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July 2008 Archives

July 2, 2008

HHC Agrees to Changes After Tragic Video

From today's New York Times:

New York City's Health and Hospitals Corporation agreed on Tuesday to increase the monitoring of patients at a public psychiatric ward in Brooklyn. The agreement came after a videotape surfaced showing a patient collapsing onto a floor after waiting nearly 24 hours to be seen, and lying there for about an hour while hospital workers did nothing for her. The patient soon died.

Read the rest here.

Insurance Department Delays Malpractice Premium Update

The Business Review in Albany covers the delay of the excess medical malpractice insurance premiums for '08-'09:

The New York State Insurance Department has postponed the setting of new medical malpractice insurance rates, originally scheduled for July 1.

Superintendent of Insurance Eric Dinallo said the delay will provide time for the negotiation of reforms to the malpractice system, which could result in reduced rates. When rates for 2008-2009 are determined, they will be retroactive to today.

Read the full story here.

DOH Seeks Input on Universal Coverage Proposals

From the DOH website:

New York State Health Commissioner Richard F. Daines, M.D., and Insurance Superintendent Eric Dinallo today invited public comments on instructions that will guide the modeling of proposals to expand health insurance coverage in New York State.

The DOH press release is here. The instructions can be found here on the partnership4coverage website (PDF document).

Some ideas about "doing science" and public health policy-post #1

The many NYSTEM public meetings, and the presentations given during them, are important for public discourse and the most up to date education about the hopes for stem cell research in public health.
As can be seen via its public meetings,the NYSTEM endeavor moves away from any popularizing of stem cell science --which has at times occurred in the past when interdisciplinary policy/decision makers have met together to develop public policy in this new area of scientific research. Why not use a 'popular science" approach to communicate about it in the context of public policy? One consideration follows.
From “The Philosophy of Science, An Introduction” by Stephen Toulmin, page 11, paragraph 1.2, “Popular physics and the layman”.

…there is no doubt that authentic science is being discussed [in books on popular science], but the terms in which it is presented are not as explanatory as they first seem. There is a tendency for the writer in this field to tell us only about the models and conceptions employed in a novel theory, instead of first giving us a firm anchor in the facts which the theory explains, and afterwards showing us in what manner the theory fits these facts. The best the layman can then hope for is a misleadingly unbalanced picture of the theory…
[T]he whole reason for accepting the atomic model is that it helps us to explain things we could not explain before. Cut off from these phenomena, the model can only mislead, raising unreal and needless fears about what will happen…the same goes for the pretty pictures which captured our imaginations: pictures of the electrons in an atom as like bees in a cathedral, the picture of the brain as a telephone exchange and the rest…

… a mode of expression which to the outsider is self-contradictory points to something the laymen needs to be told about the language of physical theories. When a theory is developed , all kinds of phrases which in ordinary life are devoid of meaning are given a use, many familiar terms acquire fresh meanings, and a variety of new terms is introduced to serve the purposes of the theory. ..[T]his has its consequences when a scientist comes to explain some new theory to the layman. For then he may unwittingly use in his exposition terms and a turn of phrase which can be understood properly only by someone already familiar with the theory….So also in popular sciences: the layman is not just ignorant of the theories of science, but also unequipped to understand the terms in which a scientist will naturally begin to explain them…

For the words of scientist are not always what they seem and may be misleading taken out of context. As Einstein has said, “If you want to find out anything from the theoretical physicists about the methods they use, I advise you to stick closely to one principle: don’t listen to their words ,fix your attention on their deeds.

And to that end, I’d like to highlight Dr. Silverstein's interesting presentation given at the last NYSTEM meeting about the role of education in the life sciences. (see archived webcast)
My editorial: Going to a lab, doing the work scientists do, studying AND then solving the problems, is one of the best ways to test your knowledge of the science. And with support, anyone can do it to some extent. And, the appreciation deepens the more time you can spend "doing" the science in the lab and solving the problems it asks.
The other presentation made at the last NYSTEM meeting was also an important building block for public knowledge--more about it in post #2 and some ideas on building scientific knowledge.
(1)http://stemcell.ny.gov/events_full_board_meetings.html
"Secondary School Initiatives" presentation Samuel Silverstein, M.D.

Continue reading "Some ideas about "doing science" and public health policy-post #1" »

Update your CDER bearings

For more information on clinical investigators, protection of human subjects, and regulatory and compliance programs, a recent CDER news item sugggests CDER's "Information for Clinical Investigators" webpage. This webpage provides guidance for conducting clinical trials with investigational drugs and information for compliance with the regulations of the FDA.
For clinical investigators who are not familiar with FDA regulations and the guidance that the Agency provides for good clinical practice, CDER advises that there are two sources of information which investigators should read first.
-Federal Regulations for Clinical Investigators contains Code of Federal Regulations pertaining to the responsibilities of clinical investigators.
-Guidance for Industry: Good Clinical Practice Consolidated Guideline.(E6, 63 pp) This guidance, developed with the European Union, Japan, and other countries represents the Agency's current thinking on good clinical practice, and contains 62 definitions of terms used in clinical trials.(1)
CDER's point:

Clinical trials represent the ultimate premarket testing ground for unapproved drugs. During these trials, an investigation compound is administered to humans and is evaluated for its safety and effectiveness in treating, preventing, or diagnosing a specific disease or condition. The results of this testing will comprise the single most important factor in the approval or disapproval of a new drug.
Although the goal of clinical trials is to obtain safety and effectiveness data, the overriding consideration in these studies is the safety of those in the trials. CDER monitors the study design and conduct of clinical trials to ensure that people in the trials are not exposed to unnecessary risks.

Update your CDER bearings:
http://www.fda.gov/cder/cderorg/cder-all.pdf showing the updated CEDER org. chart-June 20th 2008
http://www.fda.gov/cder/guidance/CompList06-2008.pdf a comprehensive "guidance" listing/dates
(1) E6 Guidance document: http://www.fda.gov/cder/guidance/959fnl.pdf

July 3, 2008

Natural Products-Sources of New Drugs

This Review article, 'Natural Products as Sources of New Drugs over the last 25 Years' (on-line 2/07,17pp) provides an analysis of the sources of new and approved drugs for the treatment of human diseases--from David Newman and Gordon Cragg at the Natural Products Branch, Developmental Therapeutics Program of the National Cancer Institute (NCI).
Their review covers all approved agents for all diseases worldwide over this time frame and from 1950 to 6/2006 for all approved antitumor drugs worldwide. They characterize a subdivision of drugs to describe "natural product mimics" ('NM') to join the original primary drug divisions.(1)
They present extensive data and technical analysis yet overall this Review is readable by the non- scientist-- their 'Discussion" section is very interesting.

From the data presented, the utility of natural products as sources of novel structures but not necessarily the final drug entity is still alive and well. In the area of cancer,over the time frame from around 1940s to date, of the 155 small molecules, 73% are other than "S" (synthetic), with 47% actually being either natural products or directly derived therefrom. ... Although combinatorial chemistry techniques have succeeded as methods of optimizing structures and have, in fact, been used in the opitimization of many recently approved agents, we are able to identify only one de novo combinatorial compound approved as a drug in this 25 year plus time frame.

...[T]he development of high throughput screening based on molecular targets had led to a demand for the generation of large libraries of compounds to satisfy the enormous capacity of these screens... [but] the shift away from large combinatorial libraries has continued, with the emphasis now being on small , focused collections that contain much of the 'structural aspects' of natural products. Various names have been given to this process, including "Diversity Oriented Syntheses" but we prefer to simply say 'more natural product-like' in [certain] terms.

...the developmental capability of combinatorial chemistry as a means for structural optimization once an active skeleton has been identified without par. The expected surge in productivity however has not materialized...thus, the number of new active substances (NASs), also known as New Chemical Entities (NCEs)...hit a 24-year low of 25 in 2004 with a rebound in 2005 to 54...

...Research being conducted is continuing the modification of active natural product skeletons as leads to novel agents, so in due course, the numbers of materials developed by linking Mother Nature to combinatorial synthetic techniques should increase. This aspect, plus the potential contributions from the utilization of genetic analysis of microbes, [is] discussed at the end of this review.

In the middle of 2006, the botanical preparation Hemoxin was approved in Nigeria following demonstration of efficacy in clinical trials as a treatment for sickle cell anemia. This is a mix of plants that came from native healer information and thus classified as 'true ethnobotanical preparation'.
To us, a multi-disciplinary approach to drug discovery, involving the truly novel molecular diversity from natural products sources, combined with total and molecular combinatorial synthetic methodologies, and including the manipulation of biosynthetic pathways, provides the best solutions to the current productivity crisis facing the scientific community engaged in drug discovery and development.

So it is no surprise that natural products, herbal remedies and the like are so much in the news and also a focus of regulatory agencies-- in most instances asking for the science behind their medicinal claims.
For scientists who study molecules, they find their subject in both natural and unnatural, organic and inorganic entities. The questions they ask know only the boundaries established by their current understanding of the phenomena they study.
Also, the recognition of the role natural products play in the current scientific trend is shaping in great part interactions/discussions by and among representatives of Eastern and Western countries who meet again and again in various international venues to share and protect their traditional knowledge and scientific prowess. Viewpoints continue to take shape in giving the various endeavors fair direction in setting mutual priorities and developing capablities.

(1)http://pubs.acs.org/cgi-bin/sample.cgi/jnprdf/asap/pdf/np068054v.pdf published in J. Nat. Prod. 2007, 70, 461-477, See below for a few helpful key terms for reference from 2000, 2003 chemistry textbooks.

Continue reading "Natural Products-Sources of New Drugs" »

Commissioner: Berger Commission Measures Implemented

Commissioner Daines reported July 2 that the Berger Commission's mandates, which involved closure of 9 hospitals and 7 nursing homes, as well as the downsizing and restructuring of dozens of other institutions, have been implemented.

Measures to reform and restructure New York's health care system as recommended by the Commission on Health Care Facilities in the 21st Century (Berger Commission) have been implemented, State Health Commissioner Richard F. Daines, M.D., reported today.

. . .

The Berger Commission recommendations became legal mandates in New York on January 1, 2007, and were given a June 30, 2008, deadline for implementation. The Commission cited the need to eliminate excess hospital and nursing home bed capacity, eliminate hospital duplication of services, modernize outdated health care facilities, and provide New Yorkers with greater access to primary and preventive care.

Dr. Daines' full press release is here. A comprehensive chart showing the original commission mandates and the status of the mandate, as well as the HEAL grant monies disbursed, is here.

July 5, 2008

Connecting for Health (public-private collab):electronic data stream scenarios for drug prescription transactions

News from CDT's Policy 14.9 June 24, 2008, Privacy and Security Principles for Health Information Technology (1). CDT joined prominent health care providers, Internet companies, insurers, and other consumer advocates in endorsing a set of practices for new Internet services that allow individuals to access and maintain their personal health information. The framework, developed in a collaborative process organized by the Markle Foundation, recommends a detailed and comprehensive set of practices that can help protect the privacy and security of Personal Health Records (PHRs) and other services.
Of interest to Supra biotech readers: Consumer Technology 1 ('CT1') under 'Technology Overview' -this document provides scenarios designed to illustrate electronic data streams for the most common transaction in health care: a drug prescription.

The first scenario describes a common and simplified set of transactions stemming from a small clinical practice. The second scenario adds sophistication and complexity, depicting transactions that are less common today (although they may become more common in the emerging electronic environment).(2)

Connecting to Health accepts that much of our valuable personal health data is stored in and managed by numerous entities. The next key challenge is to establish the rules and techniques that establish trust among participants over a 'network of networks'. Policy rules will be needed in a number of areas, including patient consent, secondary use, and data management.

Identity has quickly emerged as a primary problem in network access...our desire to stimulate national progress in addressing this particular obstacle to consumer's access to networked use of personal health records....we hope that this paper contributes to a growing consensus that the path forward on consumer authentication requires careful thinking, new research, and innovative approaches.(3)

Connecting for Health is a public-private collaborative with representatives from more than 100 organizations across the spectrum of health care stakeholders. Its purpose is to catalyze the widespread changes necessary to realize the full benefits of health information technology (HIT), while protecting patient privacy and the security of personal health information.(4)

(1)http://cdt.org/publications/policyposts/2008/9
(2)http://www.connectingforhealth.org/phti/docs/CT1.pdf
(3)http://www.connectingforhealth.org/phti/docs/CT2.pdf
(4)http://www.connectingforhealth.org/aboutus/collaborators.html
This work was originally published as part of a compendium called The Connecting for Health Common Framework for Networked Personal Health Information and is made available subject to the terms of a license (License) which may be viewed in its entirety at: http://www.connectingforhealth.org/license.html. You may make copies of this work; however, by copying or exercising any other rights to the work, you accept and agree to be bound by the terms of the License. All copies of this work must reproduce this copyright information and notice.

see below for more on Connecting for Health and CDT

Continue reading "Connecting for Health (public-private collab):electronic data stream scenarios for drug prescription transactions" »

July 7, 2008

Dump HIPAA? Careful What You Wish For!

It is probably too early to call it a "trend," but my news aggregator seems suddenly to be spitting out "dump HIPAA" articles in goodly number.

To spare front-page gazers the length of my remarks on this issue, I've put this in an extended entry below the fold.

Continue reading "Dump HIPAA? Careful What You Wish For!" »

July 8, 2008

Mixed Reviews of NY Hospitals in First DOH Infection Report

From the DOH website today:

New York hospitals have lower rates of central-line infections in pediatric and coronary intensive care units than the rest of the nation but higher rates in surgical intensive care units, the New York State Department of Health announced in a new report today.

Read the press release here. There are apparently two versions of the report, one to the legislature (32 pages) and one to the hospitals themselves (115 pages). The report to the legislature is here. The report to the hospitals is here.

July 9, 2008

Another context-the Pharmaceutical Business Review newsletter

For stargazers who visit Supra, here is a weekly publication I have found useful over time--it is grounded in business. The 'Business Digest' newsletter from the Pharmaceutical Business Review (1) published weekly, originates in the UK. With due respect to posting about it on the Supra blog as it is likely to be of interest and helpful to visitors by its nature, the newsletter contains unique content and is edited by Chris Eatough and it may be subscribed to (2). As one function of their other "Business Review" websites, it offers content that is produced by a dedicated team of journalists and global industry experts. In addition to the free content made available on the sites, an intelligence store ($$$) offers premium market analysis reports from the leading global suppliers of market research and industry analysis.
How is this related to the health care law? The newletters show a comprehensive and reliably current context on the subjects it covers-- legal references are sprinkled throughout. Invariably I would expect that you will find their 'Regulatory Developments' section interesting; it often focuses on the US Federal agencies. Or also, their 'Analyst's View',(about a page of reading sectioned into the newsletter itself) will contain US 'legal' material. For example, in this week's (July 8, 2008) 'Analyst's View' (reference to several Datamonitor reports from the intelligence store), they opine in part:

Following the controversy with Vioxx in 2004, US legislators were prompted to significantly expand the FDA's authority by passing the FDA Amendments Act of 2007. Although it is not yet certain to what extent the FDA will use its new powers, this crucial legislation changes the balance of power between pharmaceutical companies and the FDA, giving the agency greater powers to impose additional safety studies both prior to and post-approval. Thus, the legislation has the potential to increase development costs, reduce market penetration and impact upon approval rates. However, the new FDA power to demand post-marketing studies may actually be beneficial for certain drugs that would not be approved otherwise. Additionally, in recent years, the duration of clinical trials has increased so that, despite swifter approval times, the duration between the start of Phase I clinical trials and approval is becoming longer.

So I mention it here not for the purposes of advertising it, but because it can be especially useful to see what people, informed experts as well, are thinking from different perspectives who find/get different information, and so may ascertain the same or different trends that Supra readers may wish to know about.
This week's headliners include news on the AWP litigation and a potentially groundbreaking discovery in cancer treatment. (for a bit more of their news on this, click to below the fold)
(1)http://www.pharmaceutical-business-review.com/news.asp
(2)http://www.pharmaceutical-business-review.com/newsletters.asp

Continue reading "Another context-the Pharmaceutical Business Review newsletter" »

Family of Deceased Psych Patient Will Sue

Unsurprisingly, the family of the patient who died waiting in HHC's psych ward intends to sue:

NEW YORK (AP) - - The daughter of a woman who died unnoticed on the floor of a hospital psychiatric unit called Tuesday for criminal prosecution of the workers who did nothing to help her.

"What I want is justice," Tecia Harrison said, hours after her family notified the hospital, the city and the city's Health and Hospitals Corporation that they intend to file a $25 million lawsuit. "Whoever committed a criminal act should be held responsible."

Read the USA Today story here. The prior Supraspinatus entry on the event is here.

July 10, 2008

FDA /CDERWarning Letters 2008-Bioresearch monitoring program

For purposes of thinking about trends, I found it interesting to take a look at the last 6 months of FDA/CDER Warning Letters resulting from inspections in regard to its Bioresearch Monitoring Program. The Warning Letters show recent and 'real' fact patterns which reveal particular aspects about how certain law/regulations are being applied/enforced. These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. (1) This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information.
FDA's Biomonitoring Research program includes inspections designed to evaluate the conduct of research and to ensure that the rights, safety and welfare of the human subjects of those studies have been protected. Based on the Inspection Reports that were issued, these 2008 particular "Warning Letters" frequently cite to a failure to follow investigational plans and protocols. Noteworthy however, are the cites in the letters concerning deficiencies of obtaining informed consent from the human subjects participating in the clinical study for an investigational drug.
Other letters reflect concerns such as:
-a failure to excuse member from participating in the initial review of a project in which a member had a conflicting interest except to provide info. requested by the IRB,
-failure to provide additional safeguards for children in clinical investigations
-failure to maintain records showing financial interests,
-failure to protect the rights, safety and welfare of subjects under care,
-deficiencies relating to promotional materials.
(1)http://www.fda.gov/cder/warn/warn2008.htm#June
Read more on the deficiencies below the fold.

Continue reading "FDA /CDERWarning Letters 2008-Bioresearch monitoring program" »

Coming Soon From JCAHO: "Bad Behavior" Codes

The Joint Commission today announced its intention to limit bad behavior in the health care environment:

Intimidating and disruptive behaviors can foster medical errors,contribute to poor patient satisfaction and to preventable adverse outcomes, increase the cost of care, and cause qualified clinicians, administrators and managers to seek new positions in more professional environments. Safety and quality of patient care is dependent on teamwork, communication, and a collaborative work environment. To assure quality and to promote a culture of safety, health care organizations must address the problem of behaviors that threaten the performance of the health care team. (Citations omitted.)

Beginning January 1, 2009, the Joint Commission will review accreditation-seeking organizations on two new leadership standards targeted at bad behavior:

EP 4: The hospital/organization has a code of conduct that defines acceptable and disruptive and inappropriate behaviors.

EP 5: Leaders create and implement a process for managing disruptive and inappropriate behaviors.

Additional revisions to the Medical Staff chapter are also intended to address interpersonal skills and professionalism.

So what is disruptive behavior?

Intimidating and disruptive behaviors include overt actions such as verbal outbursts and physical threats, as well as passive activities such as refusing to perform assigned tasks or quietly exhibiting uncooperative attitudes during routine activities. Intimidating and disruptive behaviors are often manifested by health care professionals in positions of power. Such behaviors include reluctance or refusal to answer questions, return phone calls or pages; condescending language or voice intonation; and impatience with questions.

Hopefully the Joint Commission's effort will not bleed over into the world of fictional hospitals. Fans of the Fox TV series "House" would find themselves sorely disappointed with a main character that answers questions politely, does his clinic time willingly, and treats subordinate team members with patience and respect. Real world health care team members may, however, welcome the new code for its principles and the protections it will afford, even if administrators look forward to enforcement of the new standards with some trepidation.

Read the Joint Commission's July 9 press release here, and the related Sentinel Event Alert here.

On the Heels of Martinez, NYCLU Sues Healthnow/BCBS of Western New York

Here's from an NYCLU press release:

Following up on its landmark legal victory that recognized lesbian and gay couples’ valid out-of-state marriages, the New York Civil Liberties Union today filed a lawsuit in the Erie County Supreme Court against an insurance company for denying spousal health care benefits to a validly married lesbian couple.

The press release is here. The complaint itself (courtesy of the NYCLU website) is here.

July 14, 2008

2008 World Stem Cell Summit, Madison, WI

From StemCell.com's recent newsletter, The Genetics Policy Institute will present the 2008 World Stem Cell Summit in Madison, Wisconsin on September 22-23, 2008. Read more about it.(1)

The World Stem Cell Summit is the preeminent gathering for the global stem cell community with the shared mission to advance stem cell research from the laboratory to lifesaving treatments.This networking event brings together researchers, industry leaders, policy-makers, regulators, patient advocates, legal experts, investors and philanthropists to illuminate the critical issues and together chart the future of regenerative medicine.

50 sponsors are shown in support of the event as well as 12 media partners. From the legal world, Darby & Darby and Fish & Richardson are listed as sponsors.
Lab on the Lake:
The showcase title event will be real lab experience through which participants can experience hands-on methods that scientists use to grow and study stem cells. Lab on the Lake will include a Career and Education Fair, stem cell documentaries, experts panels, and music on the Memorial Union Terrace. Stem cell enthusiasts will be able to enjoy Lab on the Lake, a public forum and festival as part of the 2008 World Stem Cell Summit organized by the Genetics Policy Institute, University of Wisconsin-Madison Stem Cell & Regenerative Medicine Center and WiCell Research Institute.

Regenerative medicine and stem cell technologies are estimated to become a $500 billion industry over the next 20 years. We are at the ground floor of a vastly important field of life science discovery. Nations and states are making stem cell research a target for economic development. The 2008 World Stem Cell Summit will present market trends and provide the critical tools to evaluate new business opportunities in this exciting and burgeoning field.

(1)http://www.worldstemcellsummit.com/
(2)http://www.worldstemcellsummit.com/sponsors.html

US News Releases "Best Hospital" List for 2008

US News & World Report on Friday released its 2008 "America's Best Hospitals" list. The list - - lists, actually, since there are many - - are organized around categories of specialties: cancer, endocrinology, orthopedics, urology, etc. There are sixteen categories in all.

Of the New York hospitals, only New York-Presbyterian University Hospital of Columbia and Cornell made the "honor roll," which is a special list reserved for those hospitals achieving high scores in six or more specialties. The honor roll is here.

New York hospitals placing in the top ten in various categories include:
Cancer: Memorial Sloan-Kettering Cancer Center (2nd)
Endocrinology: New York-Presbyterian University Hospital of Columbia and Cornell (5th)
Gastrointestinal Disorders: Mount Sinai Medical Center (7th)
Geriatric Care: Mount Sinai Medical Center (3rd)
Gynecology: New York-Presbyterian University Hospital of Columbia and Cornell (6th)
Heart and Heart Surgery: New York-Presbyterian University Hospital of Columbia and Cornell (6th)
Kidney Disease: New York-Presbyterian University Hospital of Columbia and Cornell (3rd)
Neurology and Neurosurgery: New York-Presbyterian University Hospital of Columbia and Cornell (5th); NYU Medical Center (10th)
Orthopedics: Hospital for Special Surgery (1st); New York-Presbyterian University Hospital of Columbia and Cornell (5th); NYU Hospital for Joint Diseases (8th)
Psychiatry: New York-Presbyterian University Hospital of Columbia and Cornell (3rd)
Rehabilitation: Rusk Institute, NYU Medical Center (8th)
Respiratory Disorders: New York-Presbyterian University Hospital of Columbia and Cornell (10th)
Rheumatology: Hospital for Special Surgery (4th)
Urology: Memorial Sloan-Kettering Cancer Center (5th); New York-Presbyterian University Hospital of Columbia and Cornell (8th)

Only categories with New York hospitals in the top ten are represented here.

The US News lists are not without controvery, as one might imagine, as this snippet from the Cleveland Plain Dealer illustrates:

The U.S. News rankings of 170 hospitals carry a lot of weight, but they favor large academic centers and lean heavily on reputation - not necessarily the best available quality measures.

A better yardstick of hospital performance may be Medicare's "Hospital Compare" Web site, said Dr. Douglas Einstadter of MetroHealth Medical Center. Medicare recently added patient-satisfaction scores to the quality measures, and the Clinic was below average in several categories.

The Cleveland Plain Dealer article is here.

BIOTECH ARCHIVE INDEX FOR POSTINGS 7/13/07-7/12/08

For the biotech part of Supra, I'd hoped to develop a reference tool in part.
Thanks today to Supra Paul Gillan's NYSBA listserv posting which happens to coincide with a year too for the biotech postings and so I had prepared 2 dox for archive purposes.
Here is one of them.
Below the fold is the--
BIOTECH ARCHIVE INDEX FOR POSTINGS JULY 13, 2007 TO JULY 12, 2008 (11 PAGES)
POSTING ENTRY TITLE, DATE AND FIRST SENTENCE.

Continue reading "BIOTECH ARCHIVE INDEX FOR POSTINGS 7/13/07-7/12/08" »

BIOTECH ARCHIVE INDEX OF WEBLINKS PER POSTING 7/13,07 TO 7/12/08

Here is a second document for archives purposes which I also hope will be helpful.
This index shows the weblinks visited and referenced via the Supra weblink per posting for this last year of biotech posts.

BIOTECH ARCHIVE INDEX OF WEBLINKS PER POSTING JULY 13,2007 TO JULY 12,2008 (9 PAGES)
See below the fold.

Continue reading "BIOTECH ARCHIVE INDEX OF WEBLINKS PER POSTING 7/13,07 TO 7/12/08" »

July 21, 2008

Medical Home Projects Lifting Off

Today's New York Times has an interesting but not particularly deep piece on medical home projects:

The idea is that by paying family physicians, internists and pediatricians to devote more time and attention to their patients, insurers and patients can save thousands of dollars downstream on unnecessary tests, visits to expensive specialists and avoidable trips to the hospital.

Link to the article here.

July 22, 2008

HealthNow Zapped With $1 Million Fine

A fine by the State Insurance Department against HealthNow of Buffalo has drawn quite a bit of attention around the state:

The single complaint of an Ithaca woman denied insurance coverage for infertility treatments has led to a more than $1 million fine against HealthNow New York Inc. and an agreement by the insurer to reprocess and pay similar claims for as many as 2,500 women.

The Insurance Department release, quoted above, is here. An article in The Buffalo News is here, the Syracuse Post-Standard coverage is here, and the Rochester Democrat & Chronicle's piece is here. The actual amount of the fine was $1,050,000.00. HealthNow's settlement agreement with the Insurance Department can be accessed on the Insurance Department's website here.

Medicare Upping Payments for Electronic Prescriptions

AP reports:

Beginning Jan. 1, the federal government will boost Medicare's payments to doctors that send prescriptions electronically to a pharmacy rather than writing them out on paper and handing them to the patient.

Read the AP release here.

HHS OCR: No More Mr. HIPAA-Nice Guy

Until recently, lawyers advising clients on HIPAA issues could say that while HIPAA regulations give regulators the ability to impose some fairly significant fines, the focus of enforcement activities thus far has been on remediation and compliance. No longer:

The U.S. Department of Health & Human Services (HHS) has entered into a Resolution Agreement with Seattle-based Providence Health & Services (Providence) to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. In the agreement, Providence agrees to pay $100,000 and implement a detailed Corrective Action Plan to ensure that it will appropriately safeguard identifiable electronic patient information against theft or loss.

The $100,000 fine, while not stunning, is certainly meaningful enough to catch the attention of covered entities subject to HIPAA's strictures. Between this and the recent uptick of criminal prosecutions under HIPAA, a "no harm, no foul" compliance strategy is no longer a viable option.

HHS's press release is here. The Providence Corrective Action Plan can be accessed on the HHS website here.

NY Court of Appeals: Non-clinical Hospital Employees Not Eligible for Enhanced Healthcare Whistleblower Protection

Reddington v. Staten Island Univ. Hosp., No. 112 (Jul. 1, 2008).

Examining the statutory definition of "employee" eligible for protection under the enhanced whistleblower protections of New York Labor Law Section 741, the Court held that the phrase "any person who performs health care services for and under the control and direction of any public or private employer which provides health care services for wages or other remuneration" means employees that actually perform the services.

In the case at hand, the employee's job involved interacting with patients and patient families but was not a clinical position. Section 741, the Court wrote, "is meant to safeguard only those employees who are qualified by virtue of training and/or experience to make knowledgeable judgments as to the quality of patient care, and whose jobs require them to make these judgments."

The full opinion is on the Court of Appeals website here.

July 24, 2008

Benchmarking of research output- a global study

From Biomed Central, a 'Health Research Policy and Systems 2008' paper provides a large set of data which the authors (1) point out needs qualitative aspects estimated. Nevertheless, the paper provides some interesting data to think about regarding aspects of the role that publishing has for building scientific knowledge.
The present sudy was performed to establish a first overview on global publication activities as a benchmark of quantitative research output.

Institutional operating figures and benchmarking systems are important features for the implementation of efficacy in basic and applied sciences. They are needed for research evaluations and funding policy.

This study assessed benchmarking by research output. The paper describes their data search strategies using the Web of Science on line academic database which covers 8700 leading journals in science, technology, social sciences, and humanities.
Specific areas of major research activity were identified by comparing publication density on different organ systems. Comparisons of data were made in selected countries.This study is the first large scale analysis of global research and output activity over the last 50 years. The authors propose that their study describing an assessment of operating figures at the national and international level can be used to identify single areas of research that are heavily focused. Further research on qualitative output benchmarking is needed to improve policy settings for research evaluations.
They found a dichotomy between Western countries such as the US, UK or Germany and Asian Countries such as Japan, China, or Korea concerning research focuses. They note also a remarkable difference present in the individual focus of each country they analyzed.
Whereas the Western countries have a clear focus on heart and brain related publications, the Asian countries all primarily focus on publications related to the organ liver. They observe that this cannot be attributed to the burden of disease which is dominated by cardio vascular, neurovascular, respiratory and infectious diseases.
Some of the data shows comparative rankings of selected countries by the total numbers of published items. There is also a comparison made by relating the total published items to the respective country's GDP, among other comparisons made.
The authors provide interesting density-equalizing mappings for visualization of their data according to a recently published method.
(1)http://www.health-policy-systems.com/content/6/1/6'Institutional operating figures in basic and applied science: Scientometric analysis of quantitative output benchmarking' by Beatrix Groneberg-Kloft, Cristian Scutaru, Carolin Kreiter, Silvana Kolzow, Axel Fishcher, and David Quaroo of Free University of Berlin and Humboldt- University.

July 25, 2008

OIG Issues Advisory Opinion on Physician Investment in an ASC

The OIG posted a new advisory opinion regarding investment in an ambulatory surgery center (ASC) by surgeons and a hospital corporation. The proposed 70/30 physician/hospital joint venture does not meet the ASC safe harbor because ((1) the surgeons are investing in the ASC thru a partnership rather than a direct investment, (2) 4/18 surgeons do not meet the requirement that they derive at least one-third of their income from performing ASC procedures, (3) the hospital corporation is in a position to make or influence referrals to the ASC, and (4) the services provided by the hospital corporation to the ASC do not meet the personal services safe harbor. The OIG concluded, however, that the failure to meet these requirements of the safe harbor did not raise significant risks based on the circumstances of the joint venture and the safeguards put into place by the parties.

July 29, 2008

NYCLU Declares Victory Over BCBSWNY/HealthNow

According to a press release at the NYCLU website:

Less than three weeks after the New York Civil Liberties Union filed a lawsuit against Blue Cross & Blue Shield of Western New York for denying spousal health care benefits to a validly married lesbian couple, the health insurance company has announced it will begin covering married same-sex couples.

Read the press release here.

Massive Privacy Error at Georgia BCBS (Updated)

According to a piece at the Atlanta Journal-Constitution online:

Georgia's largest health insurer sent an estimated 202,000 benefits letters containing personal and health information to the wrong addresses last week, in a privacy breach that also raised concerns about potential identity theft.

How?

Blue Cross said the mix-up was caused by a change in the computer system that was not properly tested.

The mixup provoked at least one call for increased regulation:

Joy Pritts, director of Georgetown University's Center on Medical Record Rights and Privacy, said the push for electronic medical records "should proceed hand in hand with additional privacy and security protections."

The ajc.com article is here.

UPDATE (7/30/08)
My first reaction yesterday to Pritts' call for increased electronic privacy protections was that the call, while perhaps valid, is misplaced in the context of this event. I'm more convinced of that after seeing the WSJ Health Blog's treatment of the mis-mailing yesterday afternoon. Sarah Rubenstein begins by saying, "Those worried patient-privacy advocates may have a point," and then, after discussing some of the details, writes "And this is one of a steady stream of mistakes by the health-care industry when it comes to protecting electronic data."

The point should not be lost in this discussion that this was a mailing error that occured on paper. So far as I've read, there was no misdirection of electronic medical information. It is true that the problem was traced back to a computer system error, but that in and of itself doesn't make this a electronic privacy problem. Much more would have to be known about the data flows behind the mailing before determining whether stricter electronic privacy rules would have made any difference.

July 31, 2008

Long Island College Hospital Shuttering Maternity Ward

From today's New York Times:

A community hospital in gentrifying Brooklyn is closing down its maternity ward and plans to sell the building that houses some of its obstetrical clinics and another building across the street.

The hospital, Long Island College Hospital in Cobble Hill, delivered 2,800 babies --- an average of seven or eight a day --- in 2007, officials said, although the numbers are expected to decline this year after some prominent obstetricians moved to nearby New York Methodist Hospital.

Read the full article here.

Health Policymakers Acknowledge Influence of Blogs

Yesterday's Congressional Quarterly included an article in which federal HHS Secretary Michael Leavitt acknowledged the influece of blogs in the health policy debate:

The ever-evolving blogosphere is now helping to shape the health policy debate by allowing more interaction between the public and policy makers, said Department of Health and Human Services (HHS) Secretary Michael O. Leavitt , a blogger himself.

Leavitt, who launched his blog on the HHS Web site in August 2007, said his entries follow a range of topics, from day-to-day experiences, to his thoughts and decisions surrounding health care issues and policies.

People can post comments on his blog, which Leavitt said has provided valuable information.

“There have been times when someone has made an argument to me that I found compelling that I am sure began to mold and shape my thinking,” he said during a Kaiser Family Foundation event Tuesday.

Interesting to me that Leavitt is a blogger, so his penchant (or proclivity, as you see fit) for perusing blogs may have more to do with their influence on his thinking than would be true for non-blogging policymakers. Still, I note that Supraspinatus has regular readers at a number of state agencies and in the state legislature. If anything, they are paying attention to the fact that we are paying attention. And that's as fine a place to start as any.

Read the CQ article here.

Deadline for Comments on Medicaid Primary Care Standards

The New York State Department of Health is seeking input on the draft practice standards for primary care clinicians and programs by August 8, 2008. Medicaid will require compliance with the standards in January 2009. DOH wants to know if these are the right standards to apply and whether providers can currently meet the standards.

About July 2008

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

June 2008 is the previous archive.

August 2008 is the next archive.

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