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December 2008 Archives

December 3, 2008

NY Presbyterian Suspends Worker Over Burress Coverup

I've been trying to follow the story of NFL receiver Plaxico Burress shooting himself in the leg and somehow obtaining emergency care without the gunshot wound being reported, but with only middling success. CNN has a nice encapsulation going. Here's the lede:

A New York hospital worker was suspended for failing to report the gunshot wound of NFL star Plaxico Burress, a hospital spokeswoman told CNN Monday. The spokeswoman, Kathy Robinson, gave no further detail on the New York Presbyterian Hospital employee.

"We can confirm that the individual at New York Presbyterian Hospital, who was responsible for failing to report the incident, has been suspended," hospital spokeswoman Robinson said.

Burress has garnered media attention recently for accidentally shooting himself with a gun he is accused of bringing into a crowded New York night club.

I was wondering when they were going to get around to doing that. Read the rest here.

FDA/WebMD collaboration; FDA Co Branding Policy- Consumer Health Info.

FDA and WebMD announced a collaboration that expands consumers' access to the agency's timely and reliable important health information. WebMD, which attracts nearly 50 million unique visitors each month, provides consumers with credible and timely health news and information. (1) The partnership includes:
-A new online consumer health information resource on WebMD.com (www.webmd.com/fda);
-FDA Consumer Updates will also be featured at least 3 times a year in WebMD's bimonthly magazine (distributed to physician office waiting rooms across the country).

Consumers have increasingly consulted all types of sources to find health information, and the Internet is their fastest growing resource, according to a national study released in August 2008 by the Center for Studying Health System Change. Researchers found that 32 percent of American consumers—70 million adults—conducted online health searches in 2007, compared with 16 percent in 2001. The study also found that most consumers who researched health concerns reported positive outcomes. More than half of those surveyed said the information changed their overall approach to maintaining their health. Four in five said the information helped them better understand how to treat an illness or condition.

An agency policy statement summarizing the criteria and processes for development of such partnerships is available on the FDA's Web site. (2)The purpose of this policy statement is to establish terms of collaboration between FDA and other public and private entities involving the co-branding of FDA Consumer Health Information. The overall goal of such partnerships is to empower the public to improve their health, safety and well-being.
Partnership proposals should include a statement agreeing to the terms of the agency's co-branding policy statement.
FDA criteria includes(summarized):
-FDA Consumer Health Information should be easily distinguishable from non-FDA content.
-Printed and online pages containing FDA Consumer Health Information must be free of advertisements to avoid implying FDA's endorsement or support for a particular product, service or Web site.
-Co-branding arrangements are not exclusive.
-Co-branding organizations agree to comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 (see HHS policy on Section 508 compliance at www.hhs.gov/od/508policy/index.html); and Office of Management and Budget (OMB) policies for protecting private information (see www.usa.gov/webcontent/reqs_bestpractices/laws_regs/privacy.shtml).
-Co-branding arrangements are not intended, and may not be relied on, to create any right or benefit, substantive or procedural, enforceable by law by any party against the United States or co-branding organization.
-FDA and co-branding organizations cooperate in maintenance of trademarks/logos. The FDA logo shall not be used for marketing purposes other than to promote the co-branded -FDA Consumer Health Information. Use of FDA logos must adhere to published FDA logo policies.
-Both parties agree that information FDA provides to co-branding organizations shall be public domain material.
-For on-line collaborations, co-branding organizations provide FDA with statistical information at least every 2 months on the number of users viewing FDA Consumer Health Information for purposes of joint review/evaluation.
-Co-branding organizations promote/maintain current FDA Consumer Health Information and must also remove it under various provisions, they also ensure that the most recent information on a particular topic is highlighted in an acceptable manner.
Co-branding arrangements do not transfer to either party any rights in any technology/IP.

ESSCB's Annual Report: New York's stem cell research program off to a strong start

The 2007-2008 Annual Report of the Empire State Stem Cell Board is now
available online (1). The report covers the Board's activities during its first year of operation
and includes abstracts of initial contracts awarded.
NYS DOH Commissioner Richard F. Daines, M.D. writes in his message:

With the support of Gov. David A. Paterson and the State Legislature, much progress has been made in getting New York's stem cell research program off to a strong start.... Lieutenant Gov. Mr. Paterson was instrumental in passing legislation that created the Empire State Stem Cell Fund and Board...in addition I want to acknowledge that this initiative could not have occurred without the support of the medical , scientific, voluntary health and patient advocacy communities who urged the state to embrace this promising field of science...We want New York's stem cell research to be world-class, not only in the sense that it leads to breakthroughs in the prevention and treatment of diseases. We also want the research to be world-class in its adherence to the most widely accepted and reviewed ethical, medical and scientific standards....

Upcoming Meetings are scheduled for:
Funding Committee Meeting Thursday, December 18, 2008
Ethics Committee Meeting Monday, January 26, 2009


December 4, 2008

New York City Moves Forward With New Cardiac Arrest Transport Protocol

FDNY will soon be implementing an interesting new transport protocol for cardiac arrest patients. Here's the lede from today's New York Times:

Starting on Jan. 1, New York City ambulances will take many cardiac arrest patients only to hospitals that use a delicate cooling therapy believed to reduce the chances of brain damage and increase the chances of survival, even if it means bypassing closer emergency rooms.

The rest of the article is here.

The project is referred to as "New York City Project Hypothermia." According to the September 2008 GNYHA Newsletter, FDNY intends to eventually incorporate cooling ("therapeutic hypothermia") into the prehospital care environment.

Selective destination protocols are not new in New York. A similar type of transport protocol was put in place statewide in 2005, the idea being that patients experiencing a stroke are better off going to designated "stroke centers" even if such centers are at a greater distance than local hospitals that are not so designated. The stroke protocol can be found here.

December 8, 2008

Stark IV Regulations

The 2009 Hospital Inpatient Prospective Payment System Final Rule published on August 19, 2008 (pp. 48688-48745) makes some significant changes to the Stark regulations. A previous post discussed the changes to the stand-in-the-shoes regulations. This post discusses the new provisions in 42 CFR § 411.353(c) that provide guidance on defining the period of disallowance when referrals are prohibited due to a financial relationship between an entity and a physician that does not meet an exception.

Under these new provisions, if the noncompliance is unrelated to compensation, the financial relationship is brought into compliance on the date the relationship satisfies all requirements of an applicable exception. If the noncompliance is due to the payment of excess compensation, all excess compensation must be returned to end the period of disallowance. If noncompliance results from the payment of insufficient compensation, then all additional required compensation must be paid. Under this interpretation of the Stark law, a physician may not refer a Medicare patient to a hospital for a designated health service if the physician failed to pay additional rent owed to the hospital under a lease agreement until such additional rent was paid, even if the lease agreement had expired and the physician had vacated the space.

CMS will allow a compensation arrangement to meet an exception if the only missing element is a signature of one or more of the parties to an agreement that otherwise satisfies the requirements of the applicable exception and the signature is later obtained. If the failure to comply with the signature requirement was inadvertent, the parties have ninety (90) days from the date on which the arrangement became non-compliant to obtain the missing signature. If the failure to comply was not inadvertent, but knowing, the parties must obtain the required signature within thirty (30) calendar days following the date on which the compensation arrangement became noncompliant. Under other Medicare statutes, knowing means not only actual knowledge, but also reckless disregard or deliberate ignorance.

December 11, 2008

Share the wealth: NYSBA members comment on recent economic turmoil

From the New York State Bar Association Journal Editorial Blog (1), posted by
David Wilkes, Esq., with NYSBA members' comments:

November/December Poll Question

How has the recent economic turmoil affected your law practice?

(1) http://nysbar.com/blogs/barjournal/

December 12, 2008

Daschle to Lead HHS, Also to Direct White House Office of Health Care Reform

From today's New York Times:

Calling an overhaul of the health care system a basic element of his administration's economic recovery programs, President-elect Barack Obama on Thursday presented former Senator Tom Daschle as his choice to become secretary of health and human services and to lead efforts to secure "affordable, accessible health care for every single American."

Read the rest here.

NY Leaning on Hospitals to Share Data

From the December 3 GovernmentHealthIT:

As part of its certificate of need process, New York state is requiring that hospitals investing in major clinical information technology systems enable those systems to communicate with the developing Statewide Health Information Network for New York (SHIN-NY).

The new requirement will have its first effect Dec. 11 when the State Hospital Review and Planning Council is expected to approve an application by Mount Sinai Hospital in New York City to spend more than $34 million on a new inpatient medical records system.

Read the rest here.

Hat tip to Maureen Blazowski for suggesting this article. Thanks, Maureen!

December 15, 2008

Governor to Deliver Budget Address Tomorrow

Governor David A. Paterson will deliver his 2009-10 Budget Address at 11 a.m. on Tuesday, December 16 at the New York State Convention Center, located at the Empire State Plaza in Albany. The event, which is exclusively for members of the Legislature and the press, will be broadcast via satellite (coordinates below) and available for live webcast viewing at www.ny.gov/governor/budgetwebcast to allow members of the public to view the address simultaneously.

December 22, 2008

New Conscience Regulation

The Bush administration has issued a new rule that will require hospitals and other facilities that receive federal funding to certify compliance with the federal healthcare conscience protection statutes, which protect an entity's and individual's right to refuse to participate in an abortion. New York law already prohibits an employer from discriminating against an employee who refuses to assist with performing an abortion due to his/her conscience or religious beliefs and has filed a prior written refusal with the appropriate person. The new rule requires health care entities, including individual physicians, to submit the following certification in an application for a grant, cooperative agreement, contract, grant under a contract, memorandum of understanding or other funding or employment instrument or contract or when receiving funds from a recipient of such instrument:

As the duly authorized representative of the recipient I certify that the recipient of funds made available through this instrument will not subject any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortion as part of the federal program for which it receives funding.

The new rule goes into effect January 1, 2009, but HHS agencies have until October 1, 2009 to phase in the written certification requirement. Senators Clinton and Murry have introduced legislation to overturn the new rule.

December 30, 2008

ESSCB Funding Committee Meeting 12/18/2008 Awards:Targeted Research and Investigator-Initiated Research

The webcast of the ESSCB Funding committee meeting held December 18 2008 is archived for the public to view on the NYS DOH website.(1) At this meeting, the Funding Committee voted on recommendations made by their national peer review contractor, American Institute of Biological Sciences.(2) ESSCB By-Laws require that the Funding Committee provide for the establishment of one or more Independent Scientific Peer Review Panels (ISPRP) as needed to review applications submitted to the committee. The ISPRP reviews/ranks applications based upon criteria, requirements and standards adopted by the Funding Committee for the specified requests for proposals or requests for applications and makes recommendations to the Funding Committee for the award of grants and contracts.(3)
At this Funding Committee meeting, Board members approved certain Targeted Research Award and Investigator-Initiated Research Award Recommendations, together comprising over 90 separate awards.
New York is well positioned to be a leader in the field of stem cell research. The State of New York has committed to invest $600 million in stem cell research over 11 years. Categories for target distribution during the 5 year plan (targeted plan expenditure total of $300 million) of the Empire State Stem Cell Trust fund include research, scientific training, infrastructure development, ELSIE, and Administration. (4)
Here are some rough counts I’ve made based on my notes sketched while viewing this webcast on a one time basis. As it is year end, I would guess the info is welcomed news for many people. For that reason, I am happy to share here in this post what I noted for purposes of the Supra blog visitors alone. Authoritative reports, ESSCB Meeting minutes as approved and the news should be your first sources for reliance to find accurate and complete info on this subject matter. Of course watching the webcast itself is a solid source. Revisions will probably ensue.
ESSCB Funding Committee approvals included:

6 Idea Apps. together granting about $ 1.3 million
14 Principal investigator Apps. together granting about $16.3 million
32 Generic research Apps together granting about $7.6 million
46 Generic investigator Apps together granting about 45.5 million.

21 awards for over $ 14 million associated with Columbia University,Columbia Medical Center/School, (1 award to Barnard College);
10 awards for over $ 6 million associated with the University of Rochester;
9 awards for over $6 million associated with Albert Einstein College of Medicine
9 awards for over $7 million associated with Mount Sinai School of Medicine;
7 awards for over $3 million associated with New York University,
6 awards for over $5 million associated with Memorial Sloan-Kettering Cancer Center;
5 awards for over $3 million associated with Regeneration Institute/Foundation,
4 awards for over $3 million associated with SUNY Buffalo;
3 awards for over $2 million associated with SUNY Stony Brook;
2 awards for over $2 million associated with Hunter CUNY ;
Remaining awards for over $1 million associated with Health Research Institute, Rensselaer Polytechnic Institute, Research Foundation for Mental Hygiene, Upstate Medical U. Albany Medical College ($240,000) and Roswell Park Cancer Institute ($960,000).
Listening to the titles of the App research proposals provides a fascinating glimpse into some of the latest stem cell research. The magnitude and detail involved in voting alone on the award applications will assure most viewers that the ESSCB Funding Committee work is hard work.
Other Funding Committee agenda items were discussed and important issues addressed and held over for discussion at the next meeting to be held Feb 12, 2009.
(1) http://www.nyhealth.gov/events/webcasts/archive/
(2) http://spars.aibs.org/
(3) http://www.stemcell.ny.gov/about_esscp_bylaws.html Note:During this Funding Committee meeting, in the case of conflicts of interests constituting “Absolute Disqualifications”, Board members with such conflicts immediately left the meeting and remained absent during the period when the application was under consideration, as required by the COI procedure set out in the ESSCB By-Laws.
(4) http://stemcell.ny.gov/docs/NYSTEM_Strategic_Plan_FINAL.pdf

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About December 2008

This page contains all entries posted to HEALTH LAW SECTION BLOG in December 2008. They are listed from oldest to newest.

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