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Is the FDA Sleeping With the Enemy?

flying cadeuciiPublishing in the BMJ, Vinay Prasad, an oncologist and healthcare’s leading evidence-based iconoclast, found that over half of medical reviewers who leave the FDA work for device and pharmaceutical industries. Prasad’s findings created disquiet amongst purists of various stripes. The media was shocked and tried shocking people by showing how shocked it was. The Lown Institute, which has been fighting physician conflict-of-interest (COI) with industry, seemed exasperated that yet another COI has emerged. Even pro-industry observers were upset by Prasad’s data-driven insinuation that a career in the FDA seems, for many, a means to a career in industry.

The reactions show deep inconsistency and a tangled-web of moral confusion which pervades healthcare. Let me start with the obvious. If nothing is inherently wrong with physician-industry relationship, and I side with the amoralists, then it scant matters that for some physicians the FDA is a stepping stone to industry. I’ll be more explicit: it is illogical to encourage physician-industry relationship and be upset when this relationship is consummated.

Conversely, if you believe the FDA is a force for public good (FWIW, I’m decidedly on the fence), then you should be happy when an FDA reviewer consults for a pharmaceutical company, particularly if you also believe that industry is not a force for public good. If you believe there’s inherent virtue in regulations, that the assessment of safety and efficacy of a new drug is a science that is as beautiful as religion, then why be upset when a regulator shows industry how to satisfy regulators? The FDA sets standards to save us from rapacious capitalists, and some FDA reviewers show rapacious capitalists how to meet the standards which keep us safe. By valuing medical reviewers for the FDA, industry signals that they value satisfying regulators. Am I alone in I failing to see a problem? Would the Church of the Latter Day Saints object to their members moving to Wall Street to proselytize investment bankers, or to Hollywood to preach prudence?

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ACO Performance Year Three: What Happened and What Does It Mean?

Since Accountable Care Organizations (ACOs) are CMS’s largest pay for performance model delivering care to over 7.5 million beneficiaries, each August Medicare policy analysts await CMS’s press release summarizing ACO financial and quality performance for the previous year.  This past August 25, CMS announced 2015 results.  Like performance year one (2013) and two (2014), performance year three again produced marginal results.  Largely because, inexplicably, CMS is not evaluating the ACO program, once again analysts are left to decipher what performance results mean for the program, how success was achieved and what ACO performance means in context of the agency’s overall efforts at lowering Medicare spending growth.   

Summary of 2015 Performance Results

In CMS’s August 25th press releases, the agency noted 120 out of 392 2015 ACOs earned share savings. 1  CMS also releases annually a data file summarizing ACO participants, participation track, number of assigned beneficiaries, financial benchmark and quality measurement data.  Based on the data file, of 392 ACOs, 115 ACOs earned shared savings, 114 in Track 1 and one in Track 2, or 29% of all ACOs. 2  This compares to 26% in 2014. 3  Of the remaining 276 ACOs, one ACO earned shared savings but did not meet their quality performance standard, 86 ACOs produced savings but did not exceed their Minimum Loss Ratio (MLR) and 95 received reimbursements beyond their benchmark and fell within their negative MLR. The worst performing ACOs were the 95, or 24%, that received reimbursements that exceeded their negative MLR.  Had this last group not been in Track 1 they would have owed CMS half of their above benchmark reimbursements.  As in 2014 earned shared savings was highly concentrated.  Ten of the 115 successful ACOs earned $220 million in shared savings, or more than one-third of total $645 million in shared savings payments. 

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The Letter of Recommendation: A Two Way Legal Instrument

Letters of recommendation (LORs) are a common part of the job application. Employers rely on them to help choose new hires. Many physicians have written reference letters for their peers and trainees. It is important to appreciate that LOR is a legal instrument that holds not only the applicant accountable but also the writer. It is a signed document that is retained in the employee’s files and its origin can be traced.

I will describe the case of a physician group which was successfully sued for writing an inaccurate reference letter for a former colleague. Litigation involving inaccurate and misleading references in the broader employment arena will be discussed to highlight the nature of liability in LORs.

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Fail to Scale: Why Great Ideas In Healthcare Don’t Thrive Everywhere

In the world of fine wine, it is well known that some types of wine grapes grow only in very specific climates and ecologies. The concept borrowed from the French is “terroir” (ter-WAHR). Terroir explains why the finest champagne grapes grow only in a small district in northeastern France, characterized by rolling hills and a chalky limestone subsoil that provides a steady level of moisture and imparts a mineral note to the wine’s flavor.

Health policy advocates have sought for generations to propagate promising forms of health care organization across the country. Yet one finds repeatedly that some forms of organization that prosper in one part of the country fail to thrive in others. Is it possible that the concept of terroir also applies in health care?

The Case Of Kaiser Permanente

Kaiser Permanente’s health plans would be a great example. Kaiser has been a darling of health policy advocates such as Alain Enthoven, Paul Ellwood, and others because of its integrated structure, global risk, and salaried employment model of physician practice. Yet, despite repeated federal interventions, beginning with the Health Maintenance Organization Act of 1973, Kaiser only recently exceeded 10 million in enrollment for the first time in its 71 year history. Moreover, 82 percent of that enrollment is in two states—Oregon and California—where Kaiser originated. The percentage of Kaiser’s enrollment that derives from its origin states is basically unchanged in a decade.

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Advancing Health IT and Preventing Data Blocking through Model Contract Language

As we move to transform the health care system into one that delivers more coordinated care across various clinicians and providers, it is important that data is available to providers and patients when and where they need it. To achieve this goal of ensuring the flow of health data and, ultimately, better care, the country has invested in the technology and infrastructure to connect patients’ clinical experiences.

That is why CMS and ONC are working together to make sure this investment stays on the right track. We are simplifying regulations, taking steps to require open technology, and have released a Health IT Playbook to help clinicians assess their needs and navigate the electronic health record (EHR) market. In addition, today we are releasing an EHR contracting guide  – EHR Contracts Untangled: Selecting Wisely, Negotiating Terms, and Understanding the Fine Print – that will help clinicians and hospitals make sure that contract terms do not inhibit the utility of their EHR technologies. Quite simply, our health care system cannot realize the promise of EHRs if information cannot flow across practices – and to and from patients – easily and in a cost-efficient manner.

The growing maturity of the health information technology market presents health care providers with new, varied, complex, and often confusing choices about EHR systems. From the small practice manager exploring new cloud-based EHR products and services, to the CIO contemplating a major EHR procurement, making the right choice for a practice – and advancing interoperability – hinges on having reliable, easy-to-understand information. But we have heard from providers in the field, professional associations, and other observers that such information can be hard to find. Moreover, EHR contracts can be confusing and may result in data blocking and other practices that limit opportunities to use EHRs to deliver safer and more efficient care.

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Building Better Metrics:  Focus on Patient Empowerment

flying cadeuciiGrowing up during the 1970’s and 80’s, the “Little House on the Prairie” television series was an iconic part of my childhood.  Doc Baker was the physician and veterinarian for all of Walnut Grove, in spite of limited resources.  Medical lessons were everywhere in the beloved television series:  Mary experiencing onset of blindness (most recently attributed to viral meningoencephalitis, likely from Measles), the death of Laura’s infant son by unknown cause, and Rose’s survival after smallpox infection.

When patients ask me how to start solid foods, how to get a baby to sleep through the night, or how to treat minor injuries or burns, I frequently wonder if they would have asked the town doctor these same questions one hundred years ago.

Probably not, because they would know to watch their baby for hunger cues, let infants cry it out at night, or slap some egg white, aloe, or honey on their wounds or burns to prevent infection back then.  Empowering patients to treat themselves where appropriate has tremendous value to cut down on cost and consumption of precious resources.  It was also how medicine was practiced more than a century ago.

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Interview with Rasu Shrestha, CIO at UPMC

More about Health 2.0 Rasu Shrestha, CIO at the University of Pittsburg Medical Center, will be joining me on stage this afternoon in our Provider Symposium (on his birthday) and again on Tuesday, September 27th for our Information Blocking, APIs & App Stores: The State of Play in Data Access session. Below is the interview I had with him a couple of weeks ago about how a huge medical center like UPMC deals with the innovation side of the house. Not too late to sign up and come to Health 2.0 and come hear what else Rasu has to say!

The Rise and Decline
of the Dartmouth Atlas

flying cadeuciiIn my first comment  in this series (an open letter to President Obama), I criticized Obama for stating in an article  in the Journal of the American Medical Association that the Affordable Care Act is deflationary. I promised him I would post more essays showing how badly he had been misled by three experts who influenced him: Elliott Fisher and his colleagues at the Dartmouth Institute, Atul Gawande, and Peter Orszag.

My second post presented evidence that the research by Fisher et al. on regional variation in Medicare spending has been enormously influential with US policymakers for the last three decades.

In this comment, I demonstrate the gross inaccuracy of the Dartmouth group’s research.

Let me state at the outset: Even if every paper Fisher et al. wrote about regional variation in Medicare spending were true, none of them constituted evidence for the “accountable care organization.” In other words, even if we accept the Dartmouth group’s claim that regional and hospital variation is due primarily to overuse, we would still have no reason to accept the group’s claim that ACOs are the solution to all that overuse.Continue reading…

Practicing Physicians and Healthcare Reform: Population Health vs. Compensation Wealth

In her August 14th 2016 interview with the LA Times regarding the ACA and value-based reimbursement, HHS Secretary Sylvia Burwell stated, …”and medical providers want this.1” After reading this article, I wondered for a moment if I am working in the same healthcare system as the Secretary.   Having spent a significant part of my 36-year career negotiating financial transactions with and/or on behalf of practicing physicians, I can unequivocally state that, unlike healthcare thought -leaders and policy wonks, a scant few practicing physicians are on board with population health management, value-based care and the “triple aim.”

It is essential to significantly improve the value of healthcare and it will require a lot of work by all.  Given the disconnect between the policy makers/‘thought- leaders’ and the nation’s practicing physicians, I am pretty sure we are not going to get very far.   Most practicing physicians consider the current movement to value based care/population health to be ineffective, expensive, bureaucratic interference with the practice of medicine.

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A chat with Ian Morrison

My old friend and former boss Ian Morrison will be giving the keynote at Health 2.0’s 10th Annual Fall Conference on the afternoon of Tuesday, September 27thIan was President of Institute for the Future in the 1990s, founded the Strategic Health Perspectives service, and is in more health care board rooms and conference halls than almost anyone. At Health 2.0, Ian will share his latest insights into the future of health care. Did we tell you he’s the pre-eminent jokester on the health care speaking circuit? Well he is! You can still Register and come hear what else Ian has to say! But here’s a taster — Matthew Holt

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