it, back it up, you have to have disaster recovery, all those things layered across each other,” Hackney said.

Hackney’s position was created in 2016 after a third state attempt to construct an HIE by the Department of Social Services ended without a product and the responsibility was transferred to Hackney and an advisory council.

Despite the previous work, the fourth attempt began by working to understand what providers really needed, with $10 million in combined federal and state money.

The state knew from experience that if it were going to succeed this time, it needed the input of individuals who would be using the system as well as technology that wouldn’t become outdated before the project was complete.

At the same time, DSS requested more than $14 million in grant money — 90 percent percent from the federal government and 10 percent from the state — to implement a Medicaid-specific health information system that eventually would tie into the larger state system, if both are successful. 

According to the office of the lieutenant governor, DSS needs to construct its own system as quickly as possible because of specific Medicaid reporting requirements.

But efforts to implement a strategy to make reporting for Medicaid easier have always been a central part of the state HIE efforts, whether they were led by DSS or not, and that is no different with the fourth attempt, planning documents show. But it is not clear when the universal statewide system would implement the needed Medicaid features.

The system is scheduled to be functioning by the beginning of 2018, but various features and access to different kinds of data will be added incrementally, based on priorities identified by the system’s users.

Unlike the CTHealthLink model, the state is working on a system that allows data to be pulled directly from its source instead of being gathered all in one location, a lower-cost and lower-risk option, Hackney said.

The state system will be built to connect all clinicians, from physicians to pharmacists to behavioral health workers, even if they are participating in CTHealthLink or any other, smaller exchanges already, Hackney said.

Eventually, the system will allow all medical information, including veterans’ information from the Department of Defense as well as prescriptions and immunization records, to be accessed by all participating medical professionals.

The order of the first few features to be created will be decided by September, according to the office of the lieutenant governor.

Despite the potential for a more user-friendly product, according to Hackney, this will take time, and Dr. Jeff Gordon, CSMS president, who works in a private practice owned by Hartford Healthcare, said the state already has lost the faith of many health professionals because of its many failed attempts. 

“CSMS have a model that they’re using that’s been proven to be financially sustainable,” Gordon said. “Hospitals and physician groups have a good relationship with us; they don’t have a good relationship with the state.”

Despite the previous failures, Agresta said he has more faith in the state’s latest attempt because the technology is finally ready for it.

“Unlike the first few attempts, when we tried to do this in the past, and very few people understood what exchanges could do, there is more understanding of data,” Agresta said. “During the 2010-2012 time frame, we were still trying to get physicians to adopt EHRs. Basically we were asking them to learn to crawl, to walk and to run all at the same time.”

Although CTHealthLink hopes the Kansas model will work just as well in Connecticut, Hackney is not as confident.

The difference in Connecticut, Hackney said, is that healthcare providers already have invested millions in their own internal systems, and the major providers of those systems have connections to allow record exchanges between clinicians that use the same vendor. Hartford Healthcare, Yale New Haven and Trinity New England, parent of St. Francis and St. Mary’s hospitals, all use the same vendor, Epic, and UConn Health is in the process of switching over to it, Agresta said.

Other hospitals, physician groups, behavioral health facilities and small practices have yet to be linked in such a way. They are still waiting for a system like CTHealthLink or the state system to connect them with their patients’ other providers.

Hackney said he doesn’t want Connecticut to fall into the same trap that many other states have, where systems are developed and then not adopted by many providers, or the systems become obsolete after only a short time as technology progresses.

“My view on this is that the only way state efforts will win is if it is collaborative and focused on value,” Hackney said. “If we focus on value, you know you’re going to hit people with a difference in the way they deliver health care.”

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Provider User-Experience Challenge

A Notice by the Health and Human Services Department on 03/03/2016

Action

Notice.

Summary

Like the Consumer Health Data Aggregator Challenge, the Provider User-Experience Challenge incents the development of applications for health care providers that use open, standardized APIs to enable innovative ways for providers to interact with patient health data. This challenge will focus on demonstrating how data made accessible to apps through Application Programming Interfaces (APIs) can positively impact providers' experience with EHRs by making clinical workflows more intuitive, specific to clinical specialty, and actionable. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

DATES:

Phase 1

• Challenge launch: March 1, 2016
• Submissions due: May 30
• Evaluation period: May 31-June 28
• Phase 1 winners announced: June 30

Phase 2

• Submission period begins: May 31
• Submissions due: November 7
• Evaluation period: November 14-December 14
• Phase 2 winners announced: December 15, 2016

FOR FURTHER INFORMATION CONTACT:

Adam Wong, adam.wong@hhs.gov (preferred), 202-720-2866.

SUPPLEMENTARY INFORMATION:

Award Approving Official

Karen DeSalvo, National Coordinator for Health Information Technology.

Subject of Challenge Competition

The Provider User-Experience Challenge is intended to spur development of third-party applications for use by clinicians and use FHIR to pull various patient health data into a dashboard. The challenge has two phases—the first requiring submission of technical and business plans for the application (app), the second a working app that is available for providers. Phase 2 of the competition will not be limited to only those who won Phase 1—all Phase 1 competitors, and those who did not participate in Phase 1, can submit a final app at the end of Phase 2.

The final application must meet the following requirements:

• Uses FHIR Draft Standard for Technical Use 2 (DSTU2)
• Aggregate all data as specified in the 2015 Edition Common Clinical Data Set (Data column in https://www.healthit.gov/sites/default/files/commonclinicaldataset_ml_11-4-15.pdf)
• Verified compatibility with different health IT developer systems implemented in production settings, 1 of which must be from the top 10 systems measured by Meaningful Use attestation per HealthIT.gov. Apps must be integrated with a minimum of 3 unique health IT developer systems in 2 unique provider settings
• Has been tested with patients and used in production settings
• Available to providers through at least one of the following modes: Direct from Web, iOS Store, or Android stores

Phase 1

Participants interested in competing for Phase 1 awards will need to submit an app development plan that must include:

• Mockup/wireframes
• Technical specifications, including but not limited to planned data sources, system architecture
• Business/sustainability plan
• Provider partnership

To augment technical development and enhance the likelihood of a successful app that will continue to exist beyond the end of the challenge, a progress update/matchmaking event will be held that will seek to connect participants with provider partners. Up to five app proposals will be recognized as winners and awarded up to $15,000 each.

Phase 2

The second phase will entail the actual development of the apps, verification of technical capabilities, user testing/piloting, and public release of the apps. This will include remote testing with providers and health IT developers to test the technical abilities of the apps to connect to in-production systems. Participants will submit:

• Working prototype of the app
• Video demonstrating the app (maximum of 5 minutes, on YouTube or Vimeo)
• Slide deck describing app (maximum of 10 slides)

The grand prize winner will receive $50,000 and a second place winner will receive $25,000. There will be an additional $25,000 prize for the app that connects to the greatest number of unique health IT developer systems implemented in production settings, which can be won by the grand or 2nd place winner.

Eligibility Rules for Participating in the Competition: To be eligible to win a prize under this challenge, an individual or entity:

1. Shall have registered to participate in the competition under the rules promulgated by the Office of the National Coordinator for Health Information Technology.

2. Shall have complied with all the requirements under this section.

3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States.

4. May not be a Federal entity or Federal employee acting within the scope of their employment.

5. Shall not be an HHS employee working on their applications or submissions during assigned duty hours.

6. Shall not be an employee of the Office of the National Coordinator for Health IT.

7. Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award.

8. Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge submission.

An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.

Entrants must agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from my participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.

Entrants must also agree to indemnify the Federal Government against third party claims for damages arising from or related to competition activities.

Submission Requirements

In order for a submission to be eligible to win this Challenge, it must meet the following requirements:

1. No HHS or ONC logo—The product must not use HHS' or ONC's logos or official seals and must not claim endorsement.

2. Functionality/Accuracy—A product may be disqualified if it fails to function as expressed in the description provided by the user, or if it provides inaccurate or incomplete information.

3. Security—Submissions must be free of malware. Contestant agrees that ONC may conduct testing on the product to determine whether malware or other security threats may be present. ONC may disqualify the product if, in ONC's judgment, the app may damage government or others' equipment or operating environment.

Registration Process for Participants: To register for this Challenge, participants can access http://www.challenge.gov and search for “Provider User-Experience Challenge.”

Prize

• Phase 1: Up to 5 winners each receive up to $15,000.
• Phase 2: One final winner receives $50,000; 2nd place receives $25,000; and an additional $25,000 connector prize.
• Total: Up to $175,000 in prizes.

Payment of the Prize: Prize will be paid by contractor.

Basis Upon Which Winner Will Be Selected: The review panel will make selections based upon the following criteria:

Phase 1

• Technical feasibility of plan, including number of EHR sources targeted.
• Adherence to data privacy and security best practices.
• Strength of business/sustainability plan.
• Impact potential in clinical setting.
• Provider and/or health IT developer partnerships.

Phase 2

• Number, sources, and types of data aggregation using FHIR.
• Functionality and quality of data aggregation.
• Privacy and security of patient data.
• Impact potential in clinical setting.
• User experience and visual appeal.

Additional Information

General Conditions: ONC reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at ONC's sole discretion.

Intellectual Property: 

Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement. By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

Authority:

15 U.S.C. 3719.

Dated: February 23, 2016.

Karen DeSalvo,

National Coordinator for Health Information Technology.

[FR Doc. 2016-04466 Filed 3-1-16; 11:15 am]

BILLING CODE 4150-45-P

Advancing the Agenda on How Healthcare is Delivered

Comments of CMS Acting Administrator Andy Slavitt at the J.P. Morgan Annual Health Care Conference, Jan. 11, 2016

JANUARY 12

Thanks for the introduction. Glad to be here and speak about the major policy areas that will affect the health care sector in 2016. I am particularly glad to be here with Jim from AMA, because between us we are working on an incredible amount of change across the health care sector.

When they put a private sector guy in charge at CMS, I made clear my intention to talk regularly to the health care investor community. From my not-so-distant past, I remember how CMS often felt opaque to me, and I probably said more than once how helpful it would be to know CMS’s agenda rather than divining them by poring through an often intricate set of regulations like they were Fed minutes.

I’m a believer in the maxim that it’s always 90 percent about implementation, and possibly to the annoyance of my colleagues, it’s a constant refrain from me. We only succeed if we bring the ideas behind the big legislation successfully to the kitchen table of the American family and the exam room of their physicians.

I’m blessed to be here now because in many ways the day-to-day work of CMS at this point in time is to start up new consumer and provider-facing capabilities and then scale them, nurture and mature them. It demands we change our culture and execute with clarity, with discipline, and with collaboration. Things we haven’t always been known for.

2015 was a meaningful year for execution on a number of fronts. From committing publicly to change how we pay for care, to leading the largest data transparency initiative in health care, releasing tens of millions of lines of data and new consumer websites, to investing in the growth of Medicare Advantage, to seeing record levels of quality, safety and continued low medical trend. To implementing the ICD-10 changeover, the biggest event no one heard about. And of course expanding Medicaid into three new states, and we’ve now crossed 17 million newly insured since the start of the ACA and have had a strong start to our third open enrollment.

Through the year, I developed a view I will share with you of how CMS operates and a new cultural focus to execute most effectively. CMS works on three important levels.

First, setting policy and acting as a regulator to make sure the laws of Congress and the rules we set advance the interests of consumers and taxpayers. Here our most important job is to listen and learn, policy is often a blunt instrument and in the real-world it takes continual adjusting.

Second, we act as an operator, providing service to our beneficiaries, technical support to health care providers, and partnering with states and commercial health plans to deliver our programs.  Our mantra here is to give people the tools they need to thrive in the face of significant change.

And third, we often operate as a market signaler, acting as a catalyst to bring together the disparate pieces of the health care to make improvement more rapidly and more efficiently such as how we pay for care.

So, 2016. Let me start with how we are advancing the agenda on how health care is delivered. To the 130 million Americans in the Medicare, Medicaid and CHIP programs, and by extension how care is paid for across all of health care, 2016 will be an enormous and pivotal year for progress and it’s starting off with a bang.

***

We announced today the participants in the Next Generation ACO model. In Next Gen, provider groups take full financial responsibility for a patient’s care and have innovative options like telemedicine, home visits, and direct consumer incentive and engagement options. It’s a model driven by all the lessons learned and feedback from previous participants and results. And the news is very good.

With 21 new Next Gen ACOs, there will be over 475 total ACOs with 30,000 physicians participating around the country, including 64 that are 2-sided or full risk, up from 19 just last year and of course zero before the Affordable Care Act.

My read of this news is that in 2016, we have not only more ACOs, but better ACOs. In total, 8.9 million Medicare FFS beneficiaries, or greater than 1 in 5, in 49 states and the District of Colombia, will now be a part of an ACO, with 1.6 million in better, more advanced models.

Many have wondered whether ACOs would succeed or would end up in the dustbin of health care’s three-letter acronyms. As a recovering entrepreneur, I can certainly tell you that the execution in the first stage is often the hardest part. But today’s news is strong evidence that ACO’s will be part of ushering in the new wave of alternative payment models. They have demonstrated improvements in quality, patient experience and have been certified to reduce costs.

But it’s important to remember where we are. Think of the Next Gen model like the second generation iPhone. There will still be progress and setbacks and we will continually improve.

***

The implementation of the bipartisan MACRA legislation is a major item squarely on our punch list that has everyone’s attention. At its most basic level it is a program that brings pay for value into the mainstream through something called the Merit-based incentive program, which compels us to measure physicians on four categories: quality, cost, the use of technology, and practice improvement.

The stakes are high for this program. As any physician will tell you, physician burden and frustration levels are real. Programs designed to improve often distract. Done poorly, measures are divorced from how physicians practice and add to the cynicism that people who build these programs just don’t get it. Over the next several months, we will be rolling out details, but for now a couple of themes.

At its core, we need to simplify. We have the opportunity to sunset three old programs and align them together in a single new program. That program needs to be streamlined and simple to use so physicians can focus where they need to – on their patients.

We are designing from the outside-in. We started by working with front-line physicians, tech companies, and practice managers over a four day session and through an RFI to garner direct feedback on the right measures for each specialty and how to implement the program most simply.  Jim and the AMA team were of significant help.

We are committed to building a program that is flexible and adapts around the goals of a provider’s individual practice and patient population.

I would be remiss if I didn’t add that like any good start up, we will start small and leave a lot of tool building opportunities to the private sector.

Let me dive a little deeper on the technology component. Now that we effectively have technology into virtually every place care is provided, we are now in the process of ending Meaningful Use and moving to a new regime culminating with the MACRA implementation.

The Meaningful Use program as it has existed, will now be effectively over and replaced with something better. Since late last year we have been working side by side with physician organizations across many communities — including with great advocacy from the AMA — and have listened to the needs and concerns of many. We will be putting out the details on this next stage over the next few months, but I will give you a themes guiding our implementation.

For one, the focus will move away from rewarding providers for the use of technology and towards the outcome they achieve with their patients.

Second, providers will be able to customize their goals so tech companies can build around the individual practice needs, not the needs of the government. Technology must be user-centered and support physicians, not distract them.

Third, one way to aid this is by leveling the technology playing field for start-ups and new entrants. We are requiring open APIs in order to the physician desktop can be opened up and move away from the lock that early EHR decisions placed on physician organizations so that allow apps, analytic tools, and connected technologies to get data in and out of an EHR securely.

And finally, we are deadly serious about interoperability. We will begin initiatives in collaboration with physicians and consumers toward pointing technology to fill critical use cases like closing referral loops and engaging a patient in their care. And technology companies that look for ways to practice “data blocking” in opposition to new regulations will find that it won’t be tolerated.

***

Medicaid is another significant item on our punch list this year. Over the last two plus years, over 13.5 million people have gained the security of Medicaid or CHIP coverage. But even as we are focused on helping interested states expand coverage, we are equally focused on rapidly modernizing Medicaid coverage so that it works as well or better than any insurance program.

This last year, we have released proposed or final rules to modernize how Medicaid managed care works, how states and CMS ensure access to care, and are working state by state on their plans to improve incentives for value-based care with delivery systems. Our priority this year is to attract new innovative companies to invest in the Medicaid IT space. From where I sit, investing in the future of Medicaid is one of the single best opportunities in the health care sector.

First, it’s big: Last month CMS permanently extended the 90 percent federal match for investments in Medicaid systems. Overall, CMS’ annual investment in state Medicaid IT is more than $5 billion. With over 30 states currently redesigning their Medicaid IT systems, 2016 will the most active year to date for Medicaid IT opportunities.

Second, the opportunity for innovation and differentiation is large and we are making it easier than ever: state investment is geared specifically towards technologies that are modular, reusable, and cloud-based. This opens up opportunities for innovative new entrants to disrupt this market. To assist potential new entrants in entering this solution space, today we are launching a one-stop-shop with a set of resources that will help private sector companies identify opportunities to participate in this important market. I will tweet this URL and a link to a blog with more details after this talk.

***

The final significant item on the punch list is the health and long term stability of the Health Insurance Marketplaces. Stepping back, the Marketplace is still in the early stages. Consumers are still getting educated and health plans are experimenting with the right product and network designs. Even as the market meets today’s needs and signs millions of new consumers up in record numbers, we also pay attention to adjustments that are needed as the Marketplace matures. And today I want to talk about steps we are taking to move from a startup stage to a more mature stage.

We have an experienced team of leaders and actuaries from the private sector and many who come directly from our Medicare Advantage and Part D operations where we have set up and operate very successful large marketplaces already. We study the data and meet regularly with all market participants and take a strategic view to determine what adjustments are warranted.  Our focus is simple – Marketplaces must be attractive to health plans to reach and build relationships with desirable consumers; the offerings need to be attractive to consumers so they come and shop; and we need a predictable set of underwriting and other rules that compensate fairly for risk and keep the risk pool stable and balanced.

On the first point, we are seeing the characteristics of an attractive customer base for health plans to serve: A growing market; a younger population; and with high levels of engagement and responsiveness to new offerings. This Open Enrollment period, we’ve seen a significant influx of new consumers making it clear there is still a large untapped market to serve.

And the tax penalty is bringing more young and healthy consumers into the market. We are using a large portion of our marketing resources to make sure that consumers are aware of the increasing fee for people that go without insurance.

41% of all new consumers this Open Enrollment are under 35, compared to 38% a year ago. And if past patterns continue to hold, the percentage of young people will climb throughout the rest of Open Enrollment.

There are also high levels of consumer engagement– as over 60% of Marketplace consumers have made active decisions about their health insurance choices.

And even at this early stage we are beginning to see health care look and feel like many other retail markets where consumer preferences are creating meaningful consumer improvements. 90% of consumers have an average of three insurance companies to choose from translating into 50 plan options. Consumers can now pick a plan based upon the insurance their doctor accepts or the drug they are looking for. And the vast majority are getting direct services like primary care and generic drugs outside their deductible.

The presence of federal subsidies has exploded the universe of consumers in the individual market. A truly retail market with these type of organic innovations should bring in even more consumers, including higher income individuals who will be attracted to better experiences and better services.

Finally, moving into the third year and beyond, we are focused on continually maintaining and improving a set of marketplace rules that create a healthy, stable and balanced risk pool. These changes will lead directly to a stable rate environment and more affordability for consumers. I want to lay out some of the specific steps we are taking over the next 45 days.

First, we think it is critical to enforce the integrity of the Open Enrollment period. In the first two years of the Marketplace, a number of Special Enrollment Periods or SEPs were created as consumers were learning how to enroll in coverage for the first time. SEPs play an important role for consumers but we are making changes so that as the Marketplace matures, SEPs serve the purpose they are intended.

Last month, we announced the elimination of the tax season special enrollment period; and this week, we will be announcing that we will be eliminating certain other select SEPs and making the language on others clearer to prevent bad actors from signing people up for insurance inappropriately. We have established an enforcement unit and have already terminated coverage for individuals who were improperly enrolled by certain brokers.

But lifting up, most importantly, consumers need to know that Open Enrollment– the next 20 days– is the time to get covered for potential illness and avoid the tax penalty.

Next, we are committed to making sure that risk adjustment works as it is intended to allow coverage of individuals with pre-existing conditions. This year we will be taking a number of steps. First, in response to health plan feedback, we will be providing early estimates of health plan specific risk adjustment calculations. Along with the newly launched backend automation, this will give plans more timely information in order to facilitate informed rate setting.

Second, on March 25, we are hosting a public conference to bring together all market participants to review the risk adjustment methodology so we can build in changes based on the first several years of experience. We have the tools to make certain the proper incentives exist to insure sicker populations.

And outside of risk adjustment, in the next 45 days you will see other announcements and more specificity intended to address the risk pool.

Overall, we’re taking steps to move from a start-up period to a more normalized set of operating rules. The start-up stage of anything has unique challenges. The Administration and Congress recognized the challenges that were placed on health plans with building a stable marketplace over the first few years and passed a one-year moratorium on the Health Insurance Tax to assist with that transition.

Just as the reinsurance program, which has paid out $7.9 billion, at a 25% higher level than expected, has been a stabilizing force to date; the one-year tax holiday, of $13.9 billion will help stabilize premiums next year.

The actions we are focused on, while targeting health plans, are aimed at directly benefitting consumers as they enhance predictability and affordability. That is a critical goal as we move to the next stage of Marketplace evolution.

***

Let me recap the themes in our 2016 agenda.

We maintain our cultural focus on listening and learning that we really launched in earnest this year. We have a number of start-up activities as well as areas where we must move to a more mature stage, which makes that focus even more important.

And we must execute in our role as a market catalyst and signaler– signaling that care delivery payments are changing, and reward people who provide the best care and we are pushing to a tipping point by 2018. Signaling that Medicaid, with the benefit of new innovation, will be a priority area of growth and innovation; and signaling that we have the focus, the tools and the experience to continue to make sure the Marketplace remains healthy.

On a personal note, it is a great honor and very energizing to serve as a leader in CMS at a time when there is such a significant amount to execute on. Taking this assignment on for me after my time in the private sector has been invigorating and inspiring so far, even when all the missiles appear to be pointed directly at us.

Quite simply, it’s because of the consumer — 130 million of them – many on fixed and low incomes who I wake up thinking about every day. When I took this job I decided to keep my email address public and I know now many of them wake up thinking about me.

I quickly realized how many people are just hoping for basic things, to have their family well taken care of when they’re sick, to have them home and to lead as productive and healthy life as possible. Whether living with a disability, trying to afford a prescription, or hoping to keep coverage as they look for a better job. Millions more of you are counting on us making smart decisions now so that these programs work for you when you need them. And it’s because of the people we serve that our punch list needs to be bold, clear and ultimately successful.

We are committed to continuing to working side-by-side with you to make this happen.

http://blog.cms.gov/2016/01/12/comments-of-cms-acting-administrator-andy-slavitt-at-the-j-p-morgan-annual-health-care-conference-jan-11-2016/

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Patient enrollment, use, and satisfaction with patient portals

Many physicians are adopting patient portals in response to governmental incentives for meaningful use (MU), but the stage 2 requirements for portal use may be particularly challenging for newer electronic health record (EHR) users. This study examines enrollment, use based on MU requirements, and satisfaction in a recently-adopting fee-for-service multispecialty system. The Centers for Medicare and Medicaid Services (CMS) financial incentives for meaningful use (MU)1 likely will persuade many reluctant doctors to adopt electronic health records (EHRs). However, there are strong concerns about whether most physicians will be able to adopt and utilize these EHRs to meet MU standards.

The study team examined data from 2010 to 2012 of users of a available patient portal linked to the EHR of a multispecialty academic group practice and 10 affiliated community primary care clinics. Patient portals linked to commercial EHRs are likely to offer the most commercially practical way for new EHR users to meet CMS MU patient access regulations. The results indicate that even some large centers with patient portals will have difficulty with some of their physicians' enrollment targets.

The study suggests that patients at later-adopting centers are moving quickly to embrace online programs, and that primary care, but not specialty physicians, can satisfy many of their expectations even without large redesigns of care.

http://www.medicalnewstoday.com/releases/274538.php

Healthcare software innovation: Why in-house accelerators are better

This post was originally published on Vector, Boston Children’s Hospital’s science & innovation blog.

Considering that Boston is home to some of the country’s best medical, scientific and technological minds, it is little surprise that the city has a vibrant startup ecosystem. That ecosystem lowers barriers to creating groundbreaking innovations, connecting innovators to funding, mentorship and human capital. Yet, it isn’t very well-suited to help health care software innovators, who face a unique set of challenges.

The unique and increasingly complex IT environment within health care institutions is one of the biggest barriers to the development of novel clinical software solutions. To start with, health care delivery IT environments boast complicated safeguards to keep medical information secure. In addition, as these environments grow in scope and complexity, keeping pace with advances in clinical technology, it becomes harder to incorporate new software. Breakthroughs that enable Boston Children’s Hospital to be a leader in robotic surgery, for example, also make it harder to design technologies that can easily integrate with a hospital’s IT system.

The clinical IT environment is further complicated by a myriad of regulatory requirements. Plotting a course through the IT complexity, while complying with stringent security and HIPAA requirements, can be daunting. Furthermore, the FDA may soon be regulating clinical mobile apps and novel software as it does medical devices and pharmaceuticals. With regulatory concerns and complexity, it’s not difficult to see why many potential health care software innovators can get stuck in the early stages of the innovation lifecycle.

And the IT environment is not the only challenge for innovators wanting to develop new clinical solutions. Innovators need not only time and resources, but also highly specialized technical skills. Typically, innovators will reach out to their institution’s IT developers for help—only to discover that those developers have limited bandwidth and are busy working on higher priority projects.

As a result, innovators may seek an external software development vendor to build the solution they have in mind. But finding the right vendor is not easy. And even when there is a good health care software developer with which to partner, there are hurdles to negotiating contracts—and that is assuming there is money available to pay for the work.

Looking inward for answers

At Boston Children’s Hospital, we have built a unique program to help free aspiring innovators from many of the traditional challenges in building new clinical IT software. Known as FastTrack Innovation in Technology (FIT), part of the hospital’s Innovation Acceleration Program, it offers annual software development awards in the form of time with a special team of Boston Children’s project managers, business analysts and software developers.

The FIT team can rapidly translate a clinician’s idea into functional software that can be piloted in the hospital setting—and generally does so more efficiently and at a lower cost than most traditional software development vendors. FIT solutions have ranged from clinical software to mobile apps, and from clinician to patient-oriented solutions. Here are three examples:

• A Twitter-inspired app, called BEAPPER, allows emergency department staff to easily share and update information about their patients in real time and to get lab results on their mobile device.

• Another mobile app, MyPassport, helps inpatients communicate with their clinicians, access their care plan and track their progress toward discharge.

• ALICE, a digital “smart board,” has replaced the white boards and hand notations Boston Children’s clinicians used to keep track of patients in each unit.

A harvest of solutions

Having an in-house incubator has allowed Boston Children’s to rapidly create and test novel software solutions. Because our FIT developers understand the hospital’s IT environment, their technologies integrate far more smoothly than most vendors’ solutions to the same problem.

Innovating around clinical software solutions has traditionally been difficult. Because we can provide dedicated healthcare software development resources, our staff’s ideas are bearing fruit and helping us to enhance the delivery of pediatric care. To see so many innovators embrace these resources is not only gratifying to all of us in the IAP, it is also tremendously beneficial to the people who matter most—our patients.

Read more: http://medcitynews.com/2014/01/healthcare-software-innovation-house-accelerators-better/#ixzz2rbV0pFKT

Data Mining, Meaningful Use, Secondary Use, & Potential Misuse of Electronic Health Records

Donna Hanrahan

Donna Hanrahan
Ethical Technology

Posted: Nov 15, 2013

Healthcare providers are establishing electronic health record (EHR) systems at an astonishing rate, due in part to the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act was created as a part of the American Recovery and Reinvestment Act of 2009.

ⁱ The $27 billion dollar piece of legislation offers eligible providers incentives for expanding the use of healthcare information technology (HIT).ⁱⁱ This includes promoting the “meaningful use” of EHRs. The “meaningful use” standard was designed to use HIT to improve quality of care and health outcomes for patients, as well as to lower costs by eliminating repeat medical tests and reducing preventable medical errors that pervade the health-care system today. This legislation has been extremely effective in persuading healthcare providers to use of electronic health records. In fact, the incentives outlined in the HITECH Act are estimated to increase EHR adoption rates to 90% of all physicians by 2019.ⁱⁱⁱ Despite healthcare technology’s vast potential to improve patient health in the medical arena, there exists a host of complex legal, technical, and ethical concerns surrounding the use of HIT as incentivized in the HITECH Act, namely issues of privacy, confidentiality, autonomy, and the preservation of the physician-patient relationship.

The HITECH Act and “Meaningful Use”

The Health Information Technology for Economic and Clinical Health (HITECH) Act offers hospitals and eligible healthcare professionals incentives for expanding the use of healthcare information technology, including the “meaningful use” of EHRs.^iv Incentive payments are made available through the Medicaid and Medicare programs. The Centers for Medicare & Medicaid Services (CMS) judges whether a health care provide has satisfied the meaningful use core objectives through the use certified health technologies.

The Department of Health and Human Services defines meaningful use as using certified EHR technology to: (1) improve quality, safety, efficiency, and reduce health disparities; (2) engage patients and families; improve care coordination, and population and public health; and (3) maintain privacy and security of patient health information.^v The “meaningful use” framework incentivizes improvement to clinical care and quality by encouraging healthcare professionals to take advantage of instantaneous and patient-specific information. There are three stages of “meaningful use.” The first stage is the use of HIT for basic data collection, including demographic and medication history. The second stage is the use of EHR data to improve clinical processes including patient controlled data, clinical decision support, health information exchange (HIE), and quality measurement and research. The third stage is the use of EHR data to improve health outcomes, quality, safety, efficiency, and population health at the national level.^vi Hospitals and providers eligible for the EHR Incentive Program do not need to attest to meaningful use in their first year of participation. Rather, they must simply implement an EHR to receive an incentive payment from their State.

The incentive payments under HITECH are quite substantial. To receive payments, eligible professionals and hospitals must meet at least 5 of the “meaningful use” criteria defined, consisting of 15 core data points and 10 menu options.^vii These criteria include the entry of patient demographic and insurance information,
e-prescribing, and the use of drug interaction software to ensure patient safety.^viii Eligible professionals and hospitals that meet the criteria can be rewarded up to $44,000 in Medicare and $63,750 in Medicaid payments over 5 years. After 2015, physicians who fail to meaningfully use EHRs will be subject to reductions in Medicare and Medicaid reimbursement.^ix

Health Information Exchanges

The HITECH Act is a step towards the eventual goal of a national, interoperable, private, and secure electronic system to allow information to be shared among all the sites where patients receive care.^x While still in its infancy, Health Information Exchanges (HIEs) are being established at the community, state, and national level to facilitate the electronic exchange between systems. The State Health Information Exchange Cooperative Agreement and the Nationwide Health Information Network (NHIN) received $600 million in federal funding to create a platform for health information exchange across the United States. ^xi At the state level, governments are creating statewide health information networks (HINs). At the national level, the Office of the National Coordinator (ONC), which oversees deployment of the HITECH Act, is executing plan to create a National Health Information Network (NHIN). Provider organizations participating in NHIN include Kaiser Permanente, the Cleveland Clinic, and the Veterans Administration.

These networks can lead to the development of data repositories filled with rich sets of health data for millions of individuals. Such data repositories can provide researchers with information necessary to improve quality of care and make significant discoveries in medicine that they may not otherwise have access to. Despite their great potential, progress in developing HIEs and repositories has been gradual. Many hospitals and clinics are hesitant to implement the systems because they do not have the finances or infrastructure necessary to do so. Moreover, there are also significant concerns over patient privacy and autonomy, which is to be discussed “Ethical Implications” sections below.

Secondary Use of Health Data

Until recently, collecting data for “secondary use” was an arduous task. “Secondary use” in healthcare is defined as the use of information collected from health records, electronic or manual, outside of direct patient care delivery. This includes data collection for the purpose of “research, quality and safety measurement, public health, payment, provider certification or accreditation, marketing, and other business applications.”^xii Such use of healthcare data in biomedical research has the potential to drastically improve the quality and affordability of healthcare services in the United States. EHRs contain structured information about patients, which is extremely valuable in research because now information can be retrieved in a much quicker and more efficient fashion than more traditional methods of record keeping. Researchers can develop algorithms to search through EHRs, including free-text clinician notes, to find data valuable to a specific study.^xiii

The effective secondary use of health data for research has great potential to improve health outcomes, reduce medical errors, predict health trends, and demonstrate the comparative value of drugs and other treatments.^xivOther benefits include the increased ability to analyze the efficacy of treatment options and identify evidence-based best practices. Furthermore, predictive modeling techniques may be applied to electronic health data to identify medical conditions before the onset of symptoms and promote earlier interventions. While experimental studies, such as randomized controlled clinical trials, are likely to continue to be the gold standard of clinical research compared to observational studies, they more expensive and time consuming. As such, electronic health data serves as a rich resource for the conduction of observational studies.

Nevertheless, the unprecedented surge in the amount of healthcare data, as well as the relative ease with which that data can be aggregated and exchanged between providers and researcher will raise ethical questions about its use in research, specifically concerning patient privacy and autonomy. The Health Insurance Portability and Accountability Act (HIPAA) requires patient health information (PHI) to be de-identified or authorized by the patient for release. However, de-identified data would omit significant clinical, demographic, and time-related data that would render the data sets much less useful for many research purposes. While de-identified data is invalid and leads to incomplete data sets, it seems like is a small price to pay for protected the privacy of patients, especially those with stigmatized conditions.

Accordingly, researchers are forced to walk a fine line between ensuring patient privacy and maximizing the descriptive power of their data sets. Before the value of secondary use can be fully realized, ethical considerations surrounding the mining of electronic health data must be explored, namely infringements on an individual's privacy, confidentiality, and autonomy. It is necessary to establish a national framework of policies for the secondary use electronic health data to allow stakeholders to harness valuable information to improve the U.S. health care systems while maintaining patient autonomy and privacy protections.^xv

Ethical Implications of EHRs and Meaningful Use: Data Quality Concerns

The mass of recent electronic health data makes it possible to assess the overall burden of disease and evaluate the impact of interventions on a national scale. Despite its promise, research through electronic health data mining and “secondary use” is not without flaws. Data quality concerns are inherent in data that is being used for any purpose other than what it was originally intended, especially considering the fragmented nature of the healthcare industry and the numerous platforms on which data is being collected.^xvi First, there are hundreds of different EHR systems, each with a distinct representation of data that makes it difficult to aggregate. Second, even within the same EHR system, information incompleteness, inaccuracy, and inconsistency are common challenges, as different healthcare professionals tend to use the same system differently.^xvii Third, clinicians tend to prefer using free text compared to structured data entry because it is more easily adapted to their individual practice styles and work flows, although it may make it more difficult to compile and analyze. ^xviii While there are established clinical coding standards such as SNOMED and ICD-9 to facilitate easier data aggregation, consistency has still proved to be a challenge in clinical research. Fourth, incomplete and duplicate records threaten the quality of research using data mined from EHRs.

Furthermore, some critics may argue that EHRs make it more possible for clinician to falsify charts and reports, which would lead to both data quality and trust issues with patients. However, the falsification of records would not only violate the moral imperative against lying, but also infringe on the fiduciary relationship between the physician and patient. Furthermore, there are methods to protect against such acts, include audits, fraud charges, and reclamation of funds under the False Claims Act and the Deficit Reduction Act.^xix These measures act as valid disincentives to data falsification when it comes to patient records. Lastly, while the incentives and mandates of HITECH and “meaningful use” have led to an enormous amount of data being stored and generated by the U.S. healthcare system, there is an extreme lack of interoperability. The electronic data exists in different formats on hundreds of different systems.

Aggregating this sizeable amount of this data for research purposes will prove difficult, if not impossible, without a national regulatory framework to reduce intersystem variation and improve data quality. The federal government must determine national data standards or guidelines and clinicians to decrease data variation between systems. By implementing legislation to address these issues, the federal government can alleviate many ethical concerns and while allowing the United States healthcare system to benefits from more effective and larger scale use of secondary data.

Ethical Implications of EHRs and Meaningful Use: HIPAA and Privacy Concerns

With improved access to data comes increased risk of wrongful disclosure of patient health information. EHR data is at risk of human error, hacking, IT glitches, and theft of hardware than contains such information. HITECH challenges certain the notions of privacy and security found in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), yet enhances others. HIPAA prohibits the disclosure of protected health information (PHI) without the consent of the patient except for the purposes treatment, payment, or healthcare operations. Under HIPAA, “business associates” of covered entities with access to PHI are not directly regulated. ^xx Rather, they are obliged to comply with HIPAA pursuant to mandatory written agreements within the covered entities for which they work. The HITECH Act, on the other hand, provides for regulation of business associates and stipulates that HIPAA’s privacy and security rules directly apply to them.

When it comes to a security breaches involving PHI, HITECH mandates public notification when unsecure, unencrypted PHI is disclosed or used for an unauthorized purpose, similar to many state and federal financial data breach laws. The HITECH Act also requires that patients be notified of both internal and external breach of their data security. If a breach affects over 500 patients, the Department of Health and Human Services (HHS) must also be notified and the name of the breaching institution will be posted on the HHS web site. There are also certain circumstances where local media will need to be notified to inform the public of breaches than effect many people within a given area.^xxi

While HITECH is a federal law, it the Department of Health and Human Services and state attorneys general are granted with the authority to enforce the law. Subtitle D of the HITECH Act addresses the privacy and security concerns of EHRS by strengthening both the civil and criminal enforcement of the HIPAA rules. ^xxii Section 13410(d) of the HITECH Act revised the Social Security Act by establishing significant penalties for violation of security policy of the HITECH Act.^xxiii If an institution or individual is unaware of a violation despite due diligence, the minimum penalty is $100 per violation, with a cap of $25,000 for violations of an identical requirement within the same year.^xxiv If the security violation is due to “willful neglect,” the minimum penalty is $10,000 per violation, with a cap of $250,000. ^xxv The maximum penalty is $50,000 per violation, with a cap of $1.5 million. ^xxviThese are clear examples of the HITECH’s acts attempts to deter data breaches and mitigate security concerns.

The healthcare industry continues to tread carefully when it comes pursuing “meaningful use” of HIT while protecting patient privacy under HIPAA regulations. Critics current HIPAA does not accommodate the powerful research opportunities that may become possible as HIT and HIEs become more commonplace. The public health benefits of secondary use merit judicious consideration of how such data can be optimized while protecting patient autonomy.

Ethical Concerns of EHRs and Meaningful Use:Confidentiality & Physician-Patient Relationship

Patients often express concerns about keeping their PHI is kept confidential and secure. Moreover, patients may fear re-identification of their de-identified health information. Furthermore, understanding that EHRs provide a rich source of data that is highly desirable to pharmaceutical companies, insurance firms, and researchers, it seems valid to be concerned that these entities may try to purchase, use, and resell this data. There must be high security standards and regulations set to ensure that patient information is secure and not vulnerable to such misuse. Such concerns by the patient are harmful to the vital physician-patient relationship. The physician-patient relationship is a unique and complex status in which confidentiality is key; Privacy of a patient’s health information is considered sacred in the medical field. Any perceived infringement on patient privacy will severely damage this unique physician-patient relationship.

If a patient does not feel confident about the security of his or her health information, he or she may feel the need to conceal sensitive information. For example, a patient might fear that sensitive health matters such as those relating to sexual health and mental health could be accessed by others and refrain from sharing information about those issues. This is particularly true pertaining to sensitive health issues, such as sexually transmitted infections or mental health disorders. As a result, the patient’s health and treatment may be compromised. This may result in patients not fully disclosing important facts or, worse, avoiding medical care entirely, which would clearly result in negative health outcomes.

Accordingly, it is essential for physicians to ensure doctor-patient confidentiality by openly discussing these concerns with patients and explaining the security attempts detailed above that are in place to mitigate them. Furthermore, it is important that patients be able to access their EHRs with relative ease. It would be wise to allow patients to have a degree of control over the records’ content by allowing them to write notes or amendments to the record. Lastly, a new informed consent system must be established to enable patients to play a role in the decisions about how much of their EHRs they wish to make public to researchers and other stakeholders. A system must established to enable patients to play a role in the decisions about how much of their EHRs they wish to make public to researchers. Allowing patients to set the level if access they choose to share with certain health care providers and researchers will maintain respect for their autonomy and right to confidentiality. While variation in data due to informed consent redactions may result in significant differences in the completeness of individual datasets, making them less powerful tools for research, it is a risk that we must face to protect patient autonomy while optimizing the research potential of electronic health data. ^xxvii Patient ownership of their health data, in terms of both privacy and content, is critical to the ethical to use EHR data.

Ethical Concerns of EHRs & Meaningful Use: Autonomy, Informed Consent, and Syndromic Surveillance

While the secondary use of electronic health data has the potential to improve the quality of care in the United States, there are several ethical considerations that must be addressed before a national framework is implemented to address issues of autonomy and informed consent. Patient autonomy is threatened when an individual’s personal health information is shared without that person’s knowledge or consent. When data mining electronic health data, it is unlikely that patients are told that their data is being accessed. It is even less likely that they are contacted for their consent. This is concerning, as champions of patient autonomy would argue that informed consent is necessary for the secondary use of health data. Patients often believe they have a right to know who is viewing their medical information, why it’s being accessed, and how it is being used. Additionally, those who champion patient autonomy believe that patients have a right to take an active part in decisions about the access, content, and ownership of EHR data. It would appear to be a violation of autonomy to aggregate and generate new information about a patient’s health without their knowledge or permission. Patients provide information to healthcare professionals in confidence with the specific goal of advancing their own personal health outcome. If the principle of autonomy is intrinsically linked to advancing an individuals own personal health outcome, then any form of secondary use (by definition as the use of PHI outside of direct patient care delivery) appears to be a violation of the principle of “respect for persons.” The real question here is whether or not you can turn a patient into a research subject without their knowledge or consent.

To overcome these issues of autonomy, patients should be able to access their EMRs with relative ease. Moreover, patients should maintain the right to have a degree of control over the records’ content. While it seems unreasonable to allows patients to modify or delete any of the content entered by health care professionals per se, it seems judicious to allow autonomous patients to review, annotate, or challenge their own electronic medical record. Furthermore, federal regulations must be reassessed to determine considered valid informed consent for research using electronic health data specifically. Some HIEs are attempting to develop new consent processes to overcome HIPAA compliance issues. Some are calling for a blanket “opt-in” or “opt-out” policy, while others suggest the independent ability to exclude certain types of sensitive data in one’s own health record. Ideally, to maintain the highest level of patient autonomy, the patient would have full say as to what specific information may be shared and with whom it may be shared.

That being said, there are certain public health situations where it is necessary and desirable to use electronic health data without informed consent. This is particularly true in public health emergencies. In the interest of population health, the HITECH framework allows for syndromic surveillance to notify public health officials of reportable conditions. Syndromic surveillance systems seek to use existing health data in real time to provide immediate analysis for early detection of disease outbreaks, and to monitor disease trends.^xxviii It has been well established the government has the authority to do so under their police power authority to regulate for the safety and welfare for the population. However, it is important to consider from a bioethical perspective where the line ends between public health surveillance and an intrusion on one’s own individual liberty and autonomy. On the other hand, it could be argued that it would be a “tragedy of the commons” if individuals independently acted according to each one's self-interest and refused to be surveilled. To take a communitarian perspective, aggregation of public health data is an essential resource to public health officials and necessary for the welfare and beneficence of the population as a whole.

It is also necessary to note the point of “electronic exceptionalism.” There is a longstanding history of manual disease surveillance. However it seem more ethically unsettling when this process is done with high technology tools that can quickly aggregate and share data in unprecedented ways. While critics may look at syndromic surveillance through EHR data as exceptional because of its electronic nature, its use may not be so different than traditional methods after all. There has been mandatory reporting of certain conditions to public health officials at the local and national level for decades before EHRs existed, including the reporting of drug-resistant tuberculosis, certain cancers, and HIV. EHRs will make reporting of these conditions and others deemed necessary to protect public health easier, and may actually do a better job at protected patient health data by encrypting and preventing unauthorized access through password protection.

Ethical Implications of EHRs and Meaningful Use: Meaningful for Whom?

It is clear that the “meaningful use” of EHRs is on the rise, but is important to question for whom is it meaningful, and how meaningful is it? Let us consider one of the primary goals of “meaningful use,” which is to provide patients with electronic resources to increase participation in their own care. This involves providing patients with an electronic copy of their health information within three business days if requested, including diagnostic test results, medication lists, allergies, discharge summary, and procedures.^xxix Accordingly, providers often offer patients access to online personal health record (PHR). PHRs are largely secure as they are encrypted and password-protected. However, it is important to note that patients need more than just Internet access and a very basic understanding of health information to fully benefit from PHRs.^xxx Rather, they need access to the basic resources required to act on the information provided through this technology. Not only must patients be able to read and interpret lab results; they must be willing and capable to act on the information he or she receives. This point has been largely neglected in discussions surrounding the HITECH Act. For those without access the Internet, those with very limited health literacy, and those unable to act on that information for financial or other reasons, EHRs have limited to no directed benefit. It is important to note this limitation and ethical concern of the HITECH Act, as well as to acknowledge the justice and access issues it presents.

It is also necessary to consider community outreach and education programs that focus on Internet and health literacy, rather than merely advertising new electronic and personal health record capabilities.^xxxi Many fear that patients will misunderstand or misinterpret information if they read it without a medical professional to interpret it. It is possible that the HITECH Act granted health care providers a new ethical obligation to work with patients to ensure they understand these tools and how to use them. Furthermore, healthcare professionals run the risk of relying solely on PHRs to communicate important health information to their patients. This stands to cause great harm to the doctor-patient relationship. Electronic tools must not replace the face-to-face communication between healthcare provider and patient that is essential to maintaining trust and achieving improved health outcomes.

Beneficence of Electronic Data in Medical Research

Despite the ethical concerns addressed above, the use of electronic health data is critical to ensuring patient health, improving our healthcare system, and making new scientific discoveries in this technological age. Critics may question whether EHRs are truly meaningful or whether it is an “excessive bureaucratic requirement to spend public dollars on doctors’ computer systems.”^xxxii This answer to this question can be discussed through the principle of justice. It is ethical, one could argue, to expend public funds for EHR systems that provides for the greater good and benefits for the public as a whole. Having data that is structured and easily retrievable benefits clinicians, patients, and the greater population. These benefits include safer prescribing, prevention of medication errors, epidemiological tracking to protect population health, and public medical error reporting. Furthermore, there is a clear need to switch from outdated, burdensome, and inefficient clinical charting traditions to electronic format.

EHR adoption aims to reduce cost, which is a primary goal of health reform in the United States. The increase in information available to clinicians can help prevent redundant or unnecessary tests and imaging. Furthermore, EHRs can provide point-of-care clinical decision support (CDS) as doctors prescribe tests, medications, and imaging requests, which can also help reduce costs. Lastly, “shared savings,” or “gain-sharing,” allows hospitals and healthcare providers to collaborate to reach quality metrics.^xxxiii Accordingly, EHRs enable users to measure desired outcomes and report this data more quickly and easily, saving both time and money. With regard to the costs associated with EHRs, studies have documented the strong return on financial investment that may be achieved following EHR implementation.^xxxiv Other financial benefits include increased revenues due to improved care coordination, averted costs of paperwork, chart pulls, and billing errors, and fee-for-service savings including the rate of new procedures and charge capture. Furthermore, the secondary use of health record information is anticipated to become one of the healthcare industry’s greatest assets and the key to greater quality and cost savings over the next five years.^xxxv In fact, a recent report by the McKinsey Global Institute, estimates the potential annual value to the healthcare industry at over 300 billion dollars.^xxxvi These savings in cost benefit both the patient and provider.

There are also several patient-centered benefits that result from the “meaningful use” EHR data. Perhaps one of the most promising results of EHR data mining is the use of predictive modeling techniques to identify medical conditions and promote interventions before the onset of symptoms. Furthermore, retrospective analysis of the health data mined from EHRs could expedite scientific discovery in medicine by providing valuable information for research. In addition, physicians’ access to data and analysis could demonstrate the efficacy of different treatment options across large populations, which could help treat and prevent chronic conditions. Lastly, such data can be used to identify evidence-based best practices, identify potential patients for clinical trials, and monitor patient compliance and drug safety. These measures show beneficence towards the patient by providing better more individualized care.

Conclusion

EHRs can facilitate the efficient delivery of health care in a cost-effective, safe, and patient-centered way. The safety, privacy, and of patients and potential research participants is of utmost concern and can be maintained while capitalizing on technological advances to improve the United States healthcare system. It is possible to reconcile the use electronic health data for research while maintaining respect for patient’s autonomy. Accomplishing this will require collaboration among ethicists, researchers, clinicians, informatics specialists, and policy makers.^xxxvii By reevaluating, clarifying, and enforcing HIPAA guidelines as they pertain specifically to secondary use, the federal government could point the healthcare field in a direction that both protects of patients’ privacy and autonomy while empowering researchers with valuable data sets. Permitting the establishment HIEs and data repositories of EHR data for research purposes has great potential for identifying evidence-based best practices, monitoring patient compliance and drug safety, and showing the efficacy of different treatment options across large populations. However, we must provide patients with the right to dictate which information they choose to share and allow them to opt out of the platform to protect patient autonomy while optimizing the research potential of electronic health data. Moreover, EHRs cannot be considered a cure-all for patient health and we must acknowledge the effect it may have on the physician-patient relationship.

The HITECH Act’s initiatives take us a step closer to President Obama’s stated goal of “an EHR for every American by 2014.”^xxxviii The integration of HIT into our health care system is more than just a technological upgrade; it represents a fundamental change in our approach healthcare practice in the United States. EHRs will continue to evolve as a critical component in the medical field, and can be ethically integrated to deliver the highest quality healthcare to Americans in the 21st century.

http://ieet.org/index.php/IEET/more/hanrahan20131115