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Utilizing Technology to Propel Precision Medicine Forward

April 04, 2016
11:18 am

As we’ve seen, there has been a steadily increasing level of discussion and enthusiasm surrounding precision medicine.  The Healthcare Leadership Council (HLC) has remained engaged in this conversation, given the expertise and involvement of its members.  HLC hosted a briefing on Capitol Hill last April on the subject, in which Bio-Reference Laboratories, New York-Presbyterian Hospital/Columbia University Medical Center and Mayo Clinic detailed the benefits that have already been realized, and the potential that has yet to be reached.  They each shared stories of how targeted therapy transformed the lives of patients in ways that conventional medicine could not.  Although the cost of sequencing will continue to benefit and see increased usage from price declines, early genetic testing has allowed for immediate diagnosis and treatment, bypassing the costly trial and error approach.  Our member experts all agreed that one organization alone cannot succeed in integrating genome based knowledge into personalized care.

Last year the Precision Medicine Initiative (PMI) was announced by the National Institute of Health (NIH).  This year the White House hosted a PMI Summit, in which President Obama both participated and partnered with the NIH in an educational tweet chat that answered questions from the public regarding the initiative.  During this chat, NIH Director Francis Collins cited a paradox, “Only by studying populations at scale can you really understand individual differences.”  The PMI Cohort Program is currently working towards collecting one million or more participants that reflect the diversity of our country.

Precision medicine is an area that would directly benefit from the ability to collect, store and share data electronically.  In order to see real success, harmonization of data privacy laws is a necessary next step.  Diverse state privacy regulations regarding patient information accompany HIPAA laws, adding to the complexity of sharing data in a way that would improve the quality of patient care.  Federal rules for research subjects intersect with additional privacy policies that are also burdensome to the healthcare system.  The ability to utilize any data gathered from partnering facilities is an important function, and dialogue between the federal government and states is needed to ensure this is feasible across the country.  This is a field of health policy we have discussed fully in the Healthcare Leadership Council’s recently-released “VIable Options: Six Steps to Transform Healthcare Now” policy recommendations. The U.S. is on the cusp of a new era in healthcare, and the flow of health data is a crucial part of it.

The Amazing, Classy, Winning (and Completely Ridiculous) $300 Billion Proposal

February 19, 2016
1:12 pm

It’s a notion we’ve heard a fair amount during the presidential campaign, this idea that Medicare should ‘negotiate’ prescription drug prices.  (There’s a very good reason I put ‘negotiate’ in quotes.  We’ll get to that in a moment.)  The concept reached all new levels of visibility in recent days when the leader in the polls on the Republican side told MSNBC’s “Morning Joe” program, “We don’t negotiate.  We don’t negotiate….If we negotiated the price of drugs, Joe, we’d save $300 billion a year.”

I’m not going to devote this post to litigating the $300 billion boast.  The Washington Post has already done that by giving it “Four Pinocchios” on its lack-of-truthfulness scale.  It is, of course, a mathematical impossibility to save $300 billion annually from a Medicare Part D prescription drug program that spends less than $80 billion per year.  A candidate making that claim has ventured into loaves-and-fishes territory.

But that particular absurdity notwithstanding, let’s discuss the proposal coming from the current presidential race leaders in both parties that the heavy hand of the federal government should be involved in drug pricing.  There are some myths attached to this idea that, in any reasonable debate, shouldn’t be shunted aside.

Myth #1 – In the Medicare program today, there are no negotiations to reduce drug prices.

This, of course, is patently untrue.  Prices in the Medicare Part D program are determined through a negotiation process involving private health plans and pharmacy benefit management (PBM) companies.  PBMs handle millions of individual pharmaceutical transactions yearly and have the bargaining power to achieve reasonable and realistic pricing.

The proof here is in the proverbial pudding.  Average monthly premiums for enrollees in the Part D program have, according to the Centers for Medicare and Medicaid Services, remained stable at an affordable level for the past five years.

Myth #2 – Federal government involvement in Medicare drug pricing is a pro-consumer idea.

Proponents of federally-dictated drug pricing make it seem all so simple, that if the government takes over drug price negotiations then Medicare prices will drop to the level of the Veterans Administration.  They don’t, however, explain the tradeoffs that come with this kind of policy change.  When you arbitrarily lower prices, you invariably restrict accessibility.  In the VA, for example, nearly one-fifth of the 200 most commonly prescribed drugs are not on its national formulary.  As noted in a paper by the Center for Medicine in the Public Interest, the vast majority of drugs not made available to VA patients are accessible within Medicare Part D prescription drug plans.

This is why the Congressional Budget Office has traditionally been reluctant to ascribe any real savings to the concept of federal price negotiations within Medicare, because of the unlikelihood that lawmakers will tell their senior citizen constituents that many of the drugs on which they depend will no longer be available to them.

And let’s not forget that artificial price controls on pharmaceuticals have an inevitable impact on research and development of new therapies, an unacceptable outcome when devastating (and costly) chronic illnesses like diabetes and heart disease are affecting millions.

Myth #3 – We need hard-nosed federal negotiators sitting at the table with pharmaceutical company executives to push down prices.

The mental image of two sides bickering over numbers from their respective sides of a table is a fallacy.  The reason I put ‘negotiate’ in quotation marks is because there really is no such thing.  The federal government establishes pricing levels and drugmakers must agree to meet those prices in order to be in the Medicare Part D formulary.  This has two effects – (1) the aforementioned restricted access to therapies and (2) the end of competition in the Part D program.  Today, plans compete with each other to provide greater value to enrollees.  With a single federally-set pricing level, the benefits of consumer choice and competition are lost.

The good news here is that there are ways to address healthcare costs while, instead of hurting patients and consumers, actually elevating care quality and bolstering innovation.  The Healthcare Leadership Council unveiled a series of proposals this week to accomplish those goals and I’ll be discussing these in more details in a series of forthcoming posts. Watch this space.

Bringing Value to the Patient and the Healthcare System: A New Report

February 04, 2016
4:52 pm

This week the Patient-Centered Primary Care Collaborative (PCPCC) unveiled its fifth annual report on the patient centered medical home’s (PCMH) impact on cost and quality.  In the quest to improve population health and reduce cost, PCPCC has collected data from peer-reviewed studies on medical homes’ costs and utilization.  Several Healthcare Leadership Council (HLC) members – Anthem, Aetna, Johnson & Johnson, McKesson, Merck, Premier and Takeda — are executive members of PCPCC. The results are instructive in the continuing discussion on how to elevate healthcare quality while containing overall spending.  Key takeaways from the report include:

  • A focus on primary care drives down cost and utilization
  • Best results came from sites that used multiple payers
  • It is essential to align payment with performance

The panel that discussed the findings included Marci Nielsen, CEO of PCPCC, Alissa Fox, SVP of the Office of Policy and Representation at Blue Cross Blue Shield Association, Chris Koller, President of Milbank Memorial Fund, and Len Nichols, Director of the Center for Health Policy Research and Ethics at George Mason University.

The experts stated that PCMH’s have demonstrated the ability to control costs by providing the right care.  Delivery reform and payment reform go hand in hand; one will not succeed without the other.  As the nation works toward a value-based healthcare system it is important to be mindful of the cost of transformation.  Incentives must be right, there will be a need for antitrust exemptions, and the industry will rely on national standards but local relationships.  Currently, fee-for-service does not reimburse services that are key to coordinating patient care.  The PCMH model is not one size fits all, according to the panel, and more research is needed to identify which varying components are demonstrating the most value.  Defining measures and identifying best practices are necessary steps in ensuring successful implementation of the PCMH model.

This discussion on how to improve value within the healthcare system will reach an important juncture later this month when the Healthcare Leadership Council unveils specific policy recommendations – endorsed by virtually all sectors of the healthcare industry in addition to patient advocacy organizations – on how to remove barriers to quality-enhancing, cost-saving health innovations.  Watch this space for more information.

He’s Not a Pharmaceutical CEO

December 18, 2015
12:56 pm

In the movie Wall Street, the amoral corporate takeover specialist Gordon Gekko is intent on taking over the fictional airline company BlueStar so he can break it up into pieces to sell off for a hefty profit.   In a technical sense, he would become an airline CEO, even if he didn’t know a fuselage from a tail fin.

Martin Shkreli is a real-life Gordon Gekko.  Just arrested this week on securities fraud charges, Shkreli, the 32-year-old co-founder of the MSMB Capital Management hedge fund, has been a fixture in the news over the last several months because of his purchase of Turing Pharmaceuticals and the subsequent decision to raise the price of a decades-old anti-parasite drug from $13.50 a pill to $750.

Headlines about Shkreli’s arrest refer to him as a “pharmaceutical company CEO.”  In the strictest sense, that’s true.  In reality, he bears no resemblance to the leaders of the nation’s research-based pharmaceutical companies who invest billions of dollars in the development of new cures and improved treatments.  It’s a gross inaccuracy to paint the entire biopharmaceutical industry with the stain of Shkreli’s profiteering example.

Some are doing exactly that, though, and using the Turing episode as a catalyst to call for greater government price controls on prescription medications.  Here’s an example just this week from the Vox website:

“The story of Martin Shkreli and Daraprim’s giant price increase is, more fundamentally, a story about America’s unique drug pricing policies. We are the only developed nation that lets drugmakers set their own prices — maximizing profits the same way that sellers of chairs, mugs, shoes, or any other seller of manufactured goods would. In Europe, Canada, and Australia, governments view the market for cures as essentially uncompetitive and set the price as part of a bureaucratic process — similar to how electricity or water are priced in regulated US utility markets.”

The analogy is, of course, severely flawed.  The supply of electricity and water is not contingent upon innovation in the same way that new medicines must be developed and constantly improved to combat cancer, heart disease, diabetes and Alzheimer’s, to name just a few chronic illnesses that affect tens of millions of us.  It’s notable that the calls for bureaucratic price controls, using Shkreli as the poster boy for egregious corporate greed, seldom mention the inevitable tradeoffs in the form of fewer resources for medical research.

Yes, the cost and accessibility of medications is a concern and one that should be addressed, but not with so-called solutions that make society choose between greater affordability today versus better health outcomes in the foreseeable future.  As we’ve seen with the price drop on the Hepatitis C cure once other companies developed their own medications to compete with Gilead Pharmaceutical’s Sovaldi, the market is often self-adjusting when it comes to price.  There are other ideas that warrant discussion, such as regulatory reforms to reduce the extraordinary cost and expense involved in moving a new drug from laboratory to patient.

The point is, it makes no more sense to let an outlier like Martin Shkreli drive pharmaceutical pricing policy any more than it would to arrest every financial services executive because Michael Douglas was so believable as Gordon Gekko.

The Proliferation of Progress Generated by Medicare Advantage

December 11, 2015
3:20 pm

This week the Blue Cross Blue Shield Association, representing plans that serve over four million individuals in Medicare Advantage and Medicare Part D prescription drug plans, hosted a congressional briefing to discuss innovations in Medicare Advantage.    Experts shared abundant evidence that Medicare Advantage plans have risen above and beyond traditional Medicare in providing quality healthcare that is cost-effective.

Several case studies were presented that highlighted continuing improvements being made to improve senior health:

  • Care at Home, a service launched by BCBS of Western New York and Landmark Health, offers a team that does not replace the primary care physician, but rather collaborates with the doctors and stays apprised on how patients are faring in their own residences.  Care at Home has enrolled 2,500 seniors since November 2014.  Patients with multiple chronic diseases generate more than seven times the healthcare costs of patients with only one chronic disease.  Medicare Advantage members who have six or more chronic diseases are eligible for Care at Home.  The coordinated care, which includes nurturing and education family caregivers, has, thus far, helped prevent 617 emergency room visits.
  • CareMore Health System, an Anthem company, uses doctors called extensivists to coordinate care for patients with chronic conditions.  They also ensure that there is proper follow up with patients and that protocols are adhered to by all involved in the patients’ care.  Predictive modeling is utilized to determine risk and practice early intervention, helping to keep costs low.  An average day at CareMore includes visits to homes for social and behavioral support, reading results from monitors in patients’ homes, following up after discharge, and providing rides for patients who have no form of transportation to reach points of care.
  • BCBS of Rhode Island identified pharmaceutical management as a way to lower healthcare costs and improve health outcomes.  The patient- centered pharmacy program serves members with multiple chronic conditions who take at least four medications and spend over $3,000 on drugs.  The medication therapy management includes comprehensive medication reviews, prescriber consultations, counseling for adherence and education, and monitoring to ensure good adherence habits are established.  In just the first three quarters of 2015, 8,632 members were served with an estimated savings of $2.8 million.

These are just a few examples demonstrating how innovation in Medicare Advantage has protected patients from high out-of-pocket costs, maintained quality care, and kept consumer satisfaction levels high.  These individual successes, and the others like them, need to be kept in mind by policymakers when they debate future support for the Medicare Advantage program.  The best practices and outcomes achieved by these pioneers in healthcare should be shared and encouraged so they can be replicated across the country.