Life Science Compliance Update

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31 posts from November 2013

November 27, 2013

NIH, FDA and Academic Institutions: Announce Industry Academic Collaborations

Several recent announcements have discussed new industry-academic collaborations as well as new funding opportunities to help translate scientific discoveries to improve patient care and health.

Harvard and AstraZeneca

AstraZeneca and Harvard University's Wyss Institute for Biologically Inspired Engineering recently announced a partnership "to use its organs-on-chips technology--miniature human organs made of a clear, flexible polymer that contain tiny tubes lined with living human cells--to help improve the way it tests drugs for humans," according to a press release.

"The chips are translucent, which could provide an insight into the inner workings of both animal and human organs," reported FierceBiotechResearch.

"This collaboration with AstraZeneca will help us to validate this approach as a potential alternative to animal testing by carrying out direct comparisons between organ chips containing cells from animals versus humans in organ-mimicking environments," Wyss Founding Director Dr. Don Ingber said in a statement. "If successful, this effort should lead to ways to streamline the drug development process and more effectively predict safety of drugs and chemicals in humans."

Wyss researchers have created chips that mimic the lung, heart and intestine, the article noted. "They are working to build 10 different human organs-on-chips in total and link them together to replicate the physiology of a whole human body."

"AstraZeneca and Wyss scientists will use the technology to develop new animal versions of the chips, which will be used alongside human models to test the safety of investigational drugs," Fierce reported.

"There is a huge need for alternative methods to replace traditional animal models since animal tests do not always accurately predict how humans will react to a new medication. Safety data from animal tests is needed before drug developers can get the green light for testing in humans, so more reliable preclinical models could lead to better drugs for humans. Researchers hope the chips could eventually replace animal testing altogether."

FDA Awards Over 12 Grants for Rare Disease Research

 

The U.S. Food and Drug Administration (FDA) recently announced the offering of more than $14 million in grants for the development of products for patients with rare diseases, as reported by Drug Store News.

The FDA announced that it had granted 15 grants for orphan drug research. A panel of outside experts with experience in the disease-related fields reviewed applications for the grants, which will be administered through the FDA's Orphan Products Grants Program.

As defined by the agency for drugs, orphan diseases affect fewer than 200,000 people in the United States. For devices, a rare disease occurs so infrequently in the country that there is no reasonable explanation that a medical device for such a disease will be developed without assistance.

According to the National Institutes of Health (NIH), there are about 6,800 rare diseases and conditions, affecting nearly 30 million Americans. Among the grants,

  • Alkeus Pharmaceuticals received $167,000 for a drug for Stargardt disease currently in phase-1 development;
  • Children's Hospital Medical Center in Cincinnati received $600,000 for a phase-1 study of a drug to treat Fanconi anemia;
  • Children's Hospital received $600,000 for a phase-1 study of a drug for Wiskott-Aldrich syndrome; and
  • Vanderbilt University received $1.59 million for a phase-2 study of montelukast, which Merck markets as the asthma and allergy drug Singulair, for the treatment of sickle-cell anemia.

"The FDA is committed to fostering and encoring the development of products for rare diseases, most of which have no available or adequate treatments," FDA Office of Orphan Product Development director Gayatri Rao said. "The grants awarded this year support studies in very vulnerable, difficult-to-treat populations who have no available options."

NIH Announces 15 Clinical and Translational Science Awards

The National Institutes of Health (NIH) recently announced more than $79 million in fiscal year 2013 funding to support 15 Institutional Clinical and Translational Science Awards (CTSA). A list of the recipients can be found in the press release.

Led by the National Center for Advancing Translational Sciences (NCATS), the CTSA program catalyzes improvements across the entire spectrum of translational research through efforts to broadly develop, demonstrate and disseminate health interventions. It serves as a connector to engage key partners including other NIH institutes and centers, patient groups, communities, health care providers, industry, and regulatory organizations.

"Science and technology are progressing at an unprecedented pace, and the CTSA program — which represents NIH's largest single investment in clinical research — is helping researchers harness these innovations and deliver improved diagnostics, treatments and cures for disease," said NIH Director Francis S. Collins, M.D., Ph.D.

These latest awards represent NIH's commitment to the CTSA program, which supports a consortium of more than 60 research institutions across the country that is focused on strengthening translational research. Under NCATS' leadership, the program is focused on solving roadblocks common to clinical translational efforts for all diseases.

"The CTSA Consortium is leading national efforts to enhance the efficiency, quality, and safety of translational research, no matter the disease or condition," said NCATS Director Christopher P. Austin, M.D. "This aligns with the NCATS mission to create new technologies and methods that can be applied widely to streamline development and implementation of interventions that improve human health.

NIH Launches New Centers

NIH also recently announced at the end of September the launch of a major initiative to improve how basic science advances and discoveries are translated into commercially viable products that improve patient care and advance public health.

The NIH Centers for Accelerated Innovations (NCAIs), funded by the NIH's National Heart, Lung, and Blood Institute (NHLBI), will target technologies to improve the diagnosis, treatment, management, and prevention of heart, lung, blood, and sleep disorders and diseases.

"The NCAIs will foster a transformational change in the way basic science discoveries move from the laboratory into commercial products," said Dr. Gary H. Gibbons, director of NHLBI. "These centers essentially will offer a one-stop shop to accelerate the translation of early-stage technologies for further development by the private sector and ultimate commercialization. As a result, the public will gain access sooner to new biomedical products that improve human health while also benefiting from the economic growth associated with the creation of new companies and the expansion of existing ones."

NHLBI issued grants totaling $31.5 million to establish three inaugural, multi-institution NCAIs.

  • Boston Biomedical Innovation Center:Brigham and Women's Hospital, Boston Children's Hospital, Massachusetts General Hospital, and President and Fellows of Harvard College
  • Cleveland Clinic Innovation Accelerator: The Cleveland Clinic Lerner College of Medicine; Case Western Reserve University, Cleveland; Cincinnati Children's Hospital; The Ohio State University, Columbus; and University of Cincinnati
  • UC BRAID Center for Accelerated Innovation: University of California, Los Angeles; University of California, Davis; University of California, Irvine; University of California, San Diego; and University of California, San Francisco

NCAIs will provide an integrated, systematic, and comprehensive approach to navigating the translation of early stage biomedical innovations from the research laboratory to commercial development and successful deployment to patients. Each center will be a consortium of academic, government, non-profit, and private sector organizations that will provide funding for feasibility studies; regulatory, legal, and business development expertise; and entrepreneurial training and mentorship. To enhance the scope and impact of the NHLBI investment, each awardee has secured non-federal funding equal to or greater than the NHLBI award.

NCAI awardees will leverage existing federal government resources, including those offered by NIH and by other federal program partners including the U.S. Food and Drug Administration, the United States Patent Office, and the Centers for Medicare & Medicaid Services.

"NIH and NHLBI have long been committed to supporting resources that enable pre-clinical studies," said Dr. Jodi Black, deputy director of the Division of Extramural Research Activities, NHLBI. "This landmark program will help NHLBI derive maximum benefit from its existing research and development investments and ensure that the resulting breakthrough innovations move rapidly and effectively into available products that reduce the health burden of heart, lung, blood, and sleep disorders and diseases."

According to NHLBI's Fact Book for the 2012 fiscal year, in 2009, the estimated economic cost for cardiovascular, lung, and blood diseases was $424 billion—23 percent of the total economic costs of illness, injuries, and death in the United States. In addition, cardiovascular and lung diseases accounted for three of the four leading causes of death in the United States and four of the 10 leading causes of infant death.

NIH Announces 2013 High-Risk High-Reward Research Awards

Finally, NIH announced 78 awards to support innovation in biomedical research to scientists "proposing highly innovative approaches to major contemporary challenges in biomedical research, under the High Risk-High Reward program supported by the National Institutes of Health Common Fund." The press release gives a full list of the various award recipients.

"NIH is excited to continue support of visionary investigators, among all career stages, pursuing science with the potential to transform scientific fields and accelerate the translation of scientific research into improved health, through the Common Fund's High Risk-High Reward Research Program,'' said NIH Director Francis S. Collins, M.D., Ph.D. "This program allows researchers to propose highly creative research projects across a broad range of biomedical research areas, that involve inherent risk, but have the potential to lead to breakthroughs."

NIH Pioneer, New Innovator, Transformative Research, and Early Independence Awards encourage creative thinkers to pursue exciting and innovative ideas about biomedical and behavioral research. The Pioneer Award, in its 10th year, challenges investigators at all career levels to develop highly innovative approaches that could have a powerful impact on a broad area of biomedical or behavioral research.

The New Innovator Award initiative, established in 2007, supports investigators who are within 10 years of their terminal degree or clinical residency, but who have not yet received a Research Project Grant (R01) or equivalent NIH grant, to conduct exceptionally innovative research.

The Transformative Research Awards program, established in 2009, promotes cross-cutting, interdisciplinary approaches and is open to individuals and teams of investigators who propose research that could create or challenge existing models.

The Early Independence Award, with the first awards given in 2011, provides an opportunity for exceptional junior scientists, who have recently received their doctoral degree or finished medical residency, to skip traditional post-doctoral training and move immediately into independent research positions.

In 2013, NIH is awarding 12 Pioneer Awards, 41 New Innovator Awards, 10 Transformative Research Awards, and 15 Early Independence Awards. The total funding, which represents contributions from the NIH Common Fund and multiple NIH institutes and centers, is approximately $123 million.

Global Database on CME Meetings and Providers

MedMeme LLC, a global leader in providing comprehensive integrated medical and scientific information database platforms to the top pharmaceutical and biotechnology companies recently launched its new MEPmemeTM (MEP) database that offers the latest information on medical education providers, according to a press release from the company.

"This robust product will help pharmaceutical and healthcare professionals such as medical affairs, personnel managers, researchers and pharmaceutical executives to easily filter through the massive amount of data on medical education providers and make the best possible decision on their strategic education plans."

The database will cover information on medical education providers worldwide such as medical societies and associations (i.e. American Society of Clinical Oncology or American College of Cardiology) more than 40000 medical meetings and events (including more than 21000 organizations sponsoring these events) medical institutions (including research institutions and hospitals offering education programs as well as their branches and departments) and other providers.

MEPmemeTM will allow users to create comprehensive customized reports by filtering medical education provider information based on geographic locations therapeutic areas disease and condition information industry publications medical meetings (including information about the topics at meetings presentations) medical specialties medical organizations and institutions networks foundations and commercial continuing medical education (CME) providers; among other options.

This dynamic database will be updated daily to ensure its accuracy stay abreast of the latest industry news and remove the outdated information.

MEPmemeTM will detail wide-ranging information on the medical education providers including the following:

  • Organization/provider details: name ID designation and type of provider.
  • Contact information: generic contact information as well as details on departments officers staff and Boards of Trustees. The contact details include website URLs email addresses mailing addresses as well as phone and fax numbers.
  • Meetings: Providers offering meetings such as conferences grand rounds and seminars will be listed with the appropriate event or editorial contacts. The data will also include specific event details such as meeting dates and schedules locations and titles of presentations. Additionally the database will outline information on committees as well as the CME credit categories and values.

"Medical education remains in high demand as pharmaceutical and healthcare executives are looking to expand their expertise" said Mahesh Naithani CEO and founder MedMeme. "MEPmemeTM is a natural extension of our database product portfolio. Given that the medical education industry includes a variety of activities ranging from live symposiums to publications and online programs our goal is to provide a tool that can help these busy professionals easily scan and evaluate all the potential options and choose the best possible path."

Additional insights and perspectives are also available through various combination subscriptions that include other related MedMeme's databases. For example MEPmemeTM subscription can be complemented by InsightmemeTM the largest continually updated database of medical meeting and publication abstracts (including 10-year archives) searchable based on medical society disease meeting presentation topics and the Pub-Plan/MemeTM database that provides analysis of medical publication content including share-of-voice by topics percentage of topic coverage and a value ranking of publications.

In addition to MEPmemeTM, ReelDx recently announced the launch of a platform containing an ever-expanding collection of videos of real patients from real doctors, that changes the way professionals and students improve their diagnostic abilities. The company also announced the launch of its first library, ReelDx: Pediatrics.

ReelDx is video-based platform that brings a first-person point-of-view to patient diagnosis and care. The peer-reviewed and evidence-based case studies between real patients and doctors provide 24/7 educational opportunities for practicing clinicians and students alike. All cases are eligible for AMA PRA Category 1 Credit

"The use of video has exploded in people's personal and professional lives. It has become an invaluable tool for learning in nearly every facet of education, except for the education of medical practitioners," said Dr. David Spiro co-founder and chief medical officer, ReelDx. "We seek to change that. ReelDx enables quick access to a series of cases in response to searches on symptom, sign or diagnosis. This allows any medical professional to get support in the diagnostic or treatment moment, and more effectively learn in the context of their specific practice."

In partnership with a nationwide network of physicians in practice, as well as academic health centers like Oregon Health & Science University, ReelDx has produced the most robust libraries of medical diagnostic videos available today. The libraries are useful to higher education institutions, hospital and clinical environments, and individual healthcare professionals.

Each case features an easy to digest one-minute video shot by a clinician or medical videographer focusing on the presentation of key signs and symptoms, including the patient's own description of what is wrong. Many also feature expert commentary and supplemental images to provide additional insight into the case. Every case also features a description of research-based standards of care and links to relevant journal materials. The cases are viewable on any web-enabled device, including tablets and smartphones.

ReelDx cases are accredited for AMA PRA Category 1 Credit™,providing engaging and relevant continuing medical education for any medical professional.

The concentrated experience offered by video cases helps professionals hone their diagnostic and patient care abilities. ReelDx offers the best choice for institutions to help their students and staff utilize case studies in classes and on rounds, and to become a contributing part of the largest video medical case study system in the world.

"ReelDx offers a valuable new paradigm in medical education--once only available to a treating physician. The easy-to-use visual format allows for any viewer to witness a focused clinical encounter," said James Bennett MD, pediatrician, Pediatric Group of Monterey. "ReelDx will significantly improve medical understanding for parents, students and even seasoned practitioners."

The first library is ReelDx: Pediatrics. Additional libraries are in development with some of the highest quality medical schools and practice facilities in the US.

The company seeks other partnerships with teaching and practice environments interested in bringing powerful video case studies to students and practitioners everywhere.

November 26, 2013

Electronic Health Records: Update on Meaningful Use, and Five Steps for a Meaningful Use Audit

We have written previously about the "Meaningful Use" electronic health record (EHR) initiative, which is run by the Centers for Medicare & Medicaid Services (CMS). We most recently noted that stakeholders are requesting delays in Meaningful Use Stage 2 requirements and penalties.

As a brief refresher: Under the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act (part of the Recovery Act), hospitals and healthcare providers must be able to demonstrate by 2015 that their EHR systems are capable of certain tasks that constitute "meaningful use."

Currently, to receive a payment, providers must meet 19 of 24 "meaningful use" objectives that include electronically tracking patients' medications and allergies, sending reminders, sharing lab test results and producing summaries of a patient's office visit.

In order to receive incentive payments under the meaningful use program, CMS subjects providers and entities to audits to ensure compliance with the regulations promulgated by the agency. We noted back in September 2012 that CMS "quietly" began auditing providers.

"Only a small percentage of providers attesting to Meaningful Use will be audited by the government, but the outcome could be harsh, since any single shortfall will be grounds for loss of the full incentive payment, according to attorney Brian Flood with Husch Blackwell in Austin, Texas, who spoke on a webinar conducted Sept. 26, by the American Bar Association's Health Law Section."

Several of the red flags that might trigger an audit, according to the speakers, as reported by FierceEMR include:

  • Elements of attestation, such as inconsistencies in numerators and denominators that should be related
  • Attestation data that's inconsistent with Centers for Medicare & Medicaid Services data, such as measures inconsistent with the providers' patient mix, or local public health capabilities
  • Vendor characteristics. "Some vendors are known for having issues with their systems," Zavala said. "Those systems are more likely to be subject to an audit."

The Meaningful Use audits, which include both pre- and post-payment audits, began in 2012 and are continuing.

Interestingly, two recent articles from Fierce discuss "5 steps to survive a Meaningful Use audit" and "5 ways to fail a Meaningful Use Audit."

5 Steps to Survive a Meaningful Use Audit

This story, written by Gienna Shaw, summarized recommendations from two leaders in EHRs: Elizabeth Johnson, vice president of applied clinical Informatics at Tenet Healthcare Corporation, which has 78 hospitals in 20 states, and Pam McNutt, senior vice president & CIO at the six-hospital Methodist Health System in North Texas. Both recently spoke at the CHIME13 CIO forum in Scottsdale Arizona.

McNutt and Johnson took audience members through the steps they took to prepare for--and survive--audits at their organizations. "Much of the work needs to be done before you even get the audit notice, starting with collecting data and making sure you hold onto it."

Step 1: Resist the Purge

Meaningful Use audits can go as far back as six years--so that's how long organizations must keep data to support attestation claims. Protect that data at all costs.  While some organizations have "aggressive" purge criteria for their systems, this led to negative results because those entities had "no recourse to fall back and prove things by looking at audit logs or polling data in an easy fashion from a data repository."

In addition, Johnson recommended that entities "back up the binder" or create "attestation evidence." In other words, organizations need a copy to know exactly what they attested against and to have a "way to quickly retrieve and produce it." While much of this information may be kept in a binder on a shelf, Johnson said to put that information in a PDF so it can be quickly produced in the future.

Step 2: Plan Ahead

To prepare for a Meaningful Use audit, "ensure logs and system settings can help you produce the data when you need it, especially proof for "yes or no" attestation items, such as medication checking."

"Think about system settings ahead of time so that patient records and audit logs contain the kind of detail an auditor will seek. Logs and system settings will help produce the data when you need it ... as long as you plan ahead."

"Our vendor software was not able to show exactly when that field in our dictionaries had been flipped on and off. And I suspect that's the case with most software, because that [functionality] was not part of the certification requirement," McNutt.

"We ran reports from our audit logs to show our medication interactions and our formulary was triggering every single day for the time period ... we really couldn't prove it any other way."

"To make documentation easier, make sure the vendor's name and the software version are on the header of all Meaningful Use reports, to show they came from a certified system. When that's not available, provide screen shots showing the system name and version number to prove it was from a certified system."

"You're in a better position if you can use your vendor's generated reports," McNutt said.

"We keep all of our information electronically from the very beginning," Johnson said. Tenet created a software program to store and manage MU data for its 78 hospitals. It allows them to upload and transmit evidence directly from the program to the portal.

Step 3: Expect the Unexpected

Both Tenet and Methodist were among the first organizations to undergo Meaningful Use attestation audits--and those first days were rocky.  Although Johnson and McNutt told FierceHealthIT that many of the kinks have since been smoothed out, there were plenty of surprises.

"One of unexpected areas of focus for us was that they dove pretty deeply into our HIPAA security risk assessment," McNutt said. "We learned that the audit needs to specifically mention your EHR and your certified modules."

Like other organizations, Methodist does vulnerability testing and an annual HIPAA risk assessment, but those may not suffice for an MU audit. "They want proof the audits focus directly on your certified EHR technology and the version that you're running," McNutt said.

"Additionally, your audit, your report and your reaction to the report all must be done within the attestation time period. So if you're attesting for 90 days, you need to do the audit before the end of the reporting period, she said."

Step 4: Upgrade with Caution

Although the auditors didn't dive as deeply into quality measures as McNutt expected, she did have advice for the CHIME13 audience on getting quality reports in order. "The quality metrics are not something you can compute in a spreadsheet or some other fashion. You must use the report as delivered by your certified quality metric reporting vendor … and show that to the auditors," she said.

"You need to prove you were on a certified release the entire time," McNutt added. "I know of some organizations that got tripped up with this during upgrade cycles, believing that all you had to do was be on the certified release before you ran all your reports. Well, that's not the case. You need to prove it with screen shots showing the date that your certified EHR technology went into production. And that needed to be on or before the start date of your attestation period."

"You cannot upgrade in the course of a year and say you were on that certified release the entire year. So every time you are doing an upgrade, if you're in the path of Meaningful Use reporting, you need to think about that."

Step 5: Act Fast

Once your organization gets notice of a Meaningful Use audit, "you have two weeks to respond and send documentation via an online portal. But you may not want to wait two weeks." In fact, the policy at Tenet Healthcare Corporation is to file the response and documentation within seven days, Johnson said.

"One reason to be ready to file in less than two weeks: There's no guarantee that the email notification of the audit will go to the right person--or that the right person will be in the office to get the email. Speakers and audience members told stories of emails that went to the wrong person or were almost overlooked."

Although Tenet designated a contact person for CMS to notify of an audit, Johnson received some email notices herself; others were sent directly to individual hospitals. "To guard against that problem, make sure everyone in your organization knows how to recognize an audit notification, understands the importance of fast action and knows who to alert."

"Because Tenet is such a large, geographically spread out organization, fast response time is critical. The response team includes people who are directly responsible for the Meaningful Use program, including Johnson and leaders from government relations, audit services, compliance and IT. They hold a conference call within 24 hours and then meet again the following day after gathering data and reviewing evidence to write the cover letter. The team uploads the supporting data within seven days."

5 Ways to Fail a Meaningful Use Audit

While these tips above describe how organizations can survive a meaningful use audit, below are 5 ways to fail one based off a recent article on HITECHanswers.net from Meaningful Use audit expert Jim Tate. Tate identifies some of the "worst practices" he's seen hospitals engage in, including these 5:

  1. Fail to put one person in charge of the audit
  2. Ignore Meaningful Use requirements you don't understand
  3. Don't document attestation work 
  4. Blame the vendor for your problems
  5. Fail to conduct a security risk analysis

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