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The Mess That is MACRA

Apr 21, 2016• 15

By KIP SULLIVAN

MACRA (the Medicare Access and CHIP Reauthorization Act) is a mess. It is extremely difficult to comprehend, it is based on assumptions that defy commonsense and research, and it may raise costs.

The Medicare Payment Advisory Commission (MedPAC) would never say what I have just said, but MedPAC definitely understands MACRA’s defects. The transcripts of MedPAC’s October 8, 2015 and January 15, 2016 meetings indicate that members and staff perceive daunting impediments to the implementation of MACRA. But those transcripts also suggest that MedPAC won’t tell Congress to rewrite or repeal MACRA. Rather, the evidence suggests MedPAC will mince words. It appears MedPAC will send CMS and Congress a few wishes dressed up as “principles” and wait for MACRA’s inevitable failure before offering more useful advice.

Before I attempt to explain MACRA, let me first convey to you MACRA’s mind-numbing complexity by quoting four commissioners. Each statement below is followed by the last name of the commissioner who made it, the date the statement was made, and the page number of the transcript where the statement appears.

Is Pornography Creating a Public Health Crisis?

Apr 21, 2016• 16

By STEVEN FINDLAY

flying cadeucii Well, it’s not Zika and it won’t kill you, but pornography is being discussed—seriously—as a public health problem, even a “crisis.”

The path to this claim is a long one, with a slow burn over many years. It was kicked into higher gear in recent months with:(a) legislative action in one state;(b) a coverstory in TIME magazine (April 11 issue);(c) a Washington Post op-ed piece by anti-porn advocate Gail Dines; (d) a response to that in Atlantic Monthly; and (e) the publication of two books that discuss at length the effect of porn and the new sexual culture on teen girls—American Girls-Social Media and the Secret Lives of Teenagers by Mary Jo Sales and Girls & Sex-Navigating the Complicated New Landscape by Peggy Orenstein.

The legislative action took place in Utah. The Republican-led House of Representatives in that state became the first legislative body in the nation to pass a resolution declaring pornography “a public health hazard leading to a broad spectrum of individual and public health impacts and societal harms.” Dines and her fellow anti-porn crusaders want to carry that fight to other states.

This is going to be fun to watch! (Pun intended.)

Making Medicine Great Again

Apr 21, 2016

By MICHAEL MILLENSON

The annual Lown Institute Conference advocates for the “right” kind of patient care, as in “the correct course of action.” But the political meanings of “right” and “left” also echo, sounding like a healthcare version of the recover-lost-glory demands of Donald Trump and the moral crusade of Bernie Sanders.

The program for this year’s meeting, held in Chicago, urged attendees to “take back health [care];” you could almost hear a Trumpian, “Make medicine great again!” In an opening address, the institute’s senior vice president, Shannon Brownlee, proclaimed, “We are gathered out of a shared sense of moral purpose and a shared sense of outrage at the state of American healthcare.” The targets of that outrage that “we” need to take back healthcare from comprised a Sanders-type litany of the “pharma, biotech and device companies…[who] have illegally marketed products.”

There was one more villain, very carefully defined. That would be “a culture of overtesting and overtreatment…[that] harms patients, clinicians and communities.” Got that? While Brownlee’s acclaimed 2007 book, Overtreated, repeatedly highlights the abuses of fee-for-service medicine, the Lown Institute’s namesake founder and its president are academic physicians. And so, the doctors and hospitals responsible for and often profiting from overtreatment magically become just one more set of victims of the “culture.”

Ideological blinders notwithstanding, the institute’s work celebrates and highlights an impressive array of individuals working diligently for every conceivable kind of “right care.” There was Dr. Jeffrey Brenner, a Camden, NJ family physician whose description of his dogged, data-driven efforts on behalf of the poor and sick brought a standing ovation. And Dr. Joanne Lynn, a long-time advocate for the frail elderly, explaining why a MediCaring community model that mixed medical and social services was what the vulnerable old and their families really needed.

Don Quixote and the Health Professional’s Endless Quest

Apr 20, 2016• 4

By RICHARD GUNDERMAN, MD

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April 22 marks the 400^th anniversary of the death of the greatest novelist who ever lived, Miguel de Cervantes. Though the day will pace unnoticed by most physicians, it is in fact one many should note. Why? Because both his life and work can serve as vital sources of inspiration and resilience for health professionals everywhere.

In a 2002 Nobel Institute survey, 100 of the world’s most highly regarded writers named his Don Quixote the greatest novel of all time, outscoring its nearest rivals –works by Dickens, Tolstoy, and Joyce – by more than 50%. Said the head judge who announced the results, “If there is one novel you should read before you die, it is Don Quixote.”

Preparing Your Organization for MACRA 1.0

Apr 20, 2016

By BOBBI BROWN

flying cadeucii What does the Medicare Access and CHIP Reauthorization Act (MACRA), signed into law in 2015, mean for healthcare organizations and providers? At HIMSS 2016, the CMS Center for Clinical Standards and Quality Director, Kate Goodrich, MD, stated MACRA’s goal: “to have a single, unified program with flexibility. The new Merit-Based Incentive Payment System (MIPS) will offer that flexibility and not be a one-size fits all program. The new rule will reimburse physicians based on four factors.”

Health systems are still waiting for additional details about the “four factors” Goodrich mentioned (listed in this article under “MIPS”) or how CMS will reward providers for delivering better care. We’re aware of MACRA’s general structure, but still waiting for clearly defined rules and regulations. Until then, it will be difficult to evaluate this new law.

Even though health systems are currently in a waiting period for clarifying details about the proposed MACRA regulations (with major impacts in 2019), MACRA’s base year will likely be 2017—and 2017 is just around the corner. This article provides an overview of MACRA and guidance about what health systems should do to prepare for MACRA now.

Will New Funding Improve Alzheimer’s Dementia Outcomes?

Apr 20, 2016• 3

By RONALD LOUIE, MD and W ARCHIE BLEYER, MD

Alzheimer dementia mortality is increasing in the United States, while heart disease and cancer death rates have decreased at least 25% recently.¹ New cardiac and cancer treatments frequently make headlines. However, the assessment of Alzheimer’s therapy is stark: “…there are currently no treatments that change the course of this progressive brain disorder,” [original italics] so stated in the 2014-2015 Alzheimer Disease Progress Report by the National Institute of Aging (NIA).²

President Obama signed the National Alzheimer’s Project Act in 2011, with a goal of having effective therapy by 2025. Now five years later, clinicaltrials.gov lists fewer than 120 Alzheimer drug trials in the US recruiting subjects, with nearly 500,000 new patients each year. Heart disease has almost 800 drug trials, while adult cancer has almost 4000 drug trials listed.

Clinical research efforts in a disease are reflected by the number of pertinent clinical trial publications. We examined Pub Med data along with US mortality statistics to show the juxtaposition of those measures for Alzheimer’s disease, heart disease, cancer and six other leading causes of death, (Figure 1).^3,4

Reductions in US disease mortality have been proportional to the number of trials conducted in each disease except Alzheimer’s, during the years 2000-2013. Alzheimer’s disease is a significant outlier, since mortality is increasing while the number of peer-reviewed publications lags behind other conditions.

Why I Left My Pharma-Sponsored Academic Research Gig

Apr 18, 2016• 5

By BRAD FLANSBAUM

flying cadeucii Not long back, I departed a pharma-sponsored research project. I based my decision to leave in something I occasioned over a decade ago. I thought it was time to share the episode and the lessons learned given the attention being paid to physician conflict of interest nowadays (as well as the annual Open Payments review and dispute period approaching).

When I finished training, very few docs practiced hospital medicine—or even knew what the term hospitalist meant. Several forward-thinking medical centers hitched their wagons to the hospitalist model, as did some astute information technology and staffing companies.

However, few healthcare players embraced the hospitalist movement in a serious fashion like the pharmaceutical industry. They realized hospitalists prescribed a narrow band of products, in big lots, within a centralized location. The higher ups in the pharma sector saw the benefits in directing reps our way.

The Joint Commission Pain Standards: Five Misconceptions

Apr 18, 2016• 5

By DAVID W BAKER, MD

Baker_David_275 In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame. Often, The Joint Commission’s pain standards take that blame. We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.

The Joint Commission first established standards for pain assessment and treatment in 2001 in response to the national outcry about the widespread problem of undertreatment of pain. The Joint Commission’s current standards require that organizations establish policies regarding pain assessment and treatment and conduct educational efforts to ensure compliance. The standards DO NOT require the use of drugs to manage a patient’s pain; and when a drug is appropriate, the standards do not specify which drug should be prescribed.

Our foundational standards are quite simple. They are:

The hospital educates all licensed independent practitioners on assessing and managing pain.

The hospital respects the patient’s right to pain management.

The hospital assesses and manages the patient’s pain.

Requirements for what should be addressed in organizations’ policies include:

Beyond the Valley of Hype and the Plateau of Despair

Apr 18, 2016• 2

By DAVID SHAYWITZ, MD

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I can’t get Dan Lyons out of my head.

Lyons is the author of Disrupted, the buzzy new book about what happens when a curmudgeonly fifty-ish tech writer gets unceremoniously dumped from a plum role at Newsweek and takes a job as a “content generator” at Hubspot, a white-hot Boston startup selling marketing software.

Best known for creating a “Fake Steve Jobs” blog, and more recently for his work on the writing team for HBO’s achingly funny Silicon Valley, Lyons has a taste for the absurd, and his prologue (excerpt here)–describing his initial experience at Hubspot–is a laugh-out-loud takedown of tech startup culture.

The fun only lasts a few chapters, however (captured perfectly in this review by Erin Griffith), as Lyons hopes to convey a more serious point (conveniently summarized in an op-ed in today’s New York Times): that the excitement around technology companies is largely empty hype, enthusiasm used to sucker naïve young adults to work for peanuts (and candy), and to enrich savvy founders and venture capital investors, and the investment bankers who enable them, at the expense of the gullible mom and pop investors who buy shares of these fast-growing but often profitless companies after they go public.Continue reading…

How a Physician Can Work With a Not Yet Approved Drug Through Compassionate Use

Apr 17, 2016• 4

By ALISON BATEMAN-HOUSE

Screen Shot 2016-04-18 at 8.05.22 AM In a time when evidence-based prescribing and clinical guidelines are hot topics in medicine, trying to access a not-yet-approved drug to use in a patient can feel like navigating uncharted waters. Many physicians are unaware that the US Food and Drug Administration (FDA) allows the use of unapproved drugs outside of clinical trials and — even if they did know it is possible — have no idea how to access such investigational drugs for their patients.

This knowledge is largely sequestered into certain clinical specialties, such as oncology or rare disease, and it is not taught in medical school or during residency: instead, is largely self-taught. Thus, while some physicians have become very accustomed to requesting pre-approval access to drugs, the majority lack this knowledge. In this essay, I use a fictional case to trace the process for requesting access to an unapproved drug. I hope to explode several myths about the process, such as the notion that the FDA is the primary actor in granting access to unapproved drugs and the belief that physicians must spend 100 hours or more completing paperwork for pre-approval access.

Imagine you are a physician, and you have a pregnant patient who has tested positive for Zika. While she is only mildly ill, she’s terrified that her unborn child may be impacted by the virus, which has been provisionally linked with microcephaly and other abnormalities. She’s so concerned that she is contemplating an abortion, even though she and her husband have been trying to have a child and were overjoyed to learn she was pregnant.