Creating and Implementing Healthcare Innovation – BioPharmaceuticals, Delivery System and Reimbursements

March 22, 2011 / Michael D. Miller MD / Delivery of Healthcare, Economics & Financing, Health System Reform, Innovation / 3 Comments

Healthcare innovation is an extremely hot topic right now, ranging from the new Center for Medicare and Medicaid Innovation, FDA’s approach to approving therapies and devices, an entire issue of Health Affairs, and of course patient-centered medical homes and Accountable Care Organizations [Patient-centered medical homes are also known as Advanced Primary Care Model practices, and ACOs are a combination of delivery and reimbursement innovations.]

I’ve been working for many years to create value for patients and society by speeding adoption of these types of innovations by clinicians, other providers, patients, payers, regulators, communities, etc., and have found that healthcare innovations have at least three things in common:

Healthcare innovations occur in steps, with each advance building on the shoulders of what came before
These stepwise advances also produce indirect benefits that can be greater than the innovation’s direct effects
Adoption of innovations doesn’t just “happen.”

…

Medical Homes (PCMH) in 2011 – Patient and Consumer Centric

February 23, 2011 / Michael D. Miller MD / Clinician-Patient Relationships, Delivery of Healthcare, Health System Reform, Quality of Care & Safety / No Comments

Patient-Centered Medical Homes (PCMH) are continuing to be a bigger and broader part of the real-world discussions about health reform and transformation in the US. According to the the National Committee for Quality Assurance (NCQA) at the end of 2010 there were 7,676 clinicians in 1,506 recognized PCMH practices in the US. This information was released last week by NCQA with their updated 2011 PCMH Standards.

Another marker of medical homes’ increasing pervasiveness is the blurb – “Home sweet medical home” – in the March 2011 issue of Consumer Reports magazine that starts with, “If you haven’t already heard the term ‘patient-centered medical home,’ chances are you will soon.”…

Health Reform’s Effects on Star Trek Medicine – Diabetes and Otherwise

May 11, 2010 / Michael D. Miller MD / Health System Reform, Innovation / 1 Comment

A long-time colleague recently asked me what effect the new health reform law would have on the use of the famous Star Trek Medical Tricorder.* I told him that provisions of the new health law will try to reduce the number of unnecessary imaging tests, and since the tricorder is a hand-held imaging scanner the new law might reduce its use – if it really existed.

Thinking about it later, I realized that if/when such hand-held scanners are developed they would replace much larger and more expensive devices. The impact of innovations like this on healthcare spending depends upon how health insurance pays for these tests.…

Making Health Reform Work

May 6, 2010 / Michael D. Miller MD / Delivery of Healthcare, Economics & Financing, Health System Reform, Quality of Care & Safety / No Comments

The May issue of Health Affairs focuses on Reinventing Primary Care – a topic that has been part of health policy discussions for at least 20 years. A few things have changed in that time: now there is better evidence about the importance of primary care providers in coordinating care to improve quality and reduce costs; the structural concept of this care coordination has been codified under the new term the “Patient Centered Medical Home,” (which has also been given precise parameters by NCQA); the complexity of medical care has increased so that the need for care coordination is greater; and electronic information storage, analysis, and communications technologies have been developed which – in theory – should make care coordination and the resultant quality improvement and cost control easier and more practical.…

The Internet Solves Everything in Healthcare – – – NOT

April 23, 2010 / Michael D. Miller MD / Delivery of Healthcare, Economics & Financing, Information & Communications, Quality of Care & Safety / 3 Comments

Improving healthcare will require people having better information. That concept is generally agreed upon. The challenge is getting the right information to the right people at the right time. That is the interconnected goal of different facets of health information technology – from EMRs and PHRs, to health information exchanges.

People Are Complex
However, the complexity of medical care and individual variability – both human physiology and patient preferences – makes collecting and analyzing health information so that it is useful for individual clinical decisions much more difficult than presenting information about TVs, computers or cameras on a website such as CNET.…

Checklists and Physicians’ Behaviors

January 12, 2010 / Michael D. Miller MD / Delivery of Healthcare, Economics & Financing, Quality of Care & Safety / 1 Comment

I recently heard Dr. Atul Gawande talk about his new book “The Checklist Manifesto.” While the evidence demonstrating the value of checklists for improving the quality of healthcare is increasingly abundant, in his presentation Atul talked about how in a study assessing a surgical checklist they ran into resistance from about 20% of physicians.

Another story he told involved his surgical group’s considering how they might manage bundled reimbursements, e.g. accepting a single payment for all the care and testing related to thyroid cancer surgery. Their discussions came to a screeching halt when it became clear that this “might” mean less money for each of the surgeons.…

Historical Perspectives on Health Policy: Part 3

December 4, 2009 / Michael D. Miller MD / Comparative Effectiveness, Federal Healthcare Reform, Health Policy and Communications Blog, Health System Reform, Miscellaneous / 1 Comment

I just found my copy of the book “Improving Health Policy and Management” edited by Stephen Shortell and Uwe Reinhardt. The book’s eleven chapters address many of the hot-button issues in today’s health reform debate:

Creating and Executing Health Policy
Minimum Health Insurance Benefits
Caring for the Disabled Elderly
An Overview of Rural Health Care
Effectiveness Research and the Impact of Financial Incentives and Outcomes
Changing Provider Behavior: Applying Research on Outcomes and Effectiveness in Health Care
Health Care Cost Containment
Redesign of Delivery Systems to Enhance Productivity
Medical Malpractice
Prolongation of Life: The Issues and the Questions
Challenges for Health Services Research

The observant ready will notice one critical issue from today’s debate missing from this list… Information technology. …

Historical Perspective on Health Reform – Part 1, Medical Effectiveness

November 16, 2009 / Michael D. Miller MD / Comparative Effectiveness, Delivery of Healthcare, Public Health / 1 Comment

Since the time-line for health reform legislation has continued to be stretched, I recently spent some time cleaning out old files. In my excavations I came across papers, articles, memos and briefing books which demonstrate that no matter how much things change, some aspects of health reform have stayed the same. For example, below are a couple of snippets from memos about a proposed Medical Effectiveness Initiative from circa 1989:

Establishing a Medical Effectiveness Initiative at the OASH [Office of the Assistant Secretary of Health] level. (FY90 request = $52 million) This initiative would assess which medical treatments are cost-effective, and identify inappropriate and unnecessary medical practices.

…

Off-Label Communications: Is More Less?

October 4, 2009 / Michael D. Miller MD / Delivery of Healthcare, FDA, Information & Communications, Quality of Care & Safety / No Comments

Allergan corporation has filed a law suit against the Federal government challenging the FDA’s limits for companies discussing or promoting off-label uses of approved medicines. This is not a new issue, but the news reports indicate that Allergan is going very old school and basing their legal challenge on Constitutional freedom of speech rights.

The issue is not can doctors and patients use approved medicines for conditions, (or in ways), which are not specifically approved by the FDA, but can companies discuss these off-label uses with physicians or provide them with published information about these off-label uses?

Competing Risk-Benefit Perspectives
The competing risk-benefit perspectives that surround this issue are nearly identical to the trade-offs that all stakeholders in biomedical research and development face – including the FDA, companies, patients, clinicians, and legislators:

Creating a landscape that protects individuals and public safety
Being flexible enough to provide clinicians and patients access to the best available treatment possibilities
Providing companies a reasonable market environment that creates incentives for developing new treatments and investigating new uses for already approved medicines, which also has marketing rules that are as clear as possible so companies can conduct business without being excessively concerned about straying into regulatory gray zones

Off-label use is common in clinical practice – particularly for disease areas like cancer – because it often represents the standard of care. …

Encouraging Communications About Patients’ Goals

September 18, 2009 / Michael D. Miller MD / Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Information & Communications, Quality of Care & Safety / No Comments

I attended a great event yesterday where experts discussed how to improve healthcare quality and safety by increasing patients’ involvement in making healthcare decisions.

This seminar, “Patient-Centeredness and Patient Safety: How Are They Interconnected,” was organized by the Kenneth B. Schwartz Center and sponsored by the Massachusetts Medical Society and CRICO/RMF. Don Berwick (President & CEO of the Institute for Healthcare Improvement) was the main speaker followed by a panel consisting of two patient safety leaders from local hospitals and a patient involved with promoting patient engagement in quality improvement.

To start the event, Dr. Berwick discussed how his thinking about healthcare quality had evolved over several decades, and his increasing belief in the importance of patient involvement.…

Real Health Reform in Massachusetts

July 29, 2009 / Michael D. Miller MD / Delivery of Healthcare, Federal Healthcare Reform, Health System Reform, Quality of Care & Safety, State-Level Healthcare Reform / 5 Comments

The Massachusetts Special Commission on Payment Reform recently issued its recommendations for shifting the state’s health care system from Fee-For-Service (FFS) to Global Payments over a 5 year period. The Special Commission’s report lays out a good case for making this change, describing why it needs to be adopted by all payers, (although each payer would still pay different rates, they would all use the same fundamental global payment structure), and some of the challenges for successfully navigating a 5 year transition period from the current mostly FFS system to one dominated by global payments.

The report summarizes its recommendations into 9 areas:

The development of Accountable Care Organizations (ACOs).

…

Biotechs Biting the Dust

July 22, 2009 / Michael D. Miller MD / Economics & Financing, Innovation, Patents & IP / No Comments

On Tuesday, Epix Pharmaceuticals announced that they were dissolving. And unlike many innovative life sciences companies, they’re not being acquired by another company to take advantage of their research, nor are they evaporating because their one line of research failed in clinical development. Rather, they’ve just run out of money, can’t raise any more, and their assets are worth less than their debt. So they’re selling off what they can, and locking the door behind them.

While the company’s announcement isn’t too reveling about their history, looking at their information on Yahoo! Finance shows that while they have consistently lost money, (as do virtually all biotech companies without products to sell), year-over-year, revenue was increasing and the losses were shrinking. …

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