Life Science Compliance Update

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22 posts from February 2009

February 26, 2009

Health Care Reform: Obama Budget Down Payment on Healthcare Reform

The Health and Human Services Portion (HHS) of the Obama budget established a reserve fund of $630 billion over ten years to finance fundamental healthcare reform.

The reserve is funded equally by new revenue and by savings proposals.  If adopted, the goal is to put 


further down the path of health care reform

Funding Highlights:

 • Accelerates the adoption of health information technology and utilization of electronic health records.

 • Expands research comparing the effectiveness of medical treatments to give patients and physicians better information on what works best.

• Invests over $6 billion for cancer research at the National Institutes of Health as part of the Administration’s multi-year commitment to double cancer research funding.

• Strengthens the Native American health system with sustained investments in healthcare services for Native Americans and Alaskan Natives to address persistent health disparities and foster healthy Native American communities.

• Invests $330 million to increase the number of doctors, nurses, and dentists practicing in areas of the country experiencing shortages of health professionals.

• Supports families by providing additional funding for affordable, high-quality child care, expanding Early Head Start and Head Start, and creating the Nurse Home Visitation program to support first-time mothers.

• Strengthens the Medicare program by encouraging high-quality and efficient care, and improving program integrity.

• Invests over $1 billion for Food and Drug Administration food safety efforts to increase and improve inspections, domestic surveillance, laboratory capacity, and domestic response to prevent and control food-borne illness.

In this budget, the President is committing roughly $63 billion per year for healthcare reform initiatives.  The healthcare economy is currently $2.1 trillion, and his commitment in the budget represents 3% of the total healthcare budget, which is less than the predicted growth in healthcare spending.  The total budget for Medicare will expand from $386 billion (2008) to $872 billion (2019).  The President is predicting $317 billion in undefined healthcare savings over ten years.  

As the President alluded to in his speech to Congress, we will see change, including healthcare reform but more than likely it will be incremental, and in this case very incremental.

President’s 2010 Budget HHS Section

                  Full 2010 Budget

Letters from Grassley: HHS OIG – Investigate Emory

Emory University’s (Emory) Charles Nemeroff, M.D., who in December stepped down as Chairman of the Department of Psychiatry and agreed to very strict probation policy is again under fire by Senator Grassley for his bad behavior for not disclosing income earned from promotional talks.

The Senator is asking the Health and Human Services (HHS) Office of the Inspector General (OIG) to investigate Emory University over possible violations including:

1.    Possible violation of National Institutes of Health’s (NIH) Conflict of Interest Rules;

2.    Possible violations of Institutional Review Board (IRB) protocols and failure to report IRB violations to the Office of Human Subject Research Protection (OHRP);

3.    Possible violations of Federal Contracting Rules regarding commitment of time for NIH Grants; and

4.    Possible misleading information provided to NIH.

The Senator would like the OIG to begin an investigation into this matter immediately.

In addition, Senator Grassley requested the OIG to conduct a further accounting of this issue to ensure that Emory did not, either directly or indirectly, mislead the NIH about the nature of Dr. Nemeroff’s promotional talks for GlaxoSmithKline and advocacy on behalf of Paxil.

The letter included a packet of information on a promotional program from 2000.  The document looks like a standard promotional program packet with the exception of the confidentiality information.

Dr. Nemeroff is not exactly a choir boy in this exercise and perhaps the steps that Emory has taken could have been stronger.

But do these possible violations deserve the attention of an OIG investigation?  Since Emory just recently learned of the failed disclosure, they perhaps have not thought about submitting information to the various offices at NIH.  NIH was aware of the situation and rescinded a $9.3 million grant, perhaps NIH thought that was sufficient.

Whatever the situation is, Senator Grassley does not want this case to go away.  This is not the last chapter of the Nemeroff/Grassley story.

Senator Grassley:    Letter to HHS OIG

OIG Letter PsychNet Attachment 2-24-09

The Wall Street Journal Blog:  What did Emory Tell about Nemeroff’s Pharma Pay

Previous Stories:

            Letters from Grassley: Emory Surrenders

Letters from Grassley: Emory -- Release the Hounds

            Letters from Grassley: Emory Professor Caught with Hands in Cookie Jar

February 25, 2009

Health Care Reform: Obama State of Health Care – Incremental Change

Obama: 'We will rebuild, we will recover'

We can’t afford to put it (healthcare) on hold.  It’s time.  President Obama, Speech to Congress, February 24, 2009.

With the economy on the precipice, the President in his speech to congress gave mention to health care reform plans for 2009, rather than calling for a separate package the President presented an incremental version within his budget.

For that same reason (financial crisis), we must also address the crushing cost of health care.

This is a cost that now causes a bankruptcy in


every thirty seconds.  By the end of the year, it could cause 1.5 million Americans to lose their homes.  In the last eight years, premiums have grown four times faster than wages. And in each of these years, one million more Americans have lost their health insurance. It is one of the major reasons why small businesses close their doors and corporations ship jobs overseas. And it’s one of the largest and fastest-growing parts of our budget.

Given these facts, we can no longer afford to put health care reform on hold.   Already, we have done more to advance the cause of health care reform in the last thirty days than we have in the last decade. When it was days old, this Congress passed a law (SCHIP) to provide and protect health insurance for eleven million American children whose parents work full-time.

Our recovery plan will invest in electronic health records and new technology that will reduce errors, bring down costs, ensure privacy, and save lives.

It will launch a new effort to conquer a disease that has touched the life of nearly every American by seeking a cure for cancer in our time.

And it makes the largest investment ever in preventive care, because that is one of the best ways to keep our people healthy and our costs under control.

This budget builds on these reforms. It includes an historic commitment to comprehensive health care reform – a down-payment on the principle that we must have quality, affordable health care for every American.

It’s a commitment that’s paid for in part by efficiencies in our system that are long overdue. And it’s a step we must take if we hope to bring down our deficit in the years to come.

Now, there will be many different opinions and ideas about how to achieve reform, and that is why I’m bringing together businesses and workers, doctors and health care providers, Democrats and Republicans to begin work on this issue next week.

I suffer no illusions that this will be an easy process. It will be hard.

But I also know that nearly a century after Teddy Roosevelt first called for reform, the cost of our health care has weighed down our economy and the conscience of our nation long enough. So let there be no doubt: health care reform cannot wait, it must not wait, and it will not wait another year.”

This past week, the President held a fiscal responsibility summit, next week a healthcare summit.  It will be interesting to see what ideas are actually in the budget and what those changes will mean to the healthcare economy.  The one thing we can all count on with President Obama is we will see change.



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