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John Irvine

Will Trumpcare Repeal & Replace Obamacare?

Nov 23, 2016• 8

BY DEVON HERRICK

Donald Trump made repealing Obamacare one of the cornerstones of his campaign. Now that he has won, his administration will face the daunting task of unraveling nearly seven years of Obamacare. Republican policymakers cannot agree how to proceed. Some Republicans believe Trump should repeal Obamacare piecemeal; others worry that would be a disaster.

Whether you oppose or support the Affordable Care Act (ACA), it has structural flaws that will have to be addressed. Addressing those flaws will be less painful if repeal of the costly insurance provisions is accompanied by a replacement plan. Congress can repeal some Obamacare provisions using budget reconciliation, which requires only a simple majority. Only those provisions involving taxes and the budget can be repealed this way. The individual and employer mandates and all the ACA taxes can be repealed using budget reconciliation. However, the regulations that prevent insurers from designing affordable health plans cannot. Repealing the insurance mandates require a filibuster-proof majority. A slight Republican majority in Congress means the Trump Administration likely has the power to gut the ACA. However, Trump cannot replace Obamacare without maybe a dozen Senate Democrats willing to go along.Continue reading…

Congress Shouldn’t Pass FDA Reform Bills Without Addressing Patient Safety and Drug Prices

Nov 23, 2016

By DIANA ZUCKERMAN

A major proposed law that alters the way the Food and Drug Administration (FDA) approves drugs and medical devices has been wending its way through Congress since 2014. Momentum is building on Capitol Hill to pass the legislation in the current “lame-duck” session of Congress.

That shouldn’t happen.

The House passed its version of the legislation—the 21^st Century Cures Act (hereafter the Cures bill) —in July 2015. The Senate health committee created and passed 19 related bills, under the banner “Innovation for Healthier Americans,” this past spring.

Sen. Lamar Alexander (R-Tenn) pushed, without success, to get the legislation to the Senate floor this past summer. Now, he and proponents—which include the pharmaceutical and medical device industries and dozens of research and patient groups who get support from those industries—seek to pass the legislation in the lame-duck session.

Rethinking Outcomes Improvement and Data Governance

Nov 21, 2016

By HEALTH CATALYST

Over the last year, we have noticed a very common trend. As organizations decide that they are ready to embark on a data-driven journey, they go through a rigorous process to select their technology and vendor(s) of choice, but then they often slow to a crawl when considering how to organizationally manage and handle the many changes that will be needed to succeed. A small sample of the many questions we hear are:

Who will lead out on data-driven outcomes improvement?
Where will this function be funded and led?
Who owns the data?
How do we identify opportunities and prioritize what we will do?
How do we resolve discrepancies?
How do we measure success?

So, this week we are featuring a webinar on Outcomes Improvement Governance, presented by our co-founder, Tom Burton and David Grauer, a former Intermountain Healthcare executive with years of executive governance experience. Plus, we’ve included three articles that we have written on ‘data’ governance, a sub-component of governance. If your organization faces any of these important issues, please join us for this informative webinar and its question and answer period.

Randomized Trialomania

Nov 18, 2016• 2

BY ANISH KOKA, MD

This story is old, but the age of the story should not detract from the lessons of the story.

It was 1982, the place was Tsukuba, Ibaraki Prefecture, Japan. Workers at Fujisawa pharmaceuticals began testing fermented broths of Streptomyces species that had been retrieved from soil samples at the base of Mount Tsukuba. They were working to solve the remaining achilles heel of organ transplantation – effective suppression of the immune system that would prevent the body from attacking its new guest. It had quickly became apparent to the medical community that the key to long term survival of patients now lay in the development of effective, non-toxic immunosuppressive agents.

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After two years of testing, isolate no. 9993, which later came to be named FK506, or Tacrolimus, showed promise in inhibiting lymphocyte reactions. First reports emerged in the literature in 1987, and were impressive. The agent appeared to suppress mixed lymphocyte culture at concentration 30 to 100 times lower than the gold standard at the time: cyclosporin. (1)

The father of organ transplant, Thomas Starzl was in Pittsburgh at the time, and quickly seized on the potential of this new agent. By 1990, he had used the drug successfully in patients who were rejecting their liver transplants on conventional cyclosporine based immunosuppression. The positive results of the ‘rescue’ trial prompted initiation of a randomized control trial in Pittsburgh that compared cyclosporine to FK506 from the time of transplant.
At the time, the randomized control trial was in its relative infancy, and had not yet achieved the hallowed status it has today. This, of course, was changing rapidly. Physicians recognized the fallacy of epistemology sourced purely from intuition and tradition, and sought the shelter of certainty that randomized control trials (RCTs) promised with the random allocation of patients to treatment and control arms. The Pittsburgh team thus randomized 81 patient, 40 to cyclosporine – the conventional treatment – and 41 to FK506, the new kid on the block. Investigators studied patient mortality and survival of the transplanted organ at various time points. By convention, results were analyzed using statistical hypothesis testing – and to the lay person would seem to be underwhelming.

Software as a Drug

Nov 18, 2016• 3

By JOE RILEY

flying cadeucii What if your spouse were a borderline Type 2 diabetic? If you had the money, you could hire someone to follow her or him around the clock, sort of like a glorified personal trainer. Your spouse would make sure he or she took a daily mile-long walk, did some weight training to build muscle mass and would stop you from eating ice cream or cake or drinking a glass of wine.

A good idea – but too expensive, right?

It doesn’t have to be, because a new and highly efficient modality – digital therapeutics – has entered the picture. Commonly referred to as “software as a drug,” digital therapeutics relies on software to similarly deter your spouse from becoming diabetic – in tandem with online coaches, electronic messages and the use of social networks.

Making Cancer Care Great Again

Nov 17, 2016• 1

By MICHAEL MILLENSON

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Q: Donald Trump’s campaign for the presidency included a promise to repeal “Obamacare” in its entirety. If he succeeds in fulfilling that promise, what impact can we expect on American cancer prevention and cancer treatment?

A: Donald Trump, emboldened by eliminating ISIS, ending illegal immigration and energizing the economy, will eradicate cancer. Or at the very least, I predict, he will append it to his list of promised achievements as president.

Our current chief executive, dubbed “No Drama Obama” by his staff during the 2008 campaign, couldn’t resist the heady promise of a cancer “moonshot.” Trump, who’s declared, “I will take care of ISIS,” “close up those borders” and “jump-start America,” will likely rev up the rhetoric back to Nixonian “War on Cancer” levels.

A candidate whose campaign centered on his personal pledge to “make America great again” will surely be galvanized by the chance to make cancer care “great,” too.

The current Cancer Moonshot initiative, featured in President Barack Obama’s last State of the Union Address, is codified in a presidential memorandum of Jan. 28, 2016 and placed within the Office of the Vice President. While fighting cancer was of deep personal interest to Vice President Joe Biden, Vice President-elect Mike Pence was governor of Indiana, where pharmaceutical giant Eli Lilly has a major portfolio of oncology products. Coincidentally, Lilly in October introduced a new version of its PACE Continuous Innovation Indicator (CII), a customizable, online tool to review progress against cancer in order to inform public policy and accelerate innovation.

Why Trump’s Health Care Plan Will Fail

Nov 15, 2016• 10

BY KEN TERRY

Donald Trump—along with some Republican leaders—says he wants to keep certain parts of Obamacare, such as letting young adults stay on their parents’ plans through age 26 and banning pre-existing condition exclusions. Coupled with the plan that Trump recently unveiled on his website—a grab-bag of hoary Republican talking points–these comments show how little Trump knows about health care.

Take the pre-existing exclusion ban, for example. As New York State proved years ago, requiring the guaranteed issue of coverage without a mandate to buy it makes individual health insurance unaffordable. Insurers must raise their rates if not enough healthy people buy their product or if people can wait until they become acutely ill before they seek coverage.

Selling insurance across state lines is another Republican replacement for rational thought. If people are allowed to shop for insurance across state lines, insurance companies will set up plans in the state that regulates insurance the least—say, Mississippi. Then they’ll sell cheap, skimpy plans across the country. Unfortunately, their customers will discover that those plans cover very little when they get sick.

In addition, the plans that are selling coverage in Mississippi would need to create provider networks all across the country. That would be a gargantuan task, and the insurers would likely build the same kind of narrow networks that Obamacare has been criticized for. The net result: crappy coverage and little choice.

The piece de resistance of the Trumpian healthcare plan is more consumer-directed plans with health savings accounts (HSAs) and high deductibles. HSAs are tax-favored accounts that can be rolled over from year to year and can be used to pay for medical expenses. They may be funded jointly by employers and employees or solely by individuals. These consumer-directed plans have expanded under Obama, and Trump wants to encourage them to grow further.

Trumpcare Beta: mHealth, MACRA and ACOs

Nov 15, 2016• 1

BY JAAN SIDOROV

While readers digest the reality of a Trump Presidency and Republican control of both houses of Congress, your correspondent has been trying to assess the “down ballot” implications for healthcare and mHealth providers.

While the universe has been turned upside down, its initial reaction for mHealth is bullish. As for the rest……. read on.

While he was a wacky campaigner, your correspondent suspects that Mr. Trump’s “campaign promises” were really opening negotiating positions. While immigration, the Supreme Court and business regulatory reform will be top of mind, he’ll eventually get around to making deals in the healthcare space, because that is his nature. That is the real wild card and increases uncertainty.

That being said, what can your correspondent predict?

Given Mr. Trump’s and the Republican majority antipathy to Obamacare, the Affordable Care Act is likely to be gutted. While U.S. Senate Democrats can create mischief with the filibuster, many are also up for election in two years. As a result, commercial insurance premium subsidies, the minimum benefit, the IRS penalty and ACOs are toast.

Because it’s working pretty well, your humble correspondent rates it as unlikely that Congress will alter the basic underpinnings of fee-for-service Medicare and the Medicare Advantage programs. Unfortunately, however, that also means that the complex reporting and payment changes of MACRA – and its premise of “value-driven” Medicare – will stay on track.

The Age of Trumpian Uncertainty

Nov 14, 2016• 3

By PAUL KECKLEY

Paul Keckley The new Chief Executive Officer of the United States of America Inc. will take office January 20th and likely make good on his promise to repeal the Patient Protection and Affordable Care Act. It only requires a majority in both houses of Congress to pass and that’s assured based on the election results last week.

Immediately, the focus will shift to its replacement which is certain to be more complicated. Speculation about how his healthcare team will craft its own version of health reform 2.0 is at fever pitch. Questions are swirling about pieces of the law that might be carried over and those that might get the ax….
Will the Trump C suite align its replacement policy with Speaker Ryan’s “Better Way” though the positions of the two seem somewhat at odds, especially around reforms to Medicare including its transition to a premium support plan that encourages seniors to purchase coverage from private insurers with subsidies up to $8000 per senior?
What’s to become of the ACA’s insurance mandates for employers and individuals? Do they go away?
Will excise taxes paid by insurers, medical device manufacturers and increased personal income taxes paid by U.S. federal taxpayers be refunded since they were included in the ACA as a means of funding the trillion-dollar program?
How will President Trump deliver on promises to make healthcare affordable while keeping the ACA’s guaranteed issue restrictions on insurers?
How will Medicaid expansion be a funded in the 31 states that chose to accept the federal deal in the ACA, and what’s it mean for the 19 states that didn’t?
What becomes of alternative payment programs like accountable care organizations, bundled payments, value-based purchasing and others that have consumed a considerable time and attention by provider organizations?
And as the fourth marketplace enrollment period nears ends in January, what’s to become of the tax subsidies for the 12 million expected to enroll?
And beyond the ACA’s repeal, speculation about appointments to the Supreme Court and key healthcare agencies, strategies to allow importation of prescription drugs, how the Justice Department will weigh in on industry consolidation, private inurement and many other issues is running high as the team Trump’s health policy agenda takes shape.

Healthcare’s sky isn’t falling; President-elect Trump’s path forward

Nov 14, 2016• 4

By GARY MENDOZA

Friday, Healthcare IT News reported that most healthcare executives “express a dystopian view of a Trump presidency’s impact on healthcare”.

While significant changes to the ACA and beyond are coming, the sky won’t be falling any time soon.

Political reality, market and fiscal pressures and President-elect Trump’s statements before his election and since make that clear.

Here’s what lies ahead.

What will change. Trump’s election will accelerate the ACA’s demise.

His victory won’t be its cause.

The ACA’s combination of a weak individual mandate, broad mandated benefits and guaranteed issue hard-wired that outcome.

The individual mandate is the ACA’s least popular provision. That’s why the Obama Administration weakened it during implementation. It’s certain to go.