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Diving into Genomics at Datapalooza

May 03, 2017
2:15 pm

I had the privilege of moderating a panel at Datapalooza – the annual gathering of hundreds of leaders in health data innovation — that focused on innovations in genomic science, which are rapidly spurring discoveries in personalized medicine.  Clinicians face enormous challenges in keeping pace with evolving best practices in data management and implementing these technologies into routine care.  The panelists focused on how genomic sequencing could be utilized with today’s healthcare information technology infrastructure, and the most effective way to do so.

Keith Stewart, the Carlson and Nelson Endowed Director of the Center for Individualized Medicine at the Mayo Clinic, where he is also a professor of medicine at the Mayo College of Medicine, discussed the importance of understanding genomes.  He said that 24 percent of people who have their genes sequenced discover new medical findings.  Utilizing this information can lead to more precise treatment.  Personalized treatment means that patients have the capability of finding out which drugs will give them more or fewer side effects, and which will be more effective overall.  Different people react to drugs in different ways, and this advanced knowledge can significantly increase quality of life for those who would otherwise suffer from severe side effects.  Dr. Stewart questioned how genome sequencing results can be stored in a way that they can be easily referenced for treatment.  Mayo Clinic, he said, is working on a way to bring genomic sequencing directly to the consumer, without the need for a doctor as a middleman.

Emma Huang, associate scientific director for Janssen research and development, said that the entire health continuum — from prevention to interception to cure — can be pushed forward by genomics.  Models are being developed for integrating genomic data into predictive models in real time.  What the system is lacking is the deep data collection at a population level in order to predict with greater accuracy.  There are currently global initiatives linking human genetics and clinical phenotypes.  Ms. Huang specified that data needs depend on the stage of a patient’s health.  She declared that insights from genomic data need to be available and easily interpreted by patients to achieve results.

A major implementation barrier involves data transfer, flow, and interconnectivity.  Genomics data is rarely generated, analyzed, interpreted, and clinically implemented in the same system.  Mark Dunnenberger, PharmD, program director of pharmacogenomics at NorthShore University HealthSystem, said genomic data needs to be integrated into the system for true value and should be used alongside clinical data.  NorthShore opened the first pharmacogenomics clinic of its kind in 2015, and has recently expanded the offering with an at-home testing program, MedClueRX. Electronic health records were not built to handle the huge volume and complexity of genomic data, and the current method of saving patient information as pdf files does not provide discrete data and tends to get lost in the system.  Pharmacogenomics helps clinicians choose between therapeutically equivalent treatments that benefit unique individuals in varying ways.  Patients grasp the value of pharmacogenomics, Dr. Dunnenberger said, and are willing to invest money regardless of whether it is covered by insurance.

As our nation’s efforts to bring precision medicine the forefront of clinical care accelerate, we must take care to ensure we incorporate this data in ways that will be usable for clinicians and valuable for patients – without creating additional uncertainly or unsustainable costs.  As is often the case, HLC members are forging a path forward for others to follow.

Walden Discussed Repeal and Replace Strategies at HLC Meeting

January 26, 2017
3:06 pm

On January 24 at a dinner hosted by the Healthcare Leadership Council for its members, U.S. Representative Greg Walden (R-OR), the new chairman of the influential House Energy and Commerce Committee, spoke of his panel’s goals for the upcoming healthcare overhaul.  CQ Roll Call published the following article based upon his prepared remarks.


CQ: Walden Outlines Obamacare Strategy to Health Care Executives By Joe Williams, CQ Roll Call

Energy and Commerce Chairman Greg Walden was poised Tuesday night to outline to health care industry executives his panel’s strategy for repealing and replacing the 2010 health care law, including insights on his plans to overhaul Medicaid.

The Oregon Republican planned to use his closed-door meeting with the Healthcare Leadership Council to discuss several measures his panel would consider in the coming weeks, according to prepared remarks obtained by CQ Roll Call.

A pair of hearings to be scheduled for late next week will center on stabilizing the health insurance marketplaces and on Medicaid. Walden is working with Senate Finance Chairman Orrin G. Hatch of Utah on changes to Medicaid, which provides health insurance to more than 73 million Americans.

Walden planned to confirm during his speech Tuesday night that Republicans will model their legislation largely on a repeal bill President Barack Obama vetoed last year.

“We will use our 2015 reconciliation bill as a starting point in order to repeal major portions of Obamacare, such as the individual and employer mandates, and address the Obamacare Medicaid expansion and the failing exchanges,” Walden’s prepared remarks say. They also say a “stability period” would be included in the legislation.

Walden also is expected to say that Republicans will “maintain protections for those with pre-existing conditions” and permit children to stay on their parents’ insurance plan until age 26, two provisions in the current law (PL 111-148, PL 111-152) that President Donald Trump has voiced support for keeping in a replacement plan.

In his prepared remarks, Walden calls on the Healthcare Leadership Council to engage publicly in the health care debate. The group includes executives from hospitals, insurers, pharmaceutical companies, medical device manufactures and other industries.

“We can’t do this alone. But by working together . . . we can reach our mutual goal of helping people live healthier lives and giving every American a new opportunity to get affordable health care coverage,” Walden will say, according to the prepared remarks.

Changes to Medicaid

Walden’s remarks don’t detail how the GOP would address the 2010 law’s Medicaid expansion, but he confirmed to CQ Roll Call earlier in the day he has had several meetings with Hatch to discuss their legislation on changes to the program.

Earlier this month, Walden organized a meeting between Republican lawmakers on his panel and GOP governors to discuss potential changes to Medicaid. He also attended a separate but similar meeting organized by Senate Finance.

A top aide to Trump said earlier this week the president would propose turning Medicaid into a block grant system. Some GOP governors at the meetings last week, however, suggested a per capita approach that would explicitly require the federal government to incorporate enrollment changes when determining reimbursement rates.

J. Mario Molina, president of Molina Healthcare, told CQ Roll Call both Republican and Democratic governors are likely to push for a per capita approach because it would account for potential increases in each state’s Medicaid population.

“This is going to be a debate between the states and the federal government as to how best to continue this entitlement program while trying to rein in costs,” he said in a recent interview.

Others Republican governors, including Gov. John R. Kasich of Ohio, proposed lowering the Medicaid coverage threshold to 100 percent of the poverty level and allowing people with income above that amount to get exchange coverage. The law’s expansion provides Medicaid coverage for individuals up to 138 percent of the poverty level.

 

The Challenge of Assessing Value in a Value-Based Healthcare System

September 21, 2016
5:56 pm

The Healthcare Leadership Council released its National Dialogue for Healthcare Innovation (NDHI) policy recommendations earlier this year. One of the core policy reforms we advocate involves concrete steps to speed the process by which new treatments and therapies receive federal approval and become accessible to patients and physicians.

However, just as important as accelerating the approval process is ensuring that patients have access to these treatments once they become available. HLC is pleased to cosponsor an upcoming event that will look at factors that could have a profound effect on patient access to care and health system value.

The National Pharmaceutical Council is hosting a conference in Washington, D.C., on September 29 that will be dedicated to the issue of value assessment frameworks. These frameworks are being developed by various organizations to evaluate new biopharmaceutical treatments and medical technologies and determine if they add value to the health system or, conversely, if they simply add excessive costs without a commensurate improvement in patient health. These initiatives are intended to ultimately have an impact on coverage and reimbursement decisions.

HLC strongly advocates the health system’s transition from fee-for-service to pay-for-value, but we have also insisted that cost containment must be balanced with improved care quality. The development of value assessment frameworks will have a significant impact on maintaining this balance. We look forward to the September 29 forum at which these issues will be discussed in detail.

An Innovation-Centric Approach to Pricing and Accessibility

July 07, 2016
12:44 pm

“Policy should not lose sight of the fact that new treatments represent miracles to many patients, and should encourage more, not less innovation.”

With those words in her op-ed in the Wall Street Journal, Susan DeVore, president and CEO of Premier, Inc. and chair of the Healthcare Leadership Council, gets right to the heart – or what should be the heart – of the national debate over pharmaceutical pricing.  With so many new lifesaving therapies in various stages of development and clinical testing, how do we make these medicines accessible to patients and consumers while encouraging even more beneficial innovation?

Ms. DeVore answers that question with one word – competition.  As she accurately points out, new breakthrough drugs like the cure for Hepatitis C often enter the marketplace with extremely high prices, but those costs drop considerably when competing products are made available.  Thus, one important answer to the drug pricing issue is to speed the process by which new drugs and medical technologies are approved for the market.  The Healthcare Leadership Council has made several recommendations in this area.

The answer is most certainly not to be found in the form of government price controls.  As Ms. DeVore writes, “The reality is that government negotiation will translate into price controls.  I have limited faith in the government’s ability to set pricing better than the market, or keep pace with innovation.  Their solution will invariably set prices too low, creating a chill on research and discovery as talent and capital leaves the sector to seek a better return elsewhere.”

The Premier CEO is absolutely right.  We can do better than a pharmaceutical pricing debate that, up to now, has been largely binary – either price controls or not.  We need to discuss mechanisms and policies that will bring more innovative products to the market and, in so doing, strengthen accessibility and affordability.

The Trustees Report and the Need for Action

June 22, 2016
4:56 pm

On a day in which the House Republicans are announcing their alternative health reform plan, House Democrats are staging a sit-in over gun laws, and the presumptive presidential nominees are firing insults at each other, it’s understandable if the annual issuance of the Medicare Board of Trustees report gets a little lost in the mix.

It’s a report quite worthy of attention, though, because its pages contain more than one call to action.

First, the trustees are now projecting that the Medicare program will reach insolvency in 2028, two years earlier than last year’s estimate.  This is not an insignificant change.  Think of the time required to enact comprehensive health reform, from the Nixon Administration’s efforts in the early 70s to the Affordable Care Act signing in 2010, or the decades spent trying to bring a prescription drug benefit to Medicare.   Twelve years may seem like a considerable amount of time to make Medicare financially sustainable and reliable for future generations but, in legislative terms, it’s not long at all.

We need serious discussions on how to modernize and strengthen Medicare.  The successes of the Medicare Advantage and Medicare Part D prescription drug programs provide sound examples lawmakers can use in shaping the future.  Those programs have utilized consumer choice and competition as drivers to provide high-quality care at reasonable costs.  And, in fact, the Congressional Budget Office has concluded that bringing those choice-and-competition qualities to Medicare as a whole would reduce program spending and beneficiary out-of-pocket costs.

The Medicare Trustees report sends a clear signal that this discussion shouldn’t wait.

Another important aspect of the trustees report concerns the Independent Payment Advisory Board (IPAB).  Many expected projected spending levels in this year’s report to trigger IPAB into action.  That wasn’t the case, although that threshold is expected to be reached next year.  Congress shouldn’t wait until then to make this bad idea go away for good.

Over 500 organizations representing patients, healthcare providers and employers have written to Congress already, pointing out that a mechanism which shifts power from elected representatives to unelected appointees would do significant damage to Medicare beneficiaries and the healthcare system as a whole.  By making harsh, arbitrary cuts to Medicare payments to healthcare goods and services instead of focusing on bringing greater value to the program, quality and access would be adversely affected.

No, the Medicare trustees didn’t flip the switch to activate IPAB this year, but it’s an imminent problem and it needs to be addressed sooner rather than later.