FEHBlog

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.

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 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.”

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.

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.

• 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.

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.

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 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.

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.