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May 2009 Archives

May 1, 2009

HHS' Planfirst webcast-let science drive the protocol

HHS Secretary Sebelius and DHS Secretary Napolitano hosted a Webcast to answer questions from the American people regarding the H1N1 flu, moderated by Lark McCarthy. They were joined by Acting Director of CDC, Dr. Besser. (1) The webcast is about 1 hour, it's well worth watching and provides a lot of thoughtful assurance.
24 hours into the job, Secretary Sebelius points out during this webcast the importance of their policy for managing the impact on the public of this new strain of flu: let science drive the protocol and community mitigation. The idea for the webcast is to open the lines of communication, to communicate what this flu is and what it is not. While the situation is dynamic and will change, the panel members all emphasized the goal of getting information to the public, so that people can stay informed. (Local information is also important to get.) The essence of their guidance plans is to control group settings and in that way contain the flu bug, to implement rationale control measures- take what we learn and then adjust that with more information . Manufacturers and scientists stand ready to work together to turn research into medicine when needed. HHS is working to find a good balance between the need for speed and safety in providing the medicine to treat the symptoms of this flu strain and also research for a vaccine.

The CDC is actively investigating human cases of influenza A (H1N1) in several states and is working closely with Canada, Mexico and the World Health Organization. The CDC is continuously updating its investigation information. As with any infectious disease, CDC recommends that people should take everyday preventive actions.Read the WHO report [posted on the HHS website].

(1) http://www.hhs.gov/

May 4, 2009

Berger In Retrospect

In today's Albany Times Union two CEOs comment on the Berger report.

The Berger Commission mandates dropped like a bomb on New York, and Schenectady was ground zero.

The commission ordered Bellevue Woman's Hospital to close, and St. Clare's Hospital to merge with Ellis Hospital.

"Did Berger get it right?" asked James W. Connolly, CEO of Ellis Hospital. "The answer is, unequivocally, yes."

Read the rest here.

NY Managed Care Report

The Health Department has released its 2008 Managed Care Plan Performance report. The report is generally favorable:

Commercial plans exceeded the national averages in several measures of care for children and adults, including well-child and preventive care for children and adolescents, annual monitoring of patients with persistent medications, and Chlamydia screening. For measures where commercial plans outperformed Medicaid and Child Health Plus, the differences continued to diminish in 2007, indicating a decrease in health care disparities between the two populations.

New York State’s Medicaid plans this year exceeded the national averages for over 80 percent of this year’s quality of care measures. Medicaid plans in New York State exceeded national benchmarks among members with diabetes rates for all diabetes care measures (eye exam, nephropathy screening, lipid profile, lipids controlled and blood pressure controlled) demonstrating health plans' ability to successfully manage the chronic care needs of this vulnerable population.

The report is available online here.

May 5, 2009

Hackers Take 8 Million Patient Records, Demand $10 Million Ransom

The Washington Post reports online today on a major heist of electronic medical information that happened last week and has been kept remarkably quiet.

Hackers last week broke into a Virginia state Web site used by pharmacists to track prescription drug abuse. They deleted records on more than 8 million patients and replaced the site's homepage with a ransom note demanding $10 million for the return of the records, according to a posting on Wikileaks.org, an online clearinghouse for leaked documents.

The state discovered the intrusion April 30. Read the full Post story here.

May 6, 2009

Expanding the Global Health Initiative

From The White House press releases today, on expanding the global heatlh inititative (1):

In the 21st century, disease flows freely across borders and oceans, and, in recent days, the 2009 H1N1 virus has reminded us of the urgent need for action. We cannot wall ourselves off from the world and hope for the best, nor ignore the public health challenges beyond our borders. That is why I am asking Congress to approve my Fiscal Year 2010 Budget request of $8.6 billion -- and $63 billion over six years -- to shape a new, comprehensive global health strategy. We cannot simply confront individual preventable illnesses in isolation. The world is interconnected, and that demands an integrated approach to global health. [from President Obama's statement]

As a U.S. Senator, President Obama joined a bipartisan majority in supporting the Bush Administration’s effective President’s Emergency Plan for AIDS Relief (PEPFAR).... Already, American leadership, sparked in large part by President George W. Bush and a bipartisan majority in Congress, has helped to save millions of lives from HIV/AIDS, malaria, and tuberculosis. Yet, even with that monumental progress, 26,000 children around the world die every day from extreme poverty and preventable diseases.
In response, the President’s 2010 Budget begins to focus attention on broader global health challenges, including child and maternal health, family planning, and neglected tropical diseases, with cost effective intervention. It also provides robust funding for HIV/AIDS. The initiative adopts a more integrated approach to fighting diseases, improving health, and strengthening health systems.
The U.S. global health investment is an important component of the national security 'smart power' strategy, where the power of America’s development tools [especially proven, cost-effective health care initiatives]can build the capacity of government institutions and reduce the risk of conflict before it gathers strength....[T]he Administration’s funding plan can leverage support from other nations and multilateral partners so that the world can come closer to achieving the [U.N.] health Millennium Development Goals.Discussions are underway with the G-8 partners on fulfilling all of the commitments.
(1) http://www.whitehouse.gov/the_press_office/Statement-by-the-President-on-Global-Health-Initiative/

Update on 'HHS' Planfirst webcast-let science drive the protocol'

Here's an UPDATE on my Supra post: 'HHS' Planfirst webcast-let science drive the protocol'

From FDA news today: FDA announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.The facility, located in the United States, is owned and operated by sanofi pasteur, which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur’s production capability.
(1) http://www.fda.gov/bbs/topics/NEWS/2009/NEW02008.html

Dr. Doug Melton, HSCI:A conversation about stem cells

Here is an exciting conversation with Dr. Doug Melton, co director of the Harvard Stem Cell Institute, one of the best places in the world to do stem cell reseach. On the Charlie Rose program, see the video replay of the conversation.(1) Dr. Melton shares with Charlie Rose an important update on stem cell biology in 21 minutes.
Think about healthy aging enabled by replenishment of body cells and tissues. Listen to the medical accomplishments which might be made possible through the work of stem cell biologists and bioengineers working together.
The science of renewable bodies and another exciting science, renewable energy, present the two major challenges for engaging young scientists to meet and pursue today. Dr. Melton and Charlie Rose discuss the latest topics in stem cell research, including a practical perspective on how President Obama's Executive Order removing barriers to responsible scientific research involving human stem cells (2) has impacted privately funded stem cell researchers. Scinentists who have been conducting stem cell research over the last 8 years now greatly appreciate the freedom from restraints on how their science is to be conducted, for example in day to day lab operations choosing which equipment and what supplies to use [a reference to federal funding accounting requirements which separate federally funded research items from what is not federally funded].
Dr. Melton shares with viewers the nature of the latest big stem cell biology q' :
to discover and understand the coded signals that tell a cell what to become.
(1) http://www.charlierose.com/view/interview/10274

May 11, 2009

OMIG Work Plan

The New York State Office of the Medicaid Inspector General has published its State Fiscal Year 2009-2010 Work Plan. The Work Plan is the agency's "road map" and identifies the audit and investigation areas that it will focus on for the next year. This is the second year that OMIG has issued a work plan, but this year's plan is more comprehensive and has more specifics. The Work Plan is required reading for every New York provider, even if you do not participate in the Medicaid program.

Highlights include the following:

- Board role in compliance process. If a provider is identified as having significant compliance issues, OMIG will inquire into a board's actions to assure that compliance processes and systems are in place and whether board members have exercised reasonable oversight over information and reporting systems.

- High-ordering physicians OMIG will review whether physicians who order a significant number of items or services paid for by Medicaid are complying with State and federal requirements (e.g., are properly licensed and not excluded, are enrolled in the program if they order items in excess of $75,000, and have a physician-patient relationship with the Medicaid beneficiary)

- Off-label use and relationships with manufacturers. OMIG will review the Medicaid claims data to determine the extent of off-label use of certain prescription drugs, and will also review Medicaid claims data and the IRS Form 990 information regarding relationships with pharmaceutical and device manufacturers to determine whether physicians have a potential conflict of interest when ordering a drug or device.

- Hospital financial relationships with physicians. OMIG will review hospital cost report information, minutes of board meetings, outside auditor work papers and related documents to ensure that hospitals are complying with the anti-kickback laws in their financial relationships with physicians. It will focus on payments to physicians for direct patient care and administrative services and the rental of office space to physicians.

May 13, 2009

ACLU + PUBPAT lawsuit: 'Gene Patents Stifle Patient Access To Medical Care And Critical Research'

5/12/09 The Public Patent Foundation at Benjamin N. Cardozo School of Law (PUBPAT) website news (1), (2), reports that ACLU and PUBPAT filed a lawsuit charging that patents on 2 human genes associated with breast and ovarian cancer stifle research that could lead to cures and limit women's options regarding their medical care. Mutations along the genes, known as BRCA1 and BRCA2, are responsible for most cases of hereditary breast and ovarian cancers. Here are just a few excerpts from a very interesting article (1):
The lawsuit argues that the patents on these genes are unconstitutional and invalid.
The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad. According to the lawsuit, such monopolistic control over these genes hampers clinical diagnosis and serves as a disincentive for research because Myriad not only has the right to enforce its patents against other entities but also has the rights to future mutations discovered on the BRCA2 gene. The gene patents are also illegal under patent law because genes are products of nature.
Many women with a history of breast and ovarian cancer in their families opt to undergo genetic testing to determine if they have the mutations on their BRCA genes that put them at increased risk for these diseases. This information is critical in helping these women decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal. However, the fact that Myriad can exclude others from providing this testing has several negative consequences for patients: many women cannot afford the more than $3,000 Myriad charges for the test; patients cannot get second opinions on their test results; and patients whose tests come back with inconclusive results do not have the option to seek additional testing elsewhere.
Because the ACLU/PUBPAT lawsuit challenges the whole notion of gene patenting, it could have far reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses.
(1) http://www.pubpat.org/brcafiled.htm
(2) www.aclu.org/brca

Novello Charged, Pleads Not Guilty

Former U.S. Surgeon General and N.Y. Commissioner of Health Antonia Novello, accused of forcing state employees to work overtime to handle her personal chores, pleaded not guilty to the charges:

Novello entered the plea in Albany County Court, where prosecutors unsealed a 20-count indictment that included a charge of defrauding the government, a felony. Novello could face up to 12 years in prison if convicted of all charges.

Read the AP wire here.

May 24, 2009

PublicMarkup.org, an ongoing experiment in preparing legislation more inclusively

New York's Senate 'Legislation Markup' (1) allows the public to comment on legislation that is under consideration. It is the virtual version of a session where legislative committees amend bill texts similar to the Federal site, www.publicmarkup.org.

The Elections Committee was first to post the text of eight bills (listed below under the category of Elections) that focus on laws and regulations governing casting a ballot and polling places....Click on a bill as listed and share your ideas and provide feedback. Your comments will be considered by Senate staff. Please be aware that posting comments at NYSenate Markup may constitute lobbying under New York State law. For more information, visit the website of the New York State Commission on Public Integrity

PublicMarkup.org, is an ongoing experiment in preparing legislation more inclusively by opening bills to online, public review.
From the website:
After preparing and drafting a comprehensive piece of legislation, Sunlight (3) decided that public input and scrutiny would refine the bill and improve its chances of garnering lawmakers' support. Rather than immediately looking for legislators who might sponsor the bill, Sunlight, therefore, created PublicMarkup.org as a place to post the bill, and to allow you to comment on and suggest edits to the substance of the legislation.
This project is not intended to be the ultimate technical solution to the challenge of drafting legislation online, but an experiment in online collaboration. By collecting legislation, summaries, resources and commentary in a single linkable location, PublicMarkup.org provides a simple, blog-like framework for soliciting feedback on this legislation.

I think that this creation of, in effect, 'a marketplace of ideas' is an exciting one. Also as a practical matter, there is so much specialized knowledge generated or developed in our society, not any one group is likely to grasp or capture it all; on-line collaboration can be one way for it to be made known and shared.
(3)http://www.publicmarkup.org/# Who is Sunlight?

May 29, 2009

Hospitals "Tweeting" Surgeries

This is an interesting bit.

[Children's Medical Center Dallas] posted live updates on Twitter, or "tweeted", throughout a pediatric kidney transplant. It is one of the most recent healthcare organizations to tweet live during surgery—a growing trend in hospitals that started when Henry Ford Health System in Detroit tweeted a robotic partial nephrectomy on February 9, garnering the organization a great deal of media coverage.

Two things occur to me when I read this.

The first is, this is all great when the surgery goes smoothly. But the cynic in me knows that surgeries can and do go wrong, sometimes horribly. Will the surgical team tweet throughout the entire crash? Can you imagine the family getting tweets like, "BP falling rapidly" or "SPO2% below 80, she's turning blue" or "applying the paddles @300 joules" or - - - even worse, perhaps - - suddenly no more tweets at all?

The second is a whole raft of practical and legal questions. Are hospital tweets part of the patient record? If not, should they be? And if so, how are they captured, if at all? If they are captured, how are they stored and recovered? And what use might they be either in discovery or at trial?

Finally, are lawyers (for ANY of the parties involved) ready for this?

New NYLJ Health Article: "Handling Audits and Investigations Of Health Care Providers, Part 2"

Section Member Frank Serbaroli, with the New York office of Greenberg Traurig, writes a regular "Expert Analysis" column for the New York Law Journal. The latest article, "Handling Audits and Investigations of Health Care Providers, Part 2," appears in the May 29, 2009 edition:

As we noted in Part 1, there is no such thing as an “informal” audit or a “routine” investigation. Any inquiry by a government agency—such as the Office of Inspector General of the U.S. Department of Health and Human Services, the New York State Attorney General’s Medicaid Fraud Control Unit, the Office of New York State Medicaid Inspector General, or a government contractor such as a Medicare fiscal intermediary, carrier or Recovery Audit Contractor (RAC)— must be taken seriously.

Link to the reprint posted on the Greenberg Traurig website.

About May 2009

This page contains all entries posted to HEALTH LAW SECTION BLOG in May 2009. They are listed from oldest to newest.

April 2009 is the previous archive.

June 2009 is the next archive.

Many more can be found on the main index page or by looking through the archives.