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Health Management Technology News
  March 24, 2014
In this issue:

Broad Medicaid coverage leads to lower rates of kidney failure

Millions on the sidelines for big healthcare push

Pocket diagnosis

Hospital hit by screen-grab Trojan that attempted to steal 5,400 patient records

World TB Day 2014-Find TB. Treat TB

FDA proposes making it easier to classify and reclassify medical devices according to risk

Broad Medicaid coverage leads to lower rates of kidney failure

Manjula Tamura’s interest in recent changes to Medicaid, the government’s low-income medical insurance program for adults, was initially spurred by her memory of a 23-year-old patient’s kidney failure.

“Her kidney failure was preventable,” said Tamura, MD, associate professor of nephrology at the Stanford University School of Medicine. “But by the time she came to the hospital, it was no longer reversible.”

With proper medical care, the patient’s kidney failure, known as end-stage renal disease or ESRD, could have been averted, Tamura said. The patient, who was diagnosed with lupus as a teenager, stopped getting medical care at 21, when she no longer qualified for coverage under her parents’ medical insurance and couldn’t afford her own. Now she was facing lifelong dialysis or a kidney transplant.

When the federal government expanded its Medicaid program with the passage of the Affordable Care Act, as a medical researcher Tamura was motivated to ask the question: Does expanded Medicaid coverage translate into better care for low-income patients with chronic diseases, such as kidney disease?

Read the full Stanford School of Medicine article here

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Millions on the sidelines for big healthcare push

Alan Thacker wants health coverage, but he can't get help in his home state of Georgia. Mary Moscarello Gutierrez no longer can afford insurance in New Jersey. Justin Thompson of Utah refuses to be forced into the president's health law.

Millions of people in the United States will remain uninsured despite this week's final, frenzied push to sign them up under the health law. Their reasons are all over the map.

Across the country, many of the uninsured just don't know much about the health overhaul and its March 31 deadline for enrolling in plans that can yield big discounts, researchers say.

An Associated Press-GfK poll found that only one-fourth of the uninsured had tried to sign up through the state or federal insurance marketplaces, also known as exchanges, by late January. If they don't enroll in time, many will face a fine and be locked out of the subsidized plans until next year.

President Barack Obama and a phalanx of advocacy groups, insurance companies and volunteers are scrambling to spread the word about as the deadline dangles.

But the complexities of the Affordable Care Act can stymie even the well-informed.

Read the full Boston Herald article here

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Pocket diagnosis

A recently-developed mobile phone application could make monitoring conditions such as diabetes, kidney disease, and urinary tract infections much clearer and easier for both patients and doctors, and could eventually be used to slow or limit the spread of pandemics in the developing world.

The app, developed by researchers at the University of Cambridge, accurately measures color-based, or colorimetric, tests for use in home, clinical or remote settings, and enables the transmission of medical data from patients directly to health professionals.

Decentralization of healthcare through low-cost and highly portable point-of-care diagnostics has the potential to revolutionize current limitations in patient screening. However, diagnosis can be hindered by inadequate infrastructure and shortages in skilled healthcare workers, particularly in the developing world. Overcoming such challenges by developing accessible diagnostics could reduce the burden of disease on health care workers.

Due to their portability, compact size and ease of use, colorimetric tests are widely used for medical monitoring, drug testing and environmental analysis in a range of different settings throughout the world. The tests, typically in the form of small strips, work by producing color change in a solution: the intensity of the color which is produced determines the concentration of that solution.

Read the full article from University of Cambridge here

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Hospital hit by screen-grab Trojan that attempted to steal 5,400 patient records

A US hospital has admitted suffering a mysterious malware attack that grabbed screenshots containing the personal data of 5,400 patients from hospital PCs before hiding them in an encrypted folder for probable transmission to criminals.

In a statement, the small Valley View Hospital in Glenwood Springs Colorado said that it had discovered the attack in January 2014, after which a third-party forensics firm identified the malware as a screen grabber that stored the data in an encrypted cache.

Each of the 5,400 patients whose details has been accessed was allotted a sub-folder, inside of which were grabs revealing different amounts of personal data including addresses, dates of birth, social security numbers, credit card data, patient numbers and discharge dates, the hospital said.

Read the full TechWorld article here

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World TB Day 2014-Find TB. Treat TB

Each year, World TB Day is commemorated on March 24, often with a variety of activities leading up to the official day. This annual event commemorates the date in 1882 when Dr. Robert Koch announced his discovery of Mycobacterium tuberculosis, the bacillus that causes tuberculosis (TB).

World TB Day provides the opportunity to raise awareness about TB-related problems and solutions and to support worldwide TB-control efforts. While great strides have been made to control and cure TB, people still get sick and die from this disease in our country. Much more needs to be done to eliminate this disease.

This year CDC selected the theme "Find TB. Treat TB. Working together to eliminate TB" to highlight that TB is still a life-threatening problem in the United States, despite the declining number of TB cases. Anyone can get TB, and our current efforts to find and treat latent TB infection and TB disease are not sufficient. Misdiagnosis of TB still exists and health care professionals often do not "think TB."

This World TB Day, CDC calls for further collaboration to find and treat TB. By working together to raise awareness that TB still exists and sharing the personal stories of those people affected by TB, we can bring attention to this public health problem.

This year’s World TB Day theme encourages local and state TB programs to reach out to their communities to raise awareness about TB. We don’t have to fight TB alone; we should partner with others who are also caring for those most at risk for TB such as people with HIV infection or diabetes, and the homeless. Everyone has a role in ensuring that one day TB will be eliminated. CDC and our partners are committed to a world free of TB.

In 2013, 9,588 new cases of TB were reported in the United States, for a case rate of 3 per 100,000. The number of cases in the United States is on the decline, but there are challenges that slow progress towards the TB elimination goal.

In MMWR, CDC reported that it is committed to a TB-free world and reiterated the necessity of initiatives to improve awareness, testing and treatment for latent TB and TB disease to reach the goal of TB elimination in the United States.

Visit CDC for more TB information

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FDA proposes making it easier to classify and reclassify medical devices according to risk

A new regulation proposed Friday by the US Food and Drug Administration (FDA) would change the procedures by which it classifies and reclassifies medical devices according to their perceived risk, making it much easier for FDA to make changes based on new or changing information.

The proposed regulation was called for by a 2012 law known as the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608 of the law called for FDA to be given the authority to make classification changes through administrative orders, instead of the extremely lengthy process of proposed regulations it now uses under 21 CFR 860.

That order would still need to involve a device classification panel meeting, but would be published as an administrative order in the Federal Register and subject to a limited comment period—not a proposed regulation subject to a lengthy comment period and extensive governmental review.

As pointed out by FDA Law Blog in 2012, existing regulatory pathways for reclassifying devices "have proven so cumbersome that they are rarely used…If FDA takes advantage of this new authority to accomplish the same objective by administrative order, there is great potential to improve the efficiency of FDA’s regulatory processes."

Now FDA is out with its proposed regulation intended to carry out Section 608 of FDASIA.

"The level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device," FDA states in its 21 March 2014 Federal Register notice announcing the proposed rule.

The proposed rule focuses much of its energy on regulatory definitions, which determine which category a device should be classified into. Class I devices are low-risk devices; Class II are moderate-risk; and Class III represents the highest category of risk. High-risk devices are understood by FDA to be those which are intended to support or sustain human life, pose an "unreasonable" risk of illness or injury, or are otherwise substantially important to preventing an "impairment of health."

Under the regulation, FDA said it would "identify those potentially high risk devices for which insufficient information exists to determine that special and general controls would provide reasonable assurances of safety and efficacy (RASE)."

Five categories of high-risk, Class III devices would thus be established:

1. Devices that present known risks that cannot be controlled.

2. Devices for which the risk-benefit profile is unknown or unfavorable.

3. Devices for which a full review of manufacturing information is necessary.

4. Devices for which premarket review of any change affecting safety or effectiveness is necessary.

5. Combination products.

Other portions of the guidance focus on "generic type" devices and their product codes, or procodes for short. Under the new regulation, FDA would be able to group certain procodes together, allowing for a single risk classification to cover multiple types of similar devices.

Comments on the extensive proposed regulation are due to FDA within 90 days.

Visit the Office of Federal Register for the document

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