S U P R A S P I N A T U S

A nifty new website, "USAspending.gov," provides current information on federal spending. From the site itself:

Have you ever wanted to find more information on government spending? Have you ever wondered where Federal contracting dollars and grant awards go? Or perhaps you would just like to know, as a citizen, what the Government is really doing with your money.

If you answered "yes" to any of those questions the website can help you out. Link to it here or key www.usaspending.gov into your web browser. On my first visit I was interested to see the New York State Department of Health holding the current number 2 slot for federal assistance year-to-date. Here's the top five along with the associated numbers:

TOP 5 Assistance Recipients FY 2009 YTD

1 DEPARTMENT OF HEALTH CARE SERVICES $18,908,037,649
2 NEW YORK STATE DEPT OF HEALTH $18,335,672,042
3 TEXAS HEALTH & HUMAN SERVICES COMMISSION $13,514,862,175
4 PENNSYLVANIA DEPT OF PUBLIC WELFARE $11,168,181,944
5 LOUISIANA DEPT OF HEALTH & HOSPITALS $5,031,984,907

The top 5 contractors (versus assistance recipients) were all military contractors.

A nifty new website, "USAspending.gov," provides current information on federal spending. From the site itself:

Have you ever wanted to find more information on government spending? Have you ever wondered where Federal contracting dollars and grant awards go? Or perhaps you would just like to know, as a citizen, what the Government is really doing with your money.

If you answered "yes" to any of those questions the website can help you out. Link to it here or key www.usaspending.gov into your web browser. On my first visit I was interested to see the New York State Department of Health holding the current number 2 slot for federal assistance year-to-date. Here's the top five along with the associated numbers:

TOP 5 Assistance Recipients FY 2009 YTD

1 DEPARTMENT OF HEALTH CARE SERVICES $18,908,037,649
2 NEW YORK STATE DEPT OF HEALTH $18,335,672,042
3 TEXAS HEALTH & HUMAN SERVICES COMMISSION $13,514,862,175
4 PENNSYLVANIA DEPT OF PUBLIC WELFARE $11,168,181,944
5 LOUISIANA DEPT OF HEALTH & HOSPITALS $5,031,984,907

The top 5 contractors (versus assistance recipients) were all military contractors.

Commissioner Hamburg recently presented the new FDA.gov website (1-see the video).
The new website is easier to read and navigate around due to changes in space methods and an improved, helpful organization. It's a better guide and the space and content work well together.
Also, the new FDA Transparency Blog shows q's posted along with news items and notices-- readers' responses to FDA posts are steadily being posted and shared by many in the know. The comments make some good points. One comment posted on the blog indicated that a window can be transparent in order to see what is going on inside but it is more important to understand the meaning of what one sees and to establish trust about what you are seeing. (**)

The purpose of this Transparency Blog is to discuss various ways in which the [FDA] could provide information to the public about what FDA is doing, the bases for FDA’s decisions, and the processes used to make agency decisions. The blog is expected to run for the next 6 months (June through November 2009)....FDA provides blog posts and updates over the coming weeks asking for your feedback on these topics.

From the AG's website 6/18:

Attorney General Andrew M. Cuomo today announced that Health Net, Inc. (NYSE: HNT) (“Health Net”) has agreed to end its relationship with Ingenix, the defective database insurers use to set rates, and contribute $1.6 million toward the creation of a new, independent database. . . . The agreement with Health Net marks the completion of the Attorney General’s industry-wide sweep of the health insurance industry and means that every insured New Yorker is now covered by his reforms.

Read the rest here.

On the same day, the Insurance Department unveiled the 43rd amendment to regulation No. 62, intended to codify the essence of the Cuomo agreements with insurers. See the Department's press release here and the draft regulation here.

From today's NY Times online:

City investigators admitted Friday that the staff at a city-run hospital in Brooklyn failed to provide basic medical care to a psychiatric patient who died on a waiting room floor, and then tried to cover up their neglect.

The rest is here.

HHS has released a new report on health care disparities in America. Pulling together with many grassroots and community representatives who shared yesterday (1) important information and experiences about the nature of health care disparities which exist in our current health care system, HHS Secretary Kathleen Sebelius participated in a White House Health Care Stakeholder Discussion on the importance of reform that reduces such disparities and works towards health equity.Throughout the discussion, participants voiced concerns about the existence of and need to fill many voids in 'data collection' in order to support better health policy decisions and overall the health reform initiative.

On another note, below are excerpts from a public policy briefing developed by CDT (2) on the subject of PHR.(3)

Personal health records (PHRs) — records that are managed, controlled, and shared by individuals rather than their healthcare providers—hold the potential to transform healthcare by empowering consumers and patients to become key, informed decision-makers in their own care. These records increase individual control over personal data and permit individuals to record, store, and share relevant health information, including data that may be missing from official medical records, such as pain thresholds in performing various daily activities, details on the side effects of medication, and daily nutrition and exercise logs.
However, the public will be reluctant to use PHRs without reasonable privacy and security measures in place to protect their data. To date, no comprehensive set of privacy and security rules effectively governs PHRs. Congress has taken a step toward addressing this problem as part of the recent economic stimulus legislation: [HHS] and [FTC]are tasked with drafting joint recommendations regarding PHR privacy and security requirements by February 18, 2010 for those records not covered under the privacy and security regulations of HIPAA. In addition, PHR vendors are covered by new federal requirements that they notify individuals in the event of a breach of health data. However, more action is needed to build public trust in PHRs.
In this policy post, CDT advocates for the adoption of consistent policies to govern all PHRs. CDT also identifies the deficiencies of the current HIPAA Privacy Rule as applied to PHRs and offers some recommendations for establishing privacy and security protections for these tools.

EVENT NOTE: THE HEALTH LAW SECTION'S SPECIAL COMMITTEE, E-HEALTH & INFO SYSTEMS, Chaired by Raul Tabora, Jr., presents on JUNE 18 2009 some of the practical issues affecting health info technology in New York State. Anna Colello, Esq. will moderate, NYS Office for Technology and DOH initiatives presented by Susan Beaudoin, Esq, GC (OFT ) and Dr. Patricia Hale, Deputy Director (OHITT at DOH)

The NYSBA Health Law Section has made this Act a legislative priority. Now, thanks to the tireless efforts of Section leaders like Robert Swidler and Kathy Burke, the Act is closer to passage than ever before. Please lend your support to this Act by writing to your NYS Assemblyman or Senator and asking for his or her support of this important piece of legislation.

This recent New York Times editorial makes all the right points:

Even by the low standards of New York's procrastinating State Legislature, the 17-year stalemate over a measure to allow family members to make health decisions for incapacitated patients is unacceptable and inhumane.

The Family Health Care Decisions Act was first proposed by a blue-ribbon task force in 1992. All of these years later and families in New York still have no legal authority to give consent or object to medical treatment -- or even review medical records -- for incapacitated loved ones unless those patients have signed a health care proxy, a living will or other treatment instructions.

Since only about one-fifth of Americans have signed health care proxies or living wills, this is a big problem.

New York's Legislature has come close to approving a remedy only to get derailed by cultural warfare. Senate Republicans previously balked at allowing same-sex partners to serve as surrogates and insisted on superfluous wording covering a pregnant comatose woman. This problem must be fixed.

The proposed bill would bring New York law into alignment with most of the rest of the states. Family members and others close to the incapacitated patient would be empowered to make decisions. Those decisions would have to reflect, as best as possible, the patients' wishes and values. Where that is unknown, decisions would be made in the patient's best interests.

Family members or other surrogates could decline life-sustaining treatment only if it imposes an "excessive burden" on a terminally ill or permanently unconscious patient, or if the treatment would entail an inhumane amount of pain and suffering.

With the end of the legislative session in sight, the Assembly speaker, Sheldon Silver, and the Senate majority leader, Malcolm Smith, need to arrange a prompt vote and get the bill to the desk of Gov. David Paterson for his signature. Patients and families should not have to wait any longer.

From yesterday's AP wire:

An appeals court has ruled that the state owes New York City $28.6 million in illegally "intercepted" Medicaid payments for home health care.

Read more here.

Nothing in today's NYTimes (that I could find) on this, though, and the closing quote of the AP piece is that the AG's office new nothing of the ruling.

From HealthLeadersMedia today:

Virginia officials this week began mailing direct individual notifications to more than a half-million people whose Social Security numbers may have been contained in the Prescription Monitoring Program database that was hacked into in April by a criminal demanding a $10 million ransom.

Read the rest here. Prior Supraspinatus coverage is here.

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 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

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.

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.

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

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.

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
(2)http://www.whitehouse.gov/search/?keywords=stem%20cell%20research
(3)http://www.hsci.harvard.edu/