Monday, November 30, 2015

Very Bad Numbers

flying cadeuciiThe date is July 17th, 2014. It is 10am in the Dirksen Senate building, and the congressional subcommittee on health and aging is about to focus on patient harm. The educating will be done by some of the leaders in the medical field, Ashish Jha and Tejal Gandhi from Harvard, Peter Pronovost from Johns Hopkins. The star of the proceedings is John James, a toxicologist, a PhD from Texas, and the founder of Patient Safety America.

The tone is set from the beginning by none other than Bernie Sanders. In somber tones, he relays that hospitals can make patients worse, and that a recent study suggests medical errors is America’s third leading cause of death behind only heart disease and cancer. Hospitals are killing patients, and something needs to be done about it. The panelists then go on to speak strongly about the ongoing epidemic of patients dying in hospitals, and re-enforce the staggering numbers introduced by Bernie Sanders.

Headlining the proceedings is an unassuming gentleman named John James. He has a Ph. D in pathology, and he worked as a Chief Toxicologist at NASA. He is at the congressional proceedings, and is one of the lead activists in patient safety because of personal tragedy. His 19 year old son died in the summer of 2002 due to “uninformed, careless, and unethical” care by cardiologists. He proceeded to write a book, “A Sea of Broken Hearts” that details the errors he believes cardiologists made in his son’s care that lead to his death. Of note 2 cardiologists that were sought by Dr. James’ lawyers believe the care his son got did not violate the standards of care. A further 2 appeals to the Texas Medical Board also rendered two opinions from two other separate cardiologists that the standards of care in this case were not only met, but exceeded. Dr. James, armed with information he has carefully selected from a number of different sources, strongly disagrees.

Dr. James is now a crusader for patient rights. He writes of a broken health care system on his website, and more importantly wrote a paper in 2013 in the Journal of Patient Safety that estimated 400,000 patient deaths per year that were due to medical error. No physicians on the panel or elsewhere seem to have any issue with this number, and this has become fairly widely accepted. Even Captain ‘Sully’ Sullenberger, the hero pilot who landed a plane in the Hudson, noted that this was the “equivalent of three jumbo jets going down every day with no survivors.”

As a busy clinician who spends much of his time in the hospital, it doesn’t feel like patients are dying daily because of medical errors. But of course, data necessarily must trump feelings. So, I decided to read John James’s landmark paper.

Independence—It’s What Older People Want

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We already know what older people want.  A study from the National Conference of State Legislatures and AARP, as well as other studies, confirm, time and again, that the vast majority of us want to live in our homes and communities as we age, and, if possible, to avoid dependence on others and institutionalization.

Meeting this deeply personal goal requires that we design and provide good care in our hospitals and clinics, and expand that care beyond traditional boundaries. It requires the involvement of both health care and community-based service providers; a skilled paid workforce; and a well-supported, family-based “care force.” It also, of course, requires the correct blend of policies and funding.

This is an increasingly urgent concern. A person turns sixty-five every eight seconds, and according to Census numbers, the population of people age eighty-five and older, which doubled in the past thirty years, is projected to almost triple to more than 14 million people by 2040.

One obstacle we face is that our country spends almost twice as much on health care as on social services. To enable more older people to get the care and the outcomes they seek, we must find ways to balance our investment between these types of services, work together across sectors, and use our resources in forward-looking ways.

A good framework for this approach can be found in the work of the Institute of Medicine’s Forum on Aging, Disability, and Independence, which I cochair with Fernando Torres-Gil of the University of California, Los Angeles. A collaboration of the National Academies of Sciences, Engineering, and Medicine, the forum provides a critically needed and neutral venue to bring together aging and disability stakeholders from around the country, accelerate the transfer of research to practice and policy, and identify levers of change.

Supporting this type of transition and building the coalitions to carry it out are, in many ways, the essential role of philanthropy. At the John A. Hartford Foundation, we are committed to promoting better care for older people. To help more of us remain independent, we are supporting research and evidence-based programs in two broad areas: integrating community-based services with traditional health care and providing more coordinated care focused on older people’s own goals.

Supporting family and community resources

Our health care system has been developed to perform life-saving and critically needed interventions and procedures, such as stents, transplants, radiation, and chemotherapy. But such high-tech care, while important, is often not well matched with the wants and needs of older adults, particularly those who require help with their personal care and daily activities.

A much more common need for older people and their families is coping with multiple chronic conditions and the complications they can bring. Clinics and hospitals need to be better designed to support this chronic care, but the vast majority of care actually takes place in our homes and communities. To remain at home and successfully manage one’s chronic conditions, many more older adults need excellent long-term services and supports—such as transportation, mobility aids, housing modifications, and accessible home care. Without these, they struggle.

Their caregivers need help, as well, and the Institute of Medicine’s Study on Family Caregiving for Older Adults, which will be released in spring 2016 with funding from the John A. Hartford Foundation and fourteen other sponsors, should create a blueprint for how we can best support the family and friends who provide unpaid care worth an estimated $470 billion annually. (See list of study sponsors below.)

The Affordable Care Act and the new emphasis on value-based payment to accountable care organizations (ACOs) are changing incentives and placing a new focus on the importance of social services and supports for patients and caregivers alike. But how do we best structure and provide these services?

At the John A. Hartford Foundation, we are supporting work in California by the Partners in Care Foundation, and in Massachusetts by Elder Services of Merrimack Valley and Hebrew SeniorLife, to create more integrated care systems that link community-based, social service agencies to the health care sector.

We are also working with the federal Administration for Community Living, the SCAN Foundation, and the Tufts Health Plan Foundation to help representatives of the aging services network in eleven communities build their business acumen so they can work more effectively with health care providers, fill in service gaps, and meet the needs of older adults.

Reshaping care delivery, promoting teams

Good care must be team care, and good teams don’t just happen. Our foundation has a long-standing commitment to improving team care—for example, it has supported a Geriatric Interdisciplinary Team Training program at several universities and team-based practice models in clinic, hospital, and long-term care settings.

Meeting the whole range of health and social needs of frail older adults in each of these settings requires care coordination, reliable communication among team members (who may be in other practices or specialties or outside of the formal health system), and technology that promises to facilitate and monitor care.

The Mobile Acute Care Team (MACT) model is a good example. MACT is a hospital-at-home approach for older adults, where a team of nurses, physicians, social workers, and allied health care professionals provide acute-level care through home visits and monitoring. Studies have found that this approach lowers costs by nearly one-third and reduces infections and other complications. It is highly rated by patients and caregivers alike. Initially developed at Johns Hopkins University with support from the John A. Hartford Foundation, MACT is now being tested at Mount Sinai Medical Center in New York City with a substantial amount of funding from the federal Center for Medicare and Medicaid Innovation.

Making these kinds of services widely available will require significant changes in how care is delivered, and that is not easy. But with older adults becoming an ever-larger part of our population and our health care system continuing to experience rapid change because of market and policy forces, we must focus on delivering care that people actually want. By working together, we can provide services and supports that meet people where they are and honor their goals. That’s our definition of better care.

Author’s postscript:

The following entities have sponsored the caregiving study mentioned above:

Venrock headlines Health 2.0’s Digital Health Investor Conference, WinterTech 2016

Health 2.0’s WinterTech conference on January 13, 2016 at the Julia Morgan Ballroom in San Francisco, CA showcases the latest in digital health investing featuring leaders from Venrock, Canvas Venture Fund, Helix, Doximity, Grand Rounds, Livongo, Omada Health, and more. Learn about the latest financing and market trends of digital health and hear directly from the start-ups creating the biggest waves in the industry.

Key sessions include:

  • The VC and her CEO will include Silicon Valley VC Rebecca Lynn, Partner at Canvas and her CEO, Jeff Tangney, CEO & Founder at Doximity. The pair will provide an insider’s view of the investment, evolution of the business model, and how the two collaborate.
  • Fireside Chat will feature Health 2.0’s Co-Chairman Matthew Holt leading a one-on-one discussion with Bryan Roberts, Partner at Venrock, whose investments include health IT, biotechnology, diagnostics, and medical devices.
  • 3 CEOs will feature top journalists conducting separate 15 minute interviews with three of digital health’s biggest CEOs: Owen Tripp from Grand Rounds, Glen Tullman from Livongo Health, and Sean Duffy from Omada Health.

Conference panels include:

  • Investing In Consumer Health: With perspective and insights from leading companies and investors, Lisa Suennen, Managing Partner at Venture Valkyrie will moderate a panel of speakers including Ankur Luther, Executive Director at Morgan Stanleyand more.
  • New Clinical Tools and Platforms: Dena Bravata, Co-founder & CMO, Lyra Health will join a panel of speakers sharing how they enable a smarter health care system. These innovations make the delivery of care quicker, faster, and cheaper with new technologies for analyzing patient data, diagnostics, and improving day-to-day workflow and collaboration.
  • Meeting in the Middle: The Convergence of Life Sciences and Health Tech: Justin Kao, SVP of Corporate Development at Helix and Jeffrey Brewer, Founder & CEO at Bigfoot Biomedical will dive into how the rise of wearable sensors and other connected devices continues to evolve alongside advanced genomic analysis and big data in personalized medicine. This convergence promises to make health care more accurate, accessible, and affordable.
  • The New Consumer Health Ecosystem: Everyone is talking about consumers. Many millions of dollars have been invested in health care tech for consumer-facing services. Most consumers have yet to use any of the new technologies. This panel featuring Peter Ohnemus, CEO, & President from Dacadoo and others will assess the ecosystem and quantify how close we are to success.
  • Apply to attend the Health 2.0 exclusive investor breakfast, hosted before WinterTech, where you’ll have a chance to discuss business models, examine trends, and explore portfolios before the mainstage kickoff. Past investors include Qualcomm Ventures, Morgan Stanley, Ziegler, StartUp Health, Boehringer Ingelheim and more. Submit your application here.

Health 2.0 WinterTech is the only event dedicated to digital health and investing during the nation’s leading healthcare investment mecca, JPMorgan Week. The event brings together historically distinct industries in health to challenge the current landscape to become user driven, informed, and financially profitable for all players involved. Register before prices increase at the end of the day today!

About WinterTech
Through fireside chats, interviews, and compelling panel discussions, WinterTech is back for its second year, bringing together the top names in health care tech and investing including innovative startups, entrepreneurs, VCs, policy makers and more.

Deepa is the Marketing & Operations Manager at Health 2.0.

Clinician-Led Stewardship To Curb Medical Excess

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In a recent New England Journal of Medicine (NEJM) perspective, Durand and colleagues propose “medical-imaging stewardship.” They believe that imaging can be more appropriately used through “provider-led imaging stewardship,” based on the model of antimicrobial stewardship.

Antimicrobial stewardship is a hospital program composed of an expert pharmacist and infectious disease physician. Its goal is to improve appropriateness of antimicrobial use through restriction of antibiotics, post-prescription review, and education. Clinician-led stewardship could limit overuse and improve care beyond antimicrobial use or imaging and should be considered for all areas of medicine.

The comparison of imaging to antimicrobials is appropriate. Both imaging and antimicrobials are heavily overused; up to 50 percent of both are unnecessary. Likewise, both have objective harms to patients, with imaging leading to false-positive results such as incidentalomas, contrast, and radiation exposure and antimicrobials increasing risk for Clostridium difficile infection, drug side effects, and promotion of resistance. Both imaging and antimicrobials are often the response to uncertainty in clinical decisions: just to be safe let’s get a CT scan; just to be safe, take a week of ciprofloxacin.

Imaging Stewardship

Durand and colleagues imagine an Imaging Steward would (1) implement Choosing Wisely items related to imaging; (2) allocate resources towards information technology such as clinical-decision support systems; (3) intervene to ensure review for appropriateness of image ordering through dialogue with physicians; (4) gather and share data on ordering appropriateness that could show performance by physician; and (5) provide education on imaging knowledge gaps.

Where antimicrobial stewardship has an advantage over imaging is that antimicrobials are costly for hospitals, especially for newer antimicrobials such as daptomycin or linezolid. Antimicrobial stewardship programs have often justified their existence through a business argument that stewardship would lessen inappropriate use of expensive antimicrobials and reduce costs to the system. Imaging, on the other hand, typically generates income for a hospital through direct billing. Antimicrobial stewardship has developed over the past 15 years and now is a key part of the President’s National Action Plan for Combating Antimicrobial-Resistant Bacteria and stewardship programs may become a requirement to receive Medicare payments.

Policymakers and The Joint Commission should realize the potential benefit of expert stewardship outside of antimicrobial use. Imaging is a natural place to start, but hardly the only area in which overuse of medical care could be improved. Overuse has been estimated to account for up to 30 percent of all medical care and the majority of patients receive more care than is needed. Such overuse includes inappropriate use of antimicrobials and imaging but also cancer screening tests, diagnostic tests, invasive procedures, major operations, blood transfusions, and medication use. Clinician-led stewardship could intelligently lessen overuse in many environments.

Medical Stewardship Beyond Imaging And Antibiotics

How might this appear? It is easy to imagine having stewards responsible for areas of medicine including antimicrobial use and imaging as well as surgery and procedures that have a great deal of variation in use (and therefore likely overuse). This would include interventional cardiology, orthopedics, vascular surgery, endocrine and cancer surgery, among others. Medical areas such as oncology would be a natural fit. A surfeit of new, highly expensive medications could support a steward focused on appropriate use. Primary care could have stewards look at antimicrobials (for which there is little outpatient stewardship) as well as use of tests and other medications.

In addition to appropriateness criteria, stewardship can incorporate informed patient involvement in decision-making (such as salvage chemotherapy or many forms of knee surgery). A structure for stewardship could be justified as part of patient safety and quality improvement. By improving appropriateness of care, patients would face less risk of medical harm and a lower burden of care (fewer tests and medications to remember).

Policies To Support Medical Stewardship

Whether a system can support multiple experts reviewing appropriateness with primary clinicians is an important question. The potential savings from removing unnecessary care would be greater than the costs of scattered professionals targeting the highest volume, lowest-value care.

However, low-value care is often provided because it is encouraged by our reimbursement systems. Foregoing unnecessary surgery or imaging would have the perverse impact of decreasing revenue under fee-for-service reimbursement. So, beyond the expertise to trim the harmful effects of unnecessary care, we need payment systems that reward providers and hospitals that take the necessary steps to limit overuse. Durand and coauthors point out that alternative models of Medicare payments may change this financial incentive.

The proposal to expand stewardship beyond antimicrobials is astute and should improve the appropriate use of imaging. Clinician-led stewardship efforts in many areas could intelligently limit unnecessary care while assuring provision of effective care. Stewards will need knowledge of evidence-based medicine and support from leadership to be successful. Expansion of stewardship would allow clinicians to lead in high-value care while protecting patients during the inevitable move towards more accountable care.

Author’s Note

The author received funding from the US Department of Veterans Affairs, CDC, and AHRQ.

Sunday, November 29, 2015

Cost, Value & Tools

Peter PronovostLike a pro golfer swears by a certain brand of clubs or a marathon runner has a chosen make of shoes, surgeons can form strong loyalties to the tools of their craft. Preferences for these items — such as artificial hips and knees, surgical screws, stents, pacemakers and other implants — develop over time, perhaps out of habit or acquired during their training.

Of course, surgeons should have what they need to be at the top of their trade. But the downside of too much variation is that it can drive up the costs of procedures for hospitals, insurers and even patients. When a hospital carries seven brands of the same type of product instead of one or two, it’s not as likely to get volume discounts. Moreover, if hospitals within a health system negotiate independently of one another, they may pay drastically different prices for the exact same item.

Carrying many brands of a given item may also increase risks for error and patient harm. Staff members need to be trained and competent in a variety of tools; the greater the number of tools, the greater the risk for error.

These physician preference items are no small contributor to health care costs. Around the year 2020, medical supplies are expected to eclipse labor as the biggest expense for hospitals, according to the Association for Healthcare Resource and Materials Management. Higher costs for physician preference items are major drivers of this increase.

At Johns Hopkins Medicine, when we sought to reduce the costs of supplies, we knew it couldn’t be led by finance alone, and it shouldn’t focus solely on costs. One of the enduring lessons in health care improvement is that change progresses at the speed of trust. As such, change happens best when it’s done “with” clinicians and not “to” them. We have turned to our clinical communities — peer groups of experts from across our health system’s six hospitals who work together to tackle issues related to quality, patient safety and value of care. There are now 19 clinical communities across Johns Hopkins Medicine in such areas as surgery, joint replacement and blood product utilization. These communities provide a venue for members — who previously had scant opportunities to collaborate across Johns Hopkins-affiliated hospitals — to tackle common problems, share best practices and make changes that benefit the entire organization.

To foster trust, we agreed on two key principles. First, physician choice in supplies would be maintained, although physicians would be made fully aware of the savings and risks of different items. Second, physicians would benefit from some of the savings. While the law forbids us from putting money back into their pockets, we can use the savings to support their programs, such as by investing in equipment or participating in a registry, to help them better monitor quality.

Working within those principles, our Spine Clinical Community convened “about a dozen surgeons, nurses, anesthesiologists and other clinicians to decide what Johns Hopkins should pay as the true value — instead of the list price — for products used in spinal surgery,” according to our Dome newsletter. With the clinical community’s analysis providing the justification for lower prices, the contracting manager informed vendors that all Johns Hopkins affiliates would pay the same price for these items. The new pricing schedule that resulted from this is projected to save the health system $3.3 million a year.

The article explains: “The key is drawing upon the expertise that Johns Hopkins clinicians collectively hold. A product analysis prepared by a dozen or more surgeons from across Johns Hopkins Medicine holds significant sway during supply contract negotiations. ‘Without it, vendors can more easily charge a premium for a product that isn’t unique,’ says Sibley Memorial Hospital neurosurgeon Joshua Ammerman, a clinical lead for the Spine Clinical Community.”

The article points to another money-saving campaign, an effort by our Blood Management Clinical Community to reduce the number of red blood cell units that are transfused unnecessarily. While it had been standard to give two units at a time, in many cases, the evidence calls for just one unit. Now, when staff members place red blood cell orders for patients with hemoglobin levels at or above the optimal threshold, a pop-up alert informs them that transfusion requirements can be decreased while avoiding adverse outcomes. Through this and other strategies, we hope to conserve more of this limited, lifesaving resource by 10 percent, for an annual savings of $2.8 million.

Within any hospital or health system, there can be huge variability in how care is delivered. That variability may drive up costs while undermining quality. Some might be tempted to point the finger at physicians and limit their autonomy. But we have found that the solution, in fact, requires that we engage physicians more deeply, mine their wisdom, and ask them to lead these efforts to enhance safety, quality and value.

Thursday, November 26, 2015

Hives

Hives: A raised, itchy area of skin that may be a sign of an allergic reaction. It can be rounded or flat-topped but is always elevated above the surrounding skin. It reflects circumscribed dermal edema (local swelling of the skin). The hives are usually well circumscribed but may be coalescent and will blanch with pressure. A single spot is almost always gone by 24 hours but the process may stay for weeks to months. Approximately 20% of the population has experienced a bout of hives.

The hives are also called urticaria.



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Closing the Loop on The Need for Better Telemedicine


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I’ve had the great privilege of presenting our virtual care company, CirrusMD, to potential customers and investors at some of the premier health technology conferences this fall, making the cut for both the Health 2.0 Traction event and this week in the finals of the mHealth Summit and HIMSS Venture+ event. (Breaking: we won the mHealth Summit and HIMSS Venture+ mature startup company award!)

Still, we often get an initial response, “Who needs another telemedicine company with the likes of Teladoc and American Well raising big rounds this year?” One writer even went so far as to share the thought in Forbes on the fragmentation of the digital health landscape after Health 2.0.

I want to take the opportunity to use an analogy to explain why were are different from other telemedicine offerings on the market, and why we are getting such great traction and recognition. In fact, we’re working to “unfragment” the healthcare landscape by closing up some very loose ends that occur in a typical telemedicine experience.

Today, finding our way to an unfamiliar address is easy with Google Maps or a GPS system. We just enter an address and go. The system knows where we are, where we are headed, can offer several options on how to get there, even make local recommendations along the way based on people who know the area. That’s where telemedicine needs to be, but not where it is with many of the major vendors.

Imagine if you didn’t know where you were, where you were going, and had no map. You’re lost and you find an old pay phone. You dial a number on a billboard that says “Directions and other Help”.

“Hi, I’m lost, and I have a flat tire and a bent rim,” you say.

“Where are you?” a voice asks.

“Wyoming.”

“Where in Wyoming?”

“Um, on a side road, that’s about all I know.”

“Where are you headed?”

“Somewhere better than here.”

“Well if you can get to a major highway I might be able to help you. I have a map of the major highways.”

“But I only have a bicycle.”

“Well, I can tell you how to fix your tube, but for a rim and tire, you’ll need to go to find a store. Good luck!”

That’s where many telemedicine customers are today. They can get a hold of someone, but the person on the other end of the line has little information on who or where the patient is, little idea of where the patient is in their care plan, and limited ability to effectively direct them on where they need to go. The professional on the line will have little understanding of how well the patient is capable of getting where they need to go and might have a different set of maps from what the patient and their care team have used in the past. At best, they can offer imprecise advice. That advice can only get the person vaguely in the right direction and the person won’t be able to speak to the same person again. There’s little to no opportunity for follow-up and course correction.

Having cohesive medical direction is equivalent to making sure everyone is working from the same map. When you move from one disconnected physician, to another, you may get very different advice, particularly when there is no common management or reciprocity between these two unaffiliated providers. Standards of care may, and often do, vary from practice to practice. That can cause conflicts and misdirection.

A longitudinal history ensures everyone agrees on where the patient is on “the map”. It assures that the best decisions are made under the context of care continuity. To maintain coordination, virtual care providers must have access to the patient’s primary medical record, and bricks and mortar/physical providers must have access to and notification of any virtual encounters that occur.  Additionally, the virtual and physical providers must be able to communicate and coordinate with one another around a patient’s care plan. A patient can wind up going around in circles.  Without the complete view of the patient, different decisions can be made in their care, and those decisions can lead to less than optimal outcomes. We see this happening with many of the virtual care services on the market today, especially for patients that have more complicated medical histories (remember 50% of adult Americans are living with a chronic condition).

We recently had an encounter with a patient suffering from a chronic condition who was traveling in Europe and lost their medications. They had a secure text conversation over the CirrusMD platform, and the physician was able to review their medical record and notes from the patient’s regular specialist and access their medications list.  The doctor knew that replacement medications were available over the counter in Europe and instructed the patient on what to get. The doctor then helped the patient manage their condition over several days to ensure that they were comfortable with the new medications and that the flare-up was being controlled.

That’s the power of telemedicine that knows the patient, their history and their care plan.

On another occasion, an individual with a debilitating chronic disease asked us, “If the person on the other side of the connection does not know my pathology, my meds, my symptoms with my disease, should they really be giving me medical advice?” The short answer, we believe, is “no”. We ensure our patients and physicians have access to the information needed, and the patient’s record is kept up to date through data integrations to HIEs and EMRs.

Documenting where the patient is with follow-up as they move through their care plan is also critical. Telemedicine solutions must ensure a patient receives the proper follow-up care, whether that care is in a physical clinic or via telemedicine. Virtual follow-ups are not currently enabled with the majority of telemedicine services on the market right now, and they cannot provide physical, in-person follow-ups as the doctors are generally not connected to the patient’s local healthcare establishment.  Without the ability to enable follow-up, a telemedicine visit becomes an island, a one-off event known only to the patient, and they can quickly become lost again.  This leads to fragmentation in patient care.

Finally, to guide a patient effectively as they go forward, providing the right referrals for follow-up care is also critical. To provide proper direction, you have to know the local area and where to go for the right service. Our doctors are local to the patient and have that ability.

It will be very difficult for the majority of telemedicine services today to provide common medical direction, longitudinal data access, follow-ups and referrals. With most vendors you’ll likely get a new doctor every time you call, and even if they are licensed in your state (which doesn’t mean they are in your state), they may know next to nothing about the patient, they are operating under very loose clinical guidelines with high variability in quality of care from doctor to doctor, and in some cases the telemedicine physician’s recommendations may fly in opposition to a patient’s current care providers.

We can and are doing better with our clients. We are bringing telemedicine solutions that are more consistent and work in context of a patient’s local healthcare landscape and offer full data continuity between virtual care providers and their regular doctors.

Our closed-loop telemedicine methodology solves these issues with the ability to bring physical and virtual continuous care together, including: a complete and consistent map (a more complete view of the patient with a care plan developed under consistent standards of practice), a continuous pathway of access (opportunity for follow-up and ongoing management), and local knowledge of the area to make specific recommendations on how to get what’s needed to get on track (ability to do local referrals).  With closed-loop telemedicine, we’ll know where patients are, where they are headed with more precise direction all along the way.

Andrew Alterdorfer is the CEO of CirrusMD

Narrative Matters: Bearing Fruit: The Fight For The FDA’s Food Safety Reforms

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A food safety advocate recounts one long road to the passage of the FDA Food Safety Modernization Act of 2011. Shelley A. Hearne’s article is freely available to all readers, or you can listen to the podcast.

Don’t forget to visit the free Narrative Matters essay archive, which offers written and oral versions of current and past essays. Narrative Matters is published with support from the W.K. Kellogg Foundation.

Wednesday, November 25, 2015

Avian influenza

Avian influenza: A highly contagious viral disease with up to 100 percent mortality in domestic fowl. Caused by influenza A virus subtypes H5 and H7. All types of birds are susceptible to the virus, but outbreaks occur most often in chickens and turkeys. The infection may be brought by migratory wild birds which can carry the virus, but show no signs of disease. Humans are only rarely affected. Also known as fowl plague, avian flu, and bird flu.



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How to Safeguard your Career in Treacherous Healthcare Times

Michel AccadDear medical student,

I am honored by the opportunity to offer some advice on how to safeguard your professional career in a treacherous healthcare system.

I will not elaborate on why I think the healthcare system is “treacherous.”  I will assume—and even hope—that you have at least some inkling that things are not so rosy in the world of medicine.

I am also not going to give any actual advice.  I’m a fan of Socrates, so I believe that it is more constructive to challenge you with pointed questions.  The real advice will come to you naturally as you proceed to answer these questions for yourself.  I will, however, direct you to some resources to aid you in your reflections.

I have grouped the questions into three categories of knowledge which I am sure are not covered or barely covered in your curriculum: economics, ethics, and philosophy of medicine.

I have found that reflecting on these questions has been essential to give me a sense of control over my career.  I hope that you, in turn, will find them intriguing and worth investigating.

One more thing before we proceed.  Don’t be overwhelmed by the depth of the questions posed and don’t attempt to answer them today, in a week, or in a year.  In many ways, these are questions for a lifetime of professional growth.  On the other hand, I believe that the mere task of entertaining these questions in your mind will be helpful to you.

So here we go:

Your understanding of economics

Sample questions:

  • Is there a shortage of doctors? Is there a glut?  How would you know?  How can you anticipate the demand for services in your specialty of interest?
  • As a physician, how should your economic value (i.e., your earnings) be determined?
  • Who will ultimately be the hand that feeds you?
  • Will you and the hand that feeds you see things similarly in regards to how your work should be valued?
  • How does a society become prosperous and how does it become poor?
  • What is a fair way to distribute resources in society?
  • Does the national debt matter? How could it affect your career?

If you don’t have some clarity about the answers to these questions, you may be proceeding in your professional life with some naïve optimism and inadequately prepared to safeguard yourself financially.

Granted, knowledge of economics does not always mean you will be immune from the effect of economic realities that are beyond your control.  But economic knowledge will afford you to take these realities into account as you make informed decisions about your career path, and allow you to weather any potential storm better than if you were caught by complete surprise.

Granted, economists themselves often disagree with each other, and economics may be the only discipline where the Nobel committee can grant a prize to two economists with completely opposing views.

Nevertheless, there is great benefit to having some grasp of economic principles.  And if these seem flimsy on the surface, it’s usually because politicians and economists let their political views confuse their economic discourse, and not because basic, well-reasoned economic principles are themselves faulty.

If you want to get started, I can recommend to two excellent and easy-to-read introductory texts: How an Economy Grows and How it Crashes by Peter and Andrew Schiff and Economics in One Lesson, a classic collection of essays superbly written by Henry Hazlitt.

Your understanding of ethics

Sample questions:

  • Do the ends ever justify the means? If so, when and why?  If not, why not?
  • Are there ethical principles that should always be respected? If so, which ones and why?
  • Should medicine aim to provide the most good for the greatest number? Why or why not?
  • Should doctors serve both the individual and society? Can they?
  • How important is it to have good moral character? Why? (And what does that mean?)
  • What is the goal of medicine?

Make no mistake about it, medicine is first of all an ethical endeavor.  Medicine is not about applying medical science or medical techniques, but about doing the right thing for the patient.

Science will inform you about the best means to achieve certain goals, and good techniques will help you achieve them.  But neither science no technology can tell you what those goals should be.

We live in a pluralistic society where basic ethical principles are frequently a matter of dispute.  This lack of ethical consensus and the potential for conflicts to arise understandably contribute to keeping ethics education to a minimum.

You, however, will benefit from having as clear an understanding of your own ethical principles as possible.  Otherwise, sooner or later you will realize that being ambivalent about the right course of action could cost you.

Whether it’s a matter of properly allocating financial resources in the care of patients, or issues of life, death, and justice, you don’t want to be in a position where hesitancy interferes with your ability to take a stand or make firm decisions, especially once you have committed to a job or a position where you are expected to make decisions.  (Remember, that’s what “M.D.” stands for).

Ethical principles are not necessarily obvious nor intuitive, otherwise, there would be no ethical conflicts in society.  The more you can articulate and defend the principles that you stand for, the better prepared you will be in a system where ethical conflicts are likely to be increasingly common.

You may wish to familiarize yourself with Principles of Biomedical Ethics by Beauchamp and Childress.  I do not necessarily endorse its content, but this is a commonly cited and influential text which reflects mainstream ideas about medical ethics.  This should only be a start.

Philosophy of Medicine

Sample questions:

  • Is obesity a disease? Why or why not?
  • Is hypercholesterolemia a disease?
  • If a disease is defined by a cut-off number (say, BMI>30) is it a “real” entity? Is it a “social construct?”
  • What is a disease?
  • Do you agree with the W.H.O. definition of health? Why or why not?
  • What does “normal” mean in a medical context?
  • Should the medical community define what is healthy and what is not? If so, using what criteria?
  • What can science tell us about health and disease?
  • What are the main current problems in the philosophy of biology?
  • What is a human being?

I hope you have found these philosophical questions somewhat relevant to the practice of medicine.  I believe that they are.

Unfortunately, not many people agree with me.  Instead, the common attitude is to think that these questions are difficult to answer and that medicine has made great strides without having to resolve them.  Why make a philosophical fuss?

I think a philosophical fuss is definitely in order when the healthcare system is teetering on the brink.  Deep seated problems often mean that we’ve been operating on assumptions that need revisiting.

As mere doctors, we may not always solve philosophical problems, but we should be able to recognize the assumptions on which medical doctrine and healthcare policy rest.  Sometimes, those who promote a certain viewpoint will prefer that its assumptions remain unexamined.  I think we can all benefit from having philosophical antennas.

Because the field of “philosophy of medicine” is virtually non-existent as an academic discipline, there is no standard textbook I can point you too.  However, there are two compendia of essays that were edited in the last decades and that address some of the questions I have raised here.  These are Concepts of Health and Disease: Interdisciplinary Perspectives, edited by Caplan, Engelhardt, and McCartney in 1981, andHealth, Disease, and Illness: Concepts in Medicine, edited by Caplan, McCartney, and Sisti in 2004.  Either one would be a good place to start.

Are you still with me?

If you are, you have realized that what I am giving you is a massive reading assignment.  I’ll admit it.  If I could summarize my recommendation in one word it would be this: Read!

Read more.  If you haven’t done so already, you need to develop the habit of reading all the time and of reading long form: books and long essays.  Read outside of your comfort zone.  Reading is the only activity that will quickly give you real knowledge that you need not only to survive, but to really thrive in these tumultuous times.

And don’t get discouraged by the sheer volume of the knowledge to be gained.  As I said earlier, the point here is to stimulate your curiosity about the proper questions, at a time when medical school demands are likely to quash you sense of wonderment.

Rome was not built in a day, and all you have to do is to keep on hand some material to gently chew on at your own pace, not to embark on an ill-advised intellectual binge for wisdom.  Once you get into that habit, you will find out that knowledge is not only empowering, but it is liberating.

And you’re not training to become a doctor to be at the mercy of an unhealthy system, are you?

Michel Accad is a cardiologist based in San Francisco. 

Tuesday, November 24, 2015

Norovirus

Norovirus: A group of viruses that are a common cause of food poisoning and acute gastroenteritis ("stomach flu") that can strike quickly with force and make a person feel very sick but which typically resolves within 2-3 days. The characteristic symptoms are nausea, vomiting, diarrhea, and abdominal cramping. The diarrhea is not bloody. Fever, if present, is low-grade. Dehydration is the main complication, especially in infants and the elderly, and may need medical attention.

The clinical criteria for the diagnosis of norovirus infection include:

  1. an incubation period of 12-36 hours;
  2. an illness characterized by acute onset of nausea, vomiting, diarrhea, abdominal cramping, and, in some cases, fever and malaise;
  3. an illness of 12-60 hours duration.

The virus is spread primarily from one infected person to another (by the fecal-oral route). Infected kitchen workers can contaminate a salad or sandwich as they prepare it, if they have the virus on their hands. Infected fishermen have contaminated oysters as they harvested them. Norovirus infection has become a veritable plague on cruise ships.

Norovirus was coined to refer to the Norwalk-like virus by a simpler and more memorable term. It is now the official name. Also called the calicivirus because of its characteristic "Star of David" shape with cup-shaped (chalice) indentations.



MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
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A Short Holiday Reading List: Latinos And Health Insurance, The Passing Of Rick Cohen, And More

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GrantWatch knows that some of its readers may find themselves with a little downtime later this week, perhaps waiting for the turkey to roast or stuck at the airport. To pass the time, you might check out a few links to philanthropy content—including an animated video—which you may have missed.

Happy Thanksgiving to all!

“California Expands Latino Enrollment and Access to Coverage and Care,” by Sandra R. Hernández, president and CEO of California HealthCare Foundation (CHCF), The CHCF Blog, November 19.

Hernández tells us that a good number of California Latinos have been able to sign up for health insurance, thanks to components of the Affordable Care Act: Medi-Cal (California Medicaid) expansion and Covered California, the state’s marketplace.

And, in case you missed it, Gov. Jerry Brown (D) signed into law the Health for All Kids Act, Hernández notes, “which will enable up to 250,000 undocumented children in the state—most of them Latino—to transition into comprehensive Medi-Cal coverage.”

In her opinion, though, much still remains to be done.

She states that Latinos are now 38 percent of the state’s population (and California’s largest ethnic or racial group).

And Medi-Cal will spend more than $90 billion on care for all of its enrollees this year, an amount she calls “prodigious purchasing power.”

Read the post here.

“Who Will Fill Rick Cohen’s Role in Holding Nonprofits Accountable?” by Pablo Eisenberg of the Center for Public and Nonprofit Leadership at the McCourt School of Public Policy at Georgetown University, Chronicle of Philanthropy’s Philanthropy Today e-newsletter, November 20.

In this opinion piece, Eisenberg mourns the passing of well-known reporter and watchdog Rick Cohen who “mounted carefully researched and powerful attacks on the failure of foundations and nonprofits to provide social and economic justice to the poorest Americans.” Cohen “uncovered corruption and malfeasance at major nonprofits and foundations and held the nonprofit world accountable in ways few others have done.”

He was executive director of the National Committee for Responsive Philanthropy during the years 1999–2006.

Cohen died this week: he collapsed at age sixty-four. Read more about the remarkable career of Rick Cohen, who “worked around the clock.”

“Diarrheal Disease: The Unfinished Agenda,” by Mathuram Santosham of Johns Hopkins University, on the Bill & Melinda Gates Foundation’s Impatient Optimists blog, November 9. Santosham’s affiliations include professor of international health and pediatrics at Hopkins and chair for the Rotavirus Organization of Technical Allies (ROTA) Council.

Santosham states that child deaths from diarrheal disease are down from 5 million in 1980 to 600,000 today. But, citing the journal BMC Public Health, he says that incidence of illness “has barely decreased at all,” and that is a cause for concern.

Read four things that, according to Santosham, health professionals and others around the world need to do to protect children from this awful disease. Among them is “vaccinate all children against rotavirus, the leading cause of severe and deadly diarrhea.” Only 15 percent of children in GAVI countries (which are the world’s poorest countries) receive the vaccine, he says. But did you know that even in the United States, “rotavirus vaccine coverage must be improved”?

“Public health impact has been dramatic in low- and middle-income countries where rotavirus vaccines have been introduced,” Santosham says.

__________________________

And on the lighter side, the Henry J. Kaiser Family Foundation (KFF) produced and released another animated video. This time, the subject is health status, cost and quality of care, and access to care in the United States, compared with measures in other high-income countries. The video, titled Health of the Healthcare System, contains results from the Peterson-Kaiser Health System Tracker. The sources for the statistics mentioned in the video are conveniently listed on one page (click “View as article”), for those who want more detailed information. Veteran health reporter Julie Rovner, who is now working for the KFF’s Kaiser Health News, serves as narrator of the under-four-minute video. Enjoy it!

By the way, the “tracker” is a project of the KFF and the Peterson Center on Healthcare. The Peter G. Peterson Foundation established that center.

Obamacare is failing? Not so fast.

Joe-FlowerWhat is the hue and cry about this time? United Healthcare is saying it has lost large bales and wads of money on Obamacare exchange plans, and just may give up on them entirely. Anthem and Aetna allow that they are not making very much either. Some new not-for-profit market entrants have gone belly up, and the others are having a hard time.

Before we perform the Last Rites over Obamacare, perhsp we should think for a moment about the hit ratio of the first 711 Wolf Reports from Boy W. Cried and ask a few questions.

First: Do we trust implicitly the numbers that the health plans are giving out in press releases, citing unacceptably high medical loss ratios? Medical loss ratios (MLRs) are self-reported. Yes, there is a certain amount of accountability. The numbers have to square with expenses given on their corporate tax forms and so on, but there is wiggle room in just what is reported and how. If is a reasonable supposition that if you wanted to look for the professionals with the greatest skill in juggling numbers, you would find them working for insurance companies, especially health plans, because the stakes are so high. These numbers people at the top of their game have huge incentives to report a high MLR, so if there is wiggle room, I am sure they will find it.

Beyond that, MLR is reported by state, by market segment (large group, small group, individual), against what portion of a premium is “earned” within that reporting period, and by calendar year rather than any company’s financial year. To say, “Our MLR is X” is to claim that X the correct aggregate number across their entire multi-state system, from all their subsidiaries, appropriately weighted for the size of each region. We don’t have access to those numbers, just to what they are telling us. There are plenty of reasons for them to want to report the highest MLR they can get away with, plenty of reasons to be skeptical of the numbers they are giving out, and plenty of reasons not to base drastic policy changes on such pronouncements.

But let’s get down to business here. So they lost money (or barely made it) in 2014 and 2015, and they are projecting the same in 2016? Doesn’t this mean that they misjudged the cost of healthcare, so they need to raise premiums? And they didn’t realize this soon enough to do raise them appropriately for the 2016 year?

Sounds like somebody (or a pile of somebodies) made faulty business judgments. This is not too surprising, given that these are new business models in new markets. Pricing, risk analysis, and utilization projections are hard enough in established markets, doubly difficult in emerging ones, and exponentially more difficult for a new company scrambling to grab any market share at all, like the failed cooperatives.

Well, waah. Welcome to competition, market capitalism, all that stuff. None of this is in the least surprising.

But does it mean that “Obamacare has failed”? Does it even mean that these companies have failed in Obamacare markets? No, it means what it is: These companies have failed to make the profits that they hoped for in the opening three years of Obamacare. And they are telling us all about their pain so that the government (through regulation) or the body politic (by repealing Obamacare) will make it easier for them to churn a profit.

So what’s the real problem here? In any kind of economy, you need to price your products so that (in aggregate, over time) your total cost of ownership is less than what you sell your products for. There’s your margin, the oxygen of your business. These folks are claiming that the aggregate total cost of ownership of what they are selling (access to healthcare) is close to what they are selling it for. Hmmm. That’s a problem. It has two paths out: Lower the total cost of ownership (get the actual costs of healthcare down) or raise the premium.

How about getting aggressive about the real cost of healthcare? Two problems with that part of the equation: 1) It’s really hard and takes years. 2) It does not benefit just them. It will benefit the whole market. So it’s not a path to greater profitability.

A health plan’s profit (margin) is some percentage of the total cost of care for the people they cover. So they have an incentive on the one hand to cover a lot of people (that is, increase their market share). They have an incentive to keep their premiums competitive not in absolute terms but relative to other payers in each regional market. On the other hand, they have no incentive to get aggressive about actually lowering the underlying real costs of healthcare for the whole market. That would not give them a competitive advantage.

What’s the business concern with raising their premiums appropriately? The concern is that these lower-cost narrow network exchange plans are price inelastic. If they raise their premiums, they will lose market share. But wait, if the cause really is the underlying high costs of healthcare, won’t everyone’s premiums have to go up the same amount? This complaint sounds more like an assumption that others can provision the market more efficiently, keep their premiums more competitive, and gobble up market share.

Again, is this a failure of the Obamacare model? Or is it actually proof of concept? To say that the Obamacare exchanges are failing because some companies might give up on them is to imagine that the purpose of Obamacare, the metric on which it should be measured, is to make health plans comfortable and profitable. Wrong.

The core idea of the Obamacare exchanges has been that health plans should compete on a level playing field to see who could offer the best service and the best access to healthcare at the lowest price. That’s what markets are for. The assumption built into this logic is that some organizations will do it better than others, some will not be good at it, and the market will shake out. If nobody ever failed in the Obamacare exchanges, then we would have to say that they failed to establish anything resembling a true market.

Joe Flower is a healthcare futurist and author. He is a contributing editor with THCB.

National Health Spending 1960-2013

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The last two years have seen two notable events for the U.S. health care industry. In 2014, the implementation of the Affordable Care Act (ACA) led to the largest expansion of health insurance coverage since 1965, and in 2015 the Medicare and Medicaid programs reached their 50th anniversary. These two important milestones provide an opportunity to reflect on the significant changes that have taken place in the nation’s health sector over the last half century.

Since 1960, there have been dramatic changes in how health care is provided, consumed, and financed. Using data from the National Health Expenditure Accounts, the Centers for Medicare and Medicaid Services Office of the Actuary recently explored the broad trends and specific eras that have marked these changes, as shown in Table 1. This analysis, “History of Health Spending in the United States, 1960-2013,” is available on the CMS website.

This post discusses some of the major factors that have influenced health spending over the last five decades. Variations in health care prices, in the utilization of goods and services, and in the programs and resources that pay for care have had a substantial impact on national health expenditure trends. Going forward, these factors are anticipated to continue to affect health care spending.

Table 1

CMS-Table1

Health Care Prices

Over time, the prices for health care goods and services have been influenced by numerous factors, including, but not limited to, changes in technology, legislative and regulatory action, economy-wide inflation, consumer demand, and provider supply. The growth in prices for personal health care goods and services averaged 4.7 percent between 1961 and 2013, faster than the average growth in economy-wide prices (as measured by the GDP price index) of 3.5 percent over the period. The year-to-year differences in personal health care and economy-wide price growth reflect excess medical inflation, which has varied significantly over time. During periods of strong economy-wide price growth, health care inflation also tends to be high, largely reflecting the strong growth in prices for the underlying inputs used to produce health care goods and services (such as wages, medical products, and equipment).

During the 1960s and early 1970s, personal health care prices increased at a relatively modest pace, with growth averaging 2.1 percent between 1961 and 1965 and 5.1 percent for 1966 through 1973. This growth was only slightly faster (less than 1 percentage point) than GDP price growth and was impacted by the Economic Stabilization Program that froze prices, wages, salaries, and rents for the entire economy from 1971 – 1973 and for the medical sector through 1974.

The removal of these controls and high energy prices contributed to rapid price growth in the years that followed. During the 1974 to 1982 period, health care prices increased on average 9.7 percent per year, compared to 7.7 percent for GDP prices.

Health care price growth then moderated somewhat over the next decade, increasing 5.7 percent per year over the 1983 through 1992 period, similar to the growth for 1966 through 1973. This reflected slower economy-wide price growth; increased awareness of costs by consumers, employers, and governments; and increased provider competition. Still, the growth rate for health care prices outpaced that for economy-wide prices by over 2 percentage points during the period 1983-1992.

Since 1992, economy-wide inflation has remained low and contributed to price growth for health care goods and services remaining below 4.5 percent every year. Additionally, from 1993 through 1999, average growth in health care prices was just 2.5 percent per year (close to growth of 1.8 percent in GDP prices) as enrollment in HMOs and other managed care plans increased dramatically, resulting in pre-negotiated prices that reflected significant discounts.

However, two factors led to faster health care price growth from 2000-2002, which averaged 3.2 percent per year and outpaced GDP price growth by over 1 percentage point. First, individuals demanded less restrictive health care plans during this period in response to the rise of tightly managed care plans in the 1990s. Second, prescription drug price growth was faster due in part to a large number of new blockbuster drugs that were introduced to the market in the late 1990s.

Over the last decade, health care prices have increased at lower rates. During 2003 through 2007, personal health care prices grew at about the same rate as economy-wide prices, increasing 3.2 percent compared to 2.7 percent for the GDP price index. In more recent years (2008-2013), health care prices rose more slowly, increasing at an average annual rate of 2.2 percent, but they still outpaced prices for the overall economy, which grew 1.6 percent per year. These recent lower growth rates reflect slow growth in the prices of inputs used to produce health care, the impact of the 2007-2009 recession, and lower payment updates for public programs as a result of legislative or policy decisions.

Non-Price Factors

Health care spending trends are also influenced by non-price factors, including changes in the population (both the number of people and their age and gender mix) and in the use and intensity of services. Growth in non-price factors was strongest during the following eras:

  • 1961-1965 (pre-Medicare and Medicaid),
  • 1966-1973 (coverage expansion and growth in utilization),
  • and 2000-2002 (managed care backlash and public payer changes).

A common theme over the three eras was the expansion and increased generosity of health insurance coverage.

Changes in the total population and its age and gender mix affect both aggregate health spending growth and the mix of goods and services consumed, as well as the distribution of programs and payers that pay for care. Since 1960, growth in the U.S. population has remained relatively stable, averaging 1.0 percent per year. Over that time, however, the age profile of the nation has varied considerably.

In 1960, children (aged 0-18) made up 37 percent of the population, while working-age adults (aged 19-64) and the elderly (aged 65+) accounted for 54 percent and 9 percent, respectively. In 2013, those shares were 25 percent for children, 61 percent for working-age adults, and 14 percent for the elderly. Not surprisingly, as the population has aged, the consumption of such services as hospital, home health, and nursing home care has grown while payers such as Medicare and Medicaid have increased as a share of spending.

Additional utilization of health care goods and services over time has stemmed from increased coverage (both in terms of access to care and generosity) through private health insurance expansion and the implementation and expansion of Medicare, Medicaid, and other government programs, along with greater resources to pay for care. During the 1961 -1965 era, non-price factors accounted for three quarters of personal health care spending growth and increased at an average annual rate of 6.2 percent. Greater use of health care goods and services during this era was due in part to continued expansion of private health insurance coverage.

With the implementation of the Medicare and Medicaid programs, the 1966-1973 era experienced even faster growth in non-price factors of 6.9 percent. When both programs started in 1966, 18.9 million individuals enrolled in Medicare and 4 million in the Medicaid program. The 2000-2002 era was also characterized by strong growth in non-price factors as enrollment in more loosely managed care plans increased and spending for new blockbuster prescription drugs rose rapidly. Non-price factors grew on average 4.8 percent during this period and accounted for 60 percent of personal health care spending growth, about the same average share as the 1966 – 1973 era.

Additionally, variations in practice patterns, improvements in technology, and the availability of new treatments have contributed to changes in the intensity of services provided. Improvements in medical technology are generally considered to be a significant driver of health care spending growth. Enhancements in technology, in turn, are largely affected by growth in income and increased generosity of health insurance coverage. Since 1960, improved diagnostic and surgical procedures, the availability of new drug treatments, and numerous other technological enhancements have influenced health care spending trends. An analysis conducted by the CMS Office of the Actuary indicated that technology accounted for approximately a quarter to half of health expenditure growth during 1960 through 2007.

Overall economic conditions also affect the utilization of health care goods and services. As the economy contracts, individuals, businesses, and state and local governments generally have fewer available resources to pay for health care and are inclined to become more cautious regarding spending. At the same time, individuals may experience the loss of health insurance coverage and a reduction in household income — factors that cause them to postpone or forgo health care purchases, particularly for more discretionary services.

However, during periods of economic expansion, the sponsors of health care spending generally have more resources available to pay for care and may increase their support for such expenditures. In both instances, the influence on health spending from economic factors occurs with a lag such that health sector cycles follow economic cycles.

Changes In Who Pays For Care

Over time, the responsibility for paying for health care goods and services has evolved as new programs and payers emerged and expanded. Likewise, the sponsors (households, businesses, and governments) of these payers and programs have changed significantly over the last half century. In 1960, private sponsors (households, businesses, and other private entities) financed just over three quarters of all health care expenditures; by 2013, however, private sponsors accounted for just 57 percent of all health care expenditures (Exhibit 2).

The largest shift during this period was for households, which financed 56 percent of total health spending in 1960 but just 28 percent in 2013. Over the same period, spending by governments increased from less than one quarter of all health expenditures to 43 percent, mostly due to increases in Federal spending. In 1960, Federal spending accounted for 11 percent of health expenditures; by 2013, it had increased to 26 percent, largely due to the implementation and expansion of the Medicare and Medicaid programs.

Exhibit2

The Next Era Of Health Spending

Health care spending increased from 5.0 percent of the economy in 1960 to 17.4 percent in 2013 and is projected to reach almost 20 percent by 2024. Over the last half century, the trends in these expenditures have been influenced by changes in health care prices, technology, insurance coverage, utilization, intensity, and the population, among other factors. Although the next era of health spending has yet to be determined, future changes in these factors will continue to define and influence the trajectory of expenditures.

In the near term, national health care spending is expected to be affected by improved economic conditions, as well as by increased insurance coverage—due to the ACA’s expansion of Medicaid and implementation of the health insurance Marketplace—and by the aging of the population. Over the longer term, it is more difficult to anticipate the factors (such as modifications in how health care is provided and the emergence of new medical technology) that will influence spending. In the 2015 Medicare Trustees Report, long-range per capita health care expenditures are projected to increase by 4.9 percent in 2039 (or 0.9 percent faster than per capita GDP), and spending growth is expected to decline gradually to 4.4 percent in 2089 (or 0.5 percent faster than the rate of per capita GDP).

Authors’ Note

The opinions expressed here are the authors’ and not necessarily those of the Centers for Medicare and Medicaid Services.

Editor’s Note

Today, Health Affairs Blog is also publishing a post by Richard Foster, former CMS Chief Actuary, responding to this post and discussing health spending trends. In addition, watch for the paper on 2014 national health spending by the CMS Office of the Actuary, which Health Affairs will publish as a Web First on Wednesday, December 2.

A Radical Policy Proposal: Go Easy On Older Docs

flying cadeuciiThrough Dec. 15, federal regulators will accept public comments on the next set of rules that will shape the future of medicine in the transition to a super information highway for
Electronic Health Records (EHRs).  For health providers, this is a time to speak out.

One idea:  Why not suggest options to give leniency to older doctors struggling with the shift to technology late in their careers?

By the government’s own estimate,in a report on A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure, a fully functioning EHR system, for the cross-sharing of health records among providers, will take until 2024 to materialize.The technology is simply a long way off.

Meanwhile, doctors are reporting data while the infrastructure for sharing it doesn’t exist.  Now, for the first time, physicians will be reporting to the federal government on progress toward uniform objectives for the meaningful use of electronic health records.  Those who meet requirements will be eligible for incentive payments from Medicare and Medicaid, while those who don’t may face penalties. In addition, audits are expected to begin in 2016.

Amid this shift to a new, data-driven healthcare system, the nation needs older doctors to keep practicing to meet presentneeds of an aging population, as well as an expanded Medicaid system. If burdensome reporting rules encourage retirements, as some studies indicate, the building of an information highway may result in the unintended consequence of a bottlenecked road to seeing a physician.  The likely result:  Nurse practitioners will deliver a greater share of the nation’s healthcare.

Some critics say the medical profession exaggerates a coming shortage of physicians.

Yet concierge medical practices are growing in number, luring those willing to pay a premium to see a doctor quickly for extended-time visits.

Last year, the New York Times reported on long wait times for doctor appointments as a new norm, and not just in traditionally under-served rural areas.  The article pointed to one study that found patients waiting an average of 66 days for a physical examination in Boston, and 32 days for a cardiologist appointment in Washington.

Think of what the wait times would be if mass retirements materialized, as suggested by findings of a 2014 survey of 20,000 physicians by The Physicians Foundation. Thirty-nine percent indicated plans to accelerate retirement due to changes in the healthcare system.Others reported plans to cut back on patient caseload or seek different jobs.

The potential for disruption is even more startling when you consider the number of older doctors in practice.  According to R. Jan Gurley, a physician writing on the  blog of the University of Southern California’s Center for Health Journalism, one in three doctors is over 50, and one in four is over 60 – despite roughly 20,000 newly medical school graduates a year.

Because of what’s at stake — potentially the very underpinnings of our nation’s healthcare system — health providers should speak out forcefully during the government’s open comment period.  Yes, it is late in the rulemaking game for EHRs.But new rules are being written for 2018 and beyond, and modifications are being made to rules in effect through 2017.

Would an outpouring of thoughtful, well-documented recommendations make a difference?  In a democracy, the answer should be yes.  The value of keeping older doctors in practice far outweighs the benefit of driving them crazy as they try to meet reporting requirements with often-clumsy EHR technology.  The challenge is to find a middle ground.

Diane Evans is a former Akron Beacon Journal editorial writer and columnist, and now publisher of the recently introduced MyHIPAA Guide, a news and information service for HIPAA-covered organizations trying to stay up with the seismic shift to a data-driven electronic health system. MyHIPAAGuide.com is hosting a forums discussion that is open to all who would like to share insights on key points that should be conveyed to CMS and government regulators. 

The 2017 Benefit and Payment Parameters Proposed Rule: Drilling Down

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On November 21, 2015, the Centers for Medicare and Medicaid issued a notice of proposed rulemaking (NPRM) for the 2017 Benefit and Payment Parameters (BPP), the annual rule through which it sets out Affordable Care Act policy for the coming years. This is the second of two posts analyzing this proposed rule. The first post summarized the provisions of the rule of most interest to a broader audience. This post will drill down into the details of the rule.

One note to begin: throughout, the rule uses the legally precise term “exchange” rather than the more recent term “marketplace.” This post will use the term exchange rather than marketplace throughout (and federally facilitated exchange or FFE rather than federally facilitated marketplace, or FFM), but it should be understood that both terms mean the same thing.

Topics covered in this post include definitions; rating issues; guaranteed availability and renewability; student health coverage; risk adjustment; reinsurance and risk corridors; rate review; exchange establishment; essential health benefits; navigators and assisters; brokers and agents; notices to employers; financial subsidy eligibility verification; reenrollment and binder payments; open and special enrollments; eligibility appeals; individual responsibility exemptionsthe SHOP exchange; selective contracting and standard plans in the FFE; FFE user fee; the drug formulary exceptions process; the premium adjustment percentage; the actuarial value calculator; network adequacy; essential community providers; the premium payment grace period; enforcement and appeals; quality and patient safety; third party payments; and a medical loss ratio surprise at the end. Click on a topic to navigate to the portion of the post in which it is covered.

Definitions

The NPRM begins with a definitional section. The first definition mentioned in the preface is one that the rule in fact does not change—the definition of “plan year.” The plan year of a plan is generally designated by the plan documents, but when it is not, a series of rules of thumb apply, such as the plan year is the period of time for which the deductible or out-of-pocket limit applies, an employer’s tax year, or the calendar year. The NPRM stresses, however, that for both grandfathered and non-grandfathered plans, the plan year can never exceed 12 months.

The NPRM goes on to redefine large and small employer as required by the recently enacted Protecting Affordable Coverage for Employees (PACE) Act, which provides that a large employer is an employer that employs an average of at least 51 employees during the plan year and at least one employee on the first day of the plan year, and a small employer is an employer that employs an average of at least one but not more than 50 employees during the plan year. States may elect to define large employers as employers employing more than 101 employees and small employers as employing not more than 100. In the case of new employers, the determination is based on reasonable expectations as to the average number of employees.

Rating Issues

Under the current rule, the rating area for determining health insurance rates for a business is the area that contains the group policyholder’s principal place of business. If the group plan, however, is a network plan, as most are, the plan’s service area must cover the business’s employees. If the principal place of business is merely an address registered with the state for service of process, there may be a disconnect between the rating area on which premiums are based and the service area in which services are delivered.

The proposed rule, therefore, would generally define the principal place of business for rating purposes as the area where the greatest number of employees work or reside. The SHOP marketplace will use the place of business address used to qualify the employer for SHOP coverage for rating purposes.

The preface raises several other questions for comments respecting rating, although they are not actually taken up in proposed rules. The first is whether there should be some limit on how many rating areas states may have, or how small the rating areas may be. Some states have many small rating areas, which raises concerns about inadequate risk spreading. Second, CMS asks for comments on whether insurers should be required to make their rating areas generally consistent with their service areas to avoid discrimination. Third, CMS requests comments on whether its child age rating factors adequately address different health risk for children of different ages.

Guaranteed Availability And Renewability

The ACA’s guaranteed availability requirement requires insurers in all markets to guarantee the availability of their non-grandfathered products to all applicants subject to exceptions. The NPRM proposes an additional exception to this rule, under which insurers that have given 90 days notice that they are discontinuing a product or 180 days notice that they are leaving a market would not have to accept applicants for coverage under the product. Insurers are already not required to guarantee renewability in this situation, but states may still require availability. Insurers that apply this exception must apply it uniformly regardless of health status or claims experience.

The current rules allow insurers to refuse to cover small groups if a group does not meet minimum participation requirements or the employer does not make minimum premium contributions, except during an annual one-month open enrollment period from November 15 to December 15 when the requirements are waived. The NPRM asks for comments on prohibiting insurers from applying minimum participation or contribution requirements to groups with between 51 and 100 employees in states that choose to define these groups as small groups. Employers in this category are subject to the employer mandate and arguably should not be barred from purchasing coverage if they face a penalty for failing to do so.

Current guaranteed renewability rules allow insurers to refuse to renew groups that violate group participation or employer contribution requirements or cease to participate in an association. Under both of these circumstances, insurers must guarantee availability, so it makes no sense to say they do not need to guarantee renewability. Both of these exceptions to the guaranteed renewability requirement are therefore removed.

Student Health Coverage

The NPRM proposes a couple of changes as to student health coverage. First it recognizes that although student health plans are not generally subject to the single risk pool requirement that applies to other individual coverage, allowing insurers to indiscriminately segment student health plan risk pools is problematic. Under the proposed rule, insurers could only create separate risk pools for separate educational institutions or multiple risk pools in a single institution for bona fide reasons, such as separating undergraduate and graduate students. Insurers could not, for example, base rates on the percent of students enrolled in coverage or the length of time a university had coverage through the insurer.

Because students usually do not have a choice among student health plans of different actuarial values or even with the same actuarial value, CMS proposes to waive actuarial value tier requirements for student health plans, and allow insurers to provide coverage at any actuarial value, as certified by an actuary, of at least 60 percent. CMS requests comments as to whether student health plans should have to disclose their actuarial value in the summaries of benefits and coverage.

Risk Adjustment

The NPRM proposes a number of changes in the 3R premium stabilization programs. The risk corridor and reinsurance programs remain subject to sequestration for fiscal year 2016—risk corridors at a level of 7 percent and reinsurance at a 6.8 percent level. HHS believes that the sequestered payments will be available for payment to insurers in FY 2017 unless Congress takes further action to bar this, which would seem likely. CMS has recently announced at its Regtap.info website  that is will be releasing 2014 reinsurance payments (7.3 percent of payments) and risk corridor payments in the 29 states where there are no appeals pending (7.5 percent of payments plus 2.5 percent that was held back for appeals) this month.

The risk adjustment program has recently faced heavy criticism from the health insurance cooperatives, which have asserted that it was a significant factor in the CO-OP failures. The CO-OPs claim that the risk adjustment program, which is supposed to transfer funds from health insurers that have low-risk enrollees to those that have high-risk enrollees, in fact transferred funds from small start-up insurers with low premiums to large established insurers, with high premiums, sophisticated data-capture capabilities, and historical claims information.

The NPRM does not propose significant changes in the risk adjustment program for 2017. It does propose updating risk factors for claims data from 2012, 2013, and 2014. It would also incorporate data on the use of preventive services into its simulation of plan liability, improving the risk scores of plans with healthier populations, especially in bronze and silver plans.

CMS is also considering the use of prescription drug information for risk scoring, a request of the CO-OPs. CMS is considering how to handle partial year enrollees in the risk adjustment formula, as there have been claims that insurers are experiencing high costs from partial-year enrollees on whom they may not have accumulated diagnostic information. Otherwise the risk adjustment formula is largely the same as that used in prior years.

The risk adjustment user fee is set at $1.80 per enrollee per year for 2017, up from $1.75 for 216. Entities acquiring or entering into another arrangement with an insolvent insurer, including state guaranty funds, may be able to accrue previous months of claims experience for the application of risk corridor or reinsurance payments.

An insurer subject to the risk adjustment program that fails to provide HHS access to required data in a dedicated data environment (an EDGE server) in a timely manner, or that fails to meet certain data requirements, is subject to a default charge since HHS cannot determine the insurer’s actual charge. A reinsurance-eligible insurer that fails to provide required data will forfeit reinsurance payments. Insurers that report low enrollment or claims counts compared to baselines, or that fail certain data quality metrics, can be assessed a default risk adjustment charge and forfeit reinsurance payments.

CMS is also proposing to end the good faith compliance safe harbor it observed for 2014 and 2015 and to potentially assess civil penalties against insurers that fail to comply with risk adjustment and reinsurance program data requirements, even if they do so in good faith.

For 2014, the default charge for insurers that failed to failed to establish a dedicated distributed data environment or submitted inadequate data was set at the product of the statewide average premium for the risk pool, the 75th percentile risk transfer amount, and the plan’s enrollment. For plans that fail to meet these requirements for 2015, the default charge will be based on the 90th percentile risk transfer amount. CMS believes that plans are less likely to have technical difficulties that will keep them from fulfilling requirements as of 2015 and that some might decide to simply pay the 75th percentile charge rather than meet requirements. Small insurers, with 500 billable member months or fewer, however, can simply pay a charge of 14 percent of premium rather than set up an EDGE server.

Reinsurance And Risk Corridors

The reinsurance and risk corridor programs end in 2016. The NPRM, however, proposes a few changes in these programs for 2016. First, the NPRM proposes spending all remaining reinsurance program funds in 2016. CMS will first increase the coinsurance rate to 100 percent and, if any funds remain, then reduce the attachment point below $90,000 until all funds are spent. The NPRM also amends the rule to ensure that third party administrators, administrative services-only contractors, and other third parties that determine enrollment counts—and thus program liability–for self-insured plans are subject to audit.

The NPRM would require HHS to adjust the 2015 risk corridor payments or charge for 2015 for insurers that overestimated the cost-sharing reductions they offered in 2014—which increased their incurred claims, medical loss ratio, and possibly their risk corridor payments—to correct for the difference. Insurers would be required to report any differences between estimated cost-sharing reduction amounts and actual cost-sharing reductions for 2014. Insurers would also be required to adjust their claims for 2015 to account for inaccurate estimation of unpaid claims for 2014.

Finally, CMS proposes deleting certain interim risk corridor data reporting requirements.

Rate Review

Under the NPRM, beginning in 2017 non-grandfathered coverage in the individual and small group market would be subject to rate review if the average increase — including premium rating factors such as age or geography — for all enrollees weighted by premium volume for any plan within a product exceeds the “unreasonableness” threshold, presumably 10 percent. Rating factors are being added to avoid gaming of the premium increase threshold by changing the geographic rating area for a plan.

Also beginning in 2017, insurers must submit rate filings using the Unified Rate Review Template to CMS not only when they seek an increase, but also when they are planning to decrease a rate or not modify it. CMS has concluded that it needs all rate filings to reasonably evaluate rate increases. Insurers seeking rate increases must additionally file an actuarial memorandum, and insurers seeking increases above the threshold must additionally file a written justification. Insurers must also file rate filing information for student health plans with CMS.

For all proposed rate filings, regardless of whether rates are subject to review, CMS proposes to make rate filing information publicly available if is not trade secret or confidential commercial or financial information. For states to be considered to have effective rate review programs they must also make information available to the public on proposed rate increases subject to review and final rate increases, and they must do so at a uniform time.

Exchange Establishment

The NPRM would change the timeframes for submission and approval of exchange blueprints by states wishing to establish their own exchanges. Initially the exchange rules required states seeking to establish their own exchange to give 12 months notice to HHS, which was then shortened to 6.5 months at the time when litigation threatened to end the FFE. Recognizing how long it in fact takes to establish a state exchange, the proposed rule would require a declaration letter from a state seeking to run its own exchange 21 months before open enrollment begins; a state seeking to establish a state-based exchange using the federal platform (SBE-FP) would have to submit a letter nine months before open enrollment.

A new state-based exchange would have to submit a blueprint at least 15 months before open enrollment begins and have its blueprint approved or conditionally approved 14 months before open enrollment. SBE-FPs must submit a blueprint 3 months prior to open enrollment and have it approved or conditionally approved 2 months before open enrollment. If a state exchange ceases operation, HHS will operate the exchange.

The NPRM preface discusses at length how the SBE-FP would operate. The state would remain responsible for plan management and consumer assistance functions, while the FFE would assume eligibility and enrollment functions and operate the call center. SBE-FPs must also maintain an informational website that will direct consumers to the FFE.

Initially the FFE will offer a single package of services; not a menu from which the state can select. States will not be able to add state-specific special enrollment periods, application questions, display elements, or data analysis. Insurers will need to comply with FFE eligibility and enrollment policies and standards. States will otherwise generally be required to enforce standards that apply to insurers in the FFE. The FFE would retain the authority to “suppress” the sale of QHPs where they do not meet federal requirements and the SBE-FP fails to take action.

Essential Health Benefits

The ACA requires states to cover the cost of health care services that they require qualified health plans (QHPs) to cover that are not essential health benefits (EHBs). Benefits required by state mandates adopted prior to December 31, 2011 are considered to be EHBs, but benefits mandated by states after that date are not EHBs unless the mandate was adopted to comply with federal requirements. Under the proposed regulation, states would be responsible for identifying mandated services that are not EHBs. QHP insurers are supposed to quantify the cost of these services and notify the state to defray this cost.

If, however, a state mandates that a large group HMO or state employee plan cover a service, but does not require QHPs to cover it, and the large group or state employee plan becomes the base benchmark plan, states do not need to defray the cost of the service provided by QHP insurers, even though it would be covered by QHPs as a benchmark plan EHB. If a state imposes a mandate only on individual or small group plans outside the exchange, under the ACA the mandate must apply uniformly to plans inside the exchange as well, and the state must defray the cost for QHP coverage. Finally, if a state imposes a mandate on employers in the 51 to 100 employee range and then expands the definition of small group to cover these employers, the state would have to defray the cost of mandates applied to these products adopted after 2011.

Navigators And Assisters

The NPRM proposes the imposition of a number of new requirements on navigators, non-navigator assistance personnel, and consumer assisters. Navigators in all exchanges must provide targeted assistance to underserved and vulnerable populations, as defined and identified by their exchange. This is not their exclusive mission, but a necessary part of their mission.

In the FFE, these populations would be identified through the Navigator Funding Opportunity Announcement. This standard would apply in the FFE beginning in 2018. This requirement would not extend to consumer assisters or to non-navigator assistance personnel, although they would be encouraged to reach these populations as well.

As noted in my first post, the NPRM would require navigators in all exchanges to help provide consumers with post-enrollment assistance, including assistance with filing eligibility appeals (though not representing the consumer in the appeal), filing for shared responsibility exemptions, providing basic information regarding the reconciliation of premium tax credits, and understanding basic concepts related to using health coverage. CMS notes that non-navigator assistance personnel also have some post-eligibility responsibilities. Certified application counselors do not, but nothing prohibits them from assisting consumers post enrollment.

Navigators may not offer tax assistance or interpret tax rules, but must help consumers understand the availability of exemptions through the tax filing process and assist them in understanding the forms, tools, and concepts that apply in the tax credit reconciliation process. CMS seeks comments on whether navigators should have to disclose that they are not tax advisors. The NPRM also would require navigators to refer consumers to licensed tax advisers, tax preparers, and other tax resources.

Navigators should also help consumers understand how to use their insurance, including understanding basic insurance terms like deductible and coinsurance, when to use or not use an emergency department, how to identify in-network providers and make medical appointments, how to make follow-up appointments or fill prescriptions, and how to access preventive services without cost sharing.

Exchanges are responsible for ensuring that navigators are trained for these new responsibilities. Any navigators, non-navigator assisters, or certified application counselors must complete training before carrying out any assister functions, including outreach and education.

The NPRM would clarify the rules governing the provision of gifts of nominal value, such as pens, magnets, or key chains by navigators. Navigators, non-navigator assisters, and certified enrollment counselors cannot offer gifts as inducements for enrollment. They may offer nominal value gifts at outreach and education events, however, which can include nominal value gifts to potential enrollees. Consumer assisters do not need to keep track of who has received a nominal value gift over multiple encounters as long as no more than nominal value is provided in any one encounter.

Reimbursement for legitimate expenses incurred by a consumer to receive enrollment assistance—for example, transportation costs or postage—is permitted. Provision of gifts or promotional items that promote the products or services of a third party is prohibited.

Under the NPRM, certified application counselor organizations would have to provide an exchange with information on the number of the organization’s certified application counselors and the consumer assistance they are providing. The FFE would begin collecting data monthly beginning in January 2017 including the number of people certified as application counselors; the number of consumers who receive assistance; and the number who received assistance selecting a QHP, enrolling in a QHP, and enrolling in Medicaid or CHIP.

Brokers And Agents

Brokers and agents must receive training and register with an exchange to assist consumers with enrollment. They must also sign a privacy and security agreement. Agents or brokers in SBE-FPs must comply with all applicable FFE standards. The HHS may terminate a broker or agent’s agreement with the FFE for cause based on a specific finding of noncompliance or a pattern of noncompliance. The agent or broker (including a web broker) must be given a 30-day opportunity to resolve the matter. A broker or agent may request reconsideration, but the reconsideration decision is final and non-appealable.

Under the NPRM, HHS would also be able to suspend an agent’s or broker’s registration for up to 90 days immediately upon the date of notice in cases of fraud or abusive conduct. The agent or broker would not be able to enroll consumers during the suspension period. If the agent or broker fails to submit information to resolve the issue, permanent termination could follow.

The agent or broker would also be terminated if HHS or a state or law enforcement agency reasonably confirmed the allegations of fraud or abuse. Termination would not require the normal 30-day notice. Agents and brokers could also be barred from returning to the FFE in future years for misconduct and could be subjected to civil money penalties for providing false or fraudulent information to the exchange, or disclosing private information.

CMS is further proposing standards of conduct for agents and brokers. These would include requirements that they provide consumers with correct information without omission of material fact; refrain from marketing that is misleading, coercive or discriminatory; obtain consent before enrolling individuals or employers in coverage; protect consumers’ personally identifiable information; and otherwise comply with federal and state laws and regulations. The use of the words “exchange” or “marketplace” in a name or URL that would cause confusion with a federal program or website may be considered misleading.

Violation of these standards could be grounds for termination. HHS recognizes that primary responsibility for overseeing agents and brokers resides with the state and will limit itself to compliance with FFE enrollment activities.

Currently a consumer applying for exchange enrollment through a web-broker or directly through an insurer must be redirected to the exchange website to complete the enrollment and receive an eligibility determination. HHS is considering an option where the consumer could remain on the web-broker’s or insurer’s website to complete the application and enroll in coverage, with the web-broker or insurer obtaining eligibility information from the exchange. The web-broker or insurer would have to use the FFE single streamlined application without change to obtain information. CMS is examining the web-broker experience and consider expanding audits or requiring additional information displays from web-brokers.

HHS approves vendors to offer agent and broker training. Under current requirements, vendors must identity proof agents and brokers and verify state licensure. CMS is proposing to remove these verification functions as unnecessary because the FFE verifies identify for registration purposes and QHP insurers must verify state licensure before affiliating with agents and brokers. The NPRM would add a requirement that vendors provide basic technical assistance to agent and broker users of the vendor’s training platform.

Notices To Employers

The NPRM proposes amending the process through which exchanges notify employers when an employee is determined eligible for federal financial assistance. This notice informs an employer that it may be liable for the employer mandate penalty if its employee receives assistance. The notice may also help reduce an employee’s responsibility to pay back tax credits if the employer prevails in an appeal and the employee ceases to receive tax credits.

Under the NPRM, the employer would only be notified if the employee actually enrolls in a QHP through an exchange, not upon a determination of eligibility as is currently the case. The exchange can either notify the employer on an employee-by-employee basis or for groups of employees who enroll in a QHP with financial assistance.

Financial Subsidy Eligibility Verification

Eligibility for financial assistance through the exchanges is based on projected income for the coming year. Many consumers who are eligible for income assistance have fluctuating income that is difficult to predict. Their actual income often does not match trusted data sources such as earlier tax returns, which could be two years old. Under current procedures, if no income data is available from trusted data sources or income is more than 10 percent less than income documented through such data sources, exchanges must demand income verification.

CMS has concluded that this threshold is not adequate to accommodate normal income variations. It proposes that exchanges apply more reasonable standards, such as a variation of more than 20 percent or $5,000. The threshold will be set through guidance.

The NPRM also proposes modifications in current procedures for verifying the absence of employer coverage for applicants from current accurate data sources, statistical sampling, or an alternative process approved by HHS. CMS also seeks comments on how it should alert enrollees of their potential eligibility for Medicare when they reach age 65.

Reenrollment And Binder Payments

As noted in my initial post, CMS is proposing a change in its reenrollment hierarchy to ensure that enrollees in silver plans that cease to become available are auto-reenrolled in another silver plan in a different product, rather than being reenrolled in a different metal tier plan of the same product, thus maintaining tax credit eligibility. CMS is again also exploring reenrollment possibilities that would move enrollees to lower-cost plans through auto-reenrollment when the plan they were enrolled in for the previous year becomes more costly.

One proposal is that an enrollee could designate when he or she enrolls for a year that if the plan’s premiums increase relative to those of other plans more than a certain percentage, the enrollee would be enrolled in a plan on the same metal level with the lowest-cost premium in the enrollee’s service area. Of course, the new plan could have a significantly different network or cost-sharing structure, and if the lowest-cost plan was a small plan with limited capacity it could be overwhelmed. CMS continues to solicit comments on this idea.

The NPRM proposes codifying previous guidance on binder payments. The deadline for paying the first premium for prospective coverage must be set by the insurer and must be no earlier than the effective date of coverage and no later than 30 days after that date or the date the insurer receives the enrollment transaction. Where a consumer qualifies for retroactive coverage — for example by prevailing on an appeal — the consumer must make a binder payment for all premiums due for the period of retroactive coverage, and will only receive prospective coverage if he or she only pays for one month.

Open And Special Enrollments

The NPRM proposes keeping the open enrollment period for 2017 at November 1 to January 31. CMS is considering, however, moving open enrollment to an earlier period, such as October 15, and either making it longer or ending before the end of the year.

CMS also seeks data on claims that special enrollment periods have been subject to abuse, a charge recently raised by UnitedHealth in explaining why it is considering withdrawing from the exchanges. The NPRM proposes allowing the exchanges to cancel or retroactively terminate coverage where it is determined that an enrollment was made due to fraudulent activity. Consumers would also be able to terminate their own coverage if they were enrolled through error, misconduct, or fraud perpetrated by someone else.

An enrollee who was unable to terminate coverage due to a technical error would have up to 60 days after discovering the error to terminate coverage retroactively. An individual who could demonstrate that his or her enrollment was unintentional, inadvertent, or erroneous could also request cancellation of coverage, which the exchange could grant if the enrollee’s claim was supported by the totality of the circumstances. Finally, an enrollee who is fraudulently enrolled by another could cancel within 60 days of discovering the fraud.

Eligibility Appeals

The NPRM proposes a number of provisions relating to exchange eligibility appeals. These include amended rules covering requests for information by the appellate entity and permission to submit an untimely appeal if the appeal was delayed by exceptional circumstances. Additional provisions would permit the dismissal of an appeal upon death of an appellant and holding a hearing with less than 15 days notice when the appellant requests it or the appeal is expedited.

The proposed rules would recognize retroactive eligibility to the date that would have applied had the determination been correct and provide for redetermining an employee’s eligibility when an employer prevails on an appeal, raising the question of whether the employer provides its employee affordable, minimum-value, coverage. Applicants and enrollees can appeal state exchange decisions to HHS.

Individual Responsibility Exemptions

The NPRM contains several provisions relating to the determination of exemptions from the individual responsibility requirement. Under the individual responsibility requirement, individuals must pay a tax unless they qualify for an exemption. First, the NPRM provides that members of health care sharing ministries and Indian tribes and incarcerated individuals can claim exemptions through IRS form 8965 upon filing their taxes and need not seek a certificate through the exchange. The NPRM would also limit hardship exemptions to the remainder of the calendar year during which the hardship commenced plus the next calendar year plus the month before the hardship commenced. An individual claiming continuing hardship would have to file a new application beyond that point, but could use as evidence proof submitted with a previous application up to three years earlier.

The NPRM sets out a revised non-exclusive list of the events and circumstances that would qualify for a hardship exemption, such as homelessness, domestic violence, or bankruptcy. These were formerly set out in guidance. The hardship event or circumstances must have occurred within three years of the application for the exemption. Since a hardship exemption can only last at most two years, an applicant who seeks to establish a hardship retroactively for three years may need to establish two hardship exemption periods.

Individuals who would have been eligible for Medicaid if their state had extended Medicaid to the under-65 adult population may qualify for a hardship exemption without applying for and being denied Medicaid. Individuals who qualify for a hardship exemption because their state did not expand Medicaid may claim the exemption on their tax return beginning with the 2015 tax year.

An individual responsibility exemption is available if an individual cannot afford coverage — that is, if the amount he or she would have to contribute for coverage exceeds the required contribution percentage of his or her income. An individual is also exempt if his or her required contribution exceeds the required contribution percentage for his or her household. Finally, if more than one member of a family is employed and the combined cost of coverage for all of them exceeds the required contribution percentage, the family is exempt.

The required contribution percentage was set for 2014 at 8 percent. It must be updated each year, however, for inflation—or more specifically for the excess in the rate of premium grown over the rate of income growth since 2013. The method for doing this was established in 2015, but CMS is proposing to change the database it uses for calculating this ratio. Under the proposed approach to calculating the ratio, the required contribution percentage for 2017 would be 8.16, an increase of 0.37 percentage points from 2015.

The NPRM proposes a procedure for discontinuing, with notice and an opportunity to respond, applications for exemptions that are not completed. Finally, CMS proposes to indefinitely allow state-based exchanges to use HHS to determine exemptions. States were supposed to begin processing exemptions themselves by the start of open enrollment for 2016.

The SHOP Exchange

Currently, employers in the SHOP can pick a single plan or allow employee choice within a single tier of coverage. For 2017, CMS is proposing to allow employers to permit employees “vertical choice,” the option of picking all plans across all levels from a single insurer. CMS is also considering other options, such as allowing employers to offer a choice of any plan in a single actuarial level of coverage or the level above it, or of simply allowing states in which an FFE is located to recommend additional models of employee choice. States with SBE-FP SHOPs will have to use the FF-SHOP models plus additional models they suggest.

The NPRM modifies the rules for effectuating enrollment in SHOP so that initial premium payments for new enrollees are due by the 20th day of the month prior to the month coverage begins, as opposed to the current requirement of the 15th day of the preceding month. Where an employer plan qualifies for retroactive SHOP coverage, all payments must be received for all months covered retroactively by 30 days after the event that triggers retroactive coverage before coverage is effectuated retroactively. The NPRM clarifies that employers may contribute a fixed percentage of the premiums paid by each individual employee or a percentage of the cost of a reference plan, leaving employees to pay the additional premium for a higher-cost plan. The costs of a tobacco surcharge are borne fully by the employee.

The NPRM modifies the definition of “applicant” for SHOP coverage to include employers seeking eligibility to purchase coverage through the SHOP but not enrolling in it themselves. The NPRM also clarifies that termination of SHOP enrollment is not necessarily termination of group coverage, which may continue in the outside market. FF-SHOP employers must allow their employees an open enrollment period of at least a week annually. Employers can select a coverage effective date up to 2 months in advance and submit plan selections by the 15th of a month for coverage the next month or after the 15th for coverage the second following month.

SHOPs can auto-enroll enrollees in the same coverage for a subsequent year unless the enrollee opts out or alternatively require enrollees to re-enroll themselves. When an enrollee in the SHOP changes from one plan to another during open enrollment or a special enrollment period, termination of the first plan is effective the day before the effective date of the new plan to avoid a gap in coverage. Employers must give qualified employees 90-days notice before an adult child reaches age 26 and ages off coverage. Under the proposed rule, employers or employees could appeal the failure of a SHOP to give timely notice of an eligibility determination and would be able to determine whether the effective date of coverage following a successful appeal should be prospective or retroactive.

Selective Contracting And Standard Plans In The FFE

For the first years of the operation of the FFE, HHS used an “open market” approach—all QHPs were welcome. Under the ACA, however, an exchange may refuse to certify a QHP if it is not in the interest of qualified individuals and employers. CMS proposes to continue focusing denial of certification on situations involving the integrity of plans, such as material non-compliance with applicable requirements, financial insolvency, or errors in data submissions. CMS is considering, however, becoming more of an active purchaser, possibly denying certification to plans that meet minimum certification requirements but are not in the best interest of consumers.

One specific proposal is standardizing plans offered in the exchange, an approach several states have taken. There is considerable evidence that having to choose among too many plans can cause consumer confusion and discouragement. To focus consumer choice, CMS is proposing a set of standardized plan options for 2017. Insurers would not be required to offer standard options and could offer additional options if they chose to do so, but standardized plans would be displayed at healthcare.gov in a manner that made them easy to identify so that consumers could compare standard plans across insurers.

Plan options would be standardized for the gold, silver, and bronze levels and for each of the enhanced cost-sharing tiers within the silver level. Standardized options would have a single provider tier, a four-tier (or possibly five-tier) formulary, a fixed in-network deductible, a fixed annual cost-sharing limit, and standardized copayments and coinsurance levels for key EHB services. Standardized plans would offer some services before the deductible applied, including primary care visits, generic drugs, and at silver and higher levels specialist visits and mental health and substance abuse disorder outpatient services.

The 2017 standard silver plan, for example, would have a $3,500 deductible; an annual out-of-pocket limit of $7,150 (the legal maximum); a $400 copay for emergency room care after the deductible; access to urgent care, primary care visits, specialist visits, mental health and substance abuse disorder outpatient care, and generic and preferred brand name drugs before the deductible subject only to copayments; and 20 percent coinsurance for inpatient hospitalizations and other services. The same standardized plans would be offered nationally. CMS requests comments as to how standardized cost sharing would work considering state limits on cost sharing for certain services, like emergency care.

Insurers could offer more than one standardized plan if the plans were meaningfully different, such as an HMO and PPO plan. Non-standardized plans would also continue to have to be meaningfully different. Plans are not considered meaningfully different just because one is health savings account eligible and another is not or because they do or do not offer dependent coverage. CMS may consider capping the number of plans that could be offered by a single insurer in future years.

FFE User Fee

The FFE user fee charged to market QHP plans through the FFE will continue to be 3.5 percent of premium. This continues to be less than the actual full cost of providing FFE services. SBE-FP insurers will be charged a user fee of 3 percent for the use of the federal platform services. For the 2017 benefit year, however, this fee may be reduced to 1.5 or 2 percent to permit a transition. In SBE-FPs, HHS will offer the option of collecting on behalf of the state the entire user fee to fund both SBE and FP operations. The NPRM does not mention a user fee for SBE-FPs for 2016.

The Drug Formulary Exceptions Process

Current rules require plans providing EHB to have a pharmacy exceptions process, independent of the standard appeal processes, through which an enrollee or enrollee’s physician can request and gain access to clinically appropriate drugs, on an expedited basis if necessary. For 2016 this process includes an internal and external review procedure. The costs of non-formulary drugs obtained through an exception apply to annual limitations on cost-sharing.

Some states, however, have different processes for accessing non-formulary drugs. CMS is considering amending its exceptions process so that plans may alternatively comply with state requirements in states that have procedures that are more protective of consumers or that conflict with the federal process. States would determine which process would apply. CMS is also considering allowing a second level of internal review for pharmacy appeals and for clarifying the availability of medication-assisted treatment for opioid addiction as a mental health and substance abuse disorder EHB.

The Premium Adjustment Percentage

The ACA requires HHS to determine an annual premium adjustment percentage, which is used to set the rate of increase for three ACA parameters: the maximum annual limitation on cost sharing; the required contribution percentage for individuals for minimum essential coverage, which is used by HHS to determine eligibility for hardship exemptions under the individual responsibility requirement; and the assessable payment amounts owed by employers under the employer mandate. Under the ACA, the premium adjustment percentage is the percentage (if any) by which the average per capita premium for health insurance coverage for the preceding calendar year exceeds such average per capita premium for health insurance for 2013.

For 2017, the percentage would increase 2013 amounts by 13.25256291 percent. Based on this percentage, the maximum out-of-pocket limit for 2017 will be $7,150 for an individual and $14,300 for a family, compared to $6,350 and $12,700 for 2014. For reduced cost sharing plans, the out-of-pocket maximum would be $2,350 for individuals with incomes below 200 percent of the federal poverty level and $5,700 for individuals with incomes between 200 and 250 percent of the FPL, with family maximums at twice those amounts. Maximum out-of-pocket limits for stand-alone dental plans are currently $350 for one covered child and $700 for two or more covered children.

CMS seeks comments on how these maximums should be updated for inflation for 2017.

The Actuarial Value Calculator

The NPRM proposes allowing greater flexibility for designing the AV calculator, used to determine the actuarial value of plans. CMS published with the NPRM the proposed 2017 AV calculator and AV calculator methodology.

Network Adequacy

A major subject of recent controversy has been the adequacy of health plan networks as QHP plans have moved to ever narrower networks to remain price competitive in the exchanges. The National Association of Insurance Commissioners (NAIC) has been engaged in a major effort to amend its state network adequacy model law to address this issue. Existing QHP rules require networks to be adequate to ensure access to services without unreasonable delay and also require the availability of up-to-date provider directories. The NPRM would go further.

First, states in which the FFE is operating would be asked to use quantifiable network adequacy metrics to determine adequacy. HHS will provide guidance with metrics that can be used, but they would at least include time and distance standards and minimum provider-covered person ratios for the specialties with the highest utilization rates in the state. (These specialties may not include in-hospital physicians such as anesthesiologists or pathologists, a very important omission.)

In FFE states that do not apply quantifiable network adequacy standards, the FFE would apply time and distance standards, calculated at the county level, similar to those used for evaluating Medicare Advantage plans. Plans that could not meet these requirements could submit a justification for a variance request. Multistate plans would have to meet OPM network adequacy requirements.

Second, QHP insurers in the FFE would be required to provide 30 days notice (or notice as soon as practicable) to regular patients of providers who are being dropped from the plan’s network, regardless of whether the termination is for-cause or no-cause or is simply a non-renewal. Insurers are also encouraged to inform enrollees of comparable in-network providers.

Third, QHP insurers in the FFE would be required under the NPRM to allow enrollees under treatment by a provider terminated without cause to continue treatment for up to 90 days if the patient is 1) in an ongoing course of treatment for a life-threatening condition, 2) in an ongoing course of treatment for a serious acute condition, 3) in the second or third trimester of pregnancy, or 4) in a course of treatment where the treating physician attests that discontinuing care from the provider would worsen the condition or interfere with anticipated outcomes.

An ongoing course of treatment would include mental health and substance abuse disorder treatments. Decisions with respect to these requests would be subject to internal and external appeal. CMS requests comments on whether these continuity of care requirements should extend to nonrenewal situations.

Finally, the NPRM proposes very limited protection for individuals who receive care from an in-network facility but receive services from out-of-network providers, such as anesthesiologists or pathologists – resulting in a phenomenon frequently referred to as surprise balance billing. If there is a potential of out-of-network providers providing services in in-network facilities, a plan may provide notice to an enrollee at least 10 days in advance, probably at the time of pre-authorization of the service, that this is a possibility.

If a plan fails to provide this notice, any cost-sharing imposed by out-of-network providers must be charged against the plan’s out-of-pocket limit so that the insurer absorbs costs above that limit. This provision would apply to all QHP plans, not just those in the FFE.

This is an inadequate response to the problem of surprise balance billing. First, the plan can avoid responsibility by simply providing a form notice to all patients pre-approved for services, as long as it is done 10 days in advance. Second, it is not clear that cost-sharing in fact includes balance bills — bills from providers that exceed the allowable amount payable by a health plan — as balance bills are not normally considered cost-sharing. Balance bills are often the most burdensome bills faced by consumers.

Fortunately, this provision does not preempt more protective state laws, which have already been adopted by a number of states and may be adopted by more, as the NAIC has finalized its model act.

CMS requests comments on further network adequacy issues, including network resilience policies in disasters and whether wait-time measures should be applied to determine network adequacy. CMS solicits comments on whether insures should be required to survey providers on a regular basis to see if the providers are accepting new patients, and whether insurers should be required to provide their selection and tiering criteria to regulators. Finally, CMS is considering establishing a rating or classification system for healthcare.gov that would classify plans into three different categories by network breadth to allow consumers to more easily identify narrow and less narrow networks.

Essential Community Providers

CMS continues to tinker with its policies regarding essential community providers, which serve underserved communities. Beginning in 2018, it is considering allowing health plans to count multiple contracted full-time equivalent ECP practitioners practicing at a single location as separate ECPs for meeting ECP participation ratios. The denominator at that time would be updated to include separately all ECP practitioners reported to HHS in the insurers plan service area. CMS had been considering disaggregating categories of ECP providers that must be included by a QHP, but has decided that there are too few ECPS in existing categories to do this at this time.

The Premium Payment Grace Period

The NPRM would amend the rules applying to the three-month grace period for nonpayment of premiums for individuals receiving premium tax credit assistance to clarify that if an individual loses premium tax credit assistance during that period the three month grace period would still apply. The NPRM also clarifies that if an individual reenrolls in coverage for a new year, the enrollee is not required to pay a binder payment for coverage for the new year and is protected by the three-month grace period for nonpayment. An individual can reinstate coverage during the three-month grace period by making a payment that satisfies the insurer’s payment threshold requirements.

Enforcement And Appeals

The NPRM would maker certain amendments to clarify CMS enforcement policies and insurer appeal rights. For 2014 and 2015, CMS applied a good faith compliance enforcement policy. For 2016 and future years, good faith will not be a defense in compliance actions. Where an insurer informs CMS that it cannot provide coverage to enrollees who purchase a QHP, CMS may suppress the sale of the QHP by the insurer or terminate its QHP certification. CMS may also decertify QHPs that are the subject of state enforcement actions or do not have funds to continue to provide coverage for enrollees for the remainder of the plan year.

The NPRM proposes a number of modifications in the administrative appeals process for insurers, including clarifying grounds for requesting reconsiderations and appeals involving the premium stabilization programs and timing for requesting reconsiderations.

These will not be explored in detail here. The NPRM would also require insurers to notify enrollees of benefit display errors that might have affected their plan selection and of the availability of a special enrollment period under these circumstances.

Quality And Patient Safety

CMS proposes to strengthen its quality and patient safety standards for 2017 to require hospitals with more than 50 beds to certify that they use a patient safety evaluation system to continue QHP participation. QHP participating hospitals with more than 50 beds must also implement a comprehensive person-oriented discharge program. Such hospitals are expected to contract with a patient safety organization.

HHS also strongly supports hospitals tracking patient safety events using the Agency for Healthcare Research and Quality Common Formats; it also supports hospitals implementing evidence-based patient safety standards. QHPs must collect documentation to ensure compliance with these standards.

Third Party Payments

The NPRM also attempts to tidy up the rules governing third-party payments for QHP coverage. The ACA does not prohibit third parties from paying for QHP coverage, but there would be obvious concerns if, for example, hospitals could purchase coverage for their patients, thus shifting the risk of uncompensated care.

In March of 2014, however, CMS published an interim final rule requiring QHP and stand-alone dental plan insurers to accept payments from Ryan White HIV/AIDS programs, other federal or state government programs, and Indian tribes and organizations. The NPRM would clarify that state government programs include local government programs, and that when government programs provide funding through grantees, insurers would also be required to accept premium payments from those grantees.

Entities that make third party payments would be required to notify HHS. In some situations insurers would also be required to accept cost-sharing payments from these entities. CMS continues to consider whether plans should be required to accept payments from charitable organizations and what guardrails would be needed to protect the risk pool if they were required to do so.

A Medical Loss Ratio Surprise At The End

Finally, the NPRM proposes a few changes with respect to medical loss ratio reporting and calculation. The NPRM would require insurers to use a six rather than a three month run-out period for reporting incurred claims, which should result in more accurate MLR calculations.

But in a zinger on the last page of the preface, in case anyone was still paying attention, CMS invites comments on whether it should consider insurers’ fraud prevention activities as incurred claims for calculating the MLR. This proposal was actively considered by both the NAIC and the agencies in 2010 and 2011. An accommodation on the fraud issue was made in the 2011 amended MLR rule by allowing insurers to offset fraud recoveries against claims, a reasonable accommodation.

Fraud prevention is important, but it is a quintessential administrative, cost control, expense. Not by any stretch of imagination does fraud prevention qualify as an incurred claim, and calling it so would be contrary to clear statutory language.