Tying up loose ends

During the past year, I blogged quite a bit about the generic version of the anti-coagulant drug Plavix battle between Bristol Myers and Apotex. In the latest rounds, the U.S. Court of Appeals for the Federal Circuit on December 8 affirmed the preliminary injunction that the district court awarded Bristol Myers against Apotex's continued marketing of the generic version in the U.S. The lower court did not require Apotex to withdraw the generics that it had already sold, however, and neither did the appellate court. Earlier this week, a Canadian appellate court rejected an Apotex attempt to sell the generic version in Canada. The U.S. district court now will consider whether Apotex violated Bristol Myers' patent on Plavix.

I also blogged about the theft of a Veterans Affairs Department laptop computer that held personal data on millions of veterans. That case ended with the recovery of the computer, and the FBI determined that the information had not been abused. On December 21, President Bush signed the Veterans Benefits, Health Care, and Information Technology Act of 2006 , Pub. L. No. 109-461, that tightens up information security at that Department, among other things.

Health Care Related Social Networking

Laura Landro wrote this week in the Wall Street Journal about the extension of the online social networking phenomenon, e.g. My Space, to health care issues, such as diabetes. She notes a dedicated web site called Dailystrength.org. She also notes that the American Cancer Society and the U.S. Centers for Disease Control are using a social networking site call Second Life as a bully pulpit. I had never heard of Second Life until I read this article. Second Life is a site where you can live a second life as an avatar -- over 2,000,000 users (not me). Landro reports that "The CDC has held some virtual health fairs on the Second Life Web site where visitors can learn about subjects like pandemic flu resources." Creative.

Dr. Brailer Prognosticates about 2007

Ihealthbeat.com makes available an interview with former U.S. health IT czar Dr. David Brailer who makes predictions about health care IT in 2007.

Mental Health Parity Law Extension

As part of the Tax Relief and Health Care Act of 2006 (H.R. 6111), which President Bush signed on December 20, Congress extended for another calendar year (2007) the current mental health parity law. This law generally requires group health plans, including FEHB plans, which offer mental health benefits, to place the same annual and lifetime coverage dollar limits on mental health coverage as they do for other medical services. Since 2001, the U.S. Office of Personnel Management has required broader mental health parity for FEHB plan coverage provided that the member uses network doctors and facilities and cooperates with the plan's medical management requirements. The Washington Post reports that the 110th Congress which takes office next week may enact a more expansive mental health parity law.

HHS website updates

HHS has freshened up its health information technology web site so that it has a look similar to its health care transparency web site. HHS also has added physician fees to its Medicare consumer initiatives web site. As Medicare pays fees to physicians based on a resource based relative value schedule, there is not a lot of variation in the fees for particular services other than regional adjustments. CMS suggests that you may want to use the chart to find a lower priced region to have your colonoscopy procedure (I'm not making this up), thereby reducing the coinsurance.

AHRQ Medical Expenditure Panel Survey

The Internet provides a wealth of information. I learned today the federal government's Agency for Healthcare Research and Quality (AHRQ) produces an annual Medical Expenditure Panel Survey. The survey was recently updated with 2004 data. The AHRQ website explains that

The Medical Expenditure Panel Survey, which began in 1996, is a set of large-scale surveys of families and individuals, their medical providers (doctors, hospitals, pharmacies, etc.), and employers across the United States. MEPS collects data on the specific health services that Americans use, how frequently they use them, the cost of these services, and how they are paid for, as well as data on the cost, scope, and breadth of health insurance held by and available to U.S. workers.

MEPS currently has two major components: the Household Component and the Insurance Component. The Household Component provides data from individual households and their members, which is supplemented by data from their medical providers. The Insurance Component is a separate survey of employers that provides data on employer-based health insurance.

For example, here's a link from the Insurance Component to a 2004 table showing the Percent of private-sector employees in establishments that offer health insurance by firm size and State. The survey also discloses regional variations in health insurance premiums. It's the holiday season. Enjoy!

VA to Incorporate Genetic Info in EHRs

According to Government Health IT magazine, the Veterans Affairs Department has begun to collect from consenting patients genetic information that it will link to the patient's electronic health record. "VA officials expect that the large-scale project will reveal links between certain diseases and the genetic makeup of the individuals who are prone to them. It also could increase scientists’ understanding of the effects of genetics and the environment on people’s health."

Extend the FEHBP?

Thanks to Google Alerts, I ran across this recent article discussing at a very high level the pros and cons of extending the FEHB Program to "everyone else."

More drug patent news

As discussed in this blog, 2006 has been a year in which the patents on many blockbuster brand name drugs have expired here in the U.S. Therefore it is noteworthy when a brand name drug manufacturer beats back a patent challenge. Yesterday, the U.S. Court for the Federal Circuit upheld Eli Lilly's patent on Zyprexa (olanzapine), a top selling anti-psychotic medication, against challenges from the two largest foreign generic drug manufacturers, Teva and Dr. Reddy. According to the Courts, Lilly's patent expires in 2011.

Meanwhile, the Food and Drug Administration approved for marketing a new Johnson & Johnson anti-psychotic medication called Invega. Invega reportedly is a new class of drugs to treat schizophrenia which does not cause weight gain and high blood sugar as a side effect, a problem associated with Zyprexa, according to the American Diabetes Association , which has resulted in litigation against Lilly.

Profits up at large pharmacy chains / Caremark shareholders sue

Both Walgreens, Inc., the Nation's largest pharmacy chain (by sales), and Rite-Aid, the third largest chain, reported significant increases in quarterly profits this week. Both chains report that Walmart's $4 generic drug price has not dented their sales. Among other factors, Walgreens gives credit to the Medicare Part D program and Rite Aid give credit to higher profit margins on drugs like Zoloft which recently shifted from brand name to generic status when the manufacturer's patent protection expired.

Of course, the second largest chain, CVS, is seeking to acquire the Nation's largest prescription benefit manager (PBM) Caremark. Rite-Aid indicated that it has no such acquisition plans. Rite-Aid lost money when it acquired a national PBM, PCS, a company which is now part of Caremark.

On the Caremark acquisition front, two shareholder lawsuits brought by two different pension plans were filed against Caremark this week, alleging that Caremark's directors "breached their duty to shareholders in agreeing to a buyout by CVS Corp. The shareholders said the directors failed to give enough consideration to a higher, unsolicited bid by Express Scripts Inc." One lawsuit was filed in Nashville, TN, where Caremark is headquartered and the other in Wilmington, DE, as Caremark is a Delaware corporation. On Friday, a federal judge refused to enjoined the CVS deal on the ground that Caremark's directors plan to consider the Express Scripts offer after January 1.

Genotyping Price War

The Wall Street Journal reports today that two major manufacturers of "high through put genotyping" equipment and "gene chips" -- Affymetrix Inc. and Illumina, Inc. -- are in a "price war" that appears to be accelerating genetic research. "[G]enotype scans seek to locate and identify the genes that predispose groups of people to certain chronic diseases such as heart disease, cancer, or neurodegenerative conditions such as amyotrophic lateral sclerosis, known as Lou Gehrig's disease. But the discoveries made by such scans are expected to eventually lead to new genetic diagnostic tests and therapies that can find and treat a range of genetic illnesses." For example, last month, Affymetrix announced that "A comprehensive scan of the human genome [using their equipment] has identified more than 50 genetic abnormalities in people with sporadic amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease). * * * Just a couple of years ago, this experiment would not have been possible because there simply wasn't a technology that enabled scientists to sift through the three billion molecules in the genome to find the genetic abnormalities that cause disease."

This is revolutionary. According to the Journal, "[r]esearchers say increasing affordability allows their labs to do more, bigger or different scans, boosting the chances to find genes related to diseases." Very interesting reading.

Sec'y Leavitt Announces Private Sector Support for President's Executive Order

Health and Human Services Secretary Michael Leavitt announced yesterday that over 100 private sector employers, including the auto manufacturers, IBM, and Starbucks, and the Commonwealth of Virginia have endorsed the "cornerstone principles" of the President's August 21 Executive Order as part of their health plan purchasing criteria:

• Standards for connecting health information technology, making it possible to share patient health information securely and seamlessly among health care providers.

• Quality of care reporting, so that health care providers as well as the public can learn how well each provider measures up in delivering care.

• Providing costs of health services in advance, so that when patients choose routine and elective care, they can make comparisons on the basis of both quality and how much of the total cost they will have to pay under their health plan, and
  

• Providing incentives for quality care at competitive prices, as in payments to providers based on the quality of their services, or insurance options that reward consumers for choosing on the basis of quality and cost.

OPM Reacts to the Tax Relief and Health Care Act of 2006

President Bush signed the Tax Relief and Health Care Act of 2006 yesterday (see 12/20 FEHBlog entry) and in response the U.S. Office of Personnel Management is allowing the following actions that are permitted under this law:

• Agencies may accept belated Federal Employees Health Benefits (FEHB) open season enrollments in a [High Deductible Health Plan] HDHP with a [Health Savings Account] HSA through December 31, 2006, for employees who are otherwise eligible for an HSA. [The regular Open Season closed on December 11.] Contact your agency Human Resources office for instructions.
  
• SHPS, the FSAFEDS administrator, will allow FSAFEDS enrollees to revoke their HCFSA or change their HCFSA to a Limited Expense HCFSA (LEX HCFSA) for 2007, so that they may enroll in an HDHP with an HSA. Anyone enrolling in an HDHP may also elect a LEX HCFSA [an FSA limited to dental and vision expenses]. Enrollees should go to www.fsafeds.gov for instructions. >THIS CHANGE MUST BE MADE ON OR BEFORE DECEMBER 31, 2006.
• Current FEHB Program HDHP enrollees with a [Health Reimbursement Arrangement] HRA may make a one-time transfer of the HRA balance to an HSA if they are otherwise eligible for an HSA in 2007.
• FEHB Program enrollees who choose HDHP coverage for 2007 may make a one-time balance transfer from a 2006 HCFSA [Health Care FSA] to an HSA. Anyone who enrolls now or enrolled in an HDHP during Open Season will have to transfer any remaining HCFSA funds to be eligible to have an HSA.
• For FSAFEDS enrollees wishing to make such a transfer, there may be a small processing fee for the transfer. FSAFEDS will notify participants regarding of any fee. The transfer will be made after the payment is received.

President signs Tax Relief and Health Care Act of 2006

Earlier today, President Bush signed the Tax Relief and Health Care Act of 2006 which makes several improvements to the Health Savings Account ("HSA") law (Internal Revenue Code § 223). Most significantly, as discussed in an earlier post, the new law, which is effective January 1, 2007, for the HSA changes, increases the maximum annual contribution to the indexed amounts as opposed to the lesser of the associated health plan's high deductible or the indexed amount, which has been the law.

President Bush signs three health care bills

President Bush signed into law the following three health care bills that were enacted during the recent lame duck session of the 109th Congress:

• The Combating Autism Act of 2006 -- significantly increases funding for autism research and treatment and public education about autism
  
• Pandemic and All-Hazards Preparedness Act of 2006 -- "creates a new agency within the Health and Human Services Department to oversee the development of medicine and equipment to respond to a bird flu pandemic or a bioterrorism attack."
• Ryan White HIV/AIDS Treatment Modernization Act of 2006 -- renews law and shifts funding to rural areas and the South.

Colonoscopy study and quality transparency

A study published recently in the New England Journal of Medicine concludes that the diagnostic effectiveness of a colonoscopy depends on the doctor's techniques. An article in the New York Times today gives advice on how a prospective patient can question a doctor about his or her technique. I have always thought that medicine is as much an art as it is a science, a consideration which complicates quality transparency initiatives in my opinion.

Caremark Merger Update

Reuters reports that CVS filed a registration statement today with the Securities and Exchange Commission concerning its proposed acquisition of Caremark (which is available on the SEC's EDGAR system). According to Reuters, "there is a $675 million breakup fee if either it or Caremark terminates the deal under certain circumstances."

Meanwhile the stock market continues to respond favorably to Express Script's higher offer for Caremark, pushing Express Script's stock price up 3.3% today. According to Businessweek.com analysts predict that the debt load associated with Express Script's leverage buyout proposal is "manageable." Time will tell.

More Caremark Merger News

Caremark and CVS responded to Express Script's competing bid for Caremark with measured press releases describing their agreement as "definitive" and stating that Caremark's board of directors will take the ESI proposal under advisement. The stock market responded by boosting Caremark's common stock price from $50.30 per share to $55.28 per share as investors expect a bidding war over Caremark.

Caremark Merger News

The Wall Street Journal reported overnight that "Pharmacy benefit manager Express Scripts is preparing to launch a $26 billion cash and stock offer for rival Caremark Rx, in an effort to break up the company's existing takeover deal with drug chain CVS." Express Scripts this morning confirmed the bid in a press release. According to Bloomberg.com, "Caremark investors would receive $58.50 in cash and stock for each share, 15 percent more than the Dec. 15 closing price, St. Louis, Missouri-based Express Scripts said in an e-mailed statement. CVS agreed to buy Caremark for $48.53 a share on Nov. 1, offering shareholders no premium." Caremark shares closed at $50.30 on Friday.

Now Here's an Unusual Public Health Idea

The Daily Mail of London reports that "Oversize clothes should have obesity helpline numbers sewn on them to try and reduce Britain's fat crisis, a leading professor [Naveed Sattar, Professor of Metabolic Medicine at the University of Glasgow] said today."

Hospital quality ratings questioned

HHS maintains a web based Hospital Compare tool which "provides you with information on how well the hospitals in your area care for all their adult patients with certain medical conditions." The tool is based principally on information provided by the Hospital Quality Alliance (HQA): Improving Care Through Information.

The Associated Press reports that researchers from the University of Pennsylvania have published a study in the AMA Journal that analyzed the death rates at the 3,657 hospitals evaluated by Hospital Compare. "The study examined three conditions that often lead to hospitalization — heart attacks, heart failure and pneumonia — and found that death rates for patients with those diseases were only slightly lower at top-rated hospitals in 2004 than at the lowest-rated hospitals." The researchers contend that HHS needs to develop better quality measures. An HHS rebuts that "researchers likely would have found bigger differences among hospitals if they'd examined all 22 quality measures used on Hospital Compare."

HIPAA Non-Discrimination Regulations for Group Health Plans

In yesterday's Federal Register, the Labor Department, the Internal Revenue Service, and the Health and Human Services Department published a final regulation on non-discrimination and wellness programs in the group insurance market as required by the Health Insurance Portability and Accountability Act of 1996 (fondly known as HIPAA). The rules replace interim final rules that were published in 2001. The changes will be effective for FEHB plans on January 1, 2008.

Drug advertising

The Government Accountability Office today recommended in report GAO-07-54 that the Food and Drug Administration (FDA) should improve its oversight of direct to consumer prescription drug marketing. A Wall Street Journal article explains that the advertising media for prescription drugs widely vary.

GlaxoSmithKline PLC manufactures a genital herpes treatment called Valtrex, which is a billion dollar seller. According to the Wall Street Journal, while Glaxo does not market the drug to pregnant women and the drug is not FDA labelled for treatment of neonatal herpes, Glaxo is providing funding for doctors who speak at continuing medical education seminars on the benefits of screening all pregnant women for genital herpes.

What makes this interesting is that the Government does not support testing all pregnant women for genital herpes. To the contrary,

The CDC earlier this year said that "insufficient evidence exists to recommend routine" herpes screening of pregnant women, although it said testing should be offered to those whose sexual partners have the disease.

A government-appointed panel of experts called the Preventive Services Task Force concluded last year that "there are no benefits associated with screening" asymptomatic women. It said, "The potential harm to many low-risk women and fetuses from the side effects of antiviral therapy may be great."

The new Congress is expected to take up drug safety issues.

Health insurance industry announces PHR model

On December 13, the Blue Cross and Blue Shield Association and America's Health Insurance Plans announced a model format for a computerized personal health record. "The industry model PHR is a private, secure web-based tool maintained by an insurer that contains a consumer’s claims and administrative information. PHRs enable individual patients and their designated caregivers to view and manage health information and play a greater role in their own health care." Full details on the format are available on the AHIP website.

HHS to Support NHIN Trials in 2007

HHS Secretary Leavitt announced yesterday that in 2007 HHS will support trial implementations of the National Health Information Network, which will be the backbone of the Nation's electronic health records system.

[In 2006] NHIN activities included “prototype architectures” developed by four consortia of health care and health information technology organizations through contracts with HHS. This “prototype architecture” work included developing functional requirements, security approaches and identifying needed standards for creating secure health information exchange in different health care markets.

In January 2007, the four existing consortia will present the prototype architectures at the American Health Information Community and the third NHIN forum to be held in Washington, D.C. A summary report capturing key findings from this past year will be published in early 2007.

109th Congress Adjourns Sine Die

The 109th Congress adjourned early today, ending the lame duck session, after passing a continuing resolution to fund the federal government through February 15, 2007, and tax and trade legislation which, among other things, extends otherwise expiring tax breaks, avoids the 5.0% cut in Medicare Part B payments to doctors previously scheduled for January 1, and makes several changes to the Health Savings Account (HSA) law.

The HSA law changes reportedly include setting the maximum annual contribution at the indexed amount (rather than the lesser of the annual health plan deductible or the indexed amount) and allowing a one time rollover of flexible spending account or health reimbursement account balances to fund an HSA. On a related note, the Employee Benefit Research Institute and the Commonwealth Fund released yesterday their second Annual Consumerism in Health Care Survey, 2006: Early Experience With High-Deductible and Consumer-Driven Health Plans.

The Senate also finally confirmed Dr. Andrew von Eschenbach as Food and Drug Administration Commissioner.

Purchaser's Guide to Clinical Preventive Services

The National Business Group on Health recently released a "Purchaser's Guide to Clinical Preventive Services," which "contains the scientific evidence, recommended guidance, and detailed benefit language employers need to implement a comprehensive and structured clinical preventive services program within their medical benefit plan." The NBGH developed the Guide with technical assistance from the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Disease Control and Prevention (CDC). The Guide is publicly available on the NBGH web site.

Last Gasps of the 109th Congress

Congressional negotiators are attempting to fashion and pass before the weekend a major tax bill that will eliminate the 5.0 % reduction in Medicare Part B payments to doctors scheduled for January 1 by cutting funding for a Medicare Advantage stabilization fund that is intended to help insurers and HMOs offer Medicare Advantage plans in rural areas. The Washington Post reports that the bill also increases contribution limits for Health Savings Accounts. These measures are included in a bill that also extends popular tax cuts.

Dossia Unveiled

Applied Materials, BP America, Inc., Intel Corporation, Pitney Bowes, Inc. and Wal-Mart, which have 2.5 million employees combined, announced today their decision to fund "an independent nonprofit institute to develop 'Dossia,' a Web-based framework through which U.S. employees, dependents and retirees can maintain lifelong personal health records." Information Week explains that

Dossia will have at its core a series of federated databases being developed by a member-company funded non-profit organization called the Omnimedix Institute. To begin with, Omnimedix will build between five and seven databases around the country. Once an employees joins the system and enters some personal information, the system will automatically supplement the data with records from outside sources like hospitals, insurance claims, and physicians, so one database would house insurance claims data, another lab results and so on. Once the databases are built, the cost of adding incremental patients is expected to be pennies.

Computerworld adds that

Dossia is based on the Connecting for Health Common Framework, a set of design and policy standards developed by consumer advocacy groups, physician groups, insurers and privacy organizations, [Omnimedix CEO J.D.] Kleinke said.

Each of the founding members is contributing a "seven-figure" sum to Omnimedix to help set up the system, Barrett said. In the future, the group expects to add additional employers and government participants who would pay a per-user fee to participate in the program, he added. In February, the founding members plan to announce additional companies that have joined the effort, [Intel Corp. CEO Craig] Barrett said.

America's Health Rankings

The United Health Foundation has released its America's Health Rankings report for 2006. According to the Foundation, this report is "a yearly assessment of the relative healthiness of the nation, based upon analysis of comprehensive determining factors such as personal behaviors, the environment in which people live and work, the decisions made by public and elected officials and the quality of medical care delivered by health professionals." The report compares relative U.S. healthiness among states (Minnesota is tops for the 17th year) and against other countries.

The foreword to the report warns

To our dismay, this year’s report once again documents the lack of significant progress in improving health status, a trend we first noticed in 2000. And, alarmingly, overall health in the United States continues to suffer in comparison to that of many other nations. For example, a baby girl born today in the United States has a healthy life expectancy of 71 years compared to 78 years for a baby girl born today in Japan! Our country can do better, and our children deserve better. It is our collective hope that this report will continue to stimulate action by people, communities, health professionals, policy leaders, politicians and others as we intelligently dedicate our rich national resources toward the goal of optimal health and survival for all Americans.

I scratched my head when I read that U.S. life expectancy was 71 years at birth for girls. According to the National Center on Health Statistics, the average life expectancy of a newborn girl in the U.S. was 80.1 years in 2003, which reflects quite a public health accomplishment. (It was 71.1 years in 1950.) A Japanese Aging Center website reports that the average life expectancy of 85.2 years in 2002.

I then recognized that the United Health Foundation is using a different statistic "healthy life expectancy". According to the World Health Organization, this statistic "is based on life expectancy (LEX), but includes an adjustment for time spent in poor health. This indicator measures the equivalent number of years in full health that a newborn child can expect to live based on the current mortality rates and prevalence distribution of health states in the population." I'm not sure if I buy this statistic, but you do learn something new everyday.

Here is a link to the World Health Organization's World Health Statistics 2006' and 'The World Health Report, 2006 Edition'

Status Quo Poll Results

A new Wall Street Journal Online / Harris Interactive poll projects that employer sponsored health plan participants will stay put during the current open season. (The FEHB Program historically has offered an Open Season during November and December and private sector employers who have introduced cafeteria plans now offer them as well. This poll was not directed at FEHB Program participants.) "About 86% of insured Americans expect to keep their current coverage next year, while 6% plan to switch or drop their plan." Another interesting tidbit from the poll of 2,673 adults with health-care coverage is that

About 17% of those polled said they are enrolled or will enroll in flexible spending accounts, compared with 69% who said they won't. Six percent or fewer said they will enroll in medical saving accounts, health reimbursement accounts or health savings accounts, compared with about 79% who said they will not.

Health Care Privacy and the New Congress

Today's New York Times offers an lengthy article on the outlook for increased regulation of health care privacy in the new Congress and the privacy issue's relationship to the Administration's push for widespread use of health information technology. In that regard, it should be noted that the U.S. Office of Personnel Management now features its own health information technology transparency web page.