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November 2009 Archives

November 2, 2009

Governor signs bill to protect access to reproductive health services, others.

From the Governor’s Press Release of October 28:

Governor David A. Paterson today signed five bills into law including a bill to protect women’s access to reproductive health care facilities and a bill to ensure voters’ access to their correct polling places. Additionally, the Governor vetoed two bills that would have cost taxpayers $18.6 million over the next two years.

Included in the package was A.8924/S.6112, which enhances penalties for those who cause physical harm to anyone providing or seeking to provide, obtain or assist in reproductive health services. The change becomes effective 90 days after signature.

Link to bill:
http://www.assembly.state.ny.us/leg/?bn=A08924&sh=t

Link to press release:
http://www.state.ny.us/governor/press/press_1028092.html

AG's UCR Database Gets a Name: FAIR Health, Inc.

The Attorney General released some details of the promised state-sponsored database intended to replace the private Ingenix database of out-of-network pricing information:

Attorney General Cuomo today [Oct. 27, 2009] announced historic nationwide reform of the consumer reimbursement system for out-of-network health care charges. A new not-for-profit company, FAIR Health, Inc., and an upstate research network headquartered at Syracuse University will develop a new independent database for consumer reimbursement and a new website where for the first time consumers can compare prices before they choose their doctors.

The Attorney General's press release contains a timeline and background on the AG's investigation.

To access prior Supraspinatus coverage follow the link or type "Ingenix" into the search window in the right-hand column of the Supraspinatus main page, just below the blue muscle image.

Governor Declares H1N1 Emergency, Allows Advanced EMTs to Deliver Vaccinations

Included in Governor Paterson's Executive Order No. 29 are clauses permitting certain health care providers, including some adjunct and certified providers, to administer both seasonal and H1N1 vaccinations, with appropriate training. Here is the clause for EMTs, found on page 4 of the order:

. . . for the purposes of this Executive Order only, advanced emergency medical tecnicians may administer vaccination against 2009 H1N1 influenza and seasonal influenza at PODs [points of dispensing] pursuant to a non-patient specific order and pursuant to medical direction at such PODs, provided they first receive training in techniques, indications, precautions, contraindications, infection control practices, and use of personal protective equipment sufficient to provide the basic level of competence for such tasks . . .

Similar clauses exist for physician assistants, specialist assistants, dentists, certain dental hygienists, pharmacists, midwives, and podiatrists.

November 4, 2009

PBM and Drug Company Settle Anti-Kickback Allegations

BusinessWeek reports that Omnicare, a pharmacy benefit manager for long term care facilities, and IVAX, a generic drug manufacturer, agreed to a combined $112 million in settlement payments and entered into corporate integrity agreements to resolve an ongoing investigation by the Justice Department into alleged kickback payments. According to the article, Omnicare engaged in the activities despite advice from counsel.

According to the settlement, Omnicare allegedly received $8 million in payments from IVAX in 2000-04 to buy $50 million in generic drugs and recommend that physicians prescribe them to their nursing home patients. Omnicare entered the contract even though its outside counsel repeatedly warned it might violate the federal anti-kickback law, the government alleged in its complaint . . .

In addition, Omnicare allegedly paid $50 million to nursing home chains Mariner Health Care and SavaSeniorCare in 2004 to keep referring their Medicaid and Medicare patients to Omnicare for pharmacy services. According to the government's complaint, Omnicare again ignored its outside counsel's advice that the payment was illegal.

Read the article here.

November 5, 2009

CDER's Drug Shortage Program; more on vaccines

FDA's news regularly reports on drug shortages of medically necessary products that significantly impact public health. From their FAQs webpage (1):

The Drug Shortage Program (DSP) program, within the Center for Drug Evaluation and Research (CDER), was established to address potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health. Through communication, facilitation and negotiation, DSP works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages.

Over the last ten years, the number of shortages has continued to increase. There are many reasons for this increase in shortages and some of the causes are as follows:
Manufacturing issues – this may include problems with manufacturing, enforcement activities, raw material shortages, packaging shortages, and other reasons
Business decisions may be made by firms to discontinue manufacturing of a drug – newer products continue to replace older products due to better safety profiles, better efficacy, more convenient dosing regimens, etc.
Limited manufacturing capacity – often multiple products are produced on the same equipment which means that an increase in production of one product will usually result in a delay for another product produced on the same production line
Market concentration – as firms discontinue manufacturing of various products, only one or two firms may remain as producers of a product.

Read more info. on DSP (1), for example:
How does the CDER Drug Shortage Program find out about shortages?
Once a drug is determined to be in shortage, what happens next?
What can FDA do about drug shortages?
Note: In the midst of much discussion regarding vaccine market dynamics, one interesting recent analysis/opinion for Datamonitor by Hedwig Kresse & Holger Rovini, as reported in the Nature Reviews on line news (2) briefly discusses several reasons why "the influenza vaccines market is a challenging sector....". They describe one key area of interest: ...an enhancement of vaccine immunogenicity through adjuvants. The key advantage in the influenza sector is a reduction in the amount of antigen required for protective immunization. This so-called dose-sparing effect helps to increase the number of available vaccine doses. This is particularly important in a pandemic, when the supply, limited by manufacturing capacity, cannot meet the demand.
(1) http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm
(2) http://www.nature.com/nrd/journal/v8/n11/full/nrd3026.htmlFrom Nature Reviews, Drug Discovery: News and Analysis w/ references
Nature Reviews Drug Discovery 8, 841-842 (November 2009) | doi:10.1038/nrd3026
From the analyst's couch: Influenza vaccine market dynamics

November 6, 2009

Senators Schneiderman and Breslin introduce "Ian's Law"

From Senator Schneiderman's press release:

“Ian’s Law” (S.6263) makes it illegal for insurers to drop entire classes of insurance as a pretext to deny coverage to individual policyholders; requires insurance companies to get prior approval from the Insurance Department before discontinuing a class of insurance; and expands the minimum length of time — to 18 months — that an insurance company must ensure that policyholders with total disabilities receive continued coverage after losing their policy due to the statewide cancellation of an entire class of policies.


The bill does not currently have an Assembly Sponsor.

November 13, 2009

Conference: Rethinking the Law Governing the Structure and Operation of the Supreme Court.

From the SCOTUSBLOG, a post by Erin Miller on 11/12/09 (1) notes an upcoming conference event on Nov. 20, on Rethinking the Law Governing the Structure and Operation of the Supreme Court. Based on the contents of the conference website (2):

The conference discussion is intended to explore laws governing the structure and operation of the Supreme Court. Although there are constitutional issues surrounding some of these proposals, this program is designed to focus on the policy issues surrounding these proposals, with questions of how to achieve these goals to be considered in the future. Constitutional issues will be discussed in papers found on the website, along with other papers related to the proposals.
The conference website provides links to conference dox, a diverse and broad reaching collection of web accessible reading resources. Excerpted from the website's 'About the Conference':
[H]ere are the four proposals:
1. Altering the appointment system to a regularized process,
2. Limiting the term for future Chief Justices,
3. Re-assigning most certiorari decisions to a body of experienced circuit court judges,
4. Instating a mechanism for the Chief Justice to take appropriate action when a fellow Justice becomes physically or mentally unable to perform the full range of duties of office.
Visit the conference website for the rationales and much more.
(1)www.scotusblog.com/wp
(2)http://www.law.gwu.edu/News/20092010Events/Nov09_Conference/Pages/AbouttheConference.aspx

Medicaid Fraud Ringleader Williams Gets Three to Nine, Plus Restitution

From the Attorney General's press center:

Attorney General Andrew M. Cuomo today announced the sentencing of the mastermind behind a massive Medicaid fraud scheme on Long Island. David Williams, an owner of a now-defunct Long Island medical supply company, was sentenced to three to nine years in prison for stealing over $1 million from Medicaid. In addition to incarceration, David Williams is also responsible for paying restitution of over $1.1 million to reimburse the Medicaid program.

The press release provides additional detail.

November 14, 2009

Public health and IP policy: Amicus briefs in the Bilski case

Questions presented in the recently argued Supreme Court case, Bilski v. Kappos (1), inspired the filing of a large number of Amicus Briefs and in many of them, strong concerns were expressed as to the kinds of potential impacts this Supreme Court decision might have on biotechnology patenting activities, flowing ultimately into health care issues. The oral argument transcript (63 pp, 11/9/09) reveals an interesting and helpful dialogue among the SCT justices and advocates for the parties, often using hypotheticals in comparison to explore and refine aspects of these complex questions.
Notably, the DOJ’s Deputy Solicitor General, on behalf of Respondent, observed that (2) ‘there are difficult problems out there in terms of patentability of software innovations and medical diagnostics…we thought that this case would provide an unsuitable vehicle for resolving the hard questions because the case does not involve computer software or medical diagnostic techniques and therefore we thought that the Court would…decide this case , and most of the hard questions remain unresolved…”
Nevertheless, the many Amicus briefs (with their support dox) that discuss biotech and related health care issues, presented by many IP law associations, national/international, and pro se, IP trade associations, law professors/academic centers in addition to those amicus briefs filed by parties in industry, will provide a lot of food for thought. International treaty and document references highlighting potential global impact include TRIPS, Vienna Convention on the Law of Treaties, NAFTA, the International World Health Assembly (adopting a global strategy and plan of action on public health, innovation and intellectual property).
Biotech/healthcare issues were presented or discussed in, for example:
-Brief for the American Medical Association, the American College of Medical Genetics, the American Society of Human Genetics, the Association of Professors of Human and Medical Genetics, and the Mayo Clinic in Support of Respondent
-Brief amicus curiae of Medistem Inc (in support of petitioners at the certiorari stage)
-Brief for the Biotechnology Industry Organization, Advanced Medical Technology Association, the Wisconsin Alumni Research Foundation, and Regents of University of California in Support of Neither Party
-Brief for University of South Florida in Support of Petitioner
(1)Bilski v. Kappos, argued November 9, 2009. Lyle Denniston, SCOTUSblog reports for SCOTUSWIKI recaps and analyses this case and provides links to the Amicus Briefs at http://www.scotuswiki.com/index.php?title=Bilski_v._Kappos
(2)http://www.supremecourtus.gov/oral_arguments/argument_transcripts/08-964.pdfp.47
See below for a listing of more briefs, the Questions asked and more case history.

Continue reading "Public health and IP policy: Amicus briefs in the Bilski case" »

November 18, 2009

New Mandate Relief Law Impacts Insurers

It was announced yesterday that Governor Paterson signed his Mandate Relief program bill on Nov. 12. The new law affects health insurers' right to subrogation and creates new requirements for plans with respect to municipal cooperative benefit plans. The Governor's press release can be found here

November 24, 2009

New NYLJ Health Article: "The Genetic Information Non-Discrimination Act of 2009"

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, "The Genetic Information Non-Discrimination Act of 2009," appears in the November 24, 2009 edition:

In 2008, sweeping new protections were added when Congress enacted and President George W. Bush signed into law the Genetic Information Nondiscrimination Act,3 or GINA. This complex law aims to prohibit discrimination based upon an individual’s genetic information in health plan coverage and employment. It amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act, the Internal Revenue Code, and the Social Security Act.

Link to the reprint on the Greenberg Traurig website.

Stem Cell Review -current perspectives

Courtesy of ISSCR's newsletter (The Pulse), the Stem Cell Review (1) is a 10-part series,via videos, that focus on the state of stem cell science today, including medical applications and the business of stem cells. The videos can be accessed through the ISSCR website.
The latest episode (aired Oct 29 09) of Stem Cell Review is entitled: Looking Forward to 2015 and features experts' perspectives on where they see stem cell science going in the next five years.

-How will stem cells change the way we think about treating diseases? .
-What are the diseases we'll be treating, and the tools we'll be using in 2015?
-Where will we be in terms of clinical trials?
-What are the dangers in the stem cell hype, and medical tourism?
-How will stem cells pave the way for personalized medicine, and more rational treatments?
How important will stem cells become in the drug discovery process? Discussed in the episode are the eye (macular degeneration), the skin, diabetes (type 1 & 2), blood and autoimmune diseases, glioblastoma, HIV, and more.
Since the beginning of 2008, New York State has allocated more than $165 million through the Empire State Stem Cell Board to support promising stem cell scientists in the development of new research, training, collaboration and infrastructure. Governor Paterson has led the effort to commit $600 million over the next decade to advance stem cell science in New York State as part of a New Economy based on knowledge, technology and innovation. (2)
No area of science better exemplifies New York's New Economy than does stem cell research and its potential for creating meaningful, high-paying jobs while exploring potential therapies for some of the most devastating diseases.
NYSTEM's next Board meeting is scheduled for Dec. 11, 209, Friday. (3)
See also a website video (4) presenting an Overview of Harvard Stem Cell Institute - First 5 years.
(1)http://www.isscr.org/newsletter/index.cfm?fuseaction=Newsletter.showThisIssue&Issue_ID=98
http://biobusiness.tv/videos/210 The Stem Cell Review is a BioBusiness.TV Original Production presented by Bill Kridel, produced by Jean-Loup Romet-Lemonne and Jonathan Teper.
(2)http://www.nyhealth.gov/press/releases/2009/2009-11-03_nystem_research_initiative.htm
(3)http://nystem.com/events_full_board_meetings.html
(4)http://www.hsci.harvard.edu/harvard-stem-cell-institute-first-5-years

About November 2009

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

October 2009 is the previous archive.

December 2009 is the next archive.

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