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Health Management Technology News
  March 6, 2014
In this issue:

► InterSystems joins Global Alliance for Genomics and Health

► Amphion Medical Solutions launches continuous coding quality monitoring

► AMA welcomes high court review of federal infringement on states' powers

► Health care agency passes $1 trillion milestone

► Americans may be able to keep old health-care plans longer under rewrite of rules

► FDA creates medical app regulation maze

InterSystems joins Global Alliance for Genomics and Health

InterSystems has joined the Global Alliance for Genomics and Health (GA4GH), an alliance of 148 of the world’s leading biomedical research institutions, healthcare providers, information technology and life science companies, funders of research, and disease and patient advocacy organizations. Meeting today at the Wellcome Trust in London for the first face-to-face GA4GH partner meeting, InterSystems joins 200 of the world’s leading experts in healthcare, biomedical research, technology, ethics, and patient advocacy. The non-profit partnership brings organizations from Africa, Asia, Australia, Europe, and the Americas.

InterSystems will contribute its deep expertise in advanced data management, analytics, integration, and health informatics technologies, including decades of experience providing secure, standards-based health information exchange at local, regional, national and international levels. Technological advances have led to large-scale collection of data on genome sequences and clinical outcomes, with great promise for medicine. In recent years, the cost of genome sequencing has fallen one-million fold, while more and more people are choosing to make their genetic and clinical data available for research, clinical, and personal use. However, interpreting this data requires an evidence base for biomedicine that is larger than any one party alone can develop, and that adheres to the highest standards of ethics and privacy.

Stemming from an initial meeting held in January 2013, last June almost 70 organizations announced their intention to form a global alliance to tackle the challenges of genomic and clinical data sharing. They agreed to develop and promulgate international standards, both technical and regulatory, that make it possible to share and interpret this wealth of information in a manner that is effective, responsible and secure.

Read the full press release here ► 

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Amphion Medical Solutions launches continuous coding quality monitoring

Amphion Medical Solutions announced the launch of Continuous Coding Quality Monitoring (CCQM), an innovative service to ensure ongoing coding quality and coder proficiency in ICD-10 code sets. CCQM, which takes an “educate first” approach to coding audits, delivers to hospitals, ambulatory surgery centers, physician practices and other healthcare organizations the feedback they need for accurate billing, clinical documentation improvement and targeted physician and coder education.

“CCQM takes a two-pronged approach to optimizing coding quality. First, by conducting regular audits of coded charts we are able to identify accuracy issues before they can significantly impact revenues or slow time-to-bill,” said Minnette Terlep, BS, RHIT, Amphion’s Vice President of Business Development and Chief Compliance Officer. “Second, we provide coders with immediate direct feedback supported by Official Coding guidelines to continuously improve proficiency and retention, an educational aspect to coding that is taking on greater urgency as the transition to ICD-10 draws near.”

Read the full press release here ► 

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AMA welcomes high court review of federal infringement on states' powers

"The American Medical Association (AMA) is grateful that the U.S. Supreme Court has agreed to re-evaluate a case in which the federal government is interfering with the ability of state regulatory boards to protect public health and safety.

"The decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission (FTC) allows a federal agency with no particular knowledge of medicine or dentistry, to strip authority away from experts who are charged by a state legislature to shield patients from unlawful practice.

"In support of well-founded legal principles, the Litigation Center of the AMA and State Medical Societies joined forces with several other groups to file a friend-of-the-court brief asking the High Court to hear the case. The AMA argues that the decisions of state regulatory boards meet exemption criteria from federal antitrust challenges under the 'state action doctrine' created by the U.S. Supreme Court.”

Read the full AMA statement here ► 

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Health care agency passes $1 trillion milestone

President Barack Obama's budget pushes Health and Human Services spending over $1 trillion for the first time, reflecting an aging population adding to the Medicare rolls, as well as expanded coverage for younger people through the new health law.

Released Tuesday, the HHS budget for the 2015 fiscal year calls for just over $1 trillion, which budget officials said is a new milestone for the department.

HHS runs Medicare, Medicaid and the insurance expansion in Obama's health overhaul law, which together provide coverage for about 1 in 3 Americans. Its growing prominence in the federal budget reflects the rise of benefit programs, which now account for more than two-thirds of all government spending.

And the trillion-dollar HHS budget left out a significant chunk of spending: another $60 billion for tax credits to finance private coverage under the health care law was included in the Treasury Department's budget, since those benefits are delivered through the Internal Revenue Service.

Overall, the HHS spending plan reflected a stay-the-course approach in an election year.

Read the full Business Week article here ► 

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Americans may be able to keep old health-care plans longer under rewrite of rules

The Obama administration is preparing to announce that Americans who want to keep their old health plans may do so for at least one year longer than they expected, even if the policies don't comply with law, according to insurance industry officials familiar with the latest rewrite of federal health-care rules.

The decision has become an open secret in insurance and health policy circles. And it marks the second time in four months that administration officials have adjusted their rules about health plans that do not include benefits required by the 2010 Affordable Care Act.

Last fall, a few million consumers discovered that their noncompliant policies were about to be canceled. A political furor erupted, with accusations that President Obama had broken his promise that people could keep their current insurance.

About 2.6 million Americans received the cancellation notices, according to a study published Monday by the journal Health Affairs.

Read the full Washington Post article here ► 

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FDA creates medical app regulation maze

When the US Food and Drug Administration (FDA) issued its final guidance for medical apps, inventors and investors alike pored through the document, seeking answers on what was to be regulated and what wasn't. While they indeed found more specific information than has been available from the agency, the guidance also showed the agency's uncertainty over how the world of medical apps is going to evolve.

The September 2013 guidance did specify that it would require device approval of any app intended to diagnose, treat, mitigate, or prevent a disease. But it also left an open door, possibly due to the sheer volume of mobile medical apps, vowing to exercise "enforcement discretion" if an app meets the technical definition of a medical device but poses a low risk to the patient.

An example of this gray area is the case of a hypothetical diabetes management app. At a recent panel of regulatory and industry experts, we discussed whether an app that measures glucose levels in patients with diabetes; reads QR codes to gather nutrition information from food labels; and provides carbohydrate counts, meal options, and recipes is a regulated device under the new FDA guidance. We concluded that the app could fall under several degrees of FDA scrutiny, depending on the inclusion of specific functions.

The FDA would not regulate diet recommendations, recipes, or the tracking of glucose, carbs, and exercise, as these are common diary functions that could be performed with a pen and paper and that pose relatively low risk to the patient. Reminding users to take glucose readings and medications at certain times might trigger enforcement discretion because of possible increased risk to patients. But these functions can be performed by almost any calendar application, and the FDA certainly does not want to be regulating all generic calendar apps. However, the addition of an insulin-dosing calculator based on all of the other data collected by the app would definitely trigger the need for the app to be FDA regulated, as the patient risk potential is high if there are errors in calculations.

Read the full Information Week article here ► 

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