Financial Returns from E-Prescribing – Saving Medicare $2.1 billion

July 23, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, Information & Communications, Innovation, Medicare, Quality of Care & Safety / 5 Comments

The leadership of HHS had a tele-conference on Monday to highlight the new Medicare incentives for physicians to adopt e-prescribing systems. What the Washington Post and Kaiser Family Foundation reported about this press briefing that wasn’t in the HHS press release was that the Acting Administrator of CMS said that the per physician cost of e-prescribing systems is about $3,000 up front, and then $80-400/month for operation and maintenance.

These numbers caught my eye, because with the incentives in the Medicare bill, the break-even point for physicians is as follows:

First, let’s assume that the per month cost is $240 (the mid-point between $80 and $400), or $2,800 per year.…

E-Prescribing – Good? E-Dispensing Bad!!

July 10, 2008 / Michael D. Miller MD / Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, FDA, Information & Communications, Miscellaneous, Public Health, Quality of Care & Safety / 1 Comment

With two notable government actions in the last couple of weeks there has been significant movement towards increasing the use of e-prescribing.

DEA Proposed Rule
The Drug Enforcement Agency (DEA), proposed regulations on June 27th that would make it possible for controlled substances to be prescribed electronically. Interestingly, this was released right after a National Journal article on this topic.

The DEA’s proposed rule is very important, because while it is appropriate to place stronger safeguards on medicines that are likely to be abused (which is the criteria for being a DEA scheduled medicine), having controlled medicines prescribed by pen and paper while all other medicines are e-prescribed would be a logistical problem and obviate many of the potential benefits of e-prescribing. …

Are Online Electronic Health Records Secure?

June 18, 2008 / Michael D. Miller MD / Delivery of Healthcare, Information & Communications, Innovation, Quality of Care & Safety / 5 Comments

Most of what I’ve read and previously written about electronic health records has been about making them work better or getting more clinicians to use them. Security of patients’ on-line data hasn’t been a major topic of concern. I’ve assumed that this was because these concerns had mostly been addressed back in the late 1990s during the development of the Health Insurance Portability and Accountability Act (HIPAA), or because those creating systems to allow medical information to be internet accessible – like those coalitions building dedicated Health Information Exchanges and companies like Microsoft, Google, and BlueCross BlueShield insurance plans – have resolved the security concerns.…

Cracking Down on Fake Cancer Cures

June 17, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, FDA, Public Health, Quality of Care & Safety / No Comments

The FDA announced today that they have sent letters to 25 companies to stop selling fake cancer cures. That is, things that the companies claim cure cancer, but have never been tested, or approved by the FDA. The FDA has a web-site with more information about this, and a sub-page that lists 125 Fake Cancer Cures.

I know the FDA gets lots of flack for not doing enough – and not doing it fast enough – I applaud the FDA for taking this action, and encourage them to do more because I have found the advertisement and selling of these non-medicines troubling for a long time.…

Summertime, Timing, Planning, and Boring Medicine

May 28, 2008 / Michael D. Miller MD / Delivery of Healthcare, Innovation, Quality of Care & Safety / No Comments

Memorial Day weekend is the traditional start of summer. This weekend also brought me in touch with some other markers of time, including:

A great celebration of life event for the passing of a friend’s father – a terrific gentle bear of a man who had faded away in recent years after more than four score years
A double birthday party for the children of some friends – a 9 year old and a first birthday
Senator Kennedy’s long tenure and track-record of accomplishments – which were chronicled in many news reports following his being diagnosed with a brain tumor

I was also reminded of the importance of planning over time by a recent op-ed that mentioned a national organization’s call for increasing medical school enrollment in order to avoid a future shortage of physicians.…

More Perspectives on Health Information Technology – Can We Call It Prevention?

May 23, 2008 / Michael D. Miller MD / Economics & Financing, Information & Communications, Quality of Care & Safety / 2 Comments

A few weeks ago I wrote about the challenges of adopting electronic medical records to provide value for different stakeholders and the entire health care system. Well, this week the Congressional Budget Office released a paper on “Evidence on the Costs and Benefits of Health Information Technology.” This paper is a reasonable review and synthesis of the literature, but it’s important to recognize that the CBO’s mission is to focus on how federal legislation can change government spending.

While the paper concludes that savings from adopting HIT are generally uncertain, it does make some supportive comments about its value.…

Electronic Medical Records: Salvation or Sinkhole?

May 6, 2008 / Michael D. Miller MD / Economics & Financing, Information & Communications, Medicare, Quality of Care & Safety / 14 Comments

Electronic medical records (EMRs) have been touted as one of the solutions for healthcare’s cost and quality problems. But why haven’t we seen more benefits from EMRs?

Disconnect Between Costs and Benefits
The simple answer is that there is a disconnect between those who have to pay for EMRs and those who benefit from them. For example, many (if not most) national health reform proposals call for investing billions of dollars in EMR systems claiming that EMRs will save the healthcare system lots of money. However, these savings projections hide many important factors related to the timing of any potential savings, and how different stakeholders would be affected.…

Avoiding Medical Errors and Ensuring Quality of Medical Care

April 30, 2008 / Michael D. Miller MD / Delivery of Healthcare, Quality of Care & Safety / 1 Comment

Several people have recently told me quality of care stories, and one nursing group sent me a list of 25 Tips to Help Protect Yourself from Medical Errors. The common theme for all these is that to help avoid errors, the patient (or their family) should make sure they are informed about their condition and treatments, and they need to develop relationship with clinicians that enable good communications.

The first case is a friend’s father who, after suffering a spinal cord injury, is living in a nursing home/rehabilitation facility. Cognitively he had been doing great – 80+ years old and did his own taxes this year. …

FDA’s Resources for Evaluating and Monitoring Medicines and New Science

April 24, 2008 / Michael D. Miller MD / FDA, Politics, Quality of Care & Safety / No Comments

For several years it has been clear that funding limitations are impairing the FDA’s ability to attract and retain qualified clinicians and scientists to review applications for new drugs and biologics, and to support their internal research and analysis concerning new drug development, manufacturing and monitoring technologies – particularly for biologic medicines. In addition, the FDA hasn’t been able to update its information technology systems to maximize staff productivity. (I suspect some people will be tempted to comment on the “productivity” of government employees, but I have found the FDA’s professional staff generally very qualified and hard working.)

On Tuesday, the Energy and Commerce Committee in the US House of Representatives held a hearing about the FDA’s ability to adequately oversee foreign production of medicines being sold in the US.…

Information Can Change Medical Practice, Patient Behaviors, and Kill Kids

April 10, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, FDA, Information & Communications, Public Health, Quality of Care & Safety / 1 Comment

Medical information can change how clinicians treat patients, how patients care for themselves, and how healthcare payers promote or prevent the use of treatments and diagnostic tests. However, this information can act as either a broad sword or a scalpel, and produce good or bad outcomes.

A recent report from a Canadian new service about an article from the Canadian Medical Association Journal describing the outcomes from warning about the use of anti-depressants in children brings this issue down from a general concept to being very specific. This news report stated:

Two years after Health Canada warned about prescribing anti-depressants to children, the number of children and teens who died by suicide increased 25 per cent after years of steady decline, major new Canadian research shows.

…

Toxic Dietary Supplements

April 10, 2008 / Michael D. Miller MD / FDA, Nutrition, Public Health, Quality of Care & Safety / No Comments

I’m usually either supportive or neutral about alternative therapies because they generally aren’t harmful, and can be beneficial. However, there seem to be more and more recalls of these products by the Food and Drug Administration (FDA) for mislabelings that are significant, although seemingly not extremely dangerous.

On the other hand, I was struck by a press release I got yesterday from the FDA about a recall for the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The recall was because these products had more than 200 times the amount of selenium than was printed on the products’ label – and the press release noted that, “Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.”…

Canada’s Proposal for Subsequent Entry Biologics

April 1, 2008 / Michael D. Miller MD / Economics & Financing, FDA, Patents & IP, Politics, Quality of Care & Safety, Therapeutic Substitution & Interchange / No Comments

After writing about Follow-On Biologics in a recent posting, I saw a notice about Health Canada’s proposal for how they would approve biologic products that are similar to already approved biologics whose patents have expired. They call these products Subsequent Entry Biologics (SEBs), and the proposal is open for public comment from March 14, 2008 until April 16, 2008.

While the draft guidance is lengthy, it does strike an overall well-balanced tone:

“SEBs are not ‘generic biologics'”
Approval of an SEB does not mean it can automatically be substituted for the original biologic that it is “similar” to
Comparative studies will be required to generate data showing similarity to the original biologic in terms of quality, safety and efficacy

In many ways, the draft guidance is similar (no pun intended) to the process the US FDA used to approve some generic drugs prior to the 1984 Hatch-Waxman Drug Price Competition and Patent Term Restoration Act.…

1 2 3 4 5