Sunshine Act exemption is a missed opportunity to fund/include patients at medical conferences.

Doctors Face New Scrutiny Over Gifts

New Health Law Calls for Increased Disclosures

            By PETER LOFTUS CONNECT  Wall Street Journal

FiDA highlight added

U.S. doctors are bracing for increased public scrutiny of the payments and gifts they receive from pharmaceutical and medical-device companies as a result of the new health law.

Starting this month, companies must record nearly every transaction with doctors—from sales reps bearing pizza to compensation for expert advice on research—to comply with the so-called Sunshine Act provision of the U.S. health-care overhaul. The companies must report data on individual doctors and how much they received to a federal health agency, which will post it on a searchable, public website beginning September 2014.

Many doctors say the increased disclosures are making them rethink their relationships with industry, citing concerns about privacy and accuracy, and worry that the public will misinterpret the information. Some fear patients will view the payments as tainting their medical decisions, and will lump together compensation for research-related services with payments of a more promotional nature.

Drug companies collectively pay hundreds of millions of dollars in fees and gifts to doctors every year. In 2012, Pfizer Inc., PFE +0.64% the biggest drug maker by sales, paid $173.2 million to U.S. health-care professionals. Some companies including Pfizer have decreased these payments in recent years; Pfizer's total was $195.4 million for 2011.

Consulting and speaking fees are an important source of income for some physicians, who can be paid tens of thousands of dollars a year for such services. But now physicians say they will be much more selective about the work they do and what they will accept from industry representatives. Some are even restricting access to their offices by sales reps, or requiring forms that document the value of anything brought to the office, according to medical societies.

John Mandrola, a cardiologist in Louisville, Ky., said he has been paid a total of $1,500 to $2,000 this year by medical-device makers for speaking engagements. Knowing that such transactions will become public has caused him to be more cautious about what fees to accept, he said. He avoids industry reps visiting his office, believing he can get information on new drugs elsewhere.

"I'll continue to weigh the benefits and the negatives, and I think the Sunshine Act and the public reporting of all this stuff makes us think about that," said Dr. Mandrola. "And I think that's a good thing."

A benefit of transparency, Dr. Mandrola said, is that it will help doctors evaluate medical research from peers if they know whether the researchers receive payments from certain companies. Still, he worries that the disclosures could squelch legitimate interactions—for example, when doctors receive consulting fees to help companies develop drugs and determine their best use.

"I don't think all physician-industry interaction is bad," he said.

The push for greater transparency was driven by concerns that doctors' prescribing decisions are tainted by the payments and gifts, as well as allegations that drug companies have used payments to induce doctors to prescribe drugs for unapproved, "off-label" uses. Several drug companies have paid large penalties to settle government allegations of off-label marketing, and were required to disclose physician-payment data as conditions of the settlements.

"The idea is that transparency will encourage doctors to evaluate whether these are appropriate relationships with companies or not," said Daniel Carlat, a psychiatrist and director of the prescription project at the Pew Charitable Trusts, which supported the Sunshine Act. He expects patients won't have much of a problem if their doctors receive $200 worth of company-provided lunches, but may question doctors who receive tens or hundreds of thousands of dollars from the industry annually.

Several drug and device makers—including Pfizer and Eli Lilly LLY +0.30% & Co.—have been posting physician-payment data online for the past few years. Some U.S. states already require companies to report such information. But the Sunshine Act will significantly widen the scope because it applies to most companies—any company whose products are covered by Medicare—and the government's launch of the database could draw greater public attention.

Richard B. Aguilar, a diabetes-care specialist, received a total of $42,339 from Lilly for the first three months of 2013, according to Lilly's online payment database. Dr. Aguilar, who has a private practice in Downey, Calif., said he speaks about Lilly drugs at programs to teach other doctors, and the information is consistent with the FDA-approved prescribing labels. He says the payments are fair compensation for his expertise and travel.

Dr. Aguilar plans to continue serving as a paid speaker, but he says other doctors are increasingly opting out of attending or speaking at such programs for fear of what the public will think about the payment disclosures.

Dr. Aguilar said he hopes the public would see the value of physicians learning new information about drugs from an expert at speaker programs, rather than having to rely upon their own educational resources to keep current. "This, in essence, is reducing the number of valuable expert educational speakers who might otherwise have provided teaching and experience to many health-care providers," he said.

Some doctors fear the payment data will be inaccurate and could mislead the public about the nature of their relationships with the industry. Gary M. Cowan, an ophthalmologist in Fort Worth, Texas, said he has occasionally attended company-sponsored dinners to hear a lecture from an expert in his field. He plans to monitor the payments that companies report in his name.

"I think it behooves every physician to look and see what's said about him," he said.

Drug makers said they've been preparing for the new reporting requirements and have implemented technology systems to collect the data, but they will continue to work with physicians because the interactions improve science and medicine.

The Centers for Medicare & Medicaid Services, which is implementing the Sunshine Act, is advising doctors to keep records of all payments and transfers of value received from industry. Once the agency receives payment data from manufacturers, it will give doctors about two months to review the data and work with companies to make any corrections before it is made public.

CMS also will break down the payment data into more than a dozen categories—such as meals, travel, research or speaking fees—to give a clearer idea of the nature of a doctor's relationship with industry.

One key exemption: Companies won't have to report compensation to doctors who speak at certain accredited events where physicians receive continuing medical education—as long the sponsoring company doesn't select or directly pay the speaker, but rather delegates those duties to a third-party organization. CMS initially proposed to require that such payments be reported, but granted the exemption in its final rule issued earlier this year, saying industry support for accredited or certified continuing medical education is a "unique relationship." Continuing-medical education providers pushed for the exemption, arguing that industry support would dwindle if the payments had to be reported.

Stefanie A. Doebler, an attorney with Covington & Burling LLP who represents health-care companies, said the exemption for indirect payments to speakers at continuing-medical education events could help sustain industry support for such programs. However, companies will be required to report certain other expenses for these programs, such as meals provided to physician attendees if the cost of each meal is separately identifiable. Some companies have decided not to fund such meals, she said, which could cause program providers to charge attendees for the meals.

To ensure accuracy, CMS is required to conduct audits of the data submitted and levy civil monetary penalties against companies for failing to submit data, or for submitting inaccurate data. Companies that fail to report information in a timely, accurate or complete manner face penalties of at least $1,000 per transaction, with a total maximum annual penalty of up to $1.15 million per company, according to CMS.

CMS plans to publish the data each year on a public website starting in the fall of 2014. CMS says patients will be able to look up their doctors and see if they have any financial relationships with companies, which types of payments they receive and how much.

Some companies are taking steps to prepare the doctors with whom they do business. Later this year, Roche AG's RHHBY -0.06% Genentech unit, which sells the cancer drug Avastin, will launch an online portal called "Sunshine Track," which will allow doctors to review payment data before it is reported to CMS. "We have implemented extensive processes to validate all payment information we collect," said a spokeswoman.

Genentech also allows physicians to opt out of receiving meals from the company at speaker programs or during office visits by sales reps. Doctors opting out of meals at speaker programs must certify this on a sign-in sheet and can either pay for the meal themselves or not partake, the spokeswoman said.

Write to Peter Loftus at peter.loftus@dowjones.com

Joleen Chambers comment:

More empty talk about being patient-centered:  with the exemption allowing industry to support medical education through a third party, the legislation FAILS to include a % of the funding to go to consumer organization scholarships making participation in the conferences possible.  Treatment decision makers and healthcare system designers are notorious for ignoring the patient stakeholder!   Engaged patient advocates are otherwise unfunded and pay a big price to compete for conference slots competing with those with professional credentials and a sponsoring organization.

Gummy Bear Breast Implants

Perfecting Bodies Through Chemistry?

February 22, 2013 Written by Diana Zuckerman  FiDA highlight

Do you like your body?   If there was a simple way to change it, with no risks, would you do it?

If making that change meant you would put your health at risk and have multiple surgeries for the rest of your life, would you hesitate?

Most women say they don’t like their bodies, and research shows that dissatisfaction usually starts during the middle school years and may never go away.  For many of us, it eases up a little in young adulthood as we come to appreciate our attributes and accept any “flaws,” but insecurities rev up again as aging takes its toll.  It seems ironic that we long to regain the body that seemed so imperfect when we were younger.

In the U.S., there are thousands of products and procedures that feed on women’s insecurities.  Most are ineffective – the pills and products that promise to melt fat away without diet or exercise, or to make cellulite or wrinkles disappear.  But only a few are actually dangerous to our health.  Breast implants are one of those.

The FDA just approved a new kind of breast implant, which many plastic surgeons promise will be safer and better than other kinds of breast implants.  It is made of thick silicone gel (nicknamed “gummy bear implants” for its consistency), which is supposed to prevent it from breaking, leaking, or wrecking havoc with your body.

What’s the proof that this product is safer, or even safe at all?  Apparently, that’s a secret.

When breast implants were first sold in the U.S. in the 1960s, no testing was required to make sure they were safe.  For the next 30 years, more than a million women in the U.S. got breast implants, not realizing that studies on women had never been done to prove they were safe or to determine how many months or years they would last.

In 1990, I was working as an investigator in the U.S. House of Representatives when a Senate staffer called me.  She told me that her mom had gotten breast implants after a mastectomy, which had resulted in terrible problems including silicone leaking out of her nipples.  Her mom was cured of cancer but the implants had put her through hell.  I was sure that the FDA had very strict rules about safety testing, but I promised I’d look into it.

I found out that I was wrong: the FDA had never required clinical trials for breast implants.  We held a Congressional hearing, I continued my investigation, and soon my office – and the media – was full of horror stories about women whose health had been ruined by breast implants.

Thanks to Congressional and media pressure, the FDA changed their policies.  They eventually required breast implant companies to conduct studies on hundreds of women with breast implants, to find out how safe their products were.  Public meetings were held so that women could testify about their experiences, scientists could openly discuss the research, and the media could report what was said.  Some companies failed to do the newly required research and their implants were no longer allowed to be sold in the U.S.  And, although all breast implants were found to have high complication rates, the FDA, under tremendous pressure from implant companies and plastic surgeons, decided that women were capable of making an informed choice about the risks they were willing to take.

I have no doubt that women are capable of making an informed choice.  But the FDA is still not providing the full information that women need to make an informed choice, and neither are the plastic surgeons.

In a giant step backwards, some FDA officials are reverting to their old ways.  They approved “gummy bear” implants with no public meeting and they have not made the study findings public.  Instead, in a press release that the agency quietly released on February 20, they report that the new breast implants have the same kind of complications as other types of implants – such as hard, painful, or lopsided breasts and the need for additional surgery – but don’t say how often those complications occur.  They also reported a new complication: the silicone gel in these new implants can crack.  What happens to women when that happens?  The FDA isn’t saying.

Since I did my investigation in 1990, I have been one of the FDA’s strongest critics and biggest fans.  I have often been horrified by some of the decisions FDA makes to approve unsafe or inadequately tested medical products, but I also know that when the FDA does its job well, it can save millions of lives.

When I did the Congressional hearing on breast implants, I was 7 months pregnant.  My son is now a college senior.  In those 22 years, the FDA regained and is now again at risk of weakening its public health focus, as Congressional pressure on the FDA to protect patients has been replaced by Congressional pressure to get products to market as quickly as possible and thus “create jobs.”  Whether it is breast implants, riskier birth control pills, TB drugs that do more harm than good, or sleeping pills with questionable benefits, the FDA is allowing drugs to be sold that do a lot of harm.  And when the FDA fails to hold medical products to a high standard, it is women – the consumers of most medical products – who are harmed the most.

For more information about the FDA’s recent decision on Allergan breast implants, see Statement of Dr. Diana Zuckerman on FDA approval of new Silicone-Gel Breast Implant Natrelle 410 and for more information about the risks of breast implants, see www.breastimplantinfo.org

Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School.  After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House.  She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, and in newspapers across the country.

Women: Hip Implants 29% More Likely to Fail

Hip Implants More Likely to Fail inWomen

By John Gever, Senior Editor, MedPage Today

Published: February 18, 2013

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Failure rates for hip implants were 29% higher for women than men in a large U.S. registry study after controlling for a variety of factors including device type, researchers said.

With a total of 35,140 patients undergoing primary total hip arthroplasty followed for a median of 3 years, the crude all-cause rate of failure (defined as subsequent revision surgery) was 2.3% for women (95% CI 2.1% to 2.5%) compared with 1.9% for men (95% CI 1.6% to 2.1%), according to Maria C.S. Inacio, MS, of the Southern California Permanente Research Group in San Diego, and colleagues.

After adjustments for age, body mass index, diabetes status, degree of presurgical symptom severity, implant fixation method, device category, and femoral head size, the authors calculated a hazard ratio (HR) for revision of 1.29 for women versus men (95% CI 1.11 to 1.51), they reported online in JAMA Internal Medicine.

The risk appeared most prominent for aseptic revision (HR 1.32, 95% CI 1.10 to 1.58) compared with septic failure (HR 1.17, 95% CI 0.81 to 1.68), the researchers found.

Larger femoral head sizes appeared especially problematic for women. For head sizes of 36 mm or more, the adjusted HR for failure in women versus men was 1.49 (95% CI 1.14 to 1.95), whereas differences in revision rates for smaller head sizes were not significant after adjustment.

Much of the increased risk for women also seemed concentrated in metal-on-metal implants, with a doubling in risk for women versus men (adjusted HR 1.97, 95% CI 1.29 to 3.00).

But that was primarily because of reduced risk of failure with metal-on-metal devices in men (adjusted HR 0.68 versus highly crosslinked polyethylene, 95% CI 0.45 to 1.02), whereas in women, the adjusted failure rates for metal-on-metal versus crosslinked polyethylene were similar, adjusted HR 1.07, 95% CI 0.72 to 1.60).

Clinical Implications?

In an accompanying commentary, Diana Zuckerman, PhD, of the National Research Center for Women and Families in Washington, D.C., suggested that the study's clinical implications were relatively trivial.

She noted that most patients considering hip replacement are already suffering pain and limited mobility and have few other options.

"Knowing that their chances of success are lower than men's is not helpful to women who are unable to perform many activities of daily living," Zuckerman argued.

Instead, she said, what is needed is "long-term comparative effectiveness research based on large sample sizes, indicating which total hip arthroplasty devices are less likely to fail in women and in men, with subgroup analyses based on age and other key patient traits, as well as key surgeon and hospital factors."

But Glenn Don Wera, MD, of UH Case Medical Center in Cleveland, told MedPage Today that the study provided valuable insights into the reasons for higher failure rates in women.

He noted that the higher rate of revision in women was already known from Medicare data. In the current study, however, "they were able to control for a number of clinical factors, including the kind of prosthesis the patient had, the experience level of the surgeon, and the different institutions and the different prostheses they were using."

That the increased risk in women was still evident despite adjusting for those factors indicates that something else, such as women's generally smaller stature, is responsible, Wera suggested.

Revision Rate: Beyond Infection

Data for the current study came from the Kaiser Permanente system's registry of total joint replacements from 2001 to 2010. Procedures were performed at 46 hospitals in California, Hawaii, Oregon, Washington, and Colorado by 319 different surgeons.

The registry is the largest of its type in the U.S., the authors said and includes data on surgeons' and hospitals' arthroplasty procedure volumes; the patients and the implants they received (cemented, uncemented, or hybrid); and implant bearing surface, such as metal on metal, metal or ceramic on highly crosslinked polyethylene, or ceramic on ceramic. The researchers put the DePuy metal-on-metal hip resurfacing monoblock device into its own category.

Only patients undergoing unilateral procedures were included in the analysis.

About 58% of the 35,140 procedures were performed in women (mean age 65.7 versus 63.8 for men). Just over 60% of both sexes had scores of 1 or 2 on the American Society of Anesthesiologists index, with nearly all of the remainder having scores of 3 or more.

The age difference between men and women was statistically significant. In addition, women in the cohort tended to be slightly more likely to be white or Asian and to have osteoarthritis, rheumatoid arthritis, or dysplasia. They were less likely to be diabetic or obese and to have osteonecrosis or post-traumatic arthritis.

Not surprisingly, women were much less likely to have implant femoral head sizes of 36 mm or more (32.8% versus 55.4% for men, P<0.001). About twice as many men as women had metal-on-metal bearings (19.4% versus 9.6%), whereas ceramic or metal on highly crosslinked polyethylene were more popular for female patients (P<0.001).

The DePuy resurfacing implant was used in 1.3% of women versus 2.6% of men (P<0.001).

Preferences for fixation types also differed between men and women, with hybrid methods more common in the women and cementless fixation more common in men.

Mean surgeon and hospital volumes did not differ between sexes.

The authors noted that with no significant increase in risk of septic failure for women, their results mean that "factors other than infection" are responsible for the higher overall revision rate.

Limitations to the analysis include its observational design, the relatively short follow-up period, lack of data on some potential confounding factors, and the use of revision surgery as the definition of implant failure. Also, the researchers used relatively broad categories of implant type, conceding that design variations within these categories could have influenced the results.

The study was funded by the FDA.

Study authors and Zuckerman declared no relationships with commercial entities. Several study authors were Kaiser Permanente employees.

Primary source: JAMA Internal Medicine
Source reference:
Inacio M, et al "Sex and risk of hip implant failure: Assessing total hip arthroplasty outcomes in the United States" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.3271.

Additional source: JAMA Internal Medicine
Source reference:
Zuckerman D "Hip implant failure for men and women: What and when we need to know" JAMA Intern Med 2013; DOI: 10.1001/jamainternmed.2013.19.

NPR Diane Rehm Show: Failed Implants

New Questions About The Safety Of Hip Replacements 

Link to audio recording

The Diane Rehm Show WAMU 

Thursday, February 14, 2013 - 10:06 a.m

The Food and Drug Administration recently issued new warnings on the safety of some hip replacements. As part of our occasional series, "Mind and Body," Diane and her guests discuss what patients need to know about safety and cost of hip replacements.

Guests

Barry Meier staff reporter for "The NewYork Times" and author of "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death."

Diana Zuckerman president of the National Research Center for Women and Families.

Dr. Henry Boucher orthopedic surgeon at Medstar Union Memorial Hospital in Baltimore, Md.

Sarah Brown CEO of The National Campaign to Prevent Teen and Unwanted Pregnancy and three-time hip replacement patient.

Kenneth Thorpe professor and chair of health policy and management at Emory University Rollins School of Public Health.

Found this in the mouse maze! Patient last to know.

 Being a patient advocate is like running in a maze designed to disorient and exclude.

Regina Holliday (patient advocate, artist) painted this while attending the PCORI patient-engagement workshop in DC today.  It is unreasonable of PCORI/FDA to expect any patient or advocate to demonstrate more tenacity or willingness to work productively.  This system is rigged.  I await my invitation to the December 4 PCORI meeting.

FDA PushesDevice Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated

Posted: September 11, 2012  (FiDA highlight)

FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10). The head of the health law's comparative effectiveness institute expressed interest in participating in the initiative, which FDA hopes will extend beyond the agency.

Stakeholders also debated potential governance structures, eventually floating a public-private partnership. When pressed on the role the health law's Patient-Centered Outcomes Research Institute could play, PCORI Executive Director Joe Selby said he is particularly interested in involving patients and contributing analytic methods. “We’d be glad to be party to discussions like that,” he told and FDA official during the meeting. He said, however, there should be a business case made to each party, and it is more challenging to make the case for patients and health systems.

While industry, consumer and academic stakeholders lauded FDA’s effort, concerns emerged about off-label uses and access to the data, given issues with patient protections and company proprietary concerns. “The key is going to be implementation,” said Paul Brown, government relations manager with the National Research Center for Women and Families. He cited examples in the report that spurred concerns about the potential to incentivize off-label use as the data collected through postmarket surveillance could support new indications.

“Analysis of de-identified EHR data containing a unique device identifier demonstrates that within the practice of medicine, physicians have been treating patients with incontinence due to other causes -- and the data demonstrates the device is as effective as it is in patients with incontinence due to prostate surgery,” according to an example comparing potential future uses of the system to the current state where manufacturers must conduct clinical trials to expand labeled indications. “The company submits the analysis and (the Center for Devices and Radiological Health) approves an expansion of the labeled indication solely on the basis of the collected postmarket data.”

Brown warned that, depending on implementation, the system could provide an incentive for companies not to conduct clinical trials and potentially exacerbate problems with off-label promotion. Another device safety advocate, however, said using the postmarket data would allow for a real-world analysis of devices as many risks are unknown until products are available to a broader patient population.

Brown also took issue with FDA suggestions that postmarket data could be used in support of device down classifications, saying such information should also be used to support up classification if appropriate. Further, he said FDA should have access to information in registries to detect safety signals, an issue that also emerged as academic and industry stakeholders debated who would have access to the device data as it could affect hospitals and individual practitioners. Industry stakeholders also expressed concern that the system should not try to be “all things to all people.”

FDA device center director Jeffrey Shuren emphasized that the agency would leverage national and international registries, as opposed to creating a registry repository.

“Let me be clear, we don’t need registries for every type of medical device nor is it feasible or sustainable to do so,” he said. “And we don’t want to develop a central repository.” Individual repositories should remain such as it helps protect patient privacy, he said.

Thomas Gross, director of the device center’s office of surveillance and biometrics, said the agency has already facilitated the development of dozens of registries. With regard to modernizing adverse event reporting, Gross touted the use of triggers in electronic health records to automate the reporting and a medical app that is being piloted.

FDA device officials said they hope to release a finalized version of the plan by the end of the year. -- Alaina Busch (abusch@iwpnews.com)

Patient-Generated Data - Your Input is Requested!

LINK

Federal Advisory Committees Seeking Input on Incorporation of Patient-Generated Data for Stage 3 Meaningful Use

Monday, June 18th, 2012 | Posted by: Joshua Seidman, PhD, Director, Meaningful Use, ONC | Category: FACA, HIT Policy Committee, HIT Standards Committee

ONC’s federal advisory committees (FACAs) held a full-day hearing on June 8 (written testimony can be found here) to explore how patient-generated health data (PGHD) might be incorporated into Meaningful Use (MU) of EHRs for Stage 3 of the EHR Incentive Programs. Some examples of PGHD are data from a patient’s personal health record, data from a blood glucose monitor, or information about a patient’s functional status. Three FACA workgroups hosted the hearing: The Health IT Policy Committee’s MU and Quality Measurement Workgroups, and the Health IT Standards Committee’s Consumer Engagement Power Team.

The hearing built off of not only the committee’s previous MU recommendations, but also its 2010 hearing on patient and family engagement. The blog generated several dozen thoughtful comments after the 2010 hearing, and we hope that will be the case with this blog post! ONC and the FACAs look forward to additional input via this blog, which will help inform the workgroups’ and committees’ future deliberations on recommendations for Stage 3. We encourage you to voice your perspectives in the comments section below.

In particular, the hearing and discussion among committee members generated many areas and concepts of great interest upon which we would appreciate comment. We’d greatly appreciate input on the following questions:

•               How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?

•               Although there clearly is a need to have a structure for PGHD, does all PGHD for care management need to be in a structured form?

•               In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?

•               Patients – particularly those living with chronic conditions – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR?

•               Although PGHD has some specific needs, identification and sourcing of all data sources are important; how can addressing PGHD management issues help clarify how data sources are tagged more generally in the EHR?

•               For which health issues is it clear that patients and families are the authoritative source?

•               How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive?

•               Similarly, how should we balance the concern about being overly prescriptive with ensuring a certain degree of interoperability, usability and understandability of PGHD?

•               What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination?

•               How can collection of PGHD address health disparities and what cautions exist to ensure that disparities are not widened?

We look forward to hearing from you.

Joleen Chambers says:

Your comment is awaiting moderation.

June 19, 2012 at 1:24 pm

The EHR/MHR belongs to the patient/citizen/human being. The patient/citizen/human being should have the ability to go into the record and make changes/corrections. The real life example is my brother’s clinical record stated that he smoked 20 packs of cigarettes daily when, in fact, he smoked one. The correction (Mayo Clinic) took nearly 3 months and could have cost him his health insurance and clearance for further revision surgery on his failed medical device implant (FDA MedWatch Adverse Event #5009052). The providers are merely “riders” on the EHR/MHR and all information that is entered into the record is no longer “proprietary”.

Moving testimony at ONÇ HIT meeting June 8, 2012

Incorporating Patient-generated Information to Manage Health

HIT Policy Committee Hearing

June 8, 2012

Testimony of Nikolai Kirienko

Project Director, Crohnology.MD

University of California, Berkeley

www.crohnology.md

Thank you for the opportunity to testify before this committee. At the White House Summit on Health Care Reform, it was stated that 5% percent of patients contribute 55% to the total cost of care. In solidarity with this group, as both a young adult with a chronic care condition, and as a disabled student at UC Berkeley, I hope my testimony will speak to the urgent need to give these patients representation in their medical record that they do not have today.

We, the people providers call patients, most often navigate care by voice.  We tell our stories, in clinic, and at the bedside, in search of a cure for what ails us. Yet, we are not always heard-- especially when our illness cannot be easily seen by others-- or ourselves.

From ages twelve to eighteen, I hardly looked sick, despite years of disabling symptoms, and semesters of missed school.  I was airlifted from a ski resort with a full bowel obstruction, but on the day my intestines had finally scarred shut from the progressive inflammation of Crohn's disease, not even my family would have guessed.

Through the six months that followed at Children's Hospital Oakland, I was unable to eat, and received nutrition through a surgically placed central line.  A teenaged friend in the hospital, Anastasia, also battling colitis, had one as well.  We both developed a severe complication at the same time; a blood clot at the end of our central line.  My arm swelled up like a water balloon; my hand looked like a purple mickey mouse glove. I was the lucky one.

Anastasia's clot went undiagnosed, until the day she went under general anesthesia for emergency surgery.  Her clot broke off, traveled to her lungs and she coded on the operating table with a pulmonary embolism.  They were unable to save her.

This experience made a profound impact upon my life.  Later, in college, as I was being wheeled into an operating room in Boston for my second surgery, I noticed a trace amount of swelling in my fingers.  All scrubbed into their operation, my team of surgeons did their best to convince me that it was nothing.  

I knew that this was not how my story was supposed to go; I disagreed with their assessment.  

I revoked my consent on the operating table. And I asked for an ultrasound to locate what I believed to be another undiagnosed blood clot at the end of my central IV, called a PICC line. Reluctantly, they agreed. The ultrasound revealed a clot.

Fast forward seven years, multiple surgeries, and 5 identical blood clots later: I found myself on an operating table in need of central access, once again. This time, my care team knew this story well, and everyone was in agreement-- we would not be repeating that same procedure.

Yet, down in the OR, they began to numb the fold of my arm, prepping me for a dreaded PICC line. I froze. This was not the verbally agreed upon plan. In a panic, I recited my story. The folks in the masks were unconvinced by my invisible history.

Within 24 hours, I had a deep vein thrombosis in my right subclavian artery.  It moved to my lungs, and I had a pulmonary embolism.  

Why am I sharing this story with you today-- and what does it have to do with standards for patient generated data?

Patients are a vital source tacit knowledge, not always included in the medical record.  Yet, we have but minutes at the point of care to verbally transfer up to a decade of experience and preferences for care.  

Democracy is defined by participation, so how can it be that our health records are not?  

Patients make life and death decisions with the aid of this document. We should have a right to see it when it matters most-- when decisions are being made-- not 30 days after. Our constitutions physically and as a nation should align in the electronic health record where life, liberty and pursuit of happiness rely equally upon them both.

As an incoming student at UC Berkeley, they tell us you have all the resources to change the world.  I believed them, and with a grant from the Robert Wood Johnson Foundation, I set out to give patients a voice in their care that I never had.  

We developed an app that enables patients to record observations of daily living, allowing them to visualize their experience on an iPad, which they can share with their providers at the point of care.  It can track pain via SMS, weight from a wifi weight scale, and sleep and activity via a Fitbit activity monitor, in addition to medication adherence and lab results entered on an iPhone, among other measures, equipping a more complete view of a patient's health.  

The simple idea was to create a common frame for collaboration: to empower a patient and provider to see and discuss the same health story at the same time, when it matters most-- face to face, at the point of care.

However, in our findings from Project HealthDesign, we discovered technical barriers to collaboration in the workflow.  Patients were hand transcribing lab data from their patient portal into our app, as a means to see their data all together, in context.  Physicians were able to see trending daily weight values on their patients for the first time, instead of at the usual 3 month intervals they're used to. Yet, they still had to 'eyeball' the graph, and write a text note for the chart, losing the value of the data itself. 

What I am here to say to you today is: please make meaningful use a dynamic two way street-- a national, open API for health record data.  

Grant patients easily consumable access to their data on mobile devices, and make interaction with health data as simple for a patient as logging into Facebook or Twitter-- or their bank.  Besides unleashing an ecosystem of innovation for app developers, it can engage patients and caregivers in their health on a scale equal to the great challenges we face.  

By removing these barriers to collaboration, it will unlock the potential of mobile devices to function like the digital equivalent of the patient whiteboards hanging in virtually every hospital room across the country.

Above all, please enable patients, providers and caregivers to see the same story at the same time: it will empower them to write that happy ending that our system deprives thousands of Americans who, unlike me, are losing their lives to easily preventable medical errors every day of every year, as we speak.  

Thank you.