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

The Office of the National Coordinator for Health Information Technology of the U.S. Department of Health and Human Services (HHS) selected two companies to test and certify new electronic health record (EHR) systems as eligible for federal reimbursement. The Certification Commission for Health Information Technology (CCHIT) and The Drummond Group will work with vendors and developers to assure that EHR systems conform to the standards set forth in federal regulations, including the meaningful use criteria released in July 2010. Read the HHS press release here.

Governor Paterson has vetoed a bill which would reduce the number of required witnesses to a health care proxy from two to one. He cited the gap-filling nature of the Family Health Care Decisions Act and stated:

"I am reluctant to veto a measure designed to encourage people to
execute health care proxies, but I must do so here given the relative
ease of finding a second person to witness the execution of a proxy in
most cases and the potential for significant and possibly irreparable
harm resulting from a person wrongly exercising control over another's
personal health care decisions." (Veto message # 6788 of 2010)

This is an older article but one I thought well worth adding:

Visiting the Cleveland Clinic this week, President Obama held up that well-known hospital as a model for the rest of the country. But for most of the nation's nearly 6,000 hospitals, copying the Cleveland Clinic would be like asking the Durham Bulls, a minor league team, to copy the New York Yankees.

A more accessible example is a hospital that sits a bit more than a home-run blast from the Baseball Hall of Fame here. Called Bassett Healthcare, this modest hospital of 180 beds delivers high-quality care at low costs in the face of federal reimbursement policies that discourage many of its best practices.

Read the rest of the NY Times article on its website.

As reported in the Albany Business Review August 24:

Twenty health insurers and health maintenance organizations (HMOs) have been fined a total of $716,800 for not making timely payments on undisputed insurance claims.

Find out which plans were fined by clicking through to the Business Review article, or see the Insurance Department's press release.

The New York State Insurance Department has released its 2010 Consumer Guide to Health Insurers. Here's a snippet from the Department's press release August 25, 2010:

According to data contained in the guide, consumers seeking to reverse health plans' denials of coverage won 33,921 internal appeals against commercial insurers in 2009 out of 71,787 cases closed. Consumers won 2,332 reversals in the 5,968 appeals closed against HMOs and 4,329 of the 8,946 appeals closed against non-profit insurers.

Read the Department's release or access the complete guide on the Insurance Department's website.

Published at Crain's New York Business August 26:

The impasse that blocked a new urgent care center serving the neighborhood around St. Vincent's Hospital has been broken by leaving bankrupt Saint Vincent Catholic Medical Centers out of the equation.

Restrictions placed by SVCMC held up the urgent care center, which the North Shore Long Island Jewish Health System originally had hoped would open next week. But SVCMC wanted to hold the health center to Catholic directives on birth control, and tried to negotiate a high rent and rigorous lease terms for space in the former emergency department.

Read the rest of the article on the Crains website.

The New York Times covers a recent change in New York law:

[A] state law signed on Sunday by Gov. David A. Paterson will require New York hospitals and doctors to discuss the options for breast reconstruction with their patients before performing cancer surgery, to give them information about insurance coverage and to refer them to another hospital, if necessary, for the reconstructive surgery.

The law came about largely through the efforts of Dr. Evan Garfein, the plastic surgeon at Montefiore Medical Center in the Bronx who gave Ms. Pena, who will turn 48 next week, a new breast, which made her so happy she wore a bikini last month for the first time in her life.

Read the rest of the article on the New York Times website.

Reported on the AP wire today:

An audit shows Medicaid overspent $40 million for excessive teeth cleanings and oral exams over five years, including payments to one dentist who charged the government for 79 oral exams for one patient.

Read the rest of the AP release for more details.

Strong foundations support innovative research for new medicine.
Visit NYSTEM for more about a world first + regenerative medicine. (1)

[R]esearch findings published early online in The Lancet by Jeremy Mao, Ph.D., at Columbia University Medical Center, along with his colleagues at the University of Missouri and Clemson University, have laid the groundwork for possible future joint replacement for patients with diseased or damaged joints....

See also the NYS DOH Health News article on an impressive study(2). Brief excerpts include:
-an international team of health researchers led by Dr. Haydeh Payami, a scientist at the State Department of Health's Wadsworth Center has identified a link between Parkinson's disease and the gene HLA-DR, which plays a role in the body's immune system; the disease may have an autoimmune or infectious origin.
-this is the first finding from the newly completed, vast database developed from the study conducted by NeuroGenetics Research Consortium.
-more than 2,000 Parkinson's disease patients and 2,000 healthy volunteers from their own health clinics for nearly 20 years were studied.
(1) http://nystem.com/news_of_note.html
(2) http://www.health.state.ny.us/press/releases/2010/2010-08-13_genome_research_study.htm NYS DOH reports that the study, "Common Genetic Variation in the HLA Region is Associated with Late-onset Sporadic Parkinson's disease," conducted by the NeuroGenetics Research Consortium (NGRC) August 15, 2010 online issue of Nature Genetics, a leading scientific publication

Associated Press reports today:

The now-defunct St. Vincent's Hospital was destroyed by mismanagement as it teetered at the edge of bankruptcy_ including a $278,000 golf outing and more than $100 million in unspecified spending for just one year, according to a lawsuit filed Monday.

Read more on the AP newswire.

Governor Paterson has signed a bill, Ian's Law, that addresses the discontinuance of a class of health insurance policies when such action is based on claims experience or a health status-related factor. Although such an action is prohibited by current law, the new law strenghtens notice and enforcement provisions and creates a new process to provide certain insureds relief when they are negatively affected by a discontinuance, even when such action is entirely proper. Senator Schneiderman, the lead Senate sponsor of the bill and current attorney general candidate, achieved national press coverage on the issue.

Paterson also signed a bill making changes to the False Claims Act that will give OMIG increased jurisdiction and another allowing direct admission into "Enhanced Assisted Living Residences" - fixing what was largely seen as a technical flaw in the original 2005 Assisted Living Reform Act.

The Governor's press release indicating all bills recently acted upon is here

The Healthcare Association of New York State (HANYS), with the Multi-State Managed Care Coalition, submitted comments about the calculation of Medical Loss Ratios (MLRs) to the National Association of Insurance Commissioners (NAIC), which is meeting this week in Seattle. The Patient Protection and Affordable Care Act required the establishment of MLR standards and the U.S. Department of Health and Human Services (HHS) requested assistance from the NAIC with the development of those standards. Click here to read the HANYS press release and here to read HHS's earlier letter to the NAIC.

Reported in HealthLeaders Media today:

North Shore-LIJ Health System member North Shore University Hospital will buy the bankrupt Saint Vincent’s Catholic Medical Center Certified Home Health Agency for $17 million, the Great Neck, NY-based health system announced this week.

Read the rest of the article here.

Read about the interesting findings by international research colleagues of Stanford University, Akita University; and the Chinese Academy of Sciences in the NIH 8/4/10 news release (1). Following is a brief excerpt:

Researchers supported by the [NIH] have for the first time activated mouse egg cells at the earliest stage of their development and brought them to maturity. In a related experiment, the researchers replicated the finding by also bringing human eggs to maturity in the laboratory....Current infertility treatment techniques stimulate immature eggs so they develop to the stage at which the eggs can be fertilized, but these techniques work only on eggs at a comparatively late stage of development. These later-stage eggs are few in number and much more difficult to recover than the early-stage eggs used by the researchers in this study. ...The researchers plan to continue their research in animals, examining the safety of the PTEN blocker and other activating agents and testing the feasibility of auto-transplants, in which the stimulated ovarian tissue would be transplanted to a patient’s arm or elsewhere in the body to mature. Such transplanted tissue would be easy to retrieve when the mature eggs are ready for fertilization.

(1) http://www.nih.gov/news/health/aug2010/nichd-04.htm, news from online Proceedings of the National Academy of Sciences; http://www.nichd.nih.gov/news/releases/080410-mature-egg-cells.cfmFirst author Jing Li conducted the research with Stanford University colleagues Yuan Cheng, Cynthia Klein and Aaron J.W. Hsueh; Kazuhiro Kawamura of Akita University; and Shuang Liu, Shu Liu and En-Kui Duan of the Chinese Academy of Sciences. NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation.

American Society of Gene & Cell Therapy (ASGCT) 2009-2010 President Ken Cornetta presents up to date membership concerns in his recent Editorial about the ASGCT mission of moving gene and cell technologies into clinical practice, (1) observing that:

Clearly, the NIH leaders are aware of the advances in our field. …We pointed out that many of the recent clinical successes were achieved in Europe, which reflects, in part, on the manner in which translational research is funded in the United States. Rather than viewing preclinical development, vector manufacture, toxicology studies, and early-phase clinical trials as a continuum, most institutes require investigators to submit multiple, independent grant applications for each element of translational research. This system often leads to a catch-22 scenario and challenges the five-year limit on many grants. …

Regulatory oversight topics he discusses include:
-now in translational research, investigators routinely perform work that includes animal studies, recombinant DNA, and human research, by consolidating review committees, the quality of a review can be improved, also resulting, in a considerable cost savings,
- difficulty for investigators to identify the most relevant and efficient pathway to move translational research forward, also of concern to NIH leaders,
- adapting to licensed gene and cell therapy products is a challenge that we all welcome.
- stem cell science and cell therapies are rapidly growing.
Some other int'l perspectives on gene therapy:
- European Medicines Agency (EMA) regulatory initiatives, including a draft concept paper on the development of a guideline on the risk-based approach (according to an EC directive) applied to Advanced Therapy Medicinal Products (2)
- International Conference on Harmonization (ICH) Steering Committee established its Gene Therapy Discussion Group (GTDG) to lead these activities within the ICH.(3) Objectives include proactively setting out principles that may have a beneficial impact on harmonizing regulations of gene therapy products and developing new ways of communication to ensure that the outcomes of ICH are well understood and widely disseminated such as Public ICH gene therapy workshops, establish a publicly available ICH gene therapy web page.
-FDA requested public comment as a part of its preparations for the June 2010 ICH meeting. (4)
(1)http://www.nature.com/mt/journal/v18/n8/full/mt2010158a.html 2010 Gene Therapy Year in Review,
(2) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500069264.pdf, Committee for Medicinal Products for Human Use(12/09)
(3) http://www.ich.org/cache/compo/276-254-1.htmlhttp://www.ich.org/cache/compo/276-254-1.html
The next formal meeting of ICH GTDG will take place in parallel with the ICH SC and EWG meetings in Japan,Nov 2010.
http://www.ich.org/cache/compo/276-254-1.html
(4) http://www.fda.gov/Drugs/NewsEvents/ucm204924.htm Also there, see Page 7 of 20 slides: Global Harmonization Efforts beyond ICH,by Justina A. Molzon, MS Pharma, JD, FDA/CDER/OEP.

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