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July 2007 Archives

July 3, 2007

HIPAA Stymies Useful Information Flows

An article in today's New York Times adds to the increasing body of complaints about the overzealous application of HIPAA:

Hipaa [sic.] was designed to allow Americans to take their health insurance coverage with them when they changed jobs, with provisions to keep medical information confidential. But new studies have found that some health care providers apply Hipaa regulations overzealously, leaving family members, caretakers, public health and law enforcement authorities stymied in their efforts to get information.

Experts say many providers do not understand the law, have not trained their staff members to apply it judiciously, or are fearful of the threat of fines and jail terms --- although no penalty has been levied in four years.

Among the experts cited in the article is the Health Law Section's own Robert Swidler:

Teaching staff to protect records is easier than teaching them to share them, said Robert N. Swidler, general counsel for Northeast Health, a nonprofit network in Troy, N.Y., that includes several hospitals.

"Over time, the staff has become a little more flexible and humane," Mr. Swidler said. "But nurses aren't lawyers. This is a hyper-technical law and it tells them they may disclose but doesn't say they have to."

Hyper-technical is right. Even short HIPAA legal opinions are lengthy and couched, and usually hedged to boot, and not just because they're written by lawyers.

Access the full article here.

July 9, 2007

Hospitals Building Out, Adding Amenities

An article in today's New York Times online discusses hospital construction projects in Westchester County:

At Westchester Medical Center in Valhalla, for example, the hospital recently established a concierge service for patients and their families, with operators on duty from 7 a.m. to 9 p.m. to provide notary services, direct them to nearby restaurants or provide directions to regional airports. The hospital will also invest $60 million this year in renovating patient rooms, building an 11-bed intensive-care unit and creating a new lobby entrance.

. . .

Officials at Hudson Valley Hospital Center in Cortlandt Manor, who last month announced a $100 million building project, say providing a pleasant environment can promote healing and position the institution for financial stability.

The project features the replacement of 84 beds in semiprivate rooms with 84 private rooms in the complex, which opened in its current location 41 years ago.

Read the full article here.

July 10, 2007

WSJ Rounds Up Hospital Data

Today's Wall Street Journal (subscription ordinarily required, although today - - 7/10/07 - - all online content is available free) rounds up a number of databases available online to consumers wishing to research hospitals. Notable inclusions appear below the fold.

Access the full article here.

Continue reading "WSJ Rounds Up Hospital Data" »

Department of Insurance Circular Letters

The Insurance Department has an index of health-related circular letters on its website.
There is a direct link to letters issued since 1994 and the actual letter can be downloaded or printed from the DOI website. To get copies of earlier letters, you will need to call the Department's Public Affairs & Research Bureau at (212) 480-5262. Recent circular letters include guidance from the Department regarding benefits mandated by Chapter 748 of the Laws of 2006 (“Timothy’s Law”).

July 11, 2007

Governor Broaches Issue of Universal Coverage

Today's New York Times online announces Governor Spitzer's initiative to bring a universal health coverage plan to New York:

Gov. Eliot Spitzer's administration is poised to begin an ambitious and potentially expensive push to expand health coverage to nearly three million more residents, aiming to fulfill Mr. Spitzer’s campaign promise to ultimately provide universal insurance.

Many details of the plan will be settled over the coming months, but a major component would expand existing programs for the poorest residents to cover more of the working poor and lower middle class.

Asked how much the expansion might cost, administration officials cited a recent study saying universal coverage could cost the state $3 billion to $6.2 billion annually, but could also reduce costs for employers.

. . .

"I've always believed that when all is said and done, the cost of insuring all individuals will be less than the cost of not insuring them," he said. "The unmeasured cost of the diseases we do not prevent, and the cost to society of the diseases we should be tending to but aren't, outweighs the cost of insurance."

For several months, three state agencies have been conducting joint internal briefings, officials said, and the administration is planning to begin public discussion of the issue by holding five hearings across the state, from August through November, that will explore approaches to providing coverage. The governor said that he would attend at least some of the hearings, and that high-level staffers, including the health commissioner and insurance superintendent, would probably preside.

This week, the administration also issued a formal request for proposals from consulting groups to study various universal coverage plans.

The Commissioner of Health and the Superintendent of Insurance have been directed to produce a plan by next summer. Read the full article here.

July 13, 2007

DOH Unveils Environmental Public Health Tracking Website

On July 2, 2007 the New York Department of Health launched its Environmental Public Health Tracking (EPHT) website. The site provides links to existing environmental and human health data and describes concepts on how the environment affects human health. The EPHT website is part of the state's larger program which is funded by the national CDC. According to the Department's press release:

"Our vision is to have a robust environmental public health tracking system in New York State that provides government agencies, researchers and the public with health and environmental data in a way that is responsive to their needs, that respects people's privacy and furthers our goals to protect and improve public health," Dr. Daines said.

"Concepts” and “Data” headings on the EPHT website lead to various pages of focused discussions, for example, What Surveillance Can and Can’t Tell Us. To paraphrase, surveillance is an an important tool that can help us: explore relationships among environmental hazards and health outcomes; identify unusual patterns/ trends; develop/evaluate public health programs, regulations or policies; identify data quality issues; and generate hypotheses/ provide data for research.

On the other hand, as the surveillance page informs us, “Surveillance alone can't tell us if something in the environment is causing a disease or health condition in most cases." For example, a map showing disease rates may help us identify trends and pattern --- a starting point. If we see major differences, additional questions may be:

  • Are disease rates higher in or does the geographic pattern vary by any particular age or race/ethnicity group? in urban areas or rural areas? areas with higher or lower income ? education?

  • What about changes in disease rates over time? Maps are good for identifying geographical differences, but not so good at showing changes over time. Graphing disease over time may show if the rates are consistently getting higher or lower. Do rates vary from year to year, season to season?
Another tool for collecting health information is disease screening. See DOH's Chronic Disease Teaching Tools Disease Screening:

Screening refers to the application of a medical procedure or test to people who as yet have no symptoms of a particular disease, for the purpose of determining their likelihood of having the disease. The screening procedure itself does not diagnose the illness. Those who have a positive result from the screening test will need further evaluation with subsequent diagnostic tests or procedures.

. . .

The goal of screening is to reduce morbidity or mortality from the disease by detecting diseases in their earliest stages, when treatment is usually more successful.

(emphasis in original)

Most U.S. newborns are now screened for genetic disease, as HealthDay's Carolyn Colwell has reported. She notes that the March of Dimes released their Newborn Screening Report Card (July 10 see the March of Dimes website) showing that 13 states, including New York, currently mandate all 29 newborn screenings. “The ironic thing is that in states that don’t do all these screens, when babies show up in the ER in dire circumstances, treatment—although too little , too late—is automatically provided.”

July 14, 2007

Biomarkers- progress in a complex world.

“Must Do ” events for 2007? Clinical Biomarkers Summit, Biomarker World Congress , Biomarker World Asia, Biomarker Discovery Summit, Cancer Biomarkers 2007 -- touting topics like: biomarkers in early drug development, biomarkers in clinical development, clinical biomarkers for go/no-go decisions, biomarkers to monitor response therapy, --even environmental biomarkers. See pharmaceutical taxonomy at http://www.genomicglossaries.com/content/Biomarkers.asp “What’s it all about?”

Looking forward from September 2004, longtime DHHS/FDA/CDER director Lawrence J. Lesko Ph.D. FCP and DHHA/FDA/OC Deputy Commissioner, CMO Janet Woodcock M.D. wrote an article published in “Nature Review” entitled ,”Translation of pharmacogenomics (PGx) and pharmacogenetics (PGt): a regulatory perspective” (Volume 3 September 2004). They shared their perspective that DNA based tests could lead to improvement in drug selection, identifying optimal dosing, maximize drug efficacy or minimize risk of toxicity. Rapid advances in basic research had identified many opportunities for the development of “personalized” treatments for individuals and/or subsets of patients defined by genetic and/or genomic traits. However, the integration of these tests into routine clinical practice remained a major multidisciplinary challenge even for well established biomarkers. (“Biomarker- a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or pharmacological responses to a therapeutic intervention.")
What was the promise of PGx and PGt? the potential to identify sources of inter individual variability in drug responses that affect drug efficacy and drug safety. The identification of PGx biomarkers could lead to the development of PGx tests used to individualize therapy. The authors concluded that PGx and PGt had the potential to revolutionize the drug development process and could help bring a fresh approach to addressing the pipeline problem outlined in the FDA Critical Path white paper (released 3/16/04).

Flash forward: June 1, 2007 NIH News reports on a published study- a blood test that detects proteins commonly released by a growing tumor could one day become a useful tool for monitoring the effectiveness of chemotherapy and radiation treatment in people with advanced throat cancer. The findings could help lead to the development of a blood test that enables doctors to detect the recurrence of throat cancer early on when there is still time to pursue a second line of treatment, such as surgery or drug therapy. It’s the largest long-term study of its kind. http://www.nih.gov/news/pr/jun2007/nidcd-01.htm
FDA/CBER released draft guidelines (1/ 9/07) that contain definitions of key terms about genomic biomarkers-- it represents the FDA's current thinking on this topic.http://www.fda.gov/cber/gdlns/iche15term.htm The definition of what constitutes a genomic biomarker is key to understanding the definitions of PGx and PGt (and might be applicable to proteomics).

“Regulatory agencies, pharmaceutical companies, the clinical community, third party payers, and patient advocacy groups are all interested in strategies that can improve the cost, quality, and time of drug development and reduce risks associated with drug therapy” (Lesko,Woodcock 2004 article).Basic research on biomarkers has not only significantly impacted drug R&D—it has also advanced the area of disease-related biomarkers that are used for disease screening and prognosis—think of biomarkers like blood glucose for diabetes diagnosis and management and cholesterol for cardiovascular risk.

July 15, 2007

US House Passes Drug Safety Bill 403-16

On July 11, 2007 the United States House of Representatives passed H.R. 2900, the "FDA Amendments Act of 2007," by a vote of 403 to 16. It improves current drug safety provisions, encourages greater transparency and timeliness in the drug review process, and reauthorizes the FDA’s essential user fee programs. According to the Committee on Energy and Commerce's press release,

"This bipartisan legislation provides FDA with the resources it needs to fulfill its mission of protecting the health of American consumers,” said Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce. “By approving this comprehensive bill, Congress is striking the proper balance between new drug safety measures and consumer needs."

“Today, the House paved the way for restoring public confidence in the FDA by giving it the tools it needs to safeguard the public health," said Rep. Frank Pallone (D-NJ), Chairman of the Health Subcommittee. "We have produced a bipartisan bill that gives FDA the authority and resources it needs to ensure American consumers have timely access to safe and effective prescription drugs and medical devices."

Until today, FDA focused solely on a drug’s safety before it was approved. This legislation establishes a new program within the FDA to monitor the safety of drugs after they have been approved and marketed--drugs on the market would be subject to new FDA surveillance and safety requirements.

Other measures enhance drug safety, including increasing the penalties for drug companies that violate safety standards and imposing strict conflict-of-interest provisions to ensure FDA is not making decisions based on the personal financial interests of those serving on advisory panels. It reauthorizes for 5 years both PDUFA and MDUFMA. User fees are increased (more staffing/faster approval of drugs). It permits appropriators to provide additional funding for the drug safety program that would allow the fees to be reduced by a corresponding amount. FDA will collect an estimated $287 million in fees from medical device companies over 5 years, just over a fifth of the total cost to the FDA to review new devices.

To promote drug safety, the bill also assesses a maximum penalty of $250,000 for a first offense of a “false or misleading ad” in direct-to-consumer advertising for prescription drugs and a penalty of up to $500,000 per day for subsequent offenses in any 3-yr period.

Several provisions encourage the development of pediatric drugs/devices, intended to make more new drugs available to children, who typically represent a much smaller pool of likely consumers than adults.

HR 2900 will now be conferenced with S.1082, the FDA Revitalization Act, which passed 93-1 in the Senate May 9, 2007. PhRMA Pres./CEO Billy Tauzin's statement (July 11, 2007) says:

“...Since its original enactment in 1992, PDUFA has been a resounding success for the FDA, pharmaceutical research companies, taxpayers and, most importantly, patients. The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently, while maintaining its stringent safety and efficacy standards...The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety system. The agency will be able to hire key staff for drug safety activities and enhance its use of epidemiology studies and large medical databases that contain a wealth of safety information. In addition, the agency will have the capacity to modernize its Adverse Events Reporting System used to collect and aggregate safety data, and better evaluate risk communication and risk management programs... The House PDUFA bill will enable the FDA to hire 27 additional employees to review drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated. It also will create strong incentives for companies to submit advertisements to the agency before airing them, in accordance with PhRMA’s Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs.Currently, FDA review times for advertising submissions are long and unpredictable. We believe this bill, like the legislation passed by the Senate, will lead to more expeditious and predictable review times, which ultimately benefits public health. PhRMA looks forward to continuing to work in a bipartisan manner with Members of the House and Senate to further improve the legislation as it moves to conference."

For some context, see the JAMA article FDA Responds to Institute of Medicine Drug Safety Recommendations—In Part,” by Bruce M. Psaty, MD, PhD and R. Alta Charo, JD. The authors provide an easy reference table summarizing IOM's Recommendations and the FDA's Response. They observe that “[u]nder PDUFA, the US has increasingly become the country of first launch, the public testing ground for new medicines, but no corresponding effort has been made to strengthen postmarketing risk surveillance, risk assessment, risk management and risk communication." They conclude that the life cycle approach recommended by the IOM will permit both rapid drug approvals and ongoing efforts to ensure the safety of the US drug supply. "The proposed bills pending in the US House and Senate offer a fresh opportunity to harmonize these important twin goals. "

See FDA :The future of drug safety: promoting and protecting the health of the public: FDA's response to the IOM’s 2006 report US Dept of Health and Human Services, January, 2007.

See also the public meeting notice on PDUFA renewal plans as published in the February 16, 2007 Federal Register.

July 17, 2007

Attorney General Opposes Provider Quality/Cost Rankings

Saturday's New York Times reports on an effort by the Attorney General's office to shut down UnitedHealthcare's imminent pricing and quality rankings:

In a sharply worded letter, the New York State attorney general's office asked a health insurance company yesterday to halt its planned introduction of a method for ranking doctors by quality of care and cost of service, warning of legal action if it did not comply.

The letter was addressed to Thomas J. McGuire, a senior lawyer in Hartford for UnitedHealthcare, a unit of UnitedHealth Group in Minneapolis.

It asked the company to cancel its plan to release the rankings in September, citing a furor over a similar program's introduction in Missouri in 2005. There, physician groups, including the American Medical Association, said the cost rankings primarily reflected the cost of care to the insurer --- not to patients.

Assuming that AMA's assertion is true, I'm not sure why that invalidates the rankings. Costs of care are paid out of premium dollars which are ultimately paid by patients and employers, so while the patient's interest in seeing cost is indirect, it's still rather salient.

Linda A. Lacewell, a senior lawyer in the office of Attorney General Andrew M. Cuomo, wrote in the letter that the ranking would apparently be used to steer consumers toward selected doctors. "To compound the situation," she wrote, "we understand that employers may act on these 'ratings' to offer financial inducements such as lower co-payments or deductibles to promote 'cost-effective' doctors to their employees."

Ms. Lacewell said patients might be steered toward doctors based on flawed data and UnitedHealthcare's "profit motive." She wrote, "Consumers may be encouraged to choose doctors because they are cheap rather than because they are good."

Flawed data is obviously worrisome, but if the data is valid one wonders at length why consumers shouldn't be able to choose cheap over good if that's what they want.

Read the full article here.

July 20, 2007

Bellevue Hospital to Fold Into Ellis

The Albany Times Union reports today that Bellevue Hospital, slated by the Berger commission to close, will instead fold into nearby Ellis Hospital by November 1.

The fight to save Bellevue Woman's Hospital ended in a truce Thursday with the announcement that Ellis Hospital will take over operation of the facility on Nov. 1.

Bellevue CEO Anne Saile, who fought ardently to prevent the hospital's closing, called it the second-best outcome, but a victory nonetheless. Bellevue will continue to operate as a stand-alone campus in Niskayuna for the foreseeable future, Saile said, but there is no guarantee it will remain permanently.

. . .

The Berger Commission ordered Bellevue to give up its certificate of operation by the end of the year, but it did not prevent Ellis from taking over the certificate and running Bellevue. The women's hospital is a 40-bed facility that specializes in births and women's health services. The hospital delivers about 2,000 babies and performs more than 3,000 surgeries annually.

Ellis, a Schenectady hospital with 368 beds, closed its maternity unit eight years ago. Ellis is still under a Berger mandate to merge with St. Clare's Hospital in Schenectady.

Not everyone is thrilled.

Bellevue leaders delivered the news to staff on Thursday afternoon, but Dr. Mary Joyce McGinnis, chief of obstetrics at Bellevue, missed the announcement while seeing patients. She saw a handwritten message on a patient board that said "Welcome to Bellellis."

"I didn't know what it meant," she said and she didn't find out until she was contacted by a reporter on Thursday evening. She's concerned about the Ellis takeover.

"There's a reason that Ellis closed their labor-and-delivery unit, which was they were never able to offer the quality that would attract patients and doctors," McGinnis said. "They were the people who couldn't do it well and got out of the business. I'm not sure you can place the future of women's health care in Schenectady in the hands of people who know nothing about it."

Read the full story here.

Governor Signs Legislation Governing Office Based Surgery

Governor Eliot Spitzer announced Friday that he signed legislation governing surgical procedures rendered in physician offices. The legislation: (1) requires office-based surgery ("OBS") to be performed in a setting that has obtained accreditation from an entity approved by the Commissioner of Health; and (2) requires physicians to report adverse OBS events within one business day to the Department of Health. The legislation also provides that providing OBS in an unaccredited office constitutes professional misconduct. The law takes effect in January 2008.

The law is based on recommendations made by the Committee on Quality Assurance in Office Based Surgery, established in 1997 by the New York State Public Health Council.

A copy of the law is available on the State Assembly's website here . The Governor's Press Release may be accessed here.

About July 2007

This page contains all entries posted to HEALTH LAW SECTION BLOG in July 2007. They are listed from oldest to newest.

June 2007 is the previous archive.

August 2007 is the next archive.

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