Evidence Based Medicine – NICE or Nasty?

February 27, 2008 / Michael D. Miller MD / Access to Healthcare, Comparative Effectiveness, Economics & Financing, Federal Healthcare Reform, Politics, Therapeutic Substitution & Interchange, VA/DoD / 4 Comments

The US Medicare Payment Advisory Commission (MedPAC) recently released a report on “Creating a Center for Evidence-Based Medicine” that was prepared by an outside analysis group. Before dissecting the MedPAC report, let me just lay out some of the more controversial aspects of evidence-based medicine (EBM):

How are the results of EBM research used for coverage or payment?
Are the EBM conclusions based upon reviews of prior studies or on research done specifically for the EBM analyses?
Are the EBM conclusions relevant only for a clinical research situation, or do they reflect real-world practices?
All medical practices evolve and “best medical practices” are reflected last in textbooks…..

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E-Health – A Medical Information Miracle or Mess?

February 26, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, Economics & Financing, Health System Reform, Information & Communications, Politics / 3 Comments

Information technology tools has been touted for years as a cornerstone for improving the quality of healthcare and reduce spending. While, clearly this has not been achieved, many e-health initiatives are being launched, and it is unclear how successful or efficient these will be. I am often concerned about the effect e-health systems have on the health care quality when my own physician spends so much time looking into and typing on his laptop. But to avoid discussing the challenges of e-health based upon my n of 1, below are 4 perspectives that are more expansive and analytical:

The Commonwealth Fund recently released a report about 27 state governments’ e-health activities in 2007.…

UK NHS Restricting Access to Uncovered Treatments

February 22, 2008 / Michael D. Miller MD / Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, Politics, Quality of Care & Safety / 4 Comments

A very interesting article in yesterday’s New York Times discusses how the National Health Service (NHS) in England is clamping down on patients using both their own money and the NHS services to get treatments for the same condition at the same time. The article primarily discusses the case of a woman with breast cancer where the NHS wouldn’t pay for Avastin, and told her if she paid for it herself, she would have to pay for all her medical treatments for breast cancer.

The article also discusses the complexity and apparent confusion within the medical community and the NHS about how this policy is supposed to be implemented.…

NPR Story on Presidential Candidates’ Health Plans

February 22, 2008 / Michael D. Miller MD / Access to Healthcare, Economics & Financing, Federal Healthcare Reform, Politics, State-Level Healthcare Reform / 2 Comments

I caught part of the report on NPR this morning about the Presidential candidates’ positions on healthcare. The gist of the story was that Clinton favors more extensive individual mandates than Obama (who only favors mandates to cover children), while McCain favors tax credits to make health insurance more affordable.

Whoever becomes the next President, something will clearly be different starting in 2009. Regardless of the candidates’ campaign/political statements, the next President’s actions on healthcare (unlike in foreign affairs), will largely depend on what they can negotiate with the next Congress – which seems like it will be more Democratic than it is currently, but probably not with 60 Senators to force votes on matters that the minority finds objectionable.…

Health Groups Lobbying & Executives’ $$$s

February 19, 2008 / Michael D. Miller MD / Economics & Financing, Health Policy and Communications Blog, Nutrition, Politics, Public Health / 2 Comments

The February 16th issue of National Journal has its biennial salary report (2006 data) for national advocacy and trade associations. Since most of my posts have been too long I’ll keep this one short with two (OK – actually three) interesting points:

First, in addition to salary information, National Journal reports on lobbying spending of various organizations. It’s not surprising that 3 of the top 10 trade associations [501(c)(6) organizations] in lobbying dollars are from the health industry: PhRMA, AMA, Am. Hosp. Assoc. But what is interesting, is that all of the top 5 non-profits [501(c)(3) organizations] in lobbying spending are health related organizations: Am.…

Government’s Right & Left Hands

February 18, 2008 / Michael D. Miller MD / Access to Healthcare, Economics & Financing, FDA, Information & Communications, Medicare, Politics / 2 Comments

The US government issued two proposals last week that may seem to be a case of the right and left hands not knowing what the other is doing. In the first instance, the Food and Drug Administration (FDA) issued a proposal to allow bio-pharma and medical device companies to more easily distribute published articles that discuss uses not approved by the FDA. In the FDA’s press release discussing the “Good Reprint Practices” draft guidance, Randall Lutter, FDA deputy commissioner for policy, states that “Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” and “This guidance also safeguards against off-label promotion.”…

Comparative Effectiveness in Healthcare Session at AAAS Meeting

February 15, 2008 / Michael D. Miller MD / Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Therapeutic Substitution & Interchange / 1 Comment

I attended the annual meeting of the American Association for the Advancement of Science today to hear a session titled “Health Economic Evaluations of Medical Technologies: Is the Cost Worth the Cure?” The topic of this session was really about comparative effectiveness of medical interventions – particularly pharmaceuticals. The panel was a substantial group of physicians and health services researchers/regulators:

Milton C. Weinstein, Harvard School of Public Health
Michael F. Drummond, University of York, United Kingdom & NICE (National Institute for Health and Clinical Excellence)
Jeffrey Kelman, Chief Medical Officer at CMS
Marc Berger, Eli Lilly
Tracy A.

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Technology and Health Care Costs

February 12, 2008 / Michael D. Miller MD / Comparative Effectiveness, Economics & Financing, Health System Reform, Innovation, Politics / No Comments

Peter Orszag, the Director of the Congressional Budget Office (CBO), recently testified before the Senate Budget Committee about increasing health care costs. One of his conclusions was that “the most important factor driving the long-term growth of health care costs has been the emergence, adoption, and widespread diffusion of new medical technologies and services by the U.S. health care system.”

His testimony concludes that by using “comparative effectiveness” research to “generate more information about the relative effectiveness of medical treatments and changing the incentives for providers and consumers,” would create a situation where “savings are possible without a substantial loss of clinical value.”…

Medicare Cost Containment: Trigger & Physician 10.1% Cut

February 7, 2008 / Michael D. Miller MD / Economics & Financing, Medicare, Politics / 3 Comments

The end of the 2007 Congressional session included a battle about an automatic 10.1% reduction in Medicare reimbursements to physicians scheduled to start January 1st. The resolution to this battle was a temporary legislative fix with a 0.5% increase. However, that fix was only for 6 months, so on July 1st, reimbursements are scheduled to drop by 10.6% from what they are now – the original 10.1% plus the 0.5% increase.

While that will certainly be a focus for Congress this spring, there is another, bigger Medicare fiscal battle likely to be fought because of a provision of the 2003 Medicare Modernization Act (MMA).…

Denial of Off-Label Medicines in Medicare Part D

February 5, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicare, Therapeutic Substitution & Interchange / No Comments

I have been helping the Medicare Rights Center (MRC) with some appeals of Medicare Part D plans denying coverage for off-label uses of FDA approved medicines. These denials are based on a very detailed provision in the 2003 Medicare Modernization Act that the Centers for Medicare and Medicaid Services (CMS) interprets to mean that Part D can only cover FDA approved medicines for off-labeled uses that are listed in at least one of three specific compendia.

I became involved with the MRC’s work on this issue because as a Congressional staff person I had helped write a 1993 law that expanded coverage for cancer treatments under Medicare Part B (that’s “B” as in ball) to specifically include off-label uses listed in the compendia OR supported by articles published in peer reviewed literature.…

Costs & Access

February 3, 2008 / Michael D. Miller MD / Access to Healthcare, Economics & Financing, Health System Reform, Medicaid / No Comments

Today’s Boston Globe has a lead article about the higher than expected costs for Massachusetts’ healthcare program implemented to create near universal insurance coverage. The costs of this program have been greater than expected due primarily to more people joining the subsidized health insurance program. (This greater than expected number has been attributed to underestimates of the actual number of uninsured in Massachusetts prior to the start of the Commonwealth Care program.)

The higher costs are certainly a problem for the state’s budget – although almost 50% of these costs may be paid for by the Federal government under the state’s Medicaid waiver.…

Level 4 Bio Lab at Boston University

February 1, 2008 / Michael D. Miller MD / Information & Communications, Innovation, Miscellaneous, Public Health / 1 Comment

Today’s Boston Globe had another report about the delayed opening of the Level 4 research lab at Boston University. Since it was first proposed and funded, this lab has raised controversy – primarily from those in the community who were concerned about the safety of research involving the most dangerous of organisms occurring in their urban neighborhood. While substantive process (and EPA) concerns have been raised during the building and certification of the lab, the problem really appears to have started from the beginning, with BU seeming to believe that all things biotech-science related are golden, and that their new lab would be welcomed into the neighborhood.…

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