DeSalvo: Interoperability crucial to patient safety

The former ONC chief thinks consumerism will play a major role in promoting data exchange.

Interoperability doesn’t just mean ensuring easy data exchange between two EHR systems anymore, Karen DeSalvo, MD, said on Tuesday. Patients have have an essential role to play, too.

DeSalvo, former assistant secretary for health and national coordinator for health IT, spoke at the Bipartisan Policy Center in a panel discussion with Andrew von Eschenbach, MD, former Commissioner of the U.S. Food and Drug Administration.

The discussion, moderated by former U.S. Senate Majority Leader Bill Frist, MD, was about “Patient Safety and Information Technology,” and it aimed to explore ways IT can still do better at enabling improvements to help prevent medical errors, which still cause the deaths of more than 200,000 Americans each year.

There are myriad ways health IT can help prevent adverse events, DeSalvo said, whether it’s the ability to check for drug interactions in an automated fashion rather than having to thumb through a hefty formulary with very thin pages, or advanced clinical decision support, which has shown that it can improve the safety of care.

We’ve come a long way since 2009, where the passage of the HITECH Act and subsequent federal investment of $36 billion laid the groundwork for a nationwide health information technology infrastructure, she said.

“The iPhone was barely on the market back then,” said DeSalvo. “We were barely thinking of IT in the way we do today.”

Flash forward eight years, and 90 percent of providers are up and running on EHRs.

“Many people have multiple electronic health records,” said DeSalvo. “We have a nice opportunity to leverage that data and make it more actionable.”

Culture change required for interoperability

But for all the progress the past decade, “IT is still in an adolescent phase,” she said. It can be clunky and there are challenges with usability, too. “There’s a lot of hunting and pecking still going on,” said DeSalvo, and plenty of work to do simplifying systems to reduce the signal-to-noise ratio for overburdened clinicians.

And interoperability, of course, remains a challenge.

“We’re increasingly using shared standards, but not quite there,” said DeSalvo. The flow of data is complicated too by “another suite of technologies that are unregulated because they’re about lifestyle and management,” and sometimes by providers’ misunderstanding of HIPAA, “which is meant to guide sharing, not prevent it,” she said.

One essential challenge to more widespread interoperability is cultural, said von Eschenbach. Physicians of his generation “grew up in a culture that was highly egocentric and individualistic.

“I was brought up to play golf, he said. “Today the game is basketball. We have to come together and work together in a more collaborative and interoperable way.”

DeSalvo agreed that quality improvement and value-based care depend on that collaboration.

“I don’t think you can get there without a team-based culture,” she said. “I still believe that moving to value-based payment is a driver to get more doctors to think about cooperation. Better data does change culture and behavior.”

But one key factor to changing attitudes about interoperability is often underappreciated, said DeSalvo: The role of the patient.

More widespread use of APIs has opened up opportunities for a lot of innovation, particularly with regard to consumer-mediated exchange, she said.

Giving patients more control over their health data “creates a completely different window to their health world,” said DeSalvo. “It doesn’t have to be two systems talking to each other.”

Increasingly, she sees data flowing toward places where consumers control, manage and share their data, enabled by trusted third parties and digital vaults.

“People have a willingness to free that data, so it can be put to good use,” said DeSalvo. “We are a team, and part of that team is the consumer.”

The model of healthcare is fast-evolving to make this more and more prevalent, as patients have more skin in the game with higher out-of-pocket costs, she said. They’ll have more agency to choose their providers based on the services they can provide, and “more and more they’re going to want to have access to their information.”

Providers face value-based care data challenges

Via Health Data Management »

The use of electronic health data for quality measurement and improvement in healthcare has not yet realized its full potential, a problem that must be addressed if the industry is to successfully transition from fee-for-service to value-based payment.

That’s the consensus among industry stakeholders who participated in a roundtable discussion hosted last week by the Office of the National Coordinator for Health Information Technology.

“We are at a critical point in how we think about quality measurements and how we think about quality improvement in general,” Robert Anthony, senior policy advisor in ONC’s Office of Clinical Quality and Safety, told the gathered group of subject matter experts.

Quality measures are vital as the industry moves from fee-for-service to value-based payment. According to consulting firm Discern Health, as much as 80 percent of U.S. healthcare spending will be linked to quality measures or value-based payment models by 2020.

Also SeeCMS proposes rule for collecting, submitting quality data

“We’re in a world where it’s not just about reporting any result, it’s about reporting your optimal result—and, payment is tied to it,” said David Kendrick, MD, chair of the Department of Medical Informatics at the University of Oklahoma’s School of Community Medicine. “We’re seeing the level of emotion about measurement go through the roof among providers, and that means they’re starting to really care about all those terminology issues and the issues in their EHRs.”

David Kendrick, MD

Despite the widespread adoption of EHRs, the mere fact that providers are using the systems does not automatically translate into improved quality of care. In addition, although health IT has the potential to greatly improve the quality of care, the evidence that HIT improves health outcomes is still relatively limited.

To help address the problem, Kendrick argued that measures must be standardized, replicable, validated, timely, as well as actionable.

“Medicare and most payers are betting the farm on measurement right now, and I’m very worried about our infrastructure to support that,” he added. “Claims data is a mile wide but only an inch deep. So, it has the unique benefit of encompassing most of what’s happened with the patient, but it doesn’t have the deep clinical variables in it (that) we would like to have, and it’s certainly not timely enough for most measurement that we would want to do for actual quality improvement.”

On the other hand, Kendrick said electronic health record data is “a mile deep, because it has all of that clinical information in it, but it’s only an inch wide.”

While EHRs “may be considered the core for data for eMeasurement, it’s really important—and I would even say essential—to integrate with other types of data in order to truly capture what’s happening at the patient level and being able to capture what happens across multiple providers and systems,” said Sarah Sampsel, vice president at Discern Health. “To improve quality of care, not just the quality of life for that person, we have to be able to capture more than what’s in an EHR.”

Speaking figuratively, Micky Tripathi, president and CEO of the Massachusetts eHealth Collaborative, said “it’s criminal that providers don’t have access to all their claims data—they only get it for the risk patients, if they happen to have a risk contract, but they don’t get it for everyone else.”

Another challenge cited by Kendrick is that “real patients’ care is scattered across a number of locations,” and “to do measurement appropriately, we really need to have all of this (data) so that we have the most complete picture on each patient that we’re measuring.”

Likewise, Tripathi lamented the fact that healthcare is fragmented and, as a result, so is the electronic health data.

“If you look at the distribution of patient visits across the country, 68 percent of patient visits happen in small physician practices,” said Tripathi. “When we think about quality measurement, we tend to focus on the Mayo Clinic and Intermountain Healthcare. But most of the action and therefore most of the data is in smaller settings.”

Jonathan Bush, other HIT Leaders Dive into Healthcare’s Interoperability Problem at World Health Care Congress

Via Healthcare Informatics »

A panel of three leaders in the health IT space, including outspoken athenahealth CEO Jonathan Bush, discussed the current interoperability landscape and what new strategies will help shape the future of healthcare connectivity.

Bush was joined in the keynote panel—part of this year’s World Health Care Congress, held at the Marriott Wardman Park Hotel in Washington, D.C.—by Steven J. Corwin, M.D., president and CEO of NewYork-Presbyterian (NYP, New York City) and Craig Samitt, M.D., executive vice president and chief clinical officer, Anthem, Inc. The session was moderated by Dan Diamond, health policy reporter at Politico.

When asked about what the industry is doing well and where they are failing, Drs. Corwin and Samitt had rather pessimistic tones, with Corwin noting that the current electronic health records (EHRs) at NYP, which actually only account for some 40 percent of the organization’s data, are fragmented and not interoperable. “The promise of interoperability is something that has been over-promised,” Corwin said. “The idea was that that various EHRs could be perfectly compatible, but that has not been [the case]. For us, it gets down to having a single EHR, taking [out] the expense of putting them together over a multi-layered system, and then reducing the number of exchanges and linkages we need to have. At this point, our linkage exchange looks like spaghetti wires,” adding that in NYP’s interface engine there are currently 6,000 interfaces, though the goal is to cut that number down to 3,000. “We just can’t toggle back and forth between systems,” he said.

Similarly, Samitt noted that the issue isn’t a technology one, but rather one of willingness and incentives. The Anthem senior executive said he is “highly critical of our industry since other industries have figured it out.” He added, “When there’s a will, there’s a way. I think there is a way for interoperability but less of a will. Information should be a common good as it relates to population health and better care at a lower cost, but we do not treat it that way.” He went on to talk about data ownership, noting, “Payers probably have the most complete data set but it’s not timely. Doctors have the most acute data but it’s not complete. And patients have most relevant data, but it’s not actionable.”

The panelists were then asked who’s to blame for these data sharing issues, a question that usually elicits varying responses from those pointing fingers at vendors to others assigning fault to providers and policymakers. From the payer perspective, Samitt said that claims information is only a subset of the data, and that it’s challenging to get providers to share data, though he also admitted that payers are not so willing themselves. “None of us should own the information; it should be a common good. Let’s keep the information safe and pool it so we can have a true longitudinal patient record,” Samitt said.

From the vendor vantage point, Bush—who two years ago famously tweeted at Judy Faulkner, CEO and founder of Epic Systems, that he would pay the user fee for Epic if the giant EHR vendor would join the CommonWell Health Alliance, an interoperability initiative of which athenahealth is a part of—agreed that the incentives to share healthcare data are not rewarding enough for stakeholders. “For my entire career, no one has wanted to exchange information,” Bush said. “The government has made it largely illegal for providers to get paid by digitally flowing information upstream. And [the feds] do not let just any provider see Medicare data,” adding that his company went through the laborious process of filling out applications and hiring lawyers so that they could get access to this CMS (Centers for Medicare & Medicaid Services) data, only to get denied. “Historically,” Bush said, “Hospitals have said that they are the only place that data can flow so that they keep referral volume and preserve their institution.”

However, things are beginning to change, Bush continued, noting dedication from new Health and Human Services Secretary Tom Price, M.D. to reverse things. “We are [seeing] a willingness on the part of forward-thinking healthcare systems to win by being open. Last year, the 21st Century Cures Act [was passed] and that makes it illegal to block data,” he said.

Bush also called out Epic, Cerner and Meditech, which he refers to as “pre-Internet companies” for now being more open to interconnectivity, proving that there are signs of change in regards to stakeholders’ willingness. “Payers are also giving us claims data they didn’t use to give us, and that gives us information on patients that we can pull together that we weren’t able to before,” he said.

Chiming in on the topic of data blocking, Corwin said that hospitals hoarding data is a fair criticism. “People believe that data can be monetized in healthcare, and that’s particularly true with well-curated genetic information,” he said. “I’m less enamored with that idea; I think that the data [belongs] to the patients, not to the providers. But there are those [providers] out there who do think there’s a market advantage. I’m a big believer in not monetizing data unless it improves patient outcomes,” he said.

Bush further said that athenahealth is building a master patient index (MPI) and also a calendar product that would help doctors on athenaNet get more patient appointments. He referred to EDI and HL7 as standards that will “die since they are pre-Internet.” Bush said it was these outdated companies that advocated as part of HITECH (the Health Information Technology for Economic and Clinical Health Act) to eliminate interoperability as a requirement for meaningful use.

He continued, saying these pre-Internet companies “claim to be interoperable but never will be. They need to go,” he attested. Bush added, “Cloud companies can easily be interoperable. HITECH got everyone onto systems that they’re now stuck with, and the Internet was shut out of HITECH. You have 60 medical specialties and [the idea is that] any EHR will be the right one for all 60?  That is absurd. How many apps on your iPhone were written by Apple? Four of them. So [we won’t reach] interoperability until we get rid of these servers.”

Bush went on, “That means we need to invite our competition onto the platforms and be like [Jeff] Bezos [founder of Amazon]. “We must accommodate a new generation and we have to move to the Internet in healthcare. This cannot be a questionable proposition in healthcare in 2017. The new cloud-based EHR companies are coming onto our platform; the nightmare Steven [Corwin] is experiencing connecting different old systems is becoming a thing of the past, slowly.”

Samitt agreed with Bush on how the future might look, arguing that it’s not going to be about EHR-to-EHR connectivity going forward, but rather capturing data elements in the cloud to manage population health. “EHRs connecting won’t be as relevant in the future,” he said. “Data inputted is less crucial than data outputted. So the pooling of information and the analytics will be crucial, not which EHR you are on,” he said.

To close the discussion, the panelists were asked about when healthcare connectedness will no longer be an issue. Bush estimated it would take some five years. On the other end of the spectrum, Corwin predicted that interoperability will be superseded by disruptors such as telehealth, artificial intelligence and machine learning. “Interoperability won’t be solved in the short-run. Patients will demand their own data. And connecting people via regional HIEs won’t happen. I’m very pessimistic about the [prospects] of true interoperability. Samitt was more optimistic, predicting that real interoperability can be achieved in 10 years. He noted that much of it comes down to payment reform as well, pointing out that nearly 60 percent of Anthem’s payments are now tied to value. “Connectivity is not just data connectivity, but we also need to achieve alignment with the patient at the center,” he said.

The #1 thing you need to know from the 2017 JP Morgan Healthcare Conference: Follow the money

Via Beckers Hospital Review »

If you want to understand the future of the $3 trillion U.S. healthcare industry, the lesson of the past is to ‘follow the money.’ And no one would argue that the place to do that is the infamous JP Morgan Healthcare Conference taking place this week in San Francisco.

While there are an estimated 4,000 people attending the conference, there’s roughly another 20,000 here for ‘off the grid’ meetings in every nook and cranny you can find. It is a surreal atmosphere in the form of the top executives from more than 450 private and public companies in biotech, pharmaceutical, medical device and technology, as well as healthcare providers, payers, private equity and venture capital firms and investment banks. Simply stated, this is where medicine’s flow happens.

With that said, roughly $1 trillion or one-third of annual U.S. healthcare spend flows through hospitals and healthcare delivery systems. So, if you want to understand what’s happening now and what will happen in the future, a good place to start is in the nonprofit healthcare provider track, where CEOs and CFOs of over 20 of our nation’s largest healthcare delivery systems presented their strategic plans in rapid fire 25-minute presentations.

Together these organizations represent over $100 billion or 10 percent of that $1 trillion spend. Incredible. The average organization presenting had over $6 billion in annual revenue, 15 hospitals, close to 30,000 employees and thousands of physicians on staff. Many of the name brands in healthcare including Downers Grove, Ill.-based Advocate Health Care, Irving, Texas-based CHRISTUS Health, Cleveland Clinic, Detroit-based Henry Ford Health System, Salt Lake City-based Intermountain Healthcare, Indianapolis-based IU Health, Oakland-based Kaiser Permanente, Cincinnati-based Mercy Health, New York-Presbyterian, Chicago-based Northwestern Medicine, Northwell Health in Great Neck, N.Y., and Robert Wood Johnson Barnabas Health based in West Orange, N.J., presented along with leading children’s hospitals such as Children’s Hospital of Philadelphia and innovative physician focused models such as Marshfield Clinic in Wisconsin and Geisinger Health System in Danville, Pa.

This provided an incredibly important snapshot of both the ground level view of what’s happening in the real world today as well as the bets being placed for the future. What follows is a high-level perspective of what was shared by these prominent provider organizations.

So, follow the money…and here’s the Top 10 Trends shaping how that money is flowing:

1. The Affordable Care Act
The ‘elephant in the room’ was the uncertainty relative to repealing and replacing the ACA. Surprisingly, the reaction wasn’t what you might have expected.

From an absolute dollars perspective, no one stands to lose more than the folks who were in this room. With that said, the ACA didn’t dominate the conversation. As stated by the executive team at Kaiser, “we’re not going to get out, we’re going to figure it out.”

The general consensus is that the ACA has flaws, yet there is also a shared belief that it has been a “great first step at getting more in the door” and that whatever is done moving forward must build on it, not destroy it. The CEOs and CFOs who presented shared an extraordinarily strong view that replacement has to happen at the same time as repeal.

From a financial impact perspective, several health systems believed the ACA has had a net neutral effect. One example is Henry Ford Health System, which cited “favorable reductions in charity and bad debts were substantially offset by Medicare cuts and increased Medicaid losses.” This sentiment, relative to the past and future financial impact, was consistent and the level of concern relative to a replacement of the ACA was lower than one might have expected.

The bigger issue was the overall uncertainty of what “replace” will mean. Many believe this uncertainty will be the new normal for some time and that they need to stay the course strategically. The translation of this is that the election is not causing major shifts in their approach. The direction communicated in every presentation was to keep going forward as the focus on value — high quality affordable care and health for a population — has to continue.

An interesting side note: JP Morgan Chase Chairman, President and CEO Jamie Dimon shared that the firm self-insures, spending $1.6 billion per year to cover 300,000 employees. So, add another billion dollar healthcare company to the list.

2. The Need to Manage Margins and Reduce Cost
“Affordable care” and reducing cost structure was a consistent mantra and strategic priority highlighted in nearly every presentation. Cost management has become a board-level strategy as providers continue to see downward pressure on the top line, a shift to ambulatory and a movement to risk-based, bundled contracts in high-volume and high-value specialties.

The focus is on driving out variation and many different strategies are in motion. Intermountain has been ahead of the curve for many years on cost management, coming in at $1,800 less per patient than the national average. They shared that national health costs would be “34 percent lower” if everyone else hit that same mark.

Many are making progress. Cleveland Clinic has achieved $775 million in savings over the last four years, including close to $2 million in their total joint program, partially achieved by discharging 66 percent of their patients directly to their home, delivering better clinical outcomes and a better patient experience. Advocate achieved $73 million in the Medicare Shared Savings Program, with $34 million coming back to the organization. Houston-based Memorial Hermann achieved $93 million in Medicare savings, sharing in $47 million, making it the most successful effort in the country.

There is also a shift towards investing in staffing performance improvement teams on an ongoing basis. Henry Ford Health System now has over 40 people on their performance improvement team, significantly more than most organizations. One would anticipate future investments in this area as the focus on margins is expected to continue, especially as the movement into bundled contracts in specialties such as orthopedic and cardiac care.

In order to enable this new approach from a technology perspective, organizations are investing in more advanced cost accounting systems to better understand both cost and margins. This supports a focus on clinical standardization and reducing variation, from a quality and cost perspective.

3. The Move to Revenue Diversification, Ventures and New Lines of Business
A term that is starting to gain some traction is “revenue diversification,” also known as finding new streams of revenue. Healthcare providers have recognized that their business model has to change and they can’t just sit around and wait for the next nuance to reimbursement and regulations. They need to go on offense, and there are many different ways they are starting to attack. The biggest focus appears to be on new ventures.

To be clear, revenue diversification represented the biggest shift in mindset year over year at the conference. This form of business “innovation” has become a board-level imperative, seemingly overnight. As an example, Intermountain already has a full pipeline of companies and stated plans to develop “one to two new companies per year.” Children’s Hospital of Philadelphia commercialized a driving simulator. Northwell has “70+ ventures” in motion. Mercy has set aside $50 million for direct investments in private equity and acquired their own revenue cycle company to serve their needs as well as become part of their investment portfolio. Many are moving deep into genomics. The list goes on.

The summary is that major health systems are recognizing they need to find other ways to drive value, deliver on their mission and create a more viable, sustainable enterprise.

4. Geographic Expansion and Increased Access to Care
Many health systems have expanded their geographic reach significantly in a short period of time. One example is Northwestern whose flagship Northwestern Memorial Hospital in Chicago accounted for 82 percent of revenue a few years ago, but now represents only 38% as the system has expanded into the suburbs. Northwestern executed a methodical acquisition strategy over the last four years and created an impressive balance, both financially and strategically, in a short period of time. RWJBarnabas Health, Hackensack, Meridian, Northwell and many others cited this same approach.

CHRISTUS Health is one health system that many are watching. The system has doubled in size in the last few years, not only through acquisitions in their home base of Texas, but also with an international expansion into three countries — Mexico, Chile and Columbia.

Additionally, many health systems are expanding their access to care through primary care relationships and extended outpatient services. While there is a general slowdown in acquiring physician practices, some are still moving in that direction. Others are focused on forming tight partnerships to coordinate care provided beyond the inpatient visit as they move into longitudinal population health.

5. The Growth of Value-Based Contracts
The expansion in access points across the continuum within a single healthcare delivery system has led to an increased willingness to take on risk and value-based payments in a large-scale population setting. Most of the presenting companies have some form of a health plan, but all have also taken on some form of risk-based contract. Advocate, a pioneer in accountable care, now has 865,000 covered lives accounting for a total spend of $4.6 billion in value-based agreements.

6. Consumer Engagement
The movement from treating patients to building relationships with consumers was a headline last year and this trend continues to mature. There is a major focus on the experience of care. For example, Northwestern is one of a number of providers where every employee has incentives related to satisfaction. Northwell has developed its own Customer Relationship Management system, and many others have made similar moves. Geisinger has now given over $500,000 in satisfaction rebates based on its money-back guarantee since November 2015, arguably the most effective marketing investment in healthcare today. Intermountain is now recording personal, non-health and healthcare related goals to help motivate recovery and compliance. Every health system came up with a pretty full list of investments in this area, and it is clear they are just getting started.

Branding is one part of systems’ consumer strategy that is gaining more investment. While health system rankings by U.S. News & World Report were cited by all who make the list — and this will remain a focus — the approach many are taking toward branding is getting much more sophisticated.

7. A New Focus on Mental and Behavioral Health as a Strategy
A welcomed and critical addition to the strategic plan of many health systems was mental and behavioral health, with attacking “social determinants” now making its way to the executive suite. Intermountain outlined an investment in integrated, team-based care practices — clocking out to $22 per member per year — decreased overall medical expenses by $116 per member per year compared to traditional practice management. One benefit of their team-based approach was a 23 percent reduction in emergency room visits.

With that said, this is clearly an area where many are struggling in the early innings of thinking through their strategy. Mental and behavioral health is ripe for collaboration, not just innovation in a silo. The good news is that the discussion and the work have started.

Outside of mental health, many health systems are taking a comprehensive approach to managing social determinants. One example is St. Louis-based Ascension, which has made major investments in applications and initiatives to move the dial in the community, including setting up food pharmacies.

8. Digital Tools and Data
This is the first time where the EHR was not cited as a strategy by itself, but as a baseline assumption. Virtually every organization was on either on Epic or Cerner — it was seen as table stakes. The big shift that has taken place is that the data is now available and accessible. That doesn’t mean it’s perfect, but it has opened the door on innovation relative to using that data to drive change, and many are now beginning to walk through it. There was a great deal of discussion on how to now use that data to improve outcomes and drive out cost with very specific strategies in motion to capitalize on it.

9. A New Investment in the Workforce of the Future
This was another surprising area of investment with at least four organizations opening new medical schools, you read that right. The move is primarily focused on primary care and family medicine, including Cleveland Clinic, Geisinger, Hackensack and Meridian. In that same light, other systems are investing in physician assistant and advanced practice nursing schools.

10. And the List Goes On…
Additional hot topics included the continued shift to ambulatory care, a focus on quality and outcomes, precision medicine, aligning incentives with physicians and virtual health (for example, Cleveland Clinic which has seen a 168 percent annual increase in virtual visits). There were also newer and interesting strategies that were less prominent, like shared medical appointments at Geisinger where 10 diabetes patients are seen at a time in a supportive group setting.

The bottom line: There is a noticeable shift in strategy for major healthcare providers as many begin to move from defense to offense as they look to the future. How an organization spends their money is their strategy, and it is starting to flow into some new, exciting and important directions.

ONC finalizes 2017 Interoperability Standards Advisory

The ONC’s web-based 2017 Interoperability Standards Advisory will be updated throughout the year.

21st Century Cures Act passes Senate; Barack Obama expected to sign wide-ranging healthcare bill into law

Via FierceHealthcare »

The Senate approved the 21st Century Cures Act Wednesday afternoon in a majority vote. President Barack Obama could sign it into law as early as tomorrow.

The final vote was 94 to 5.

The act covers a broad range of medical reforms and innovations, including fixes to the Food and Drug Administration’s process for approving drugs, funding for the “Cancer Moonshot” and precision medicine initiatives, and expanded access to mental health services.

RELATED: 3 ways hospitals must prepare for 21st Century Cures Act

It also aims to support health information technology goals, including electronic health record (EHR) interoperability and data privacy and security.

Language in the bill could force technology vendors to make their systems talk to one another, prohibiting information blocking and other practices that interfere with data-sharing that would benefit patients. In addition to EHR interoperability, it also addresses product standards and certification.

The act will help dig doctors out of the “ditch” that EHRs have put them in, Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor and Pensions Committee, said from the floor just before the vote.

FDA fears 

Detractors, including Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), say the act gives too much away to pharma companies and weakens FDA oversight.

Sanders, who voted against the act, noted in Senate floor debate yesterday that even President-elect Donald Trump was shocked to learn how much more Americans pay for prescriptions than people in other countries and that the federal government is restricted by law from negotiating drug prices. He urged fellow senators to vote against the bill.

Pharma’s bounty

A Los Angeles Times headline calls the act a “huge handout to the drug industry disguised as a pro-research bounty.”

If universal praise for a measure “makes your B.S. detectors twitch, you’re on the right track,” writes columnist Michael Hiltzik. “The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives. The punchline is that the regulatory rollback is real, but the funding may not be—it’s subject over the next decade to annual appropriations by Congress that might never come.”

A PBS NewsHour piece, meanwhile, lists the “winners and losers” under 21st Century Cures. Not surprisingly, big pharma and medical device manufacturers make the “winners” list. Real-world evidence for approval of new indications for FDA-approved drugs lands in the win column, along with patient advocacy groups.

Losers include randomized clinical trials: “Currently the gold standard for testing drugs and devices for safety, the adoption of real-world evidence standards may indicate that randomized clinical trials will become less important for drug and device approval,” the article notes.

Biden’s ‘Moonshot’

On Monday, the Senate voted to rename the part of the bill that will provide $1.8 billion over 7 years to fight cancer after Joe Biden’s son, Beau Biden, who died of cancer in 2015. The vice president, presiding over the session, teared up as he responded to the formal motion: “Without objection.” He later told reporters he didn’t know of the plan.

“This is one of the last times I’ll preside over an actual vote count,” Biden said on a video shot before the session and posted to Twitter. “This is the beginning of a fundamental change … the urgency with which we treat the need to cure cancer and to turn some cancers into chronic diseases.”

A broad scope

The House voted 392 to 26 in favor of the landmark legislation last week. Rep. Erik Paulsen (R-Minn.) said the legislation is an “innovation game-changer … a once-in-a-generational transformational opportunity to change the way we treat disease. It expedites the discovery, the development, and the delivery of new treatments and cures and ensures that America will be a leader in the global fight for medical innovation.”

The wide-ranging measure (PDF) includes these and other healthcare provisions:

  • It provides $4.8 billion to the National Institutes of Health, which includes $1.8 billion to fund the “Cancer Moonshot” to accelerate cancer research; $1.4 billion for the Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; and $1.6 billion for the BRAIN Initiative to improve understanding of diseases like Alzheimer’s and speed diagnosis and treatment.
  • It gives $500 million to the FDA to streamline the clinical trial process and hire new staff.
  • It provides $1 billion in grants to states to prevent opioid abuse.
  • The bill also aims to improve mental health programs, including integrating mental health services into primary care settings and expanding access to mental health treatment and services.

How the Cures law will force interoperability to move forward

Via Health Data Management »

The new 21st Century Cures Act is about to change healthcare IT, and most of the industry never saw it coming.

Passed easily on Wednesday by the House of Representatives, the bill is expected to sail through the Senate next week. It is supported by President Obama, who undoubtedly will sign it.

Much of the bill focuses on significant FDA regulatory changes, support of mental and substance abuse-related healthcare, and funding for programs such as Vice President Biden’s Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies Initiative, cancer research and regenerative stem cell-based medicine. It also includes mandates to improve healthcare IT—most notably, in relation to nationwide interoperability and information blocking. Suddenly, those “Interoperability Pledges” that EHR vendors signed earlier this year will not be toothless expressions of good will.

Certain sections of the 996-page Cures bill are focused on “improving quality of care for patients” in the area of information technology, with interoperability the front and center concern. HHS will receive $15 million in funding to change ONC’s certification process to help push interoperability and fight information blocking by EHR vendors.

Specifically, HHS will change the conditions of Meaningful Use certification of healthcare IT to include interoperability. To be certified, vendors will not have taken “any action that constitutes information blocking” or “take any action that may inhibit the appropriate exchange, access, and use of electronic health information.” They may not prevent HIT interoperability and must develop application programming interfaces (APIs) or other technologies to enable the application to be “accessed, exchanged and used without special effort.” The vendors also must have successfully tested the “real world use of the technology for interoperability.”

The act also places strong emphasis on providing patients’ access to their electronic health information in a single longitudinal format that is “easy to understand, secure and updated automatically.” It recommends that ONC include this in Health IT certification, as well as providing the ability for patients to electronically communicate their health information to providers. HHS will convene with industry stakeholders to develop regulations that provide specific definitions and criteria. Vendors found to be blocking information are subject to penalties of as much as $1 million per violation.

The act also provides for greater support of networks exchange to advance an interoperable health information technology infrastructure, “for the purpose of ensuring full network-to-network exchange of health information.” The focus will be on establishing public-private partnerships to build consensus and develop a “trusted exchange framework, including a common agreement among health information networks nationally.”

Also See: Is information blocking finally on its last leg?

While no private or public health information network will be required to adopt the trusted exchange framework, federal agencies may require adoption within their networks. Health information exchanges are prohibited from information blocking, as are providers, and are subject to penalties of as much as $1 million.

Within three years of the Cure Act’s enactment, HHS must establish a “provider digital contact information index” for access by healthcare professionals and facilities.

The act also establishes a Health Information Technology Advisory Committee that will unify and replace the existing HIT Policy Committee and the HIT Standards Committee, to provide recommendations and report to ONC. Priority target areas for HHS and the HIT Advisory Committee, working with private and public healthcare stakeholders, will be:

  • “Achieving a health information technology infrastructure, nationally and locally, that allows for the electronic access, exchange, and use of health information, including through technology that provides accurate patient information for the correct patient, including exchanging such information.”
  • The promotion and protection of privacy and security of health information in health information technology, especially in the area of accounting of disclosures and protections of sensitive information. The act includes “the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of patients to seek care.” This emphasis on segmentation of information is significant in the mental health / substance abuse world, where the existing inability of IT systems to separate out data that has not been authorized for disclosure inhibits data exchange and analysis.
  • The facilitation of secure access to health information by individuals, family members, caregivers and guardian including when related to age or other disability, cognitive impairment, or dementia.

The committee is authorized to determine other targets, and indeed, the act appears to be recommending specific emphases. It suggests considering targets related to population health, improving child healthcare, and use of telemedicine and “self-service” technologies, and patient matching, among others.

If you were at HIMSS’ 2016 Conference, you couldn’t miss the 20-feet long banners and overall chatter about “The Interoperability Pledge.” Software vendors were challenged by ONC to pledge voluntarily that they would facilitate communication of health information between providers, patients and other healthcare stakeholders. ONC appeared to be preparing for a combined industry/government initiative to get us over the long-time hump of non-interoperability between our many varied EHR systems. Indeed, vendors representing 90 percent of EHRs used by hospitals nationwide signed up.

And then? Nothing. Little has changed. Pledges were voluntary.

But now, with the new 21st Century Cures Act, compliance is going to be the name of the game, once again—and this time, for HIT vendors. It’s about to be time for them to step up and follow through.

Keys to Interoperability May be in Consumers’ Hands

Via HealthLeaders Media »

Making patients the stewards of their own health data could result in better access, despite a business environment where health systems do not make sharing a patient’s data with each other a top priority.

The barest outlines of the Trump Administration’s healthcare policy were not yet clear on the morning after Donald Trump’s upset presidential victory, but the CIO of a New York City health system was already looking forward to resolving issues unresolved by the election.

“If we were all on a common shared data platform and could easily access one another’s patient data, I think we would do a much better job of keeping people healthy,” said Daniel Barchi, senior vice president and chief information officer of New York Presbyterian Hospital in New York.

Speaking at the inaugural Techonomy Health conference last week in Half Moon Bay, CA, Barchi expressed hopes that the industry can agree to make patients the stewards of their own data moving forward.

In this way, he believes, patients can be at the center of sharing data in a business environment where health systems still do not make sharing a patient’s data with each other a top priority.

“The standard [in the 2009 American Recovery and Reinvestment Act] was so low,” he said.

“I can send a couple of packets of data. You can send me a couple of packets of data and check the box. That’s it. It’s not really interoperable in any way. And the EMR vendor was really not incented in any way. They were just helping everybody get live on all these new systems.”

No Incentive to Share Data

As a result, healthcare CIOs find themselves having built “really great complex systems within our own health systems, but aren’t incented to share data in any way, and so we’re doing it through a lot of back-door work,” Barchi said.

He equated continuity of care (CCD) documents to “electronic faxes, a couple-of-page PDF version of somebody’s care. Sure you can shoot it back and forth electronically, but you’re not going to interact with it.”

Barchi said he forward to accelerating innovation on the care coordination front.

“There’s an expectation in the technology industry that we have absolute huge airplane hangars full of people at desks making phone calls and checking up on people at home,” he said.

“Even in a $7 billion health system, I might be able to introduce you to our 17 care coordinators individually by name, so we’re not at the level where large health systems have these workforces that are incented to keep people healthy.”

Rooting Out Inefficiencies

Speaking at the same event, another speaker said technology is showing promise to squeeze inefficiencies out of back-office work.

“The provider is the main deliverer of healthcare,” said Jim Dougherty, who serves as CEO and co-founder at Madaket Health, a cloud-based service startup, which automates provider enrollment in payer plans.

“We’ve said we’re going to focus on making their lives better,” said Dougherty, a former member of the board of directors of Beth Israel Deaconess Medical Center in Boston.

Such enrollment still relies too often on laborious fax-based workflows. Via Madaket, a process that used to take a provider and payer 45 days “now takes two days, which benefits everybody,” he said.

Such cloud-based technology platforms can also be extended to accelerate other workflows.

“We at New York Presbyterian have this issue,” Barchi said, commenting on Madaket’s technology. “Mass General has this issue. Mayo has this issue. We all have this credentialing and payer issue with vendors. This is the kind of solution that will get in and solve a problem that occupies anywhere from 10 to 30 full-time employees on this kind of issue.”

One concern is whether to implement such point solutions in a piecemeal fashion, or to looking “to change the way that we’re running the healthcare system.”

Barchi said part of the answer will come from the next generation of electronic medical records.

“There are always upgrades that are happening to get better and better at sharing data,” Barchi said.

Evolving technologies pose challenge for medical device security

Via Vanderbilt University News »

It is the ultimate invasion of privacy: An unscrupulous hacker gains access to a network of interconnected medical devices and then, with a few quick keystrokes, remotely delivers a fatal electric shock to some unsuspecting victim’s pacemaker. This may sound like the plot of a spy novel, but such a scenario, at least from a technological standpoint, is not out of the realm of possibility.

As today’s health care industry relies increasingly on devices and systems that collect and share data between one another, cybersecurity breaches have become a troubling new reality. In fact, just last month, two device manufacturers—St. Jude Medical and Johnson & Johnson—issued separate warnings that their respective cardiac implants and insulin pumps were vulnerable to hackers.

While other industries, like the financial sector, have made cybersecurity a priority for 20 years or more, health care has been relatively late to the game and is now behind the curve in addressing such threats, according to M. Eric Johnson, dean of Vanderbilt Owen Graduate School of Management and Bruce D. Henderson Professor of Management.

“Health care is behind for several reasons,” he said. “It’s a very fragmented industry—you have countless clinical operations, and many of them are quite small and don’t invest in information security. And then at the other end of the spectrum, there are these hospitals that are, in effect, high-tech islands. They have these amazing surgical robots and other technology, but only in the last five years has there been a push to build a more integrated IT backbone with security.”

Johnson, who studies information technology’s impact on the extended enterprise, has co-written a new article examining the chronology of medical device security. Published in the October 2016 issue of Communications of the ACM“A Brief Chronology of Medical Device Security” is the result of an interdisciplinary project, known as Trustworthy Health and Wellness(THaW), which is funded by the National Science Foundation. A.J. Burns, assistant professor of computer science at the University of Texas–Tyler, and Peter Honeyman, research professor of computer science and engineering at the University of Michigan–Ann Arbor, collaborated on the article.

In the article Johnson and his co-authors identify four major inflection points that span the evolution of medical devices and their security: (1) “Complex Systems and Accidental Failures” (1980s–present), (2) “Implantable Medical Devices” (2000–present), (3) “Unauthorized Parties and Medical Devices” (2006–present), and (4) “Cybersecurity of Medical Devices” (2012–present). The authors also lay out a timeline of important legislation aimed at regulating and/or enhancing security and privacy in the health sector. In the end, they arrive at several conclusions:

  • The future of medical device security will be defined by the steps that the health sector takes today.
  • Security trade-offs characterize the design and deployment of medical devices.
  • Discussions of cybersecurity and medical devices often are distorted by misinformation and frightening language.

With regard to the latter, the authors wrote, “We must resist the temptation to sensationalize the issues related to cybersecurity in the health sector, and instead apply sober, rational, systematic approaches to understanding and mitigating security risks.”

What then should be the appropriate course of action for health care professionals and their patients? Is there one risk they should be concerned about above all others? Johnson and his co-authors offer a clear answer in that regard.

“It is safe to say that patients’ reluctance to accept medically indicated devices due to concerns about security poses a greater threat to their health than any threat stemming from medical device security,” they wrote.

In other words, the biggest danger to patients’ health is not the security threats themselves but rather the irrational decisions that might result from these perceived threats. While users of medical devices may be vulnerable to hackers in theory, there is not enough of a risk, according to the authors, to discourage use of the devices altogether. A hijacked pacemaker makes for an interesting plot twist in a novel, but it is not very likely to happen in real life.

“Unless you’re the president of some country,” Johnson said, “or someone with a lot of enemies, I wouldn’t worry about being personally targeted.”

Here’s a Crucial Technological Fix to Rising Health-Care Costs

Via Wall Street Journal »

Dr. Peter Pronovost (@PeterPronovost) is a practicing anesthesiologist, critical-care physician, professor, Johns Hopkins Medicine senior vice president and director of the Armstrong Institute for Patient Safety and Quality. He blogs fromVoices for Safer Care.

If we want to rein in the costs of the U.S. health-care system – now equal to nearly 18% of the nation’s gross domestic product – we cannot ignore the fragmented technologies used to help heal and save lives.

At first glance, the devices, monitors, electronic health records and machines found in today’s hospitals might inspire awe. Look beyond the slick displays with blinking lights, however, and the picture is less reassuring. Rather than working as an integrated whole, these technologies rarely “speak” to one another, reducing productivity and increasing costs. As a result, time that clinicians might spend at the bedside or discussing patient cases with colleagues is used to fill in the gaps between uncoordinated technologies.

For example, nurses scribble down a physician’s instructions for a drug infusion from one computer screen, do math to find the right dose, and then walk to the medication pump and enter the order. Every high-risk medication requires a second nurse to double-check that the pump is programmed accurately — a task that drains staff time. On a 12-bed intensive care unit, these double-checks add up to two full-time nursing positions, we found at Johns Hopkins. Yet if the electronic orders communicated with the pump, this extra work would not be needed, and the risk of entering the wrong dose would diminish.

Clinicians who want to gauge a patient’s progress and risk of complications need to make hundreds of clicks on computer screens, check devices and eyeball the settings on the patient’s bed. In one of our ICUs, the work of ensuring that patients received steps to prevent seven common harms – such as blood clots and infections – takes nearly 20 minutes. Integrate systems and that time can be cut by two-thirds, we found in a pilot project.

Hospital beds typically come with alarms that alert staff when a patient starts to get out of the bed on his or her own. Yet sometimes staff forget to turn the alarm back on — for instance, after the patient returns to the bed following an X-ray. An integrated system would quickly flag patients who are deemed a high fall risk but whose bed alarms aren’t activated. Instead, in many hospitals, staff still must walk from room to room to visually check that bed alarms are on for patients who need them.

Other fields have used systems integration approaches to become high-performing, less costly and ultra-safe. In aviation, for example, controls, instruments and mechanical systems communicate with each other, enhancing pilots’ situational awareness. Pilots don’t spend time poring over topographical maps to make sure they don’t fly the plane into a mountain; the plane gets that data and warns them if they are approaching a cliff. Yet health care has not embraced similar approaches.

Such a change is overdue. There are certainly other solutions to improve health-care productivity and decrease costs. Complications and substandard care make hospital stays longer or lead to readmissions. Staff spend too many hours on required documentation. Hospitals devote enormous administrative resources to working with hundreds of different insurers. Drug prices are constantly rising. Yet we cannot ignore the dysfunctional systems at the heart of how we care.

If we improve productivity by integrating technologies and extracting their data, we can do more than reduce costs. We can transform the patient experience: fewer complications, more “quality time” with their care team, and more opportunities to engage in their care.