Category Archives: health market quality

data saving lives, health market quality, healthcare, rapid learning health systems, research methodology

PCORI: US begins significant data linking foray to investigate comparative effectiveness

  • Patient Centered Outcomes Research Institute (PCORI) NIH-funded 10 site data linking project hoping to develop a complete clinical picture of 26-30 million Americans
  • Do certain sets of behavioral interventions work better than others for weight control? Might certain antibiotics work better for cystic fibrosis patients, based on their genetic profile?
  • It’s described in the story as the holy grail of health-care research, but it doesn’t incorporate social determinants, so how can it be? (PN)

 

http://www.washingtonpost.com/national/health-science/scientists-embark-on-unprecedented-effort-to-connect-millions-of-patient-medical-records/2014/04/15/ea7c966a-b12e-11e3-9627-c65021d6d572_story.html

Scientists embark on unprecedented effort to connect millions of patient medical records

By , Published: April 16

Inside an otherwise ordinary office building in lower Manhattan, government-funded scientists have begun collecting and connecting together terabytes of patient medical records in what may be one of the most radical projects in health care ever attempted.

The data — from every patient treated at one of New York’s major hospital centers over the past few years — include some of the most intimate details of a life. Vital signs. Diagnoses and conditions. Results of blood tests, X-rays, MRI scans. Surgeries. Insurance claims. And in some cases, links to genetic samples.

The effort is being duplicated at 10 other sites across the country using data from hospitals, academic research centers, community health clinics, insurers and other sources. If all goes well, by September 2015 they will be linked together to create a giant repository of medical information from 26 million to 30 million Americans.

Nothing of this scale has been built before, and researchers say the potential of the network to speed up research efforts and to answer questions that have long vexed scientists cannot be overstated. But the creation of the network presents tricky ethical questions about who owns and controls the data, how to protect patient privacy and how research questions will be prioritized.

“Both the opportunity and the anxiety are pretty electrifying,” Francis S. Collins, director of the National Institutes of Health, said in an interview.

The origins of the patient project lie in an obscure part of the 2010 Affordable Care Act. As part of the nation’s health-care overhaul, Congress created an independent nonprofit group to help patients and their doctors make better-informed decisions about care. Dubbed the Patient-Centered Outcomes Research Institute, or PCORI, and based in the District, the organization’s mandate is to launch, fund and coordinate research on “comparative effectiveness” — to find out which drugs, devices and treatment options are more effective than others.

Do certain sets of behavioral interventions work better than others for weight control, for example? Might certain antibiotics work better for cystic fibrosis patients, based on their genetic profile?

Such questions have been surprisingly difficult to answer, despite the thousands of clinical trials published every year.

Physicians have long grumbled that few studies can be translated into practical advice. Some studies are too small to draw any definitive conclusions. Others include patients diagnosed with a single condition, while most patients are more complicated — they suffer from multiple issues. It isn’t uncommon for studies to contradict each other, and there’s no way for clinicians to know which one is right, because they often use different methodologies.

“The whole idea was to create a way to do the kind of research that would inform the real world,” explained Eugene Rich, who researches health-care effectiveness for Mathematica Policy Research, based in Princeton, N.J.

The database — an idea that has been talked about for years by everyone from insurance companies to Google but has never been successfully executed — holds the hope that some of those obstacles can be overcome.

“We will be able to get answers with a degree of certainty that we’ve never had before,” said Joe V. Selby, PCORI’s executive director, who calls the patient records network “the holy grail” of health-care research.

Collins said the value of the network is that it gives scientists the ability to ask an endless number of questions about a massive patient population with great speed and little cost.

In the randomized trials that NIH typically supports, “you have to enroll patients from the very beginning, and that’s a big infrastructure-building process that can take quite some time. And once a trial has been conducted, the whole thing has to be taken down again,” Collins said.

“It’s a great way to answer one specific question, but it’s not an efficient way to ask lots of questions,” he explained.

Before PCORI’s vision can be realized, the project’s leaders must overcome numerous hurdles.

The technical challenges of the project are enormous. The specter of the botched launch of HealthCare.gov haunts anyone trying to get large numbers of separate computer systems to talk to each other. But it is the larger questions about governance that have triggered conflict and worry in the nation’s health-care community.

How will research questions be prioritized? How should disagreements be resolved?

Should pharmaceutical companies and insurers be able to access the records and, if so, under what circumstances? What about the Centers for Disease Control and Prevention? The information could help epidemiologists track outbreaks and clusters of disease in a way they have never done before.

And, critically important to the multibillion-dollar pharmaceutical industry, how will the Food and Drug Administration view this type of research when considering applications for new drugs or in recalling old ones?

PCORI was never imagined to be the custodian of this kind of data network. It was designed to launch and fund research in a manner similar to NIH and the National Science Foundation. But it did not get nearly the same kind of funding.

President Obama’s budget request for fiscal 2015 included $30.4 billion for NIH and nearly $7.3 billion for NSF. But PCORI, which is funded through several streams, gets only about $500 million annually. Large, randomized clinical trials such as the ones NIH does for important questions cost upwards of $150 million, meaning that PCORI has enough to fund only two or three a year.

“So about a year ago, PCORI started talking about whether there is another model that is different from the NIH model, which would be more about embedding clinical studies in the fabric of day-to-day care,” said Robert W. Dubois, chief science officer for the National Pharmaceutical Council, a health policy research group funded by the industry.

The PCORI network, which is being built at a cost of nearly $100 million, would also be a way to pinpoint patients with certain criteria who could be invited to join a clinical trial. As it stands today, identifying patients eligible for trials is often time-consuming, expensive and hit-or-miss. Researchers must use a variety of tools to get enough participants, including reaching out to a network of doctors who then contact their patients and the old-fashioned method of putting up fliers in places where people with the criteria they are looking for congregate.

The new national patient network will comprise 11 sub-networks that include records from New York and Chicago, children’s hospitals, Kaiser Permanente and other groups. Each participating organization retains all the personally identifiable data and would have the right to accept or decline a research proposal. If a research project is greenlighted, each of the smaller networks would analyze its own databases and return an anonymized, aggregated response to the researcher.

“The raw data is not what is being shared. That remains with the institution that the patient trusts,” said Devon McGraw, director of the health privacy project for the Center for Democracy and Technology and head of the data privacy task force for PCORI.

Privacy experts say the general consent forms that patients sign when they get treatment should allow the use of data already collected in the aggregate. Hospitals and other organizations participating in the project don’t have any plans to explicitly inform patients about this. If researchers wanted doctors to collect additional data as part of a clinical trial, the researchers would clearly have to get a patient’s consent. But what about projects that involve more detailed analysis of individual patient histories?

One aspect of the project that was highlighted by researchers involved is that it has included patients at every step. Patient panels have been convened to help suggest research questions, and patients serve on the committees looking at privacy and data security.

Rainu Kaushal, a researcher at Weill Cornell Medical College who heads the New York-based part of the project, said patients’ perspectives on studies are often very different than scientists’.

“As a provider, I may be interested in how a serum marker changes with a treatment. But patients may be more interested in how it affects how they feel, their ability to exercise and eat,” she said.

Brian Currie, vice president for medical research for the Montefiore Medical Center, the university hospital for the Albert Einstein College of Medicine in the Bronx, which is participating in the New York network, said the number of questions are understandable given the historical barriers between different types of institutions that have prevented this research in the past.

“It’s pushing all the fronts on how medical institutions do research,” Currie said.

health market quality, healthcare, policy, politics

US Healthcare Price Transparency

An interesting observation – unintended consequence of non-universal healthcare?: As consumers are being asked to pay more, so they’re trying to become better health-care shoppers.

  • states have passed transparency laws
  • medicare has started to dump raw service cost data
  • private firms are developing their own transparency tools
  • a report recommends:
    • total estimated price
    • out-of-pocket costs
    • patient safety and clinical outcome data

“Care providers, employers and health plans have negotiated rates, which isn’t necessarily something they want out in the public. They warn making those negotiations publicly could actually discourage negotiations for lower prices — naturally, there are conflicting opinions on this point.”

 

http://www.washingtonpost.com/blogs/wonkblog/wp/2014/04/16/price-transparency-stinks-in-health-care-heres-how-the-industry-wants-to-change-that/

Price transparency stinks in health care. Here’s how the industry wants to change that.

By Jason Millman Updated: April 16

There’s been much written in the past year about just how hard it is to get a simple price for a basic health-care procedure. The industry has heard the rumblings, and now it’s responding.

About two dozen industry stakeholders, including main lobbying groups for hospitals and health insurers, this morning are issuing new recommendations for how they can provide the cost of health-care services to patients.

The focus on health-care price transparency — discussed in Steven Brill’s 26,000-word opus on medical bills for Time last year — has intensified, not surprisingly, as people are picking up more of the tab for their health care. Employers are shifting more costs onto their workers, and many new health plans under Obamacare feature high out-of-pocket costs.

The health care-industry has some serious catching up to do on the transparency front. States have passed their own health price transparency laws, Medicare has started to dump raw data on the cost of services and what doctors get paid, and private firms have developed their own transparency tools.

“We need to own this as an industry. We need to step up,” said Joseph Fifer, president and CEO of the Healthcare Financial Management Association, who coordinated the group issuing the report this morning. The stakeholder group includes hospitals, consumer advocates, doctors and health systems.

Their recommendations delineate who in the health-care system should be responsible for providing pricing information and what kind of information to provide depending on a person’s insurance status. Just getting the different stakeholders on the same page was difficult enough in the past, said Rich Umbdenstock, president and CEO of the American Hospital Association.

“We couldn’t agree on whose role was what. We were using terms differently,” he said.

The report’s major recommendations include how to provide patients with:

  • the total estimated price of the service
  • a clear indication of whether the provider is in-network or where to find an in-network provider
  • a patient’s out-of-pocket costs
  • and other relevant information, like patient safety scores and clinical outcomes.

“I think that the focus now, unlike three years ago when it was on access, the focus is about affordability,” said Karen Ignagni, president and CEO of America’s Health Insurance Plans. “What are the prices being charged? It leads consumers to want to know, ‘How do I evaluate all that?'”

To give a sense of just how murky health pricing can be, one of the group’s recommendations is for providers to offer uninsured patients their estimated cost for a standard procedure and to make clear how complications could increase the price. You would think that shouldn’t be too hard — there’s no insurer to deal with, no contracts to consult.

But previous research points out just how difficult it can be to get the price for a basic, uncomplicated procedure. In a study published this past December, researchers found that just three out of 20 hospitals could say how much an uninsured person should expect to pay for a simple test measuring heartbeat rate.

The group’s recommendations also touches on limits to transparency and the “unintended consequences” of too much data being public. Care providers, employers and health plans have negotiated rates, which isn’t necessarily something they want out in the public. They warn making those negotiations publicly could actually discourage negotiations for lower prices — naturally, there are conflicting opinions on this point.

The report nods to other ways at achieving transparency. For example, it talks about “reference pricing” in self-funded employer health plans, in which employers limit what they’ll pay for an employee’s health-care services — thus setting the reference price.

“The employer communicates to employees a list of the providers who have agreed to accept the reference price (or less) for their services. If an employee chooses a provider who has not accepted the reference price, the employee is responsible for the amount the provider charges above the reference price,” the report reads, noting that Safeway grocery stores implemented a successful pilot program that expanded a few years ago.

Perhaps what’s most significant about these recommendations is the stakeholders’ acknowledgement that the health-care market is changing. Consumers are being asked to pay more, so they’re trying to become better health-care shoppers

AHIP’s Ignagni said most insurers already provide cost calculator tools and quality data on their Web sites. Providers, said the AHA’s Umbdenstock, need to be more accommodating to patients’ price-sensitivity.

“‘We can’t answer your question’ may have worked in the past, but it doesn’t fly any longer,” said Mark Rukavina, principal with Community Health Advisors and a report contributor. “This [report] basically lays out the principles for creating a new response to the question.”

Jason Millman covers all things health policy, with a focus on Obamacare implementation. He previously covered health policy for Politico. He is an unapologetic fan of the New York Yankees and Giants, though the Nationals and Teddy Roosevelt hold a small place in his heart. He’s on Twitter.