Thursday, November 22, 2012

Federal Register | Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2

Federal Register | Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2:
On September 4, 2012, the U.S. Department of Health and Human Services (HHS) issued the Stage 2 Meaningful Use Regulations that include several core objectives to promote patient engagement through EHR technology. Specifically, under the Stage 2 Meaningful Use Regulations, a provider must demonstrate that its EHR is able to perform certain tasks with a defined percentage of its patients: 1) to send messages to and from the patient; 2) the permit the patient to view online, download and transmit his or her health information within certain time frames; and 3) to identify patient-specific education resources and provide those resources to the patient. Ultimately, a provider's EHR technology will have to be able to meet these core objectives for all of its patients. HHS will add further meaningful use requirements over the next few years.
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Improving care delivery through enhanced communications among providers, patients, and payers


While mHealth traditionally stands for “mobile health,” this Task Force adopted the term more broadly to refer to mobile health, wireless health, and e‐Care technologies that improve patient care and the efficiency of healthcare delivery.

This Task Force report sets goals and recommendations for the FCC, other federal agencies, and industry to help leverage communication technologies to improve healthcare quality, access and efficiency.
This report is delivered with the overarching goal that by 2017 mHealth, wireless health and e‐Care solutions will be routinely available as part of best practices for medical care.  FCC leadership as well as interagency collaborations will be needed to address technical and policy barriers, including developing appropriate reimbursement and financial incentives.


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Confronting the Social Determinants of Health — Obesity, Neglect, and Inequity — NEJM

Confronting the Social Determinants of Health — Obesity, Neglect, and Inequity — NEJM: "If we are to break the vicious cycle of inequality and uphold the tradition of physicians as champions of social justice in the global arena, we must widen our perspective beyond the individual to confront the “causes of the causes” at multiple levels, so as to help create social and physical environments that promote good health for all. In the same vein, multipronged approaches that include cross-sectorial collaboration among nontraditional partners (including health care providers, lawmakers, and welfare workers) and bold change in social policy are needed to ensure equal health and justice for all. As Theodore Roosevelt once said, “The welfare of each of us is dependent fundamentally upon the welfare of all of us.”"

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Drug Policy for an Aging Population — The European Medicines Agency's Geriatric Medicines Strategy — NEJM

Drug Policy for an Aging Population — The European Medicines Agency's Geriatric Medicines Strategy — NEJM: "Although population aging is a mark of the success of public health policies, it also challenges the established way of implementing such policies. In the case of the European Medicines Agency (EMA), it has prompted an analysis of whether the regulatory system is adapted to taking the needs of older people into account in the development, approval, and use of medications."

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Lessons from Sandy — Preparing Health Systems for Future Disasters — NEJM

Lessons from Sandy — Preparing Health Systems for Future Disasters — NEJM: "Although experience is a great teacher, science can and should also inform disaster policy. Too often it does not. Careful tracking of important health and mental health problems that confound recovery, for instance, may lead to appropriate interventions that can help reduce morbidity associated with the inevitable next catastrophe."

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The Future of Obamacare — NEJM

The Future of Obamacare — NEJM: "Even as repeal fades from the agenda, then, there are many important political fights to come that will shape the future of Obamacare. The outcome of struggles over insurance subsidies and benefits, costs and financing, Medicaid and many other issues will determine whether the ACA is maintained, expanded, or undermined."

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Wednesday, November 21, 2012

USDOJ: South Carolina-based Harmony Care Hospice Inc. and CEO/Owner Daniel J. Burton to Pay U.S. $1.286 Million to Resolve False Claims Act Allegations

USDOJ: South Carolina-based Harmony Care Hospice Inc. and CEO/Owner Daniel J. Burton to Pay U.S. $1.286 Million to Resolve False Claims Act Allegations: "
Today’s settlement with Harmony and Burton resolves a lawsuit filed by former Harmony employees Mona Singletary and Lynda Fulton under the qui tam, or whistleblower, provisions of the False Claims Act.   Under the False Claims Act, private citizens can bring suit for false claims on behalf of the United States and share in any recovery. Together, Singletary and Fulton will receive $244,529.87 as their share of the government’s recovery.
 "

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USDOJ: Two Plead Guilty in Miami for Roles in $63 Million Mental Health Care Fraud Scheme

USDOJ: Two Plead Guilty in Miami for Roles in $63 Million Mental Health Care Fraud Scheme:

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Tuesday, November 20, 2012

UTICA, NEW YORK PHYSICIAN INDICTED IN $12,000,000 HEALTH CARE FRAUD SCHEME


that certain medical services, which are described in medical codes, known as CPT codes, have
“typical” time components associated with them, and that during the course of the fraud scheme, the
aggregate of the “typical” time in the codes submitted for reimbursement by KACHARE consistently
exceeded 24 hours per day.


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Coventry Health Care, Inc. Agrees to Pay $3 Million to the U.S. as Part of a Non-prosecution Agreement

Coventry Health Care, Inc. Agrees to Pay $3 Million to the U.S. as Part of a Non-prosecution Agreement: "some employees of Coventry and/or First Health Priority Services, a subsidiary, inappropriately accessed the Medicare database to obtain Medicare eligibility information for the sale of Medicare set-aside products"

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NEW DRAFT GUIDANCE


IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the
Determination of Whether an IND/IDE is Needed


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Monday, November 19, 2012

Research breakthrough selectively represses the immune system, November 18, 2012 News Release - National Institutes of Health (NIH)

Research breakthrough selectively represses the immune system, November 18, 2012 News Release - National Institutes of Health (NIH): " researchers funded by the National Institutes of Health have developed innovative technology to selectively inhibit the part of the immune system responsible for attacking myelin—the insulating material that encases nerve fibers and facilitates electrical communication between brain cells."

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Dozens of Genes Linked to Bowel Diseases - NIH Research Matters - National Institutes of Health (NIH)

Dozens of Genes Linked to Bowel Diseases - NIH Research Matters - National Institutes of Health (NIH):

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Brain Wave Synchronization Key to Working Visual Memory - NIH Research Matters - National Institutes of Health (NIH)

Brain Wave Synchronization Key to Working Visual Memory - NIH Research Matters - National Institutes of Health (NIH): "Short-term memories are stored as synchronized signals between 2 key brain hubs, according to a new study in monkeys. The findings show for the first time how the brain stores visual information for working memory tasks."

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Cataloging Human Genetic Variation - NIH Research Matters - National Institutes of Health (NIH)

Cataloging Human Genetic Variation - NIH Research Matters - National Institutes of Health (NIH): "The world's largest, most detailed catalog of human genetic variation—used by disease researchers around the world—has more than doubled in size. The newly published information will provide deeper insights into the genomic basis of human disease."

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Friday, November 16, 2012

This is your brain on freestyle rap, Thursday, November 15, 2012 News Release - National Institutes of Health (NIH)

This is your brain on freestyle rap, Thursday, November 15, 2012 News Release - National Institutes of Health (NIH): "The findings, published online in the Nov. 15 issue of the journal Scientific Reports, reveal that this form of vocal improvisation is associated with a unique functional reallocation of brain activity in the prefrontal cortex and proposes a novel neural network that appears to be intimately involved in improvisatory and creative endeavors."

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Wow! busy crooked doctor


A Chicago psychiatrist received illegal kickbacks from pharmaceutical
companies and submitted at least 140,000 false claims to Medicare and Medicaid for antipsychotic
medications he prescribed for thousands of mentally ill patients in area nursing homes, according
to a civil health care fraud lawsuit filed today by the United States.  The defendant, Dr. Michael J.
Reinstein, also submitted at least 50,000 claims to Medicare and Medicaid, falsely stating that he
provided “pharmacologic management” for his patients at more than 30 area nursing homes and
long-term care facilities, the lawsuit alleges.


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US health reform still faces challenges : The Lancet

US health reform still faces challenges : The Lancet: "Just 3 days after President Barack Obama's re-election preserved his signature legislative achievement, the Patient Protection and Affordable Care Act (ACA), his administration reset a deadline for states to take a crucial step toward implementing it."

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Europe gives gene therapy the green light : The Lancet

Europe gives gene therapy the green light : The Lancet:

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Psychiatrist and journalist win prize for defending science : The Lancet

Psychiatrist and journalist win prize for defending science : The Lancet: "In recognition of their efforts to champion science despite extreme opposition, a science journalist and psychiatrist have both received the 2012 John Maddox prize. Becky McCall reports.
Last week, the inaugural John Maddox Prize for Standing up for Science 2012 was granted to UK psychiatrist Simon Wessely for his work on chronic fatigue syndrome (CFS) and Fang Shi-min, a freelance journalist from Beijing, China, for revealing clinics using unproven medicine."

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Thursday, November 15, 2012

Reducing Administrative Costs and Improving the Health Care System — NEJM

Reducing Administrative Costs and Improving the Health Care System — NEJM: "The average U.S. physician spends 43 minutes a day interacting with health plans about payment, dealing with formularies, and obtaining authorizations for procedures.1 In addition, physicians' offices must hire coders, who spend their days translating clinical records into billing forms and submitting and monitoring reimbursements. The amount of time and money spent on administrative tasks is one of the most frustrating aspects of modern medicine."

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[PubKLaw-L] Whistleblower protection bill goes to the White House - jmichaelslocum@gmail.com - Gmail

[PubKLaw-L] Whistleblower protection bill goes to the White House - jmichaelslocum@gmail.com - Gmail:

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A RESOURCE GUIDE TO THE U.S. FOREIGN CORRUPT PRACTICES ACT


A RESOURCE GUIDE TO THE
U.S. FOREIGN CORRUPT PRACTICES ACT


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Wednesday, November 14, 2012

Soaring college administrative costs pit bureaucrats against professors

Soaring college administrative costs pit bureaucrats against professors: "Purdue has a $313,000-a-year acting provost and six vice and associate vice provosts, including a $198,000 chief diversity officer. It employs 16 deans and 11 vice presidents, among them a $253,000 marketing officer and a $433,000 business school chief.

Administrative costs on college campuses are soaring,"

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Tuesday, November 13, 2012

Obama reasserts research focus : Nature News & Comment

Obama reasserts research focus : Nature News & Comment: Obamawants to ensure that the United States “is a global leader in research and technology and clean energy, which will attract new companies and high-wage jobs to America”."

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Gene variations linked to lung cancer susceptibility in Asian women, November 11, 2012 News Release - National Institutes of Health (NIH)

Gene variations linked to lung cancer susceptibility in Asian women, November 11, 2012 News Release - National Institutes of Health (NIH): "An international group of scientists has identified three genetic regions that predispose Asian women who have never smoked to lung cancer. The finding provides further evidence that risk of lung cancer among never-smokers, especially Asian women, may be associated with certain unique inherited genetic characteristics that distinguishes it from lung cancer in smokers."

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SUFI Network Services, Inc v. US


Air Force committed multiple breaches of contract that were mostly wilful, and the existence of damage to SUFI is clear and certain.  Yet, a wide gulf exists between the amount SUFI claimed ($163,000,000)
and the amount the Board ultimately awarded ($7,416,751.52).  One might say that
SUFI’s claims must have been vastly inflated, but just as easily one could say that the
Board harshly reduced SUFI’s damages at every opportunity


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Inappropriate Payments to Skilled Nursing Facilities Cost Medicare More Than a Billion Dollars in 2009 (OEI-02-09-00200) 11-09-2012

Inappropriate Payments to Skilled Nursing Facilities Cost Medicare More Than a Billion Dollars in 2009 (OEI-02-09-00200) 11-09-2012: "inaccurate, medically unnecessary, and fraudulent claims. Further, the Medicare Payment Advisory Commission has raised concerns about SNFs' improperly billing for therapy to obtain additional Medicare payments. In fiscal year (FY) 2012, Medicare paid $32.2 billion for SNF services."

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INAPPROPRIATE PAYMENTS TO SKILLED NURSING FACILITIES COST MEDICARE MORE THAN A BILLION DOLLARS IN 2009

Major fraud, waste, and abuse.

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Brain imaging and fluid biomarker analysis in young adults at genetic risk for autosomal dominant Alzheimer's disease in the presenilin 1 E280A kindred: a case-control study : The Lancet Neurology

Brain imaging and fluid biomarker analysis in young adults at genetic risk for autosomal dominant Alzheimer's disease in the presenilin 1 E280A kindred: a case-control study : The Lancet Neurology: "Young adults at genetic risk for autosomal dominant Alzheimer's disease have functional and structural MRI findings and CSF and plasma biomarker findings consistent with Aβ1—42 overproduction. Although the extent to which the underlying brain changes are either neurodegenerative or developmental remain to be determined, this study shows the earliest known biomarker changes in cognitively normal people at genetic risk for autosomal dominant Alzheimer's disease."

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Monday, November 12, 2012

Apple and HTC Settle Patent Dispute - Slashdot

Apple and HTC Settle Patent Dispute - Slashdot:

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Gmail's Location Data Led to the Discovery of the Petraeus Affair - Megan Garber - The Atlantic

Gmail's Location Data Led to the Discovery of the Petraeus Affair - Megan Garber - The Atlantic:

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Where America's Racist Tweets Come From - Megan Garber - The Atlantic

Where America's Racist Tweets Come From - Megan Garber - The Atlantic:

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Nine Italian Cardiologists Arrested In Broad Investigation Of Research Fraud And Misconduct - Forbes

Nine Italian Cardiologists Arrested In Broad Investigation Of Research Fraud And Misconduct - Forbes: "Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. Several news reports mentioned that stents and angioplasty balloons were involved."

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Friday, November 9, 2012

hospice volunteer program to provide services to terminally ill patients


Safe harbor advisory opinion on

proposal for a hospice to establish a volunteer program to provide non-skilled services to terminally ill
patients who do not qualify for hospice care

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Plagiarism exposed in Romanian grant applications : Nature News & Comment

Plagiarism exposed in Romanian grant applications : Nature News & Comment: "Earlier this year, Nature exposed a series of plagiarism scandals in Romania that implicated the country's prime minister Victor Ponta, a former research minister and university leaders. Now evidence is emerging of plagiarism in applications for public grant money."

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Thursday, November 8, 2012

HPV vaccine may benefit HIV-infected women, November 8, 2012 News Release - National Institutes of Health (NIH)

HPV vaccine may benefit HIV-infected women, November 8, 2012 News Release - National Institutes of Health (NIH): "Women with HIV may benefit from a vaccine for human papillomavirus (HPV), despite having already been exposed to HPV, a study finds. Although many may have been exposed to less serious forms of HPV, more than 45 percent of sexually active young women who have acquired HIV appear never to have been exposed to the most common high-risk forms of HPV, according to the study from a National Institutes of Health research network."

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termination for convenience COMMERCIAL FAR CLAUSE


Recovery based on percentage of completion.  This indicates for both government and other (e.g., clinical trials) contracts how important it is to assure recovery of those "uncancellable" obligation incurred that may not be adequately covered by periodic or per case/patient/procedure fees.
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Wednesday, November 7, 2012

The Taxing Power and the Public's Health — NEJM

The Taxing Power and the Public's Health — NEJM: " While enunciating limits on the commerce and spending powers, the Court opened the door for Congress to use its taxing power to achieve myriad policy objectives. The federal government may now increasingly join state and local governments in making creative use of taxes to pursue public health goals, though political obstacles may block immediate action."

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Tuesday, November 6, 2012

USDOJ: Missouri Hospital System Agrees to Pay $9.3 Million to Resolve False Claims Act and Stark Law Violations

USDOJ: Missouri Hospital System Agrees to Pay $9.3 Million to Resolve False Claims Act and Stark Law Violations: "Freeman Health System, a healthcare provider and hospital system located in Joplin, Mo., has agreed to pay $9,316,139 to resolve allegations that it violated the Stark Law and the False Claims Act by knowingly providing incentive pay to physicians in a manner that violated federal law, the Justice Department announced today.  "

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Scientists petition Serbian government to tackle misconduct | Chemistry World

Scientists petition Serbian government to tackle misconduct | Chemistry World: "a damning situation of research and publication misconduct, including widespread plagiarism, self-plagiarism and duplication of papers; the formation of ‘citation cartels’ where friends’ names are added as co-authors on papers; and artificially upping the impact factor of predatory journals that publish low quality work by citing unrelated research from the same journals."

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Monday, November 5, 2012

Your Microbes and You - NIH News in Health, November 2012

Your Microbes and You - NIH News in Health, November 2012:

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OIG safe harbor advisory opinion on waiver of cost-share


advisory opinion regarding a proposal
to waive cost-sharing amounts on a non-routine, unadvertised basis for insured patients,
including Federal health care program beneficiaries, based on individualized
determinations of financial need


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NIMH · In-sync Brain Waves Hold Memory of Objects Just Seen

NIMH · In-sync Brain Waves Hold Memory of Objects Just Seen:

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Saturday, November 3, 2012

How do you solve a problem like misconduct? | Chemistry World

How do you solve a problem like misconduct? | Chemistry World:

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A Shift on “Pay for Delay” — Reopening Doors for Pharmaceutical Competition? — NEJM

A Shift on “Pay for Delay” — Reopening Doors for Pharmaceutical Competition? — NEJM:

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The Exclusion IllusIon


Good article on use of Exclusion for healthcare fraud
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Friday, November 2, 2012

America's future : The Lancet

America's future : The Lancet:

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Thursday, November 1, 2012

How Much Would You Give to Save a Dying Bird? Patient Advocacy and Biomedical Research — NEJM

How Much Would You Give to Save a Dying Bird? Patient Advocacy and Biomedical Research — NEJM:

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Comparing Local and Regional Variation in Health Care Spending — NEJM

Comparing Local and Regional Variation in Health Care Spending — NEJM:

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Growing Pains for the Medicare Hospice Benefit — NEJM

Growing Pains for the Medicare Hospice Benefit — NEJM:

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Risk, Responsibility, and Generic Drugs — NEJM

Risk, Responsibility, and Generic Drugs — NEJM:

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Medicare's Enduring Struggle to Define “Reasonable and Necessary” Care — NEJM

Medicare's Enduring Struggle to Define “Reasonable and Necessary” Care — NEJM:

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