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January 2008 Archives

January 1, 2008

Insurance Department Sets Public Hearings for GHI Conversion

Today's Times Union has this story:

The public will have its say at the end of the month on a proposal for New York City health plan giant Group Health Inc. to turn into a for-profit entity. GHI merged in 2006 with another large insurer, HIP Health Plan of New York City, to form a plan that now has about 4 million members. As part of its conversion from a nonprofit to for-profit corporation, GHI-HIP proposes an initial public offering of stock.

The conversion must be approved by the state insurance commissioner.

The complete TU story (time limited) is here. The Insurance Department has posted all of the GHI conversion materials, including its plan of conversion, on its website here.

January 2, 2008

DOH Posts Proposed Consumer Consent Policies for RHIOs

The New York Health Information Security and Privacy Collaboration (NYHISPC) has produced a proposed "Standardized Consumer Consent Policies and Procedures for RHIOs in New York State" which is now posted on the DOH website. (Link here.)

The purpose of this document from the New York HISPC team is to put forth for public comment recommended policies and guidelines governing consumer consent for the exchange of personal health information in a technology-enabled health care environment facilitated by Regional Health Information Organizations (RHIOs) in New York State in order to protect privacy and strengthen security. Comments received will be reviewed and considered during the development of final policy guidance that will be issued by the New York State Department of Health.

Link to the NYHISCP "Phase II" page here, where you can also access the comment form for submitting comments to the draft policy.

January 4, 2008

Cal. Expands Data Breach Notification Laws

Here is an interesting bit from the far west in today's San Francisco Chronicle:

California residents must now be notified when their electronic medical information or health insurance information has been exposed.

AB1298, which took effect Tuesday, expands California's data-breach notification law to include unencrypted medical histories, information on mental or physical conditions, and medical treatments and diagnoses.

Also covered under the law are unencrypted insurance policy or subscriber numbers, any applications for insurance, claims histories and appeals.

The full article is here. New York has data breach laws (see, for example, General Business Law sec. 899-aa and also State Tech. Law sec. 208) but the Cal. scheme seems far more extensive.

January 8, 2008

The Scoop on Spitzer's Health Care Plan

Today's Albany Times Union carries an exclusive on the health care plan to be detailed in the Governor's State of the State address this Wednesday:

In his State of the State speech Wednesday, Gov. Eliot Spitzer will propose shifting New York's health care to focus more on prevention, starting with the Medicaid program.

Excerpts from the article and an overview of the problem areas to be addressed in the plan are below the fold.

Continue reading "The Scoop on Spitzer's Health Care Plan" »

January 9, 2008

"Peace Corps for Doctors"

Today's Albany Times Union provides details on another component of the Governor's health care reform plan:

Gov. Eliot Spitzer wants to pay off the student loans of physicians who agree to serve rural and urban areas facing shortages of doctors, an administration official said Tuesday. The program referred to internally as a Peace Corps for doctors is expected to be part of Spitzer's State of the State speech on Wednesday, the second of his administration.

The measure, if approved and funded by the Legislature, is aimed at relieving a shortage of medical care in the northern part of the state as well as inner cities, the official said on the condition of anonymity because the speech isn't yet finished.

"Doctors Across New York" would provide grants to repay student loans and other unspecified inducements to reach a goal of providing a family doctor for every New York household, the official said.

Read the full story here.

January 11, 2008

Boston Mayor: "Allowing retailers to make money off of sick people is wrong"

The Mayor of Boston has launched a public campaign against in-store retail clinics.

Menino blasted state regulators for paving the way Wednesday for the in-store clinics, which are designed to provide treatment for sore throats, poison ivy, and other minor illnesses.

The decision by the state Public Health Council, "jeopardizes patient safety," Menino said in a written statement. "Limited service medical clinics run by merchants in for-profit corporations will seriously compromise quality of care and hygiene. Allowing retailers to make money off of sick people is wrong."

That's a rather interesting perspective. Read the full article here.

January 15, 2008

Quality in FDA-Regulated Clinical Research

With eager anticipation of the excellent educational content provided at the Section (and Committee) meeting events scheduled for this year's NYSBA Annual Meeting (Jan 28-Feb 2), I noted that our Health Law Section will focus on "Medical Malpractice, Quality Assurance, and Fraud: Emerging Trends" for a full day.

For a bird's eye view about Quality in FDA-Regulated Clinical Research, you might want to take a look at one of their 2007 Concept Papers.(1) One problem they put into context concerns random errors (sloppiness). They describe it as a critical destruction affecting the quality of data and it biases the data--it obscures differences between treatments and tends to undermine a showing of effectiveness or more generally of a difference between treatments. Biased data or fraudulent data is a major concern of regulators as it is designed to lead to the wrong conclusion.

The FDA inspects and performs oversight for the dual purposes of ensuring safety and welfare of trial subjects and as well the reliability and integrity of the trials and data generated from such trials now. But their role is not so static. The Concept Paper notes that clinical trials have evolved dramatically and are no longer conducted primarily at a single center-- not only are they multi-centered but multi national and trial conduct has become much more complex, both administratively and scientifically. And we need clinical trials to answer an increasing number of questions about the benefits and risks of therapies, about the best intervention to use in a given medical condition and about the best choice of therapy in a particular individual. So, FDA has undertaken the Human Subject Protection/Bioresearch Monitoring initiative (HSP/BIMO) for a comprehensive evaluation of the policy and regulatory framework informing FDA's oversight of clinical trials. It will further the goals of the Critical Path initiative.

Also of interest, see the recently issued draft FDA guidance annex(2) to a larger parent guidance document for the International Conference on Harmonization (ICH) which discusses a minimal approach and an enhanced approach regarding different aspects of pharmaceutical development and life cycle management of their products. In this document, there is of course technical industry language but throughout it as well they discuss overall approaches to pharmaceutical development for products designed to meet patients' needs and the intended product performance. Descriptions of the various approaches are condensed nicely into a comparative chart in Appendix 1. The complexity and challenges drug companies and regulators, and really all of the stakeholders involved face in this regard, are amazing.

Notes
(1) http://www.fda.gov/oc/initiatives/criticalpath/clinicalresearch.html
(2) http://www.fda.gov/cber/gdlns/ichq8pharmann.pdf

Continue reading "Quality in FDA-Regulated Clinical Research " »

January 16, 2008

Wellness Not so Well, Says WSJ

From today's Wall Street Journal online:

In December, the department's Employee Benefits Security Administration issued guidelines to its national and regional offices on "supplemental coverage," a form of health insurance covering co-pays and deductibles in regular insurance. Supplemental coverage is generally used to fill such gaps in either Medicare or Tricare, the health-care plan for current and retired military members. But in recent years, some employers have incorporated a form of supplemental insurance into their wellness programs.

New rules may prevent employers from steering workers toward healthy habits. Under such programs, workers enroll in an employer-sponsored health plan with a high insurance deductible. They can offset the deductible by earning "wellness credits" for meeting certain health benchmarks -- such as for cholesterol count -- issued under a separate supplemental policy.

Proponents liken the rewards to giving a good-driver discount, arguing 70% of health-care expenses are lifestyle-related. Exposure to higher out-of-pocket costs motivates employees to improve their health, which saves employers money.

But lawyers and consultants have voiced concerns that such programs could hurt employees with health problems. In some instances, unhealthy employees could face insurance deductibles more than $1,000 higher than healthier co-workers'.

Read the full article here.

January 17, 2008

Hearsay? blogs report on NIH investigators, peer-reviewed manuscripts at PubMed Central

BioMed Central Bloggers posted and commented recently on the NIH Public Access Policy to become mandatory. (1)
Their blog posts together describe an in-depth field setting in which this event took place, contributing their fair share of balanced insider analysis, opinions and many helpful links.
In particular, a link is provided to Peter Suber's January SPARC Open Access Newsletter (2)noting that it contains a detailed analysis of what the change means, and identifies some of the key issues that remain to be resolved.
Biomed bloggers discuss aspects of the arguments made by publishing organizations who had lobbied against the new policy. But most conclude that this new law is great news both for researchers and for the general public. How did the bloggers' blog?


Here's the language that just became law:
The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.
This is a momentous victory, despite the 12 month embargo. Measured by the ferocity of opposition overcome and the volume of literature liberated, it's the largest victory in the history of the OA movement. It's only a plateau, not a summit, but it's an immense success. Researchers, OA advocates, and everyone concerned to advance medical knowledge, are justified in feeling joy and relief.

They join in a chorus refrain as we have so often heard before about other major US policy initiatives in science and medicine, reiterating how important our Federal government agencies' regulatory and administrative work is to our lives:

[The new open access law is]... big because the NIH is big. The NIH is the world's largest funder of scientific research (not counting classified military research). Its budget last year, $28 billion, was larger than the gross domestic product of 142 nations. As [his]colleague Ray English points out, it's more than five times larger than all seven of the Research Councils UK combined. NIH-funded research results in 65,000 peer-reviewed articles every year or 178 every day. The NIH is the one funder that could do the most for OA. Its OA mandate will not only free up an unprecedented quantity of high-quality medical research. It will also make a giant step toward cultivating new expectations --among researchers, funders, governments, and voters-- that publicly-funded research should be OA.
If NIH had adopted an OA mandate in 2004 when Congress originally asked it to do so, it would have been the first anywhere. Now it will be the 21st.
.

(1)http://blogs.openaccesscentral.com/blogs/bmcblog/entry/nih_public_access_policy_to
(2)http://www.arl.org/sparc/

More on Stuber and SPARC below.

Continue reading "Hearsay? blogs report on NIH investigators, peer-reviewed manuscripts at PubMed Central" »

Governor Spitzer Delivers 2008 State of the State

Last Wednesday, Governor Eliot Spitzer delivered his 2008 State of the State address to the Legislature. The text of his speech can be found here. The Governor repledged his commitment to ensuring quality care accessible to all New Yorkers through a wide range of proposals. That pledge included a promise to expand Child Health Plus using state funds after the Centers for Medicare & Medicaid Services denied New York's request to expand the program last year. Governor Spitzer also proposed a program that would repay student loans for those physicians practicing in medically underserved areas. And the Governor outlined measures that would encourage primary and preventive care.

The Governor's broad proposals received support from various interest groups. For instance, Citizen Action of New York applauded the Governor's proposal to expand Child Health Plus. (See here.) The New York State Nurses Association issued a statement applauding the Governor's commitment to investing in higher education, promoting healthy environments in New York's schools, and fully funding Child Health Plus. (See here.) Similarly, Daniel Sisto, President of the Healthcare Association of New York State, expressed support for the Governor's proposal to expand Child Health Plus and address the physician shortage issue. (See here.)

Not surprisingly, the Governor provided few details on his health care initiatives. During the course of the next few months, the specifics of each of these proposals will be hammered out, through the budget process or through stand alone legislation. Please check back frequently for information about these and other health care initiatives that will be considered by the legislature in 2008.

January 18, 2008

DOH Releases More Berger Money

The State Department of Health yesterday announced a slew of grant awards in relation to the Berger commission recommendations, including:

This round is in addition to the $362.3 million awarded previously on September 28, 2007. Together with yesterday's announcement, most of the $550 million set aside for Berger recommendations has been awarded.

Provider Groups Oppose Spitzer Initiatives

Today's TimesUnion reports:

Gov. Eliot Spitzer hasn't even unveiled his proposed budget, but two major health care associations released reports Thursday warning about the dangers of cutting government funding to hospitals and nursing homes.

. . . The [New York Association of Homes and Services for the Aging]'s report said that one in 10 nursing homes are considering closure because of last year's cuts to Medicaid, and 17 percent are cutting back on plans for home care and other alternative services.

. . . The Healthcare Association of New York State, which represents 550 hospitals, released results of a poll Thursday. According to HANYS, the poll found that New Yorkers by a 3-1 margin oppose education increases if that means cuts to hospitals.

Read the full story here (time limited).

CMS to Audit Hospital HIPAA Security Practices

Government HealthIT reported yesterday:

The Centers for Medicare and Medicaid Services will begin on-site reviews of hospitals' compliance with security rules mandated by the Health Insurance Portability and Accountability Act of 1996.

CMS officials said at a workshop on HIPAA security yesterday that they expect to review 10 to 20 hospitals in the next nine months.

Link to the online article here.

January 21, 2008

Aetna Halts Payments for "Never Events"

From Aetna's website:

As part of its commitment to improving patient safety, Aetna (NYSE: AET) has incorporated language from the Leapfrog Group's Never Events policy in its hospital contract templates for negotiations or renegotiations that use a new contract. 'Never events' are a list of occurrences compiled by the National Quality Forum that so threaten patient safety that they should never happen. These include surgery performed on the wrong body part or on the wrong patient, leaving a foreign object inside a patient after surgery, or discharging an infant to the wrong person.

Read the full press release here.

Spitzer Commits to Expand Child Health Plus

Governor Spitzer's Executive Budget will include $37 million to extend health insurance to an additional 70,000 children of working parents. New York sought approval last year to increase income eligibility levels for the State Child Health Plus (SCHIP) program from 250% to 400% of the federal poverty level. This equates to a family income of $82,000 for a family with two children. The Bush Administration increased the overall SCHIP budget, but would not permit states to expand the eligibility criteria. Governor Spitzer proposes to have New York fund the federal government's share of the expansion, which would have been $19 million. His goal is to provide health insurance coverage to all of the state's approximately 400,000 children who are insured; about 330,00 of whom now qualify for SCHIP.

January 22, 2008

Governor Releases 2008-2009 Budget

Governor Eliot Spitzer released his proposed budget for the 2008-2009 fiscal year, recommending $124.3 billion in spending. According to the Albany Times Union, that amount is up 5.1% from the current fiscal year's budget of $118.3 billion budget.

As expected, the Governor's proposed budget includes several health care initiatives, including the expansion of the Child Health Plus program, the creation of a physician tuition loan repayment program, the expansion of nursing scholarship programs, and the establishment of certain financial incentives for ambulatory and primary care. In addition, the Governor proposed investing $15 million in public health and aging programs, such as anti-smoking and obesity prevention programs. The Governor also proposed adding an additional $5 million in funding for the Office of Medicaid Inspector General to increase staff by 75 and increase data mining capabilities. The Division of Budget anticipates these OMIG investments could yield an additional $160 million in fraud collections. Click here for a summary of the major health care budget highlights.

The Governor's proposed health care budget reduces overall spending by $980 million. These savings would be achieved in part by decreasing Medicaid pharmacy reimbursement, increasing Medicaid audit savings, modifying acute and long term care reimbursement methodologies, eliminating or reducing certain hospital, nursing home, home care and managed care plan reimbursement increases, and increasing insurer assessments. After these savings, the Governor's proposed budget would yield $465.3 billion in Medicaid spending. For more detailed information on the Governor's proposed health care budget, click here.

January 23, 2008

Two U.S. Supreme Court Cases of Interest

To find the official reporting on US Supreme court cases , please use the official website of the Supreme Court. (1)
For something different, there is also the SCOTUSblog.com website.
Lyle Denniston, shown as a regular Reporter on the SCOTUS blog, posted about 2 interesting cases on Friday, January 18th (2)
The US Supreme Court,

will hear a case on whether federal law has taken over the field [...that is] the enactment of state laws that impose their own labeling requirements to assure that drugs are safe for use (Wyeth v. Levine, 06-1249). The Vermont Supreme Court ruled that federal regulation on drug safety only provides a floor on labeling requirements so states are free to impose more restrictive labeling under their own duty-to-warn tort laws. The case involves an anti-nausea drug, Phenergan, made by Wyeth.

He also reports on the Philip Morris v. Good, et al (07-562) case which he summarizes as follows (in part):

...The Supreme Court on Friday agreed to decide whether smokers may file court challenges, based on state law, to cigarette companies' advertising claims that some brands are 'light' or 'low in tar and nicotine.' Philip Morris v. Good, et al. (07-562).
The Philip Morris case also focuses on the interaction between a federal law that regulates labeling and advertising of cigarettes and a state law -Maine- that permits lawsuits based upon deceptive commercial practices. Three former smokers of Marlboro Lights, made by Philip Morris, are pursuing a class action lawsuit claiming that the use of the word 'light' or the phrase 'low in tar and nicotine' misleads smokers into thinking that the health hazard of such cigarettes is lowered. The lawsuit contends that smokers, because of their addiction, will smoke so-called 'light' cigarettes in such a way as to defeat any filter put on them. The legal argument is that the advertising claims are violations of Maine's fair trade practices law....

SCOTUSUSblog.com has a companion, Scotus Wiki, more on that below.

(1) http://www.supremecourtus.gov/
(2) http://www.scotusblog.com/wp/orders-and-opinions/court-to-hear-case-on-light-cigarette-ads/
As always, comments are welcomed.

Continue reading "Two U.S. Supreme Court Cases of Interest " »

January 29, 2008

Roundtable on Strengthening Infection Control Practices

From the DOH website:

Senate Health Committee Chairman Kemp Hannon and State Health Commissioner Richard F. Daines, M.D. will hold a roundtable discussion on infection control practices by New York health providers on Wednesday, January 30. The roundtable will begin at 9:00 a.m. at Hofstra University in the David S. Mack Hall (University Club). Members of the roundtable will include medical practitioners, educators, and public health experts.

Read the full press release here.

Insurance Department Restyles Website


Check out the new look at the Insurance Department's website.

Wellness Program Problems - the HR Perspective

Human Resources Executive Online takes a look at the problematic December EBSA guidance on wellness programs.

In early December, The Department of Labor's Employee Benefits Security Administration issued new regulatory guidelines that, according to legal experts, "close the door" on emerging cost-saving strategies employers might have considered using to entice workers to change their healthcare-related behavior patterns.

Specifically, EBSA's guidelines apply to "supplemental coverage" that was primarily created for, among other things, reducing deductibles in standard healthcare insurance. Carriers have created products that use supplemental insurance as a basis for employee health and wellness programs, but with the new guidelines, employers must step much more carefully when choosing that strategy.

"The guidance letter effectively plugs a loophole that could have allowed programs to discriminate against people with health problems that are beyond their control," says Tom Bixby, a partner in the Health Law practice group at Neal Gerber Eisenberg, a Chicago law firm.

Read the full article here.

Retail Clinic Chain Closes Stores

Today's New York Times reports:

CheckUps, a start-up operator of walk-in medical clinics, has shut down 23 of the clinics operating in Wal-Mart stores in Florida and three other Southern states.

CheckUps, based in New York, fell behind in paying its nurses and other vendors late last year, apparently running short of cash to meet its bills, according to a lawyer for one of its creditors.

Read the full article here.

Update at 10:37 The Wall Street Journal's Health Blog treats the closings here.

Universal Healthcare Advocacy Group Cautions Against GHI/HIP Conversion

Today's Times Union ran an editorial by Richard Propp, M.D., chair of the Capital District Alliance For Universal Healthcare Inc. raising questions regarding the GHI/HIP conversion.

The huge combined health insurance company GHI/HIP wants to convert from nonprofit to for-profit status. Shocked? I doubt it. Empire Blue Cross-Blue Shield set the example in 2002. . . .

The Capital District Alliance for Universal Healthcare believes that health care is a necessity and a social good, and that everyone should have access to high-quality, appropriate and necessary health care. The GHI/HIP "for profit" quest does not appear to further that goal.

Dr. Propp points out that in four other states, proposed not-for-profit to for-profit conversions have been turned down after scrutiny by regulators, and he raises a number of questions about the conversion and the way the conversion is being handled by the Insurance Department, including the following:

  • What are the consequences of the company going from an ethic of subscriber value to one of shareholder value?
  • Will the need to assure adequate profits mean premiums will increase and that more care will be denied or delayed?
  • 2.7 million people lack health insurance in New York. What effect will conversion have on that number?
  • How much of the new revenues generated by going for-profit will finance GHI/HIP lobbyists, and will they work for consumers or shareholders?
  • Are there no other management alternatives to for-profit? Are relevant studies being carried out by this administration?
  • GHI/HIP has $900 million in reserves and just bought Connecticare for $350 million. Why does GHI/HIP need for-profit status to secure its future?

Read the full article (time limited) here.

January 30, 2008

More Restructuring Money Available

From the DOH website:

The state will make $250 million in grant funding available this spring to further the restructuring of New York's health care system to strengthen primary care, eliminate excess bed capacity and reduce overreliance on inpatient care in hospitals and nursing homes.

Read the full press release here.

January 31, 2008

Event report: NYSBA 2008 Annual meeting Presidential Summit- webcast live around the world, youth at risk, global legal services

"We are the voice of the profession here in New York and the advocate of the people. In numbers there is strength, credibility and influence."

In NYSBA President's blog post of January 14, Kathryn Grant Madigan, Levene Gouldin & Thompson LLP shares some important NYSBA membership numbers: 74,150.
She announced :

[a formal] kick-off [of] our 2010 Membership Challenge to increase NYSBA membership by 5 percent, increase Section membership by 10 percent and increase law student membership by 10 percent each year between now and 2010. To achieve our goals we need the help of every member, every Committee, every Section and every NYSBA staff person to "think membership". In fact, I urge each member and all of our staff to reach out to one non-member attorney, express the tremendous value and relevance of NYSBA membership
(1)

So one avenue to explore here on Supra: law blogging. One truism: as you refer to other blogs in posting, other blogs refer to you and web blog visitors travel to both.
Some exciting ideas presented at the IP Law section's Annual meeting this week focused on global branding. In particular, Alan Blum Esq of Quinn Emanuel Urquhart & Hedges, LLP NYC along with Edward Moed of Peppercorn NYC shared some good ideas about corporate blogs as:

[a] mainstream communication channel...to provide thought leadership content... through these conversational tools, professionals can educate, communicate, and tactfully promote topical issues that are important to their company and brands.

One amazing aspect of company blogs: "blog relation" programs... media may even obtain ideas and content from blogs for media stories.
They also talked about on line communities, (like HLS listserv) as extremely powerful mediums to communicate, suggesting that those most successful seemed to stay away from product/company promotion, offer thought leadership in an objective, non promotional way, build trust within the community and share thoughts/comments focusing on content that the community cares about. One new site mentioned, although not limited to law blogging, is "Twitter.com" a sort of a telegraph station operating across the world in real time apparently overcoming most language barriers. That should be interesting to visit.(update see 2 below)

With that in mind, yesterday the NYSBA Presidential Summit at the Annual meeting was web cast...to the world! The huge room facility was filled to capacity and the entire afternoon was truly engaging, the atmosphere of audience and speakers together fully attentive and responsive.
Hon. Judith S. Kaye's introduction for "Breaking the Cycle for Youth at Risk" shared some big numbers, especially when you think about the young human lives they represent: NY State, through the courts, literally has custody of 27, 390 children today residing in foster care, 61,000 children between the ages of 16-19 are not in school or working, 42,000 youth not graduating from school, 17,000 mothers in 2005 gave birth at ages 15-19, and there were many more statistics.
All of the speakers covered an insightful, broad range of discussion delving into the complexity of this problem and the dire need for positive change. (Access and quality of health care was factored into the complexity of the problem.)
“Providing Legal Services in a Globalized World…” was a great direction to take the first half of the program. During the afternoon, panelists again shared a lot of important and up to date insights for lawyers, including both legal and ethical concerns of practicing in a globalized world.
The web cast of this program will be really worthwhile to watch.
More from the science perspective of youth at risk as presented at the Presidential Summit in the next biotech post.
(1) http://nysbar.com/blogs/president/
(2) Here is a blurb from a Twitter's post of 1/18 which says a little bit about what they are doing.

... our open approach is more than just good karma. Twitter, Inc. is committed to building a reliable social messaging utility which people trust enough to use every day. Gaining trust means showing our work. When a technology is shared, conversations and understanding form around it.
http://blog.twitter.com/

About January 2008

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

December 2007 is the previous archive.

February 2008 is the next archive.

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