The Importance of Getting Electronic Health Records Right: Another Way Your Health Data Is at Risk

shutterstock_398517169Usually when we think of our personal health data being at risk, we think of things like dastardly hackers from far away countries or something far more mundane like a failure to have Health Insurance Portability and Accountability Act (HIPAA) protocols in place.  While both of these examples may be worth some degree of worry, a new study brings to light a source of risk that few of us may have considered.  This study, called “Workarounds to Computer Access in Healthcare Organizations: You Want My Password or a Dead Patient?,” is a potent reminder both of how cumbersome electronic health record (EHR) systems can be and why you AND your health care provider might choose to ignore digital protocols in favor of hands-on health care services.

As you might guess from the title of the study (and as is well summarized in a WSJ blog, investigators found that health professionals will ignore or “work around” digital protocols with some frequency in the interest of providing more efficient care.  This news is in some ways shocking but otherwise seems totally unsurprising.  On the plus side, providers care more about patient health than computer systems.  On the minus side, we as a society are spending remarkable amounts of money to secure health care data, and this is not feeling like money well spent.

To be fair to the health workers at the heart of this study, these systems are quite cumbersome.  They do not seem to be designed with the providers in mind.  Data fields can vary from hospital to hospital and practice to practice.  Even the idea behind the systems, to create a secure, comprehensive health record for each patient which would lead to better diagnoses, less duplication of testing and a reduction in prescription drug abuse, seems unserved by the status quo.  Perhaps if the systems truly provided this value and were set up to be more user friendly, the cybersecurity violations described in the study as commonplace would instead be rare.  In theory, we are moving towards a better system as EHRs must meet the meaningful use standards begun through the American Recovery and Reinvestment Act of 2009, as well as interoperability which may, if we are lucky, result in less variation among these systems and, therefore, greater ease of use so that providers aren’t saying: “You Want My Password or a Dead Patient?”

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Health Law Update Webinar – Thursday, July 21

Cozen O’Connor is hosting an in-person and webinar seminar on trending topics in health law on Thursday, July 21,  3:30 – 5:30 PM ET. I will be speaking on “Health Care Update from Washington: Rushing to the Finish Line Both in Congress and at HHS” with two of my colleagues, who will present “Cyber Security and Health Care: An Overview of Cyber Risks and Exposures in the Health Care Industry.” If you are interested in the webinar or would like more information, please e-mail jstuddard@cozen.com. We will providing CLE credit, which is still pending.

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Times They Are A-Changin’: Scope of Practice Finally Gets a Closer Look

shutterstock_349748126No one should question the importance of medical training or ongoing educational requirements, nor should a health problem be addressed with anything but the expertise it requires. That said, far too often, health professionals (or perhaps more accurately their professional associations or licensing boards) focus not on what they can do and how best to do it but on what others are doing to “nip at their heels” and how to stop them in their tracks. This turfiness is preventing other health professionals from practicing at the top of their licenses, at great cost to patients as well as the system at large. It is also fundamentally anti-competitive.

For decades, scope of practice and professional licensure issues were a third-rail topic, completely untouchable, but these issues are getting a much closer look these days. The biggest indication of a new world order coming was last year’s Supreme Court decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission in which the power of a state licensing board was circumscribed significantly for the first time.

At its core, North Carolina State Board held, in a 6-3 decision, that when a controlling number of the decision makers on a state licensing board are active participants in the occupation the board regulates, the board can invoke state-action immunity only if it is subject to active supervision by the state. This decision is truly groundbreaking, as most health licensing boards are dominated by participants in the occupation they regulate and these boards historically have received very little direct state supervision. Sometimes the work of these boards seems narrowly tailored to protecting the people they serve, but sometimes it can veer into seemingly anti-competitive action with no benefit, or even possible harm, for consumers.

Based on the case, many states, often through their Attorney General, are taking a closer look at how these health boards operate and whether there are antitrust or other consumer protection concerns raised. If that decision were the only change, it alone would be a lot. But the North Carolina State Board case is not alone in rocking the very foundations of health care professional licensure. While less direct in its impact, the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) begins the implementation of new payment models as well as incentive-based payment systems that many anticipate will allow for greater participation by Physician Assistants (PAs) and Nurse Practitioners in some tasks that once had to be at least directly supervised by a physician.

For example, the significant shortage of mental health professionals in many parts of the country is forcing discussions about who can be filling the gap. In the meantime, the burden is falling primarily to General Practitioners without this specialized training. In 2013, the Veterans’ Administration reported that 60 percent of its medical centers struggle to recruit and retain mental health professionals. With this problem in mind, Senators Donnelly and Boozman introduced the Frontline Mental Health Training Act (S714) to create a pilot program which would give specialized mental health training to PAs and then test the advisability of using these PAs to address VA and DOD mental health provider shortages.

Last week Politico Pro hosted a broad discussion on scope of practice, sponsored by the likes of CVS and AARP, a clear demonstration that the issue is no longer viewed as a third rail.

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Section 1557 and Beyond: True Civil Rights Are Coming to Health Care at Long Last

healthcare diversityI just watched the movie “All the Way,” an extraordinary account of LBJ’s first year in office and the passage of the Civil Rights Act of 1964. While that law was groundbreaking, many are surprised to learn it did relatively little to end discrimination in health care. The definition of “public accommodation” in the law was very limited and did not include hospitals or other health care settings. The only way to impact discrimination in hospitals through the law was not an affirmative obligation to protect civil liberties but the more distant threat that federal funding could be removed from private hospitals failing to treat patients equally.

Not until the passage of the Americans with Disabilities Act in 1990 were health care services formally added to the definition of “public accommodation,” although Professor Sara Rosenbaum notes that it was little remarked upon at the time, perhaps because many just assumed that a hospital was a public accommodation.

Finally, with the passage of the Affordable Care Act in 2010, discrimination in health care was addressed comprehensively in federal law. Section 1557 of the law prohibits discrimination on the basis of race, color, national origin, sex, age or disability in the broad range of HHS programs as well as by issuers offering insurance through the ACA Exchanges.

Unfortunately, the regulations implementing Section 1557 weren’t finalized until just last month on May 13, 2016. For those of us who have been in the trenches fighting against health disparities, this was an interminably long time, but it represents a huge step forward in this fight.

And, then, like Christmas in July (or, really, June), CMS released proposed rules this week that would require that hospitals that accept Medicaid or Medicare dollars must proactively establish policies to prohibit discrimination.

In a news cycle filled with far too much hate, these important strides toward equality in treatment are a welcome respite that I wanted to highlight.

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Understanding the Value of Medication: Whose job is it?

shutterstock_214693354There has been a lot of discussion about drugs and drug pricing of late, including the idea of value-based purchasing.  One element, though, that hasn’t been getting quite enough attention is just how a patient or a pharmacist or a doctor might come to understand what drugs are available and how to make an informed, independent judgment about each drug’s value.

I found myself thinking of this element today as a result of two pronouncements this week.  The first was the AMA’s public stance against direct to consumer advertising.  This is a good reminder that, as important as it is for patients to be informed about available options, seeing someone drive a cool sports car or frolic in a field with a puppy may not be the best way for them to do that.  The second was Janet Woodcock’s assertion at a Politico Pro event that adoption of biosimilars will be tied to acceptance by prescribers.  This made me wonder just who would be educating doctors on biosimilars.

Given how much we now spend on biologics, and the potential for biosimilars to save taxpayer dollars while increasing access to vital medication, making sure physicians understand biosimilars seems like a public good.  And yet, how will doctors be getting their information on biosimilars?  Unfortunately, as with other drugs, doctors have few independent resources for educating themselves (let alone time in which to do it), so, without developing a different solution, the uptake of biosimilars will likely be in the hands of manufacturers.

Brand manufacturers have a long history of using “detailers” to tell doctors about their products, but they are not required to inform doctors how their product compares to others on the market.  Generic and biosimilars are newer to “detailing,” and, unfortunately, while they have an incentive to provide information comparing their product to the originator product, the more detailing they pay to do, the less savings they presumably could pass on to consumers.  Academic detailing, in which an academic or at least non-commercial institution leads the effort, typically provides comparative information but is not widely available.

Where does that leave us?  There is widespread misunderstanding about biosimilars in the U.S.  While we must take great care in all things related to prescribing medication, few prescribers know how stringent the FDA’s standards are on biosimilars, let alone the success they have had abroad.  It seems likely that manufacturer efforts, whether of originator or biosimilars products, will be too targeted to specific products to address this concern.  How then can we remedy this?  Should the FDA have an educational role here?  If not the FDA, then who?

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Drug Pricing: Where Are We Now?

shutterstock_87320092Back in September, I mused that little was new in the drug pricing debate.  Today, while it is still true that novel solutions are not under discussion, there does seem to be new energy to the debate.  The issue has become a common topic on the campaign trail, and HHS is highlighting the importance of the issue by calling stakeholders together to inform and discuss possible solutions.

This event, the “HHS Pharmaceutical Forum: Innovation, Access, Affordability and Better Health,” on November 20, 2015, is by invitation only, but HHS has been inundated with requests for invitations.  As I write this, there are hundreds of interested parties who have been relegated to a waitlist and presumably hundreds more who have simply given up and will watch over webcast.

As is the norm on government events around drug pricing, there will be a careful balance between the need to make drugs accessible and the need to promote pharmaceutical innovation.  It is unlikely that the HHS event will rehash the Turing Pharmaceuticals mess, as most in attendance understand that to be an aberration.  You can bet, though, that there will be broad discussion of different approaches to pricing, such as value-based purchasing, and even some acknowledgement that our current system is outdated.  That said, don’t look for formal recommendations out of this forum, as none of the real solutions likely to be discussed will be met with widespread acceptance.

Instead, look for areas of agreement around the edges, on issues like medication adherence.  Unlike the innovation versus access debate, this is a topic where just about everyone is in agreement.  As a society, paying for drugs that patients fail to take as prescribed is, at best, a waste of resources and, at worst, the reason behind our antibiotic resistance epidemic.

It’s not clear yet whether the forum will address the newest challenges in Rx pricing, which is whether you can put a price tag on a miracle.  See, for example, the latest developments at Spark Therapeutics.  What is clear, though, is the drug pricing debate is here to stay at least a little while longer.

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Is True Mental Health Parity Finally on the Horizon?

shutterstock_103291430Nineteen years ago, the Mental Health Parity Act was signed into law.  It was a relatively small, but still important, step forward, making sure caps on mental health benefits were on par with those more medical/surgical health benefits.  Seven years ago a bigger step forward was made with the passage of the Mental Health Parity and Addiction Equity Act.  This measure required group health plans and health insurance issuers to make financial requirements (such as co-pays and deductibles) and treatment limitations (such as visit limits) no more restrictive for mental health and addiction services than for medical/surgical services.  Then, five years ago, as part of the ACA, these requirements were extended to also apply to individual coverage.  Most recently, CMS proposed a rule extending these requirements to Medicaid and CHIP.  In addition to the federal mental health parity requirements, all states, with the exception of Wyoming, have mental health parity laws of their own.

While all of the foregoing were considered big wins by mental health providers and advocates, mental health parity nonetheless has often existed more on paper than in practice.  That may be on the verge of changing.  In a recent 2nd Circuit decision, New York State Psychiatric Association, Inc. v. UnitedHealth Group, there are signs that mental health parity laws may be enforced more easily than previously thought.  In a nutshell, a mental health provider association was determined to have standing to raise a claim against an insurer.  Given the hurdles, financial and otherwise, that would face an individual provider or beneficiary seeking enforcement of mental health parity, this decision has been hailed as groundbreaking.

In addition, there is strong bipartisan support in both houses of Congress for additional federal legislative action on mental health.  Despite the onslaught of presidential politics and a belief that legislating may largely be done until after November 8, 2016, there is talk among not only advocates but also prominent lawmakers that further federal action on mental health is going to happen this year.  While the measures before Congress are likely to be fine-tuned, especially in response to differing approaches to HIPAA concerns, it is likely that they would not only strengthen parity requirements further but that there also would be additional funding for mental health services.

In the House, Tim Murphy (R, PA) is leading the charge with his Helping Families in Mental Health Crisis Act of 2015.  This bill has 128 cosponsors (89Rs, 39Ds) and already had a hearing this summer in the powerful Energy & Commerce Committee.  In the Senate, the closest parallel bill is the effort by Chris Murphy (D, CT) and Bill Cassidy (R, LA) to pass the Mental Health Reform Act of 2015.  Also in the Senate, though, the HELP Committee has already voted through the Mental Health Awareness and Improvement Act of 2015.  While this bill does not have the scope of the other legislation mentioned, its unanimous support in the HELP Committee demonstrates the Congressional appetite for moving ahead on mental health despite a deep divide among Members on many other issues.

Unfortunately, there is no shortage of high-profile tragedies to highlight the dangers that can accompany some types of mental illness, the latest being the shooting in Oregon this week.  While gun control legislation may not come out of this event, let us hope that it adds some momentum to truly strengthen our mental health system.  Were we to see stronger enforcement of existing mental health parity laws and even more comprehensive legislation, true mental health parity may finally be on the horizon.

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What’s Old is New Again: Proposals to Rein in Drug Prices are Nothing New

shutterstock_219420349It used to be that Americans would look the other way when it came to drug prices, concluding that the benefit outweighed the costs.  However, with prices continuing their march upward and with more of that price being borne directly by consumers, Americans’ willingness to give pharmaceutical manufacturers “a pass” is fading.  This growing reluctance to cut drug manufacturers slack for increasing prescription drug costs is evident in a Kaiser Family Foundation Poll from last month: 72% of Americans now think drug prices are too high and they are blaming the manufacturers for this, and 74% of respondents saying the companies put profit before people.

Not surprisingly, political leaders have looked at this information and concluded that addressing drug pricing could be a welcome health policy respite from endless debate around the Affordable Care Act.  Earlier in the summer, Ron Wyden, Ranking Member of the powerful Senate Finance Committee, talked about the need for extending value-based purchasing to pharmaceuticals.  More recently, the two lead Democratic presidential nominees, Hillary Clinton and Bernie Sanders each announced plans for reining in drug prices.

While Republicans generally have not entered the current media frenzy on the issue (with the notable exception of Republican front-runner Donald Trump calling the CEO of Turing Pharmaceuticals a “spoiled brat”), one would be foolish to forget Senate Finance Chairman Hatch’s pivotal role in creating the generic drug industry in the United States.  His legacy as a legislator is tied to increasing competition in the pharmaceutical space.

A number of different recommendations have been proposed, raising concerns – and a dip in stock prices – in the pharmaceutical marketplace and giving hope to consumer advocates eager to see drug prices reduced.  I can’t help, though, but think that it is too soon to mourn or celebrate (depending on your perspective) a reduction in pharmaceutical profits.

The truth is that none of the ideas proposed in recent months is new.  This is not to say that the ideas are necessarily bad, as I’ve been a proponent of many of them, but that they haven’t gotten very far in the past.  For example:

  • The outrage that taxpayers are paying higher prices for drugs for dual eligibles (those who are covered by both Medicare and Medicaid) began before Medicare Part D was finalized and has had a steady drumbeat ever since, and yet no movement has been made to remedy this problem.
  • Buses of seniors headed to Canada to purchase their medicine have come and gone without re-importation being legalized. 

Additionally, even if some of the ideas gain traction with legislators and regulators, it is questionable to what extent their implementation would remedy high drug prices:

  • Pay for delay settlements, which I once helped fight in court, don’t play the role they once did in artificially inflating prices.
  • Reducing data exclusivity for biologics isn’t going to lead to meaningfully greater competition if biosimilars are forced to actively market their products because they don’t share the same INN as the originator product.
  • Transparency, by itself, no matter what the form, cannot lower prices.

While it is true that more average folks and political leaders are jumping on the “these prices are immoral” bandwagon, it will take an awful lot more to turn this outrage into real change.  No matter how high the prices go, pharmaceutical companies will always be able to claim a real role, and sometimes a virtually miraculous one, in improving people’s lives.  This is a hard image to tarnish.  Couple that with the powerful lobby the industry has in Washington and the close ties between universities and the industry since passage of the Bayh-Dole Act, and we are left with no simple fix.  But who needs simple?

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A Major Loss for Consumers: FDA Proposed Rule on Biosimilar Naming Threatens Savings and Offers No Gain in Safety

shutterstock_46772755 This morning’s proposed rule on biosimilar naming marks a major win for PhRMA and BIO and a loss for consumers, not to mention a reversal of FDA policy.  At a time when more than 70% of Americans believe drug companies put profits before people, the FDA’s proposed rule helps them continue to do just that.

While it is arguably true that biologic drugs are somewhat more complicated than traditional chemical compounds and certainly true that very few policy makers and consumers truly understand the science behind these often groundbreaking drugs, this in no way should mandate that biosimilars (essentially the generic version of these drugs) should have a different medical name (formally known as a “nonproprietary name”) than the original product.

Think of it this way: If your doctor were to tell you to take 200mg over-the-counter Ibuprofen as an anti-inflammatory, you could go to the store and choose between Advil and the store-brand Ibuprofen, sitting side-by-side on the shelf.  You would have your own opinion about whether to get the branded version of the medication or the store brand but you would know that the ingredients were the same because each bottle would be labelled “200mg Ibuprofen.”  Under the scheme proposed by the FDA, your doctor would look up the name of the biologic and not necessarily see the biosimilar because they wouldn’t both have the same medicine name.

Why Does This Hurt Consumers?

A biosimilars pathway was created as part of the Affordable Care Act to make important medications more affordable, and thus more accessible, to those who need them.  By imposing a unique name on biosimilars, the FDA largely eliminates the potential savings of biosimilars.  Generics are able to be sold at a lower price than the brand version of a medication in large part because it is not necessary for them to advertise (or in pharmaceutical speak “detail”) the product, as the product has the same medicine name and sits side-by-side on the shelf (or next in line in a computer drop-down menu).  Under the proposed scheme, biosimilars companies will have to spend tremendous resources to inform providers that the product exists and should be considered as an alternative.  This added cost will be passed along to consumers, losing them valuable savings.

In countries like the United Kingdom, Japan and Australia, which already have biosimilars available on the market without similar restrictions, consumers have experienced significant savings and there have been no reported safety concerns.  There are even anecdotes about doctors using medications sooner, even prophylactically, with great outcomes for patients, but only because they can afford to take this approach.

Why Does It Not Improve Safety?

The reality of the biosimilars pathway created by the ACA is that it is, and has been implemented to be, extraordinarily cautious.  Every safety concern has been addressed and the FDA is imposing rigorous review on all market entrants.  Unknown to many, the biosimilar product actually is required to be manufactured in a way that is more rigorous than the requirements placed on the original product.  So, quite literally, the biosimilar is in some ways safer than the original.  This is not to suggest that your doctor should not carefully consider whether she believes the original product might be better suited to a particular patient, but the doctor should have readily available the knowledge that a biosimilars product is available.

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True Public Service: A Moment of Appreciation for Frances Oldham Kelsey and Dedicated Countless Others at the FDA

shutterstock_180415025Earlier this month Dr. Frances Oldham Kelsey passed away.  Although not a household name today, she became that rare thing: a civil servant who was not anonymous.  To the contrary, for a time, Dr. Kelsey was recognized by the public at large as a hero.

Despite enormous pressure from lobbyists and the same sort of pressure reviewers face today that, if approved elsewhere, a drug should also be approved here, Dr. Kelsey held her ground, insisting that more proof of safety was needed before the drug thalidomide could be approved for treatment of “morning sickness” and insomnia in pregnant women.  Ultimately, the drug was not approved here, and Dr. Kelsey was heralded by President Kennedy and others for saving unknown thousands of American children from serious birth defects.  Perhaps equally important, her experience with thalidomide led to stricter clinical testing standards and conflict of interest rules not only in the U.S. but elsewhere around the world.

I wanted to use this blog both to recognize Dr. Kelsey and to appreciate the thousands of others we will never know by name who have worked at the FDA to keep us safe.  It is easy to point to large, bureaucratic agencies as a source of delay, but it is essential that, even when questioning those agencies as we have some obligation as citizens to do, we step back and recognize their fundamental importance.  The very fact that trained experts are willing to toil day in and day out to safeguard the public at large, typically for less than they could make in other lines of work (and sometimes while subject to outspoken critiques from those they are working hardest to protect), gives me great comfort and fills me with gratitude.

As a society, with respect to pharmaceuticals, we must constantly decide how to balance safety and access.  It is inevitable that our tolerance for risk, combined with the particular medical issues we face, will cause us to reevaluate that balance from time to time, as the 21st Century Cures bill moving through Congress now does.  Like many others, I have found myself on both sides of this debate – wanting the strongest consumer protections but also wanting flexibility for those individuals facing extraordinary health challenges who want to take on additional risk.  Where does the answer lie?  We should not be overly cautious as that inevitably impedes access, but we must take great care in safeguarding the public, as only these dedicated public servants can do.  For that, I offer them my thanks.

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