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March 2009 Archives

March 5, 2009

Congress to Look at Hospital Executive Salaries

Senator Grassley of Iowa has a problem with hospital executive pay, or so says the Boston Globe:

Nonprofit hospital presidents earned nearly $500,000 a year on average in salary and other benefits, according to a recent IRS survey of 485 hospitals, and a smaller group more closely reviewed by the IRS had an average salary of $1.4 million. . . .

Senator Charles Grassley of Iowa, the top Republican on the Senate Finance Committee, said yesterday that he is concerned that such salaries may be too high and that the hospitals' boards of directors are not taking full responsibility for approving them. Grassley said he hopes to introduce legislation, possibly as part of a sweeping healthcare overhaul later this year, that would put more pressure on boards to keep salaries in check.

"It really concerns me, and something needs to be done about it," he said.

Read the rest here. And here's one more snippet:

The IRS report found that most hospitals surveyed were complying with regulations dictating how hospital boards should set compensation for executives, and that in cases where pay seemed unusually high, board decisions were generally justified.

Supraspinatus covered the IRS report when it first came out here.

March 9, 2009

Pres. Obama: ' Removing Barriers to Responsible Scientific Research Involving Human Stem Cells", "Scientific Integrity"

Monday, March 9th, 2009 - excerpts from The White House blog (1):

...President Obama marked a monumental moment for hope with an audience of Nobel Laureates, leaders of the faith community, and patient advocates. 'Today, with the Executive Order I am about to sign, we will bring the change that so many… have hoped for, and fought for, these past eight years: we will lift the ban on federal funding for promising embryonic stem cell research. We will vigorously support scientists who pursue this research. And we will aim for America to lead the world in the discoveries it one day may yield.' The President acknowledged that there are those who strongly oppose this research, and insisted that even as he had come to a different conclusion those opinions deserved full respect. He explained that the American government has not only a role but a responsibility to keep the country at the forefront of medical science. But he also made clear that his decision was not made based on his belief in science alone: 'As a person of faith, I believe we are called to care for each other and work to ease human suffering.'
The President said that a false choice has often been presented between science and faith, and that corrupting, shielding, or shying away from the facts science lays bare benefits nobody.
'That is why today, I am also signing a Presidential Memorandum directing the head of the White House Office of Science and Technology Policy to develop a strategy for restoring scientific integrity to government decision making.
The EO and Memo to Exec branch dept/agency heads signed today work exquisitely together to provide both scope and intensity in these policy making areas.
From the EO:
1.For the past 8 years, the authority of the DHHS, including NIH, to fund and conduct HESC research has been limited by Presidential actions. The purpose of this order is to remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research,…’ President Obama ordered the revocation of the Presidential statement of 8/9/01, limiting Federal funding for research involving human embryonic stem cells and EO 13435 of 6/20/07, which supplements the 8/9/01 statement on HESC research.
2.The President also declared that the HHS Secretary, through the NIH Director, may support and conduct responsible, scientifically worthy human stem cell research, including HESC research, to the extent permitted by law. Within 120 days, they shall review existing NIH guidance and other widely recognized guidelines on HESC research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research.
From the Memo:
1.'Science and the scientific process must inform and guide decisions of my Administration on a wide range of issues. The public must be able to trust the science and scientific process informing public policy decisions.’
2. The President assigned to the Director of the Office of Science and Technology Policy the responsibility for ensuring the highest level of integrity in all aspects of the executive branch's involvement with scientific and technological processes. The Director shall confer, as appropriate, with the heads of executive departments and agencies, including the OMB and offices and agencies within the Executive Office of the President and recommend a plan to achieve that goal throughout the executive branch.Within 120 days the Director shall develop recommendations for Presidential action designed to guarantee scientific integrity throughout the executive branch, based on certain principles articulated in the Memo.
3. Executive departments and agencies shall carry out the provisions of this memorandum to the extent permitted by law and consistent with their statutory and regulatory authorities and their enforcement mechanisms. ** see below (2), (3)
(1) http://www.whitehouse.gov/blog/09/03/09/A-debt-of-gratitude-to-so-many-tireless-advocates/
(2) http://www.hhs.gov/
(3) http://www.hhs.gov/about/orgchart/index.html

Continue reading "Pres. Obama: ' Removing Barriers to Responsible Scientific Research Involving Human Stem Cells", "Scientific Integrity"" »

March 10, 2009

Northeast Health Settles Nursing Antitrust Lawsuit

The New York Times reports today:

A hospital network in the Albany area has agreed to pay $1.25 million to settle a class-action antitrust lawsuit in which nurses asserted that hospitals in the area had illegally conspired to hold down their wages.

The settlement with the network, Northeast Health, based in Troy, N.Y., was the first to be reached in a series of related antitrust lawsuits that nurses have filed in Chicago, Detroit, Memphis and San Antonio.

Read the rest here. Northeast Health admitted no wrongdoing and issued a statement calling the nurses' allegations "completely false."

City Hospitals Rank Low in Error Reporting

From today's New York Times:

New York City hospitals are the least reliable in the state at reporting preventable mistakes and adverse incidents for patients like heart attacks, blood clots, hospital infections and medication errors, according to a new report by the office of City Comptroller William C. Thompson Jr.

. . .

The report does not name individual hospitals, but the comptroller's office separately released a list of the 12 lowest reporters in the city based on 2006 data. The top three --- St. Vincent's Midtown and Cabrini Medical Center in Manhattan, and Mary Immaculate in Jamaica, Queens --- have all since closed.

Read the rest here.

Gov. Paterson applauds Pres. Obama's Action

Excerpts from Governor David A. Paterson’s press release 3/9/09 (1):

In 2007 New York State strengthened its position as a leader in biomedical research when we adopted an 11-year, $600 million initiative that provided State funding for stem cell research, in part to counter President Bush’s policy restricting federal funding for human embryonic stem cell (hESC) research to those hESC lines in existence prior to August 9, 2001….I applaud President Obama for signing this Executive Order and restoring federal funding at a time when our country is reeling from a historic economic downturn. Support for stem cell research offers hope for better health to millions while providing an economic stimulus to the biomedical industry….In addition to commending President Obama today, Gov. Paterson announced $101.8 million [,the latest] State funding for stem cell research, reinforcing New York’s continued investment and leading role in this rapidly evolving scientific field. ....
Stem cell research is considered the foundation of regenerative medicine, which aims to improve human health and alleviate disease….Investigators in New York and around the world are striving to understand...stem cells.Their findings will expand knowledge about fundamental cellular biology, provide a platform for drug discovery, and help realize the potential of regenerative medicine to treat diseases such as Alzheimer’s, Parkinson’s, diabetes and heart disease.
For a full list of awards, visit www.nyhealth.gov/funding/targeted_and_generic_award_list.htm. More information on New York’s stem cell research initiative can be found on the program website at www.stemcell.ny.gov.

NIH's new 'Challenge Grants'. Bioethics, 'Nature' on the stem cell EO

Post Edit 3/13/09
From NIH (1):'The American Recovery and Reinvestment Act of 2009 ( the Recovery Act)... [2/17/09] makes supplemental appropriations for job preservation/creation, infrastructure investment, energy efficiency and science, assistance to the unemployed, and State and local fiscal stabilization, for the fiscal year ending 9/30/09, and for other purposes. As part of the Recovery Act, NIH has designated at least $200 million in FYs 2009 - 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research, to fund 200 or more grants, contingent upon the submission of a sufficient number of scientifically meritorious applications. This new program will support research on Challenge Topics which address specific scientific and health research challenges in biomedical and behavioral research that will benefit from significant 2-year jumpstart funds.'
'High Priority Topics' include '(02) Bioethics' research topics (topics of interest to many lawyers as well):
-Informed consent and data access policies;
-Unique ethical issues posed by emerging technologies;
-Ethical issues in health disparities and access to participation in research;
-Ethical issues associated with electronic sharing of health info.
-Ethical issues raised by the blurring betwen treatment and research.(2)
High Priority Topics, '(14) Stem cells' research topics include among the science projects challenges in using iPs cells.(3)
Nature news online March 9,09 "President's executive order will allow US human embryonic stem-cell research to thrive at last"(4) reports that;

NIH is now working out policies that will allow researchers to apply for grant money from the agency to study some of the hundreds of cell lines created since 9 August 2001, when President Bush limited federal funding to research on lines in existence at that time. Some scientists are already proposing to use the new lines in applications for $200 million in NIH 'Challenge' grants, which will be funded by the economic stimulus package signed into law last month. Details of these grants were unveiled last week (see NIH website).
Estimates of the number of new lines range from 400 to 1,000. Unlike the 21 lines previously eligible for federal funding, many of the lines have been made from embryos that had genetic predispositions to specific diseases, or were derived using 'animal-free' preparations, and thus could be more relevant to laboratory research and preclinical studies.

(4)http://www.nature.com/news/2009/090309/full/458130a.htmlPublished online 9 March 2009 | Nature | doi:10.1038/458130a

March 13, 2009

OMIG Self-disclosure Guidelines

OMIG has just issued in final the new voluntary self-disclosure guidance, which can be located here.

Hat tip: Ellen Weissman, via the Health Law Listserve

March 14, 2009

Pres. Obama's Weekly Address: 'Reversing a Troubling Trend in Food Safety' new FDA appointments

Pres. Obama's Weekly Address (3/14/09), excerpts from the Blog, White House transcript. The video can be viewed online at www.whitehouse.gov. 'In his weekly address, President Barack Obama announced the appointments of Dr. Margaret Hamburg as Commissioner of the FDA, and Dr. Joshua Sharfstein as the Principal Deputy Commissioner, as well as the creation of a new Food Safety Working Group.' A few of Pres. Obama's remarks :

I've often said that I don't believe government has the answer to every problem or that it can do all things for all people. We are a nation built on the strength of individual initiative. But there are certain things that we can'tdo on our own. There are certain things only a government can do. And one of those things is ensuring that the foods we eat, and the medicines we take, are safe and don't cause us harm. That is the mission of our FDA and it is a mission shared by our Department of Agriculture, and a variety of other agencies and offices at just about every level of government.
The men and women who inspect our foods and test the safety of our medicines are chemists and physicians, veterinarians and pharmacists. It is because of the work they do each and every day that the United States is one of the safest places in the world to buy groceries at a supermarket or pills at a drugstore…
But in recent years, we've seen a number of problems with the food making its way to our kitchen tables. ….
Part of the reason is that many of the laws and regulations governing food safety in America have not been updated since they were written in the time of Teddy Roosevelt. It's also because our system of inspection and enforcement is spread out so widely among so many people that it's difficult for different parts of our government to share information, work together, and solve problems. And it's also because the FDA has been underfunded and understaffed in recent years...
That is a hazard to public health. It is unacceptable. And it will change under the leadership of Dr. Margaret Hamburg, whom I am appointing today as Commissioner of the [FDA]. …
Their critical work – and the critical work of the FDA they lead – will be part of a larger effort taken up by a new Food Safety Working Group I am creating. This Working Group will bring together cabinet secretaries and senior officials to advise me on how we can upgrade our food safety laws for the 21st century; foster coordination throughout government; and ensure that we are not just designing laws that will keep the American people safe, but enforcing them.... blockquote>
For the New York in the Supra blog, Dr. Hamburg's stellar credentials include serving as Commissioner of Health for the City of New York.

March 17, 2009

AHRQ: Methods Guide for Comparative Effectiveness Reviews

Newsletter excerpts from AHRQ News and Numbers 3/16/09 Issue #272 :

AHRQ is excited about the new opportunities under ARRA to provide patients, clinicians, and others evidence-based information to make informed decisions about health care. ARRA contains $1.1 billion for comparative effectiveness research. Of the total, $300 million is for AHRQ to build on its existing collaborative and transparent Effective Health Care program… Of the remaining funds,$400 million each will go to NIH and the Office of the HHS Secretary. The legislation calls on the IOM to recommend research priorities for these funds and gather stakeholder input. [Report due 6/30/09]. In addition, the Federal Coordinating Council for Comparative Effectiveness Research will be created to offer guidance and coordination on the use of these funds.

One of many helpful and educational topics: AHRQ the Methods Guide for Comparative Effectiveness Reviews:
Effectiveness and Comparative Effectiveness Reviews, systematic reviews of existing research on the effectiveness, comparative effectiveness, and comparative harms of different health care interventions, are intended to provide relevant evidence to inform real-world health care decisions for patients, providers, and policymakers. In an effort to improve the transparency, consistency, and scientific rigor of the work of the Effective Health Care Program, through a collaborative effort, [AHRQ], the Scientific Resource Center, and the Evidence-based Practice Centers have developed a Methods Guide for Comparative Effectiveness Reviews. We intend that these documents will serve as a resource for our EPCs as well as for other investigators interested in conducting Comparative Effectiveness Reviews....The first draft of the Methods Guide for Comparative Effectiveness Reviews was posted for public comment for 8 weeks in late 2007.... In response to requests from investigators and others interested in Comparative Effectiveness Review methods, we have reposted the original chapters of the draft guide….Comments and suggestions on the Methods Guide for Comparative Effectiveness Reviews and the Effective Health Care Program can be made at http://effectivehealthcare.ahrq.gov. (1)

Patients, health care providers (including nurses, doctors and other clinicians),and policymakers all share an interest in making the best health decisions. One of the greatest challenges is finding reliable and practical data that can inform these decisions.... The Effective Health Care Program follows 3 approaches to research in order to provide current, unbiased evidence on health care interventions.
-Review and synthesize published and unpublished scientific evidence.
-Promote and generate new scientific evidence and analytic tools in an accelerated and practical format.
-Compile the findings and translate them into a variety of useful formats for stakeholders.(2)

(1) http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&ProcessID=60

Brookdale Lays Off 240

From today's New York Times online:

A hospital in central Brooklyn laid off 240 doctors, nurses and other workers on Monday, signaling growing financial weakness in the hospital industry.

Officials at the hospital, Brookdale University Hospital and Medical Center, which serves Brownsville, East New York and Canarsie, blamed the bad economy for the layoffs.

Read the rest here.

March 18, 2009

NYSTEM RFA:development of stem cell science undergrad curriculum, includes related law

The New York State Department of Health/NYSTEM is requesting applications
for the development of curriculum in stem cell science and related issues.
This Request for Applications (RFA) and application forms can be found on
the internet at: http://www.nyhealth.gov/funding/rfa/0809080957/.
The NYSTEM RFA Issued is entitled: Development and Implementation of College and University Curricula Concerning Stem Cell Science and Related Ethical, Legal and Societal Implications. The RFA indicates that the Project Work is to develop a curriculum for undergraduate science and non science majors alike.
The subject of the 'law' as related to stem cell science and society is listed as one of many educational disciplines which could form a part of the curriculum courses or modules of a course. The Applicant must be a NYS not-for-profit post secondary edu. institution or not-for-profit org. with strong ties to one or more post secondary edu. institutions and the PI must be employed by it.(A detailed description of who may apply as well as the other RFA info is set forth in the document).

March 23, 2009

More Health Layoffs

Hard on the heels of Brookdale's announcement last week comes this in last Friday's New York Times:

New York City's public hospital system announced Thursday that it was cutting 400 jobs and closing some children's mental-health programs, pharmacies and community clinics that serve more than 11,000 patients.

Read the rest here.

March 25, 2009

Republishing excerpts in blogging; Wiki on 'scraping' and 'simulated' human browsing

From Martha Neil's article (published 3/4/09, the ABA Journal Newsletter online) flagging a New York Times report on the apparent upward trend in copyright infringement lawsuits directed at bloggers and other on line publishers: How Much Excerpting is Too Much? 'Scraping' Suits May Hone Fair Use Rules (1):

It is considered a clear fair use of copyrighted material when bloggers excerpt a quotation and link to the online publication that initially printed it....If federal lawmakers don't act to revise the statutory fair-use standard, copyright litigation is likely to develop the specific rules that apply to Internet republication.

Not having read this NYT article, I linked over to it and the author's question(2):
The legal disputes are emblematic of a larger question that has emerged from the Internet’s link economy. The editors of many Web sites, including ones operated by the Times Company, post excerpts from competitors’ content from time to time. At what point does excerpting from an article become illegal copying? Courts have not provided much of an answer. In the United States, the copyright law provides a four-point definition of fair use, which takes into consideration the purpose (commercial vs. educational) and the substantiality of the excerpt...[by Brian Stelter published 3/1/09]

For info. purposes, the Wiki's take on 'scraping':
Web scraping (or Web harvesting, Web data extraction) is a computer technique of extracting information from websites using specially coded software programs. Usually, such software programs simulate human exploration of the Web by either implementing low-level Hypertext Transfer Protocol (HTTP), or embedding certain full-fledged Web browsers, such as the Internet Explorer (IE) and the Mozilla Web browser. Web scraping is closely related to Web indexing, which indexes Web content using a bot and is a universal technique adopted by most search engines. In contrast, Web scraping focuses more on the transformation of unstructured Web content, typically in HTML format, into structured data that can be stored and analyzed in a central local database or spreadsheet. Web scraping is also related to Web automation, which simulates human Web browsing using computer software. Exemplary uses of Web scraping include online price comparison, weather data monitoring, website change detection, Web research, Web content mashup and Web data integration. (3)

(4)http://www.citmedialaw.org/about Neill's article links also to:The Citizen Media Law Project (CMLP).The mission of the CMLP is to provide legal assistance, education, and resources for individuals and organizations involved in online and citizen media, [providing] research and advocacy on free speech, newsgathering, intellectual property, and other legal issues related to online speech. CMLP is jointly affiliated with Harvard Law School’s Berkman Center for Internet & Society and the Center for Citizen Media.We seek to build a community of lawyers, academics, journalists, and others who are interested in facilitating citizen participation in online media and in protecting the legal rights of those engaged in speech on the Internet.

The U.S. State Department's International Health Affairs

Time is of the essence and the Internet makes it more so.
Direct and timely from the U.S. State Department’s email subscription service, keep up to date on international health issues.
Ask Secretary Clinton a question about her trip to Mexico March 25-26, via on-line or twitter. (see State Dept. website’s home page.)
There is also the State Dept. blog, 'Dipnote'

which offers the opportunity for participants to discuss important foreign policy issues with senior Department officials. (1)

From 'About the State Dept's blog': The mission of the State Dept. is to create a more secure, democratic, and prosperous world for the benefit of the American people and the international community.Through its websites and other online resources, the Dept. offers broad public access to a wide range of info. [including international health issues] Blogs.state.gov offers the public an alternative source to mainstream media for US foreign policy info. (2)
The Office of International Health Affairs (OES/IHB) is the State Department’s general health office. IHB works with agencies throughout the U.S. government to facilitate policy-making regarding environmental health, infectious diseases , health in post-conflict situations, surveillance and response, and health security.IHB promotes effective strategies for global health by encouraging strong political leadership on health policy. The office works with other government agencies to represent the U.S. position on health matters in international fora and assists U.S. diplomatic posts in their health-related activities with foreign governments.(3)

One area of focus: chronic diseases.
Chronic diseases are now the major cause of death and disability worldwide. Although chronic diseases make up a greater proportion of deaths and illnesses in developed countries, overall the greatest numbers of chronic disease deaths and illnesses occur in the developing world. Almost half of the disease burden in low and middle-income countries is now from non-communicable diseases. Apart from the tremendous adverse effects on the quality of life of individuals involved, these conditions place enormous strains on family and community budgets. The overall economy suffers from both the labor units lost due to death and illness as well as the high direct medical costs. This phenomenon, during which health infrastructures already weakened by continuing battles with infectious disease are increasingly being taxed by rapidly growing chronic diseases, is often referred to as the double disease burden.


March 30, 2009

new global edition website

The New York TImes and Int'l Herald Tribune are launching a new joint website: the Global Edition at global.nytimes.com combining their international reporting and voices from a distinctly global perspective.
Thanks to TV5MONDE for their news report.(2)

March 31, 2009

New NYLJ Health Article: "Handling Audits and Investigations of Health Care Providers"

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," appears in the March 31, 2009 edition:

Providers such as hospitals, nursing homes, outpatient clinics, home health agencies, physician groups, clinical laboratories, imaging centers, medical equipment suppliers, and so on, account for the largest share of payments by the Medicare and Medicaid programs. As such, providers should be prepared to handle audits or investigations as more of them occur. This column is the first of two that discuss who conducts Medicare and Medicaid inquires, what can trigger them, how they are conducted, and some of the steps that providers should consider taking to protect themselves if they find themselves under audit or investigation.

Link to the reprint of the article posted on the Greenberg Traurig website.

About March 2009

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

February 2009 is the previous archive.

April 2009 is the next archive.

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