Safety, Costs and Quality of Medicines

March 25, 2008 / Michael D. Miller MD / Delivery of Healthcare, FDA, Politics, Public Health, Quality of Care & Safety, Therapeutic Substitution & Interchange / 1 Comment

I’ve been trying to figure out how to write something meaningful about the many reports over the last several months about the safety, costs and quality of medicines. I finally concluded that rather than a too lengthy blog post, a series of snapshots would create a good description of the situation – sort of like a slide show rather than a feature film:

Safety of Generic Drugs: A recent LA Times article discussed patients who had adverse reactions when switched from a brand name to a generic medicine. This article includes physicians’ experiences with several types of generic medicines, e.g. for epilepsy, depression, high blood pressure, irregular heart rhythms, and to prevent rejection of organ transplants.…

More On Evidence Based Medicine

March 6, 2008 / Michael D. Miller MD / Access to Healthcare, Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Medicare, Quality of Care & Safety / 1 Comment

In a previous post I was somewhat critical of evidence-based medicine (EBM) when it is used to make payment decisions. One of the points I was trying to make is that EBM is not a passing fad. The staying power of EBM was recently reinforced by two recent developments.

First, the Medicare Payment Advisory Commission’s (MedPAC) March 2008 Report to Congress cites their own 2005 report recommending EBM as a touchstone for comparing physicians’ practices as one way to improve quality of care and value for the Medicare program:

In the March 2005 Report to the Congress, the Commission recommended that CMS measure physicians’ resource use over time and share the results with physicians (MedPAC 2005).

…

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…..

…

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.…

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.”…

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.…

«‹4 5 6