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March 2010 Archives

March 2, 2010

Recent Legislative Activity

In an effort to keep readers up to date with goings on in the Capitol, even in the absence of significant action on major bills, I will be posting a selection of bills that are likely of interest to Section members as an "FYI." To keep information relevant, I am focusing on bills that are moving or have recently passed one house and have a companion in the other. However, please feel free to comment or contact me directly with feedback if more, less, or different information would be helpful.

A. 2008a (Gottfried)/S. 3930 (Duane) - This bill seeks to regulate pharmacy benefit managers and to establish a fiduciary duty on PBMs with respect to their dealings with health plans or providers. The bill recently passed the Assembly and remains in committee in the Senate.

A. 2263 (Gottfried)/S. 4499 (Duane) - This bill seeks to protect health care professionals from professional or criminal liability with respect to pain management services when they act within professional guidelines. The bill recently passed the Assembly and remains in committee in the Senate.

A. 5144 (Rivera, P)/S. 2449 (Parker) This bill directs DOH to contract with community organizations to distribute information regarding health care services available to immigrants. The bill recently passed the Assembly and remains in committee in the Senate.

March 3, 2010

Conflict Board Fines Doc for Soliciting Intern Slots

The March 2 New York Times online reports on a physician fined for conflict of interest in soliciting intern spots for students of a medical school in which he held high-ranking paid positions.

A former board member of New York City's public hospital system has been fined $13,500 for his role in soliciting coveted training spots in city hospitals for students from a Caribbean medical school, the city's Conflicts of Interest Board said Tuesday.

The former board member, Dr. Daniel D. Ricciardi, agreed to the fine in a settlement in which he admitted that he had held high-ranking paid positions at St. George's University School of Medicine in Grenada while soliciting clinical clerkships --- a critical part of medical education --- from personnel in the city hospital system, which he also helped to lead.

The article is available here.

Nate Littauer Hospital Receives High Praise For Energy Conservation

Nathan Littauer Hospital and Nursing Home in Gloversville, NY (Fulton County) received recognition from PRES Energy for its efforts to reduce energy consumption in its facilities:

Nathan Littauer Hospital and Nursing Home recently received results of an audit conducted by PRES Energy LLC, which was formally presented to the New York Power Authority. . . . PRES Energy was engaged by the New York Power Authority and the New York State Governor's Office to perform energy audits for a representative sample of its business customers. The audit, conducted January 6, 2010, determines cost-effective measures that could be implemented to reduce energy costs and to improve the efficiency of buildings. The results of the audit were announced to Nathan Littauer's management team today.

The report concludes that Nathan Littauer's energy maintenance efforts are a benchmark for the health care industry.

Read the hospital's press release online.

Brookhaven Settles Medicare Fraud Charges

According to a PRNewswire, Brookhaven has settled a Medicare fraud matter that stretches back to 2005:

Brookhaven Memorial Hospital Medical Center, a Long Island, N.Y.-based hospital, has agreed to pay $2.92 million, plus interest, to settle allegations that the hospital defrauded Medicare, the Justice Department announced today.

The government alleged that the hospital fraudulently inflated its charges to Medicare patients to obtain enhanced reimbursement from the federal health care program.

More details are available in the release.

March 4, 2010

American Cancer Society Questions Value of Prostate Cancer Screening

The March 4 Albany Times Union covers recent guidance from the Amercian Cancer Society concerning prostate cancer screening:

Months after experts discounted the importance of routine mammograms and Pap smears for many women, the American Cancer Society is warning more explicitly than ever that regular testing for prostate cancer is of questionable value, too, and can do men more harm than good. The cancer society has not recommended routine screening for most men since the mid-1990s, and that is not changing. But the organization is urging doctors to talk frankly with their patients about the risks and limitations of the PSA blood test when offering it.

The updated guidelines urge doctors to stop routinely giving the rectal exam.

Health insurers in New York will not be able to take advantage of the opportunity this policy presents to pare non-recommended screenings out of benefits pacakges. Since 2000 New York has had a prostate cancer screening mandate (see e.g. Ins. Law 4303(z-1) for how this pertains to HMO coverage) that requires most policies to cover screening: (a) for men of any age with a history of prostate cancer: (b) annually for asymptomatic men over 50; and (c) annually for asymptomatic men 40 and over with a family history of prostate cancer or "other prostate cancer risk factors."

This is a good example of a legislated benefit mandate failing to keep pace with medical developments, thereby subjecting patients to unnecessary and potentially harmful services while directly adding to the cost of health insurance premiums.

March 5, 2010

United Hospital Fund Release New York Insurance Coverage Snapshot

The United Hospital Fund recently released its "Health Insurance Coverage in New York, 2006-2008: A Snapshot." The snapshot is essentially a summary of the full chartbook, ""Health Insurance Coverage in New york, 2007-2008" which will be released this summer.

Among the findings: "41 percent of uninsured New Yorkers are eligible for public coverage but are not enrolled and another 46 percent have low-to-moderate incomes."

The overall uninsured rate remained largely unchanged during the period examined.

March 8, 2010

FDA's DPNM; biometrics and biology

The Division of Personalized Nutrition and Medicine

is charged with developing strategies, methods, and resources for improving individual and public health. The need for this Division and research paradigm resulted from data generated by the Human Genome and HapMap projects. Theses international efforts laid the foundation for one of the most significant scientific contributions to human kind-an evidence-based understanding that while humans are genetically similar each retains a unique genetic identity that contributes to a wide array of biochemical, physiological and morphological phenotypes in human populations. Parallel molecular genetic studies have demonstrated that nutrient and environmental chemicals directly or indirectly regulate the expression of one’s genetic make up.
This Division has 2 subdivisions-Biometry and Biology. This Report presents briefly their accomplishments and plans which contribute to FDA’s strategic goals to improve patient and consumer safety.
Of related interest: One recent scientific review discusses briefly the fundamental aspects of biomedical informatics (e.g., bioinformatics, imaging informatics, clinical informatics, and public health informatics) which may be essential in helping improve the ability to bring basic research findings to the bedside, evaluate the efficacy of interventions across communities, and enable the assessment of the eventual impact of translational medicine innovations on health policies. A brief description is provided for a selection of key biomedical informatics topics (Decision Support, Natural Language Processing, Standards, Information Retrieval, and Electronic Health Records) and their relevance to translational medicine.
Also in the European Journal of Clinical Nutrition, courtesy of Biomed Central, a timely article referenced indicating that scientists propose a new look at dietary carbohydrate chemistry, physiology and health which would allow for a more precise relations to be drawn.
(1) http://www.fda.gov/downloads/AboutFDA/CentersOffices/NCTR/ResearchAccomplishmentsPlans/UCM200349.pdf(2) http://www.translational-medicine.com/content/pdf/1479-5876-8-22.pdf
(3) http://www.nature.com/ejcn/journal/v51/n7/abs/1600427a.html
http://www.nature.com/ejcn/journal/v51/n7/pdf/1600427a.pdf

Emerging Science, Tech Advances- NIH/FDA initiatives

Programs to create a new center for the study of stem cells and to increase capacity to deal with global health issues were among 7 scientific initiatives announced recently by NIH Director Francis S. Collins, M.D., Ph.D. The programs are all scheduled to begin during fiscal year 2010. Dr. Collins indicated that

[the] strategic investments will yield critical new resources, scientific knowledge, and strategic partnerships across a broad landscape of basic biology, behavioral science, global health, and clinical medicine.
The research programs will distribute $17.8 million in NIH Common Fund (http://commonfund.nih.gov) support in fiscal year 2010, and additional funds in future years. These scientific programs include:
-Library of Integrated Network-based Cellular Signatures Program: This program, called LINCS, will build a community resource of scientific information to drive understanding of how components of biological systems, such as genes and proteins, function normally to maintain health or become disrupted by genetic and environmental stressors to cause disease. This resource will accelerate discoveries of the inner working of biological systems that can be targeted for use in new and better treatments.
-Science of Behavior Change Program: This program examines how human biology, culture and society together influence a person's ability to adopt healthy behaviors and maintain them over time. This initiative will address effective motivation strategies that might be developed to curb unhealthy behaviors such as smoking, excessive alcohol drinking, poor diet and lack of exercise.
-NIH Induced Pluripotent Stem (iPS) Cell Center: This program creates a national iPS Cell Center, under the NIH Intramural Research Program, to drive the translation of scientific knowledge about stem cell biology into new cell-based treatments.
-Global Health Program: This program is designed for increasing capacity for global health research by enhancing education, training and research opportunities in developing countries.
-Regulatory Science Program: This collaborative program (recently announced) NIH and FDA will encourage rapid and efficient use of new knowledge, technologies, and innovations in the development, investigation and regulatory review of medical products. The main goal is to ensure the development of safe and effective products based on the highest quality science in United States.

(1) http://www.nih.gov/news/health/feb2010/od-25.htm

March 12, 2010

Recent Legislative Activity

A 3787 Rosenthal/S 1990 Hannon: This bill would reduce the number of witnesses necessary for a health care proxy form from two to one, except in the case of individuals residing in mental health facilities. The bill passed the Senate on March 4. It is currently on the floor in the Assembly but has passed that house in the past.

http://www.assembly.state.ny.us/leg/?bn=A07617: This bill would require certain providers to offer information and counseling to terminal patients regarding palliative care. The bill has passed the Assembly and is currently before the Senate Health Committee.


March 16, 2010

FHCDA Signed today

This is already being reported among the section, but just in case you missed it. You can view Governor Paterson's press release here.

March 17, 2010

Family Health Care Decisions Act - A Long Road Ends in Success (Updated 3/18)

From today's Albany TimesUnion:

For 17 years, health care lawyer Robert N. Swidler guided, prodded and negotiated a new end-of-life law that has languished in the state Legislature. Gov. David Paterson finally signed the bill into law Tuesday at Albany Memorial Hospital. The Family Health Care Decisions Act allows family members or close friends to make medical care decisions for loved ones who are incapacitated -- replacing a law that essentially forced doctors to provide aggressive life-sustaining treatment to patients whose wishes were unknown -- even when family objected.

Link to the article, which includes a nice photo of Robert at the signing with Gov. Paterson in the background.

Read the bill text on the Assembly website.

Update 3/18/10: The New York Times covers the new law online:

The old case-law standard, said Robert Swidler, general counsel for Northeast Health, a health care system in the Albany region, "put hospitals and nursing homes in a very difficult position."

He said the new law would bring ethically, emotionally and medically fraught decisions "into sunlight."

HANYS issued a press release praising the law.

HANYS commends the sponsors of the legislation and the Governor for providing family members with the legal authority to make health care treatment decisions when their loved ones are incapacitated and have no health care proxy.

NPR's piece is here, including the radio broadcast from Karen DeWitt.

The new law gives close friends or family members the legal authority to make medical treatment decisions when a person is incapacitated, even if the patient has not left specific written instructions or designated a health care proxy.

"This is humane, this is ethical, this is the right legislation," said Paterson.

The new rules, which are common in most other states, come after 17 years of wrangling in the state legislature.

March 18, 2010

Autism Mandate introduced

Senator Breslin and Assemblyman Morelle have introduced S. 7000a/A. 10374, which mandates health insurance coverage for the screening, diagnosis and treatment of autsim spectrum disorder. The bill will be considered by the Senate Insurance Committee this morning.

March 22, 2010

TimesUnion Dives Into Hospital Medical Errors

The Sunday Albany Times-Union carried a lengthy piece on hospital medical errors, stating that two Capital Region hospitals had made a "watch list".

The safety analysis is part of a Hearst Newspapers' Dead by Mistake investigation into medical errors. NHQC [Niagara Health Quality Coalition], a nonprofit based in the Buffalo area, used hospital billing and discharge data that represents every patient encounter in 2007. The administrative data used for the analysis has known limitations, including gaps in the data and inputting errors, but it is recognized as the best available tool to evaluate hospital safety on a large scale. It is the first safety report to identify both the top and bottom hospitals in New York.

The article, available at the TimesUnion website, identifies the state's best and worst performers.

March 23, 2010

New NYLJ Article: "Personal Liability of Hospital Board Members, Executives for Unpaid Taxes"

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, "Personal Liability of Hospital Board Members, Executives for Unpaid Taxes," appears in the March 21, 2010 edition:

When a hospital faces severe financial problems, it may be tempted to delay payment of its employees’ federal withholding taxes, and to use that money to pay suppliers and vendors, or to meet other urgent financial needs. However, this temptation must be resisted since there are civil and even criminal consequences for non-payment of withholding taxes.

Link to the reprint posted on the Greenberg Traurig website.

March 24, 2010

CLE: Health Law Fundamentals

The New York State Bar Association's Health Law Section and the Committee on Continuing Legal Education are pleased to present Health Law Fundamentals.

Friday, April 9, 2010 | New York City | Affinia Manhattan
Friday, April 16, 2010 | Albany | New York State Nurses Association

Sponsored by the Health Law Section of the New York State Bar Association.

7.0 credit hours in areas of professional practice

NYSBA Members: Attend this program and get FREE Health Law Section membership through December 31, 2010 --- a $30 value!**

Designed for attorneys either entering into health law practice or interested in learning more about this dynamic field of practice, this program will provide a framework for understanding a wide range of health law issues. Experienced practitioners looking to expand their ability to represent clients in the health care industry will also benefit from this seminar's overview of the multifaceted field of health law. Recent developments in the health care industry will also be discussed.

To register online, click the location above that you wish to attend.

March 25, 2010

Houses announce individual Budget positions

The Assembly released and passed a budget resolution yesterday, and also released amended versions of budget bills, providing a more detailed look at that house's position than the Senate resolution released and passed earlier in the week.

According to an Assembly press release, health highlights include:

Health The Assembly budget reduces health care cuts by $126 million, rejecting $32 million in cuts to hospitals, $25.9 million in cuts to nursing homes and $36.5 million in cuts to home health care. The plan also includes a measure that would shift all Medicaid administration costs from counties to the state to streamline eligibility and service determinations, implement operational efficiencies and consolidate services and contracts. It also increases HCRA funding by $218 million by raising the cigarette tax by $1 per pack.

The Assembly budget rejects the governor's proposal to institute parental fees for the Early Intervention program.

Insurance
The proposal reinstitutes the requirement that health insurance companies may not increase premiums on certain plans without prior approval from the Insurance Department.

The Assembly's health article VII bill can be found here
The Senate resolution can be found here

March 29, 2010

Recess begins, signalling late budget

Both houses of the Legislature have passed a short-term emergency spending bill that will continue basic state operations through April 11th in light of what now appears to be an inevitably late budget. Little progress was made over the weekend, and lawmakers have now left town for the Easter/Passover recess. They will not return to Albany until April 7.

March 30, 2010

BRCA1/2 patents ruled invalid in PUBPAT/ACLU lawsuit

3/29/10 From PUBPAT: Judge Robert Sweet issued his opinion holding all of the challenged patents invalid. (1) The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed on 5/12/09, in the U.S.District Court SDNY in Manhattan against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes.

The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes. The ruling follows a lawsuit brought by a group of patients and scientists represented by PUBPAT and ACLU who charged that the challenged patents are illegal and restrict both scientific research and patients' access to medical care, and that patents on human genes violate the First Amendment and patent law because genes are products of nature….Because the PUBPAT/ACLU lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes….
A few comments about the lawsuit:
- Christopher A. Hansen, an attorney with the ACLU, told the judge at the hearing: They uncovered a law of nature. It is very much to their credit. But uncovering a law of nature is not creating an invention.
Brian M. Poissant, defendants' lawyer, (Jones Day) argued at the hearing: This is not nature's handiwork. This is an invention of man. Once the gene is isolated, it is transformed chemically. Myriad's probes and primers are like guided missiles. They go along this very long strand of DNA and they know where to stop. See LAW.com news (3)
-President and CEO of Myriad Genetics: ...we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation. More importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents. …In this case, the ACLU Plaintiffs sought a declaratory ruling that 15 claims under seven BRCA patents owned or exclusively licensed to Myriad were invalid and unenforceable. However, there are 164 claims remaining under these seven patents which were not challenged, and Myriad holds an additional 16 patents covering BRACAnalysis(R) which also were not challenged. See Myriad’s website.(4)
Judge Sweet observes in the Opinion that 2 complicated areas of science and the law are involved in this case regarding the patentability of isolating human genes and the comparison of their sequences and that resolution of the issues presented concern to breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors and those seeking to advance public health.
(1) http://www.pubpat.org/brcasjgranted.htm(2) http://www.pubpat.org/assets/files/brca/brcasjgranted.pdfJudge Robert Sweet’s Opinion (156pp).
(3) http://www.law.com/jsp/article.jsp?id=1202447064274&Genes_Linked_to_Breast_Ovarian_Cancers_Are_Ruled_Unpatentable
(4) http://investor.myriad.com/releasedetail.cfm?ReleaseID=455348

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About March 2010

This page contains all entries posted to HEALTH LAW SECTION BLOG in March 2010. They are listed from oldest to newest.

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