Avandia update

The Wall Street Journal is reporting that U.S. doctors have been "shunning" Glaxo Smith Kline's blockbuster diabetes drug Avandia since last week's New England Journal of Medicine study indicating that Avadia carries a higher heart attack risk than other diabetes drugs. The Times of London reports that Analyst Peter Cartwright at Evolution Securities said: “Our guess that [UK] patients already taking Avandia won’t switch, because of the risks involved, but in places like the US, particularly because they are so litigious, we expect to see a sharp fall in new prescriptions." Glaxo has been mounting a spirited defense, but it appears to have been taken by surprise. Meanwhile, Glaxo's stock price has "nose dived."

How about this for transparency?!

The LA Times reports that "California's largest private physician practice -- Healthcare Partners Medical Group serving over 5,000 patients -- has become one of the first doctor groups in the nation, and almost certainly the largest, to make prices for its medical procedures widely available to consumers." The fee chart for "basic services" is available here.

Recent Reports of Interest

• Prescription benefits manager Medco Health Solutions Inc., has released its 2007 Drug Trends Report.
  
• Consulting firm Towers Perrin has released its 2007 Survey on Account Based/ Consumer Driven Health Plans.
  

Memorial Day

On Memorial Day, we pay tribute to the soldiers, sailors, and airmen who have fallen in defense of the United States, our country, as well as those who now are in service. At 3 pm todat, I hope that everyone will observe the National Moment of Remembrance. In particular, I will remember my cousin Army Capt. Eric T. Paliwoda (right), 4th Infantry Division, West Point Class of 1997, who was killed in combat in Iraq on January 2, 2004. We will never forget.

FEHBP Personal Healh Records Bill Introduced

As promised at the May 18 FEHBP hearing, Senators Carper (D Del.) and Voinovich (R Ohio) did introduce yesterday their bill (S. 1456) that would mandate FEHB plans to offer the members electronic personal health records. The bill has been referred to the Committee on Homeland Security and Governmental Affairs.

Miscellany / Weekly Wrapup

• On the HIPAA National Provider Identifier (NPI) compliance date, May 23, CMS finally announced the publication of the NPI dissemination policy, which will permit payors to download NPIs off a CMS website beginning June 28. Of course, CMS has permitted health plans to create NPI contingency plans and Medicare itself has implemented such a plan. The official notice of the NPI dissemination policy will be published in the May 30 Federal Register. An advance copy of the Notice is available here.

• On May 22, a House Education and Labor subcommittee held a hearing on state health care reform movements and their interrelationship with federal law, particularly ERISA. Rep. Tammy Baldwin (D Wisc.) also testified about her bill (H.R. 506 ) which Sen. Voinovich (R Ohio) endorsed at the FEHBP hearing on May 18. Sen. Voinovich noted that Rep. Baldwin’s bill has been endorsed by both the Brookings Institution and the Heritage Foundation. Sen. Voinovich and Sen. Bingaman (D N.M.) have introduced a companion bill (S. 325) in the Senate. Rep. Baldwin’s bill would create a State Health Coverage Innovation Commission that could forward state health plan reform proposals to Congress for fast track consideration and approval. A Covington & Burling attorney testified about ERISA preemption and against state waivers.

• On May 10, the House Ways and Means health subcommittee held a hearing on Medicare's quality initiatives. GAO testified about its own analysis of Medicare participating physician practice patterns which found that the patients of outlier physicians -- MDs who treat a disproportionate share of overly expensive patients -- were spread across the country and evidently were practicing medicine inefficiently. CMS plans directed education efforts but needs legislative authority to reduce payments to inefficient MDs. In a related development, the Blue Cross and Blue Shield Association proposed legislation to create "a new, independent institute - funded by all healthcare payers - to provide consumers and providers with much needed information on which medical treatments work best."
  

Perspective

Glaxo Smith Kline's CEO Dr. Jean-Pierre Garnier offered this valuable perspective on the Avandia controversy today according to the Wall Street Journal:

"Dr. Garnier stressed that the absolute risk of heart attacks in patients taking Avandia was still low -- between 0.43% and 1.85% of patients had heart attacks, according to Dr. Nissen's paper, which was published in the New England Journal of Medicine. Those odds were 43% higher than the rate of heart attacks among patients taking other drugs or a placebo, which ranged from 0.34% to 1.44%.

Dr. Garnier said Dr. Nissen's analysis is only one piece in a body of research that overall shows that Avandia is no riskier for the heart than other diabetes medications. "You cannot look at this in isolation," he said."

Hospital Compare to report death rates

USA Today reports that next month HHS's Hospital Compare tool will begin reporting "the first broad comparison of the death rates for heart attack and heart failure" at U.S. hospitals

Here we go again!

The same cardiologist, Dr. Steven Nissen, of the Cleveland Clinic, who blew the whistle on the heart risks of the Merck blockbuster arthritis medicine Vioxx, has published a study in the New England Journal of Medicine finding that the blockbuster GlaxoSmithKline diabetes drug Avandia carries a high heart attack risk. In a press release, Glaxo announced that it "strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations." Patients and doctors are understandably confused by these developments; Glaxo's stock is falling like a rock, and the FDA must be circling the wagons for another round of Congressional oversight hearings.

According to the Wall Street Journal, Dr. Nissen conducted his study using Glaxo studies that he dredged up with the Google search engine. Google Avadia now and you'll find Avandia Heart Attack Class Action right at the top of the page. There has to be a better way to address these drug safety issues.

News Reports on the Subcommittee Hearing

Since the Senate subcommittee hearing last Friday on FEHB Program premium trends, OPM has issued a press release and reports have appeared on Govexec.com and the Kaiser Foundation's Capitol Hill Watch.

Miscellany

• The Senate subcommittee hearing on FEHB Program premiums held yesterday was uneventful. Sen. Voinovich (R Ohio) did announce that he and Sen. Carper (D Del.) will be introducing their FEHBP electronic personal health records bill next week.
  
• The Healthcare Information Technology Standards Panel is seeking public comment on the following two Requirements, Design and Standards Selection (RDSS) documents: HITSP Requirements Design and Standards Selection: Security and Privacy Capabilities for the Version 2.0 Biosurveillance, EHR-Lab and Consumer Empowerment Use Cases, and HITSP Requirements Design and Standards Selection: Emergency Responder Electronic Health Record (ER-EHR) Use Case. These are the AHIC work group use cases on which HITSP currently is focusing. Comments are due by June 14, 2007.
  
• The Hill newspaper printed an interesting article on the President's nomination of Kerry Weems as CMS Administrator and the importance of that position.
• Modern Healthcare.com reported on privacy concerns being raised in connection with the recent IRS memorandum reported on the FEHBlog that allows non-profit hospitals to subsidize electronic health records technology for their medical staffs.
  
• The Wall Street Journal reported a sharp drop in artery stent implantation in heart disease patient since the recent COURAGE study questioning the utility of the treatment. Heart.org reports that: "According to the Journal, some experts believe COURAGE may in fact be having a swift impact. "We've definitely seen a decline," Winstein quotes Dr William O'Neil (University of Miami, FL) "[The COURAGE study] is causing some people to think that angioplasty is unnecessary. A lot more patients are going to be treated with medical therapy."
• An annual University of Maryland medical conference on historic deaths concluded that President Abraham Lincoln may have survived the assassin's bullet that killed him in April 1865 if he had received modern trauma care.

Walgreen's Purchases the Take Care Clinics

Walgreen's has taken a page out of the CVS and Wal-Mart playbooks by purchasing the Take Care Health Systems. Take Care operates "50 health care clinics in Chicago, Kansas City, Milwaukee, St. Louis and Pittsburgh." Walgreen's plans to open Take Care clinics in its pharmacies which total 5700 across the United States. Grace Marie Turner of the Galen Institute opined in the Wall Street Journal earlier this week that the clinics represent the free market at work:

Rick Kellerman, president of the American Academy of Family Physicians, concedes, "The retail clinics are sending physicians a message that our current model of care is not always easy to access." The threat of competition from the in-store clinics means some doctors are keeping their practices open later and on Saturdays and holding an hour open for same-day appointments. Competition works.

And the clinics are working to solve another problem that is vexing Washington -- creation of electronic medical records. Most retail clinics create computerized patient records, with the goal of making the records accessible throughout the chain. The records also can be emailed to a hospital or to the patient's regular doctor -- or sent by fax if necessary.

This industry is in its infancy and will hardly register in our nation's $2 trillion-plus health care bill. But just as Nucor overturned the steelmaking industry with a faster-better-cheaper way of making low-end rebar, these limited service clinics could be the disruptive innovator in our health-care system. Package pricing for more complex treatments, like knee replacement surgery, may not be far behind.

Senate Committee to hold FEHBP hearing tomorrow

The Senate Homeland Security and Governmental Affairs Subcommittee on Oversight of government management, the federal workforce and the District of Columbia will be holding a Federal Employees Health Benefits Program hearing tomorrow titled "Up, Up, and Away! Growth Trends in Health Care Premiums for Active and Retired Federal Employees." The hearing begins at 10:30 am in Dirksen Senate Office Building, Rm. 342

According to the Subcommittee, "The purpose of the hearing is to review growth trends in health care premiums under the Federal Employee Health Benefits Program and assess proposals to curb the cost to employees, retirees, and the Federal government as an employer without the loss of service." The hearing was provoked by a GAO report issued last winter that the subcommittee's chairman, Sen. Daniel Akaka (D Hawaii) had requested.

The scheduled witnesses are Nancy Kichak, OPM's Associate Director and Chief Actuary; John Dicken, GAO's Health Team Director; Steven Gammerino, Blue Cross Blue Shield Association Sr. Vice President, National Programs, and Alan Lopatin, NARFE's Legislative Counsel.

IRS releases EHR guidance for non-profit hospitals

The Internal Revenue Service has released guidance stating a non-profit hospital will not jeopardize its tax exempt status if its provide doctors with staff privileges with financial incentives to acquire and implement software necessary to access the hospital's electronic health records system provided the subsidy complies with the Health and Human Services Department's regulations under the federal health care programs anti-kickback act and the Stark Act.

Mammography rates drop

A new government study reveals that fewer women are undergoing annual mammographies for various reasons, including difficulties in obtaining appointments, and the drop in hormone use following menopause (Good news, hormone users received more regular medical care -- bad news according to a 2002 government study hormone use increases the risk of breast cancer, heart attack, and stroke." At least in the FEHB Program, the cost of the test is not an issue as the Program provides 100% coverage for routine annual mammographies for the over 40 age group. However, the Washington Post notes that "the drop was greatest -- 6.8 percent -- among women ages 50 to 64, the age group most likely to benefit." The Post report quotes Carolina Hinestrosa of the National Breast Cancer Coalition, an advocacy group, as commenting "Some women are beginning to balance the risks and the benefits. If women are making a careful determination and an informed decision after weighing the risks and benefits, I don't necessarily think that's a bad thing." Other commentators and researchers take a less nuanced view of the study.

The American Cancer Society quotes lead researcher Nancy Breen, Ph. D., of the National Cancer Institute:

Whatever the cause, the drop in mammography rates is worrisome, Breen adds. She and her group are trying to develop new studies that could shed light on why mammogram use is declining.

"We really need to know why it is that screening isn't happening before we can talk about developing strategies that are going to work [to raise levels again]," she notes.

However, at least one strategy has already been proven to help boost screening rates: reminder systems. People are more likely to get screened if they get a phone call or card or email reminding them to make that appointment.

Another thing that could help, Breen says, is to keep the message about screening front and center.

"We can't assume that people who have been screening will continue to screen, and we need to continue to make it clear that this is of benefit to them," she says."

New Gardasil Study

The New England Journal of Medicine published a study on the efficacy of Merck's expensive and heavily marketed Garasil vaccine. Gardasil is intended to protect young women (and men) against an HPV virus that is a major cause of cervical cancer. The studies find that the vaccine is very effective against young people who have not been previously infected with this sexually transmitted virus. However the NEJM editorializes that

Although this is a remarkable achievement, the efficacy of the vaccine is limited by at least these two factors. First, not all cervical cancer is caused by HPV-16 or HPV-18, and second, it appears necessary to vaccinate young women before they are infected with these two serotypes. Also, whether this approach will extend the paradigm of vaccination to the prevention of death and disability from cervical cancer is an unanswered question.

[C]orrelation with the ultimate outcome — cancer prevention — will require the long-term observation of a large number of treated women. We must also carefully monitor for unintended adverse consequences of vaccination.

Many other questions are raised by these remarkable data. Should young men be vaccinated? What is the durability of immune protection? Could fewer than three vaccinations provide adequate protection? Will future HPV vaccines extend protection to cover additional pathogenic serotypes? Will the economics allow this therapy to reach all who may benefit, such as those in the developing world? Might HPV vaccination be beneficial in preventing other, noncervical HPV-induced cancers (such as HPV-related oropharyngeal cancer)?

The last sentence of this quote relates to another article in this NEJM issue about a study associating these HPV viruses with throat cancer, e.g. oral sex can cause throat cancer.

Senate passes FDA user fee reauthorization bill

On May 9, the Senate by a 93-1 vote passed its Food and Drug Administration user fee reauthorization bill (S. 1082). The user fees are paid by prescription drug manufacturers to support the new drug approval process. The bill includes many new drug safety measures. The House is working on its own version of the bill, which reportedly is similar to the Senate bill. The legislation is expected to be on the President's desk by the end of this summer.

HHS Value Driven Healthcare Event

HHS Secretary Mike Leavitt held a value driven health care event today. "Less than a year after launching his Value-Driven Health Care [A/K/A transparency] Initiative, Secretary Leavitt announced that more than 100 million Americans are now served by health plans that are committed to providing consumers with transparent quality and cost information. The federal government; half of the states; about 775 employers, including almost half of the top 200 U.S. corporations; and numerous unions, communities, doctors and hospitals have joined the movement."

Drug company grants for medical education under scrutiny

The Senate Finance Committee has released a report on drug company grants for medical education. The committee, chaired by Sen. Chair Max Baucus (D-Mont.), is investigating allegations that such grants are used for improper purposes. The report suggests that some "independent" educational programs may still be susceptible to excessive influence by pharmaceutical sponsors, and that the Accreditation Council for Continuing Medical Education's (ACCME) oversight is insufficient to guarantee independence. In a subsequent letter to ACCME President Murray Kopelow, Baucus and Senate Finance Committee Ranking Member Sen. Charles Grassley (R-Iowa) faulted the accreditation process itself, including the absence of content monitoring by ACCME of programs of accredited providers, the standards of compliance ACCME requires, and the extent to which instances of noncompliance are tolerated.

HIPAA Privacy Rule Compliance Survey

AISHealth.com reports on a Research Triangle Institute survey of HIPAA Privacy Rule compliance commissioned by the Department of Health and Human Services' Agency for Healthcare Research and Quality. The report finds much health care provider confusion over the minimum necessary use and disclosure provision of the Privacy Rule and its complex state law preemption provisions. The first finding is surprising because the minimum necessary rule merely requires the application of common sense. The second finding is hardly surprising because of the complexity of the rule's preemption provisions. More information on the survey is available here from RTI. The final report with "solutions" is due in the summer. HHS is relying heavily on this process to respond to Congressional pressure to incorporate privacy and security safeguards in the National Health Information Network's architecture. I hope they don't throw the baby out with the bath water, particular considering how much money and human capital was invested in the HIPAA privacy rule implementation process.

Miscellany

• A coalition of large employers and health insurers called the Coalition to Advance Healthcare Reform has been formed in order to encourage Congress and state legislatures to use market based reforms to improve quality and to reduce the number of uninsured.
  
• The medical community has begun to mobilize against the nurse practitioner staffed clinics being established on growing scales in workplaces, discount stores, and pharmacies.
  
• GAO issued a report today encouraging the Department of Health and Human Services to make better use of information technology to reduce the increasing quality data collection burden that the Medicare program imposes on hospitals. The Medicare program, which HHS just recently enhanced, collects data on all admissions, not just Medicare admissions, and had lead to the creation of robust online hospital quality comparison tools such as HHS's Hospital Compare tool. "GAO recommends that the Secretary of HHS identify the specific steps the department plans to take to promote the use of health IT for the collection and submission of data for CMS’s hospital quality measures and inform interested parties about those steps, the expected time frame, and associated milestones." HHS agrees with the recommendation according to the report.
  

Drug importation measure stalls in the Senate

ABC News reports that the Senate passed a bill today that would allow prescription drug importation but by a separate 49-40 vote the Senate conditioned importation on HHS certification of the safety of the importation process. That has been the law for nearly a decade and HHS under both Democrat and Republican administrations have declined to issue the certification due to a concern that importation would open the door to counterfeit drugs.

OPM Releases FY 2006 FEHBP Financial Statements

Yesterday, OPM posted on its web site the Federal Civilian Benefit Programs Annual Report for Fiscal Year 2006, which ended on September 30, 2006. This report includes the audited financial statements for the Federal Employees Health Benefits Program, as well as CSRS and FEGLI. Here's the link. The report discloses that the FEHB Program "covers approximately 82 percent of all eligible participants" (p. 27).

Kaiser HIT Study

Kaiser Permanante arranged for a telephonic survey of 1,000 health care consumers asking about their views on health information technology. Interestingly 57% of the respondents believe that their primary care doctors uses a computerized medical records system. However, a majority of the respondents had not heard about electronic medical records before the survey. In any event, a significant majority of respondents believe that electronic medical records will improve health care.

President Makes Nominations in Three Important Benefits Positions

The President today nominated a permanent administrator for the Centers for Medicare and Medicaid Services (CMS), an assistant Secretary of Labor (Pension and Welfare Benefits) to handle ERISA matters, and the Pension Benefit Guaranty Corporation director.

• Kerry N. Weems, of New Mexico, was nominated to be the CMS Administrator, replacing Leslie Norwalk, the interim administrator. Mr. Weems currently serves as Deputy Chief of Staff at the Department of Health and Human Services. Prior to this, he served as the Acting Assistant Secretary for Budget, Technology, and Finance and Chief Financial Officer. Earlier in his career, he served as Deputy Assistant Secretary for Budget at the Department of Health and Human Services. Mr. Weems received his bachelor's degree and BBA from New Mexico State University and his MBA from the University of New Mexico.
  
• Bradford P. Campbell, of Virginia, was nominated to be Assistant Secretary of Labor (Pension and Welfare Benefits). Mr. Campbell currently serves as Acting Assistant Secretary and Deputy Assistant Secretary at the Employee Benefits Security Administration. Prior to this, he served as Senior Legislative Officer in the Office of Congressional Affairs at the Department of Labor. Earlier in his career, he served as legislative director to U.S. Representative Ernie Fletcher and as senior legislative assistant to former U.S. Representative Christopher Cox. Mr. Campbell received his bachelor's degree from Harvard University.
• Charles E. F. Millard, of New York, was nominated to be Director of the Pension Benefit Guaranty Corporation. Mr. Millard currently serves as Managing Director at Broadway Partners, LLC. Previously, he served as a Managing Director at Lehman Brothers. From 1995 to 1999 he served as President of the New York City Economic Development Corporation. He also served as Group Head and Managing Director at Prudential Securities, Inc. and was twice elected to the New York City Council. Mr. Millard received his bachelor's degree from the College of the Holy Cross and his JD from Columbia University.

Athena Healthcare Report on Health Plan Payment Practices

The Wall Street Journal’s Health Blog reports on a study of health plan payment practices conducted by Athena Healthcare. The link to the press release is here, and the link to the ratings is here.

What's a reasonable insurer to do?

Big pharma Merck charges high price for a new vaccine against a cervical cancer virus (HPV), Gardasil. Insurers try to control the cost of the vaccine. Doctors and patients complain according to the Washington Post. Meanwhile, the Wall Street Journal's Health Blog reports that an American Medical Association Journal editor has published an opposition to mandatory Gardadil vaccines for girls and young women. While routine administration of Gardasil “undoubtedly is beneficial to the public’s health, as it is likely to reduce the incidence of cervical cancers, the rush to make HPV vaccination mandatory in school-aged girls presents ethical concerns and is likely to be counterproductive.”