Guinea worm disease

Guinea worm disease: A parasitic disease caused by infection with the guinea worm (Dracunculus medinensis), the largest parasite known to plague people. Guinea worm disease is also called Dracunculiasis and end-of-the-road disease because it is not seen in the big cities.

Once it infects a person, the guinea worm migrates through their body. It eventually emerges from the body (through the feet in 90% of cases) causing intensely painful edema (swelling), a blister and then an ulcer. Perforation of the skin by the guinea worm, which can be 6 feet long, is accompanied by fever and nausea and vomiting. Infected persons may remain sick for some months.

The disease is contracted by drinking water contaminated with the infected intermediate hosts of the parasite, called cyclops. The full-grown guinea worm begins to migrate throughout the infected person's body within about a year after ingestion. In areas where the disease is endemic (pervasive), it typically reappears every year during the agricultural season, with farmers in particular being affected.

There are no drugs to treat the disease. Prevention of the disease is based on effective surveillance systems; the provision of safe water including appropriate water supply systems, filtering devices and the chemical treatment of water to eliminate the vector; and health education.

Guinea worm infection is the only parasitic disease that may, it is hoped, be eradicated from the globe in the near future. Although widely distributed at the beginning of the 20th century, it is now confined to sub-Saharan Africa. The countries known to harbor the guinea worm are Benin, Burkina Faso, Central African Republic, Ethiopia, Ghana, Ivory Coast, Mali, Mauritania, Niger, Nigeria, Sudan, Togo and Uganda. Two-thirds of the world's estimated 100,000 annual cases of Guinea worm disease occur in war-torn Sudan, where peace is needed before aid workers can reach affected areas, mainly in the south. The Bill & Melinda Gates Foundation gave $28.5 million in 2000 to help eradicate Guinea worm disease by teaching people to boil water or strain it through cloth filters. The effort to finish off this disease is a project of WHO, World Bank and Jimmy Carter's Foundation.

MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
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OxyContin

OxyContin: A prescription painkiller that has become a popular and dangerous recreational drug. Also called "Oxy" in the street.

OxyContin is a time-release morphine-like narcotic intended to relieve chronic pain of moderate to severe proportions. One pill of OxyContin is designed to last 12 hours.

The active ingredient in OxyContin is oxycodone, an opioid, a close relative of morphine, heroin, codeine, fentanyl, and methadone.

OxyContin has been much abused. It is highly addicting. Those who abuse "Oxy" usually crush the pills -- to disable their time-release mechanism -- and then snort or inject them for a powerful and immediate opiate high.

MedTerms (TM) is the Medical Dictionary of MedicineNet.com.
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The Human Side of Corporate Medicine

By EVE SCHVIDLER, MD

“I want to explore employment opportunities with you.”

He is looking at me. Trying his hardest. Passion, yet anger, in his eyes.

Everything I know about him and his tenure in the community helps me understand how difficult this conversation is. Everything I see in his eyes helps me understand how painful this is.

Private practice is dying…on the vine…in America.

The practices fold or reach a critical point and they come running to Big Med to fix all the problems.

Absorb. Acquire. Integrate. Consolidate.

Every week I get a call.

“Will you buy my charts? Why not? I have been a longstanding provider in this community?

“Will you buy my practice? Why not? I have been loyal to the system?”

Fact is. We are all struggling to stay afloat. I live in the guts of Big Med and let me tell you…we are doing the best we can to survive. We are trudging the influx of government regulation, population health contracts, outcomes data, patient experience pressures, reimbursement changes, meaningful use, union negotiations, massive expansion of Medicaid and quality control.

Physicians write about “raging against the machine” or finding the “Katniss” of healthcare

But the reality is that we cannot all go out and be independent. That may work for some primary care innovation, but how does it work for subspecialty care in which providers are dependent upon a large referral network or a large amount of hospital inpatient care? How does that work for bundled payments and government payers? How does that work for the millennial physician workforce that is FLOCKING to employment?

In some ways, they just got us by the balls.

So, I take a different approach. Rather than fight the machine, I dive deep inside the confines and internal mechanics. I place my stamp of influence in the core function of the beast. If physicians are unhappy about the way our Big Med Corp is run, they should get involved and be part of the solution. Take a seat at the table. Get involved. Otherwise, stop complaining about what Big Med is “doing” to you.

While I know we were trained to be clinicians and care providers, the rapidly changing and evolving healthcare environment requires more of us. The train has left the station. More and more physicians are enrolling in leadership programs and earning advanced degrees in business administration and medical management. The age-old days of a token MD in the C-suite are a thing of the past. Physicians are also taking a seat at the helm of Big Med.

“Being employed is different from an independent model. While there are some benefits, the loss of autonomy can be a challenging and difficult adjustment…”

I spell it out to him. No sugar coating. No false promises. No unrealistic expectations.

He loves his patients. He loves his community. This is his life. He is willing to try and make it work. I’m nervous of his ability to adjust, but value his commitment to his patients and community. We agree to give it a try.

I make no excuses about the experience of being an employed physician or provider. It is very different from private practice. It’s not for everyone. But, as a leader in Big Med with a large constituency of providers in my department, I do value their employed experience. I want them to be happy. I want to set realistic expectations of what we can and cannot do. I want to be fair. I want them to have work-life balance. I want them to be paid fairly. I want to listen. I want them to want to take good care of our patients.

But, I recognize that we will continue to make difficult decisions as time goes on. Decisions that will affect some people negatively. Decisions that will push providers to change behaviors. We will no longer be able to build a care program around providers, rather we will need to build care programs around our patients and our systems. Physicians should not only have a voice in this process of change, but they should be intricately involved in creating the solutions.

Disclaimer: All medical leadership stories are fictionalized.

Eve Shvidler, MD is a physician and the author of “Burning the Short White Coat: A Story of Becoming a Woman Doctor.”

Health Policy Brief: Aligning FDA And CMS Review

A new policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) touches on recent initiatives to close gaps between the medical technology evaluation processes of the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). The two agencies have related mandates: the FDA approves drugs and devices that have proven to be “safe and effective,” while CMS authorizes coverage on products that are “reasonable and necessary.”

Product sponsors, particularly those of medical devices, have been frustrated by the delays that result because each agency has a different set of required evidentiary standards. The brief focuses on two initiatives—parallel review and coverage with evidence development (CED)—which have the potential to address this bottleneck.

What’s The Background?

The brief details the two review processes. The FDA conducts its review among the narrow population of clinical trial participants. CMS, however, wants a product to benefit the more diverse and varied universe of Medicare patients. The brief explains how the CED initiative, which first began in 1995, can bridge this gap by providing temporary reimbursement for beneficiaries enrolled in clinical studies. Parallel review, launched in 2011 as a pilot program, seeks to shorten the review timeline through increased communication among sponsors, the FDA, and CMS. Devices must meet certain eligibility criteria, outlined in the brief.

What’s The Debate?

For both programs, CMS resources hold the key to fuller implementation. The Coverage and Analysis Group within CMS, which oversees both programs, has lost about half its staffing since 2007, leading to a reduction in the overall number of national coverage determinations. The brief explains why the two programs have so far failed to reach their potential. For example, some manufacturers remain reluctant to focus their data collection on Medicare’s requirements, while others call for reforms to the program’s eligibility standards.

What’s Next?

The future of both parallel review and CED is uncertain, but, as the brief points out, CMS and the FDA may extend a modified version of parallel review. Current and future budget cuts at CMS and related agencies, and the current political environment, make their future continuation highly questionable, as the brief further explains.

About  Health Policy Briefs

Health Policy Briefs are aimed at policy makers, congressional staffers, and others needing short, jargon-free explanations of health policy basics. The briefs, which are reviewed by experts in the field, include competing arguments on policy proposals and the relevant research supporting each perspective.

Sign Up For Health Policy Briefs

Sign up for an email alert about upcoming briefs. The briefs are also available from the RWJF’s website.

Please feel free to forward the briefs to any of your colleagues who are tracking health issues. And after you’ve taken a look, we welcome your feedback at: hpbrief@healthaffairs.org.

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The Tower of Babel and the Sea of Consumer Confusion

By JOE KVEDAR, MD

Earlier this summer, I was fortunate to be invited to speak at the recent AHIP (America’s Health Insurance Plans) conference in Nashville. This is an annual gathering of health insurers and it was my first time attending. My experience there, and a few recent news items, got me thinking about about how health care is evolving and whether we once again will ignore Santayana’s admonition, “Those who cannot learn from the past are doomed to repeat it.”

As we continue our journey to change provider reimbursement to a “Pay for Value” system, the lines between health insurers and health care providers are blurring. Physician/hospital systems, like Partners HealthCare, where I work, are taking on risk for populations of patients through contracts with the Federal government and local payers. According to Secretary of Health & Human Services, Sylvia Burwell, this trend is going to continue. She stated recently that HHS set a goal of tying 85% of all traditional Medicare payments to quality or value by 2016 and 90% by 2018. Since the whole insurance industry is based on risk, we inevitably have to start thinking more like insurers if we’re going to be taking on risk.

So I cleared my calendar and attended as many content sessions as I could at the AHIP conference, in hopes that I’d soak up knowledge on how these companies approach their craft.

Sadly, I didn’t learn much. Not because I didn’t listen and not because the speakers were less than talented. I walked away feeling like I hadn’t learned anything because I felt I had gone to a foreign land and was listening to talks in a foreign tongue. I simply couldn’t decipher the health plan lingo.

This worries me because it’s time for these two sectors of the industry to collaborate more. If we can’t understand one another though, it will indeed feel like the Tower of Babel.

At the highest level, it seems like we should be natural collaborators, as we bring very complimentary skills to the shared goal of building a health care system. As providers, we excel at understanding physiology, pathophysiology diagnosis and therapy. In most cases, we have strong relationships with the end users of the services offered, our patients, which often includes a high degree of trust. When someone’s doctor recommends a course of action, most people at least take it seriously and many often follow that path.

Payers, on the other hand, have always been challenged connecting with their members (you see, we are all a member, a consumer and a patient – all in different contexts – an example of the babbling). Payers excel at understanding risk and setting premium costs, something we as providers have no feel for. But if we’re going to take on risk, we’ll have to learn. Can these former negotiating foes come together to help improve your health? The current landscape does not lead to enthusiasm.

I’ll use some telehealth implementations as examples. Several national payers are adopting virtual visits as a tool for their members. For me, this is a dream come true! BUT, most payers are doing so in collaboration with one of the major vendors in the space and creating shadow physician networks to offer the service to their MEMBERS. When that member’s primary care doctor eventually sees them in the office, she will be puzzled that her PATIENT had an encounter via their health plan that she did not know about.

Walgreens just rolled out a virtual visit program as well. This could create even more confusion, as it brings in a new entrant — the pharmacy — into the battleground for that relationship. Will EMR interoperability solve this confusion? It certainly helps, but I’m also concerned about mixed messaging to the consumer/patient/member. It seems like we’re all fighting for your attention, which may lead to conflicting messages.

This reminds me of a time, about 25 years ago, when this new thing called disease management sprung up. Payers were frustrated by the cost of managing patients (members) with chronic illness. They got no help from providers, so they took matters into their own hands, hiring call centers staffed with nurses to contact patients/members with tips on how to manage their illness, and often sent generic brochures about high blood pressure and other conditions. Payers may have influenced the care of some patients/members, but no one was ever able to prove that this was an effective strategy.

There were numerous stories about patients receiving conflicting advice from these ‘disease managers’ compared to their own doctor’s advice, leaving patients confused. Doctors would get faxes from these same disease management companies and (perhaps arrogantly) throw them in the waste basket without reading them. As a result, the disease management industry collapsed in the middle to latter half of the last decade.

In the meantime, we now have workplace wellness programs, virtual visits offered by your health plan, retail clinics, virtual visits offered by pharmacies and — dare we forget — advice your doctor gives you, which should be more in tune with prevention now that providers are taking on risk.

See what I mean by a Tower of Babel? How do we fix it?

Bread Recalled Due to Possible Glass Fragments

Bread Recalled Due to Possible Glass Fragments

The Medicaid Expansion Experience In Michigan

As of July 2015, 30 states and the District of Columbia have expanded or planned to expand Medicaid under the Affordable Care Act (ACA). Michigan is one of only six states with a fully Republican-led state government to expand the program. The Healthy Michigan Plan (Michigan’s version of the Medicaid expansion) went into effect on April 1, 2014. One year into this expansion, Michigan’s experience has confirmed some expectations but vastly exceeded others.

Michigan’s Path To Expansion

In late 2012, Republican Governor Rick Snyder expressed initial concerns that the state would not have enough health care providers to care for additional Medicaid patients and that expansion could prove costly for the state. Joint analyses produced by the University of Michigan’s Institute for Healthcare Policy and Innovation (IHPI) and the University’s Center for Healthcare Research and Transformation (CHRT) helped to ease these concerns. The reports found that:

1. Eighty-one percent of primary care physicians had capacity to serve new patients and over 90 percent of those with capacity were expecting to serve Medicaid patients (these findings were also consistent with a more recent study);
2. the expansion of Medicaid was projected to cover an additional 620,000 Michiganders by 2020, representing 5.9 percent of the state’s projected population in that year; and,
3. the net cost savings were projected to total $983 million over 10 years (2014-2023).

In February 2013, Governor Snyder’s proposed budget included funding to expand Medicaid. The legislature required two waivers as a condition of supporting expansion. The first, approved by the Centers for Medicare and Medicaid Services (CMS) in December 2013, implemented several policy changes for the newly eligible population.

For example, the waiver allowed the Healthy Michigan Plan to require enrollees to schedule a preventive health visit with a primary care provider within 60 days of enrollment and pay some level of cost-sharing (monthly contributions and co-pays) into a personal health savings account based on income. Under this waiver, total cost-sharing cannot exceed 5 percent of an enrollee’s household income and can be decreased by engaging in healthy behaviors, such as completing a health risk assessment or agreeing to healthy behaviors (e.g., tobacco cessation). As part of this waiver, a multi-disciplinary IHPI team from the University of Michigan is conducting a CMS-authorized comprehensive evaluation of the Healthy Michigan Plan in collaboration with the Michigan Department of Health and Human Services.

The second waiver, which must be submitted to CMS by September 1, 2015, will allow the Healthy Michigan Plan to increase the cost-sharing maximum from 5 to 7 percent of income for enrollees between 100 and 138 percent of the federal poverty level (FPL) who remain enrolled in Medicaid for longer than 48 cumulative months. Under this second waiver, Healthy Michigan Plan enrollees could also opt to purchase coverage through the Marketplace (using tax credits and cost-sharing subsidies). If CMS does not approve the second waiver by December 31, 2015, the Healthy Michigan Plan will end on April 30, 2016.

Michigan’s Experience To Date

At a March 2015 conference sponsored by the Center for Healthcare Research and Transformation, the University of Michigan Institute for Healthcare Policy and Innovation, and the University of Michigan School of Public Health, consumers, providers, employers, and state leaders reviewed the first-year experience of the ACA’s coverage expansions. While some described challenges, particularly in the small employer market, the Healthy Michigan Plan was almost uniformly praised as being clearly successful to date.

Healthy Michigan Plan enrollment has vastly exceeded expectations, surpassing the state’s first year projection in less than four months. As of August 3, 2015, 576,624 residents were enrolled. The majority of enrollees (nearly 500,000) had incomes below 100 percent FPL, more than 51 percent were women, and roughly 47 percent were between the ages of 19 and 34.

Operational issues with enrollment have been minimal and health plan participation has been high, with thirteen health plans serving the Healthy Michigan population in the first year. Moreover, the proportion of primary care practices willing to accept new Medicaid patients in Michigan has increased from 49 percent to 55 percent since the launch of the Healthy Michigan Plan — with median wait times for new appointments remaining less than two weeks.

Early figures suggest Healthy Michigan Plan enrollees are utilizing the program’s benefits and are connected to a primary care physician through their managed care plan enrollment. As of February 2015, over half of enrollees had visited a primary care physician and about 17 percent used preventive care services. Healthy Michigan Plan enrollees are also participating in the program’s health risk assessment component at more than twice the rate of enrollees in a typical private health insurance plan (14 percent compared to 6 percent, per state figures).

The state expected the health care needs and trends of Healthy Michigan Plan enrollees to differ from other Medicaid enrollees, as many were likely to have been without coverage for a significant period. In recognition of expected unmet medical needs, the state set the payment rate (per member per month) for managed care organizations covering Healthy Michigan Plan enrollees above the rate for traditional Medicaid members but below the rate for disabled Medicaid members. The state is currently in the middle of a Medicaid health plan re-bid with several goals, including setting new payment rates, allowing changes in service area locations, and creating a common formulary for Medicaid health plans. New health plans and rates are to become effective in January 2016.

Health plans have helped contribute new knowledge about the expansion population. For example, James Forshee, Molina Healthcare of Michigan’s vice president of Medical Affairs and Chief Medical Officer, found that during the program’s first year (April 2014 through March 2015), their Healthy Michigan Plan members’ emergency department (ED) use rate was about twice as high as their traditional Medicaid members. Pain-related conditions accounted for seven of the top 10 reasons their Healthy Michigan Plan members visited the ED. Molina Healthcare also found that cellulitis was the top medical diagnosis for hospital admissions among the new population, followed by pneumonia. The state is watching to see how such utilization trends among Healthy Michigan Plan enrollees change over the first few years and what impacts promoting and incentivizing healthy behaviors has on enrollees’ health status.

The success of the state’s enrollment efforts has brought some challenges. In particular, the legislature required that the Healthy Michigan Plan be self sustaining, meaning that the savings to the state needed to offset the state’s required match beginning in 2017. Governor Snyder proposed creating a lockbox fund to store short-term savings from Medicaid expansion to cover the program’s costs in future years. However, the legislature has not appropriated the savings to this fund, so the long-term viability of the Healthy Michigan Plan is in question. Savings are expected to cover the cost of the state’s required match in 2017, but costs may begin to exceed savings by around 2020.

Unfinished Business

Over half a million Michigan residents have access to care through the Healthy Michigan Plan, most of whom were uninsured prior to the state’s Medicaid expansion. Approval of the second Section 1115 waiver is the next challenge to assure that the Healthy Michigan Plan continues. The state and CMS are working hard to reach an agreement on this waiver. Many consumers, providers, and advocates across the state are hoping they are successful given the extent of improved coverage and access achieved to date.

Authors’ note

The Center for Healthcare Research and Transformation (CHRT) at the University of Michigan receives funding from both the University of Michigan Health System and Blue Cross Blue Shield of Michigan. John Ayanian and Richard Hirth are receiving funding from the Michigan Department of Health and Human Services through a contract with the University of Michigan to conduct the Healthy Michigan Plan evaluation authorized by the Centers for Medicare and Medicaid Services.

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Are Physicians Really Dissatisfied With EHRs? Should We Be Concerned?

By IRV LICHTENWALD

Microsoft Office was first introduced by Bill Gates at COMDEX, Las Vegas, in August, 1988.

Here we are almost exactly 27 years later, and if you plug the words ‘hate,’ ‘Microsoft’ and ‘Office’ into Google, you’ll get more than 4 million results. Remove ‘Office’ and Google returns more than 33 million results.

Clearly, some people don’t feel like Microsoft has perfected products to their satisfaction.

The perpetual unhappiness with a monolith like Office comes to mind as I read reports on the most recent surveys of physician satisfaction with electronic health records (EHRs). Let’s sum up, for those unfamiliar with the reports

First, reporting on survey data from last year, the American Medical Association (AMA) and American EHR, a division of the American College of Physicians (ACP), recently published “Physician Use of EHR Systems 2014.” Among other findings, the reports includes these nuggets:

• 42 percent thought their EHR’s ability to improve efficiency was difficult or very difficult.
• 72 percent thought their EHR’s ability to decrease workload was difficult or very difficult.
• 54 percent found their EHR increased their total operating costs.
• 43 percent said they had yet to overcome the productivity challenges related to their EHR.

Contrast those figures and levels of satisfaction with a survey of large physician practices released last week by market research firm Black Book that shows significant increases in physician EHR satisfaction. In particular, physician experience satisfaction has risen from 8 percent to 67 percent in the last three years. Physician documentation satisfaction went from 10 percent to 63 percent over the same time period, while practice productivity enhancement satisfaction has gone from 7 percent to 68 percent.

Worth nothing is that, with the AMA/ACP surveys, “Each society was allowed to select the population of their members to receive the survey. Information about EHR use by individual society members was not available. Therefore, the survey went to both users and non-users of EHRs.”

Also important: A similar ACP survey from five years ago showed significantly higher levels of satisfaction among the physicians surveyed.

The cognitive dissonance over EHRs continues, giving rise to theories on the Interwebs about the actual source of this disconnect.

At Healthcare IT News, contributing writer Jack McCarthy wonders if the constraints of Meaningful Use are antagonizing doctors, or if increased expectations and more sophisticated technology that fails to improve the daily challenge of patient care (in effect, a mashup of the two ideas) is creating dissatisfaction.

“Now, however, we have a lot more users who were forced to adopt EHRs meaning their tolerance for poor performance or usability will be lower,” notes health IT expert Shahid Shah in the article’s very interesting comments section. “I think it’s pretty easy to see why clinicians are less satisfied — if it was their choice they would be more tolerant. Since it’s not their choice in many cases, they’re less tolerant.”

Adds O’Reilly Media editor Andy Oram: “They [doctors] could be more familiar with the advantages computers offer in other areas of life … In short, having seen what a good interface can do, doctors become more demanding of the sub-par interfaces on EHRs.”

Expanding on the ‘why’ question, Michelle Ronan Noteboom (formerly ‘Inga’ of HIStalk fame) offers similar theories—MU forces doctors to use EHRs a certain way, compared to Facebook and Amazon most EHRs are clunkers, EHRs don’t deliver the ROI they promised—for the ACP survey results and asks if we should care whether or not physicians are happy.

“I’m of the opinion that physician satisfaction matters, but not nearly as much as improving the quality of patient care,” she writes at Healthcare IT News. “Patient care will be enhanced when all providers have access to thorough and accurate documentation. Ideally the patient records from one provider will integrate with records from other providers to create a single longitudinal record that is easy to decipher and provides a full picture of the patient’s health history.”

That sounds like a worthwhile goal. And Noteboom also has an explanation for the ACP survey results, pointing out “a direct correlation between physician satisfaction and the number of years a physician used his/her EHR. For example, among physicians on their system for three years or less, only 25 percent reported any level of satisfaction; satisfaction jumped to 50 percent among physicians that had used their EHR for five or more years.”

Sure, the differences between the two cited surveys could be attributed to methodology. But we know too much about how EHRs are influencing clinical culture to leave it at that. Physicians are human and subject to the same impulses—resentment when forced to do something; envy and confusion when seeing technology function well in other contexts; fear and consternation when learning something new—we probably faced when Microsoft started to become a rather sizeable part of our lives.

And, let’s recall, we’re really not that far into the ongoing transformation of American health care. Only now are we on the leading edge of value-based care as a replacement for fee for service. As EHRs evolve to improve quality, increase revenue, ensure patient safety, etc., instead of just meeting the contrived requirements of Meaningful Use, they will become the essential tools we envisioned at the beginning of this long and complex dance.

So it’s encouraging when both surveys show that physicians who’ve had their system for a while are happier with it. Indeed, while we continue to ask the specific question, “Are you happy with your EHR?”, maybe we don’t consider often enough the general frustration of digitizing processes that were once manual.

Also, it appears that plenty of hospital and health system administrators didn’t get the memo about creating buy-in before selecting and implementing an EHR. As David Whiles, former CIO at Midland Memorial Hospital said of their EHR journey, “Implementing an EHR is definitely an organizational project, not an IT project.”

And even though we are dealing with computers, this isn’t a binary choice of EHRs OR physician satisfaction. No one thinks computers are going anywhere, even if the Meaningful Use program ends. And physician satisfaction, to a reasonable extent, must be a high-level consideration for all clinical organizations. Over time, EHRs will improve and doctors will become more satisfied with them, perhaps will even depend on them, as essential clinical tools.

In the meantime, plug ‘hate’ and ‘EHRs’ into Google from time to time and see what you get. When we get over 30 million results, we’ll know we finally achieved Microsoft-ian levels of influence.

Irv Lichtenwald is president and CEO of Medsphere Systems Corporation, the solution provider for the OpenVista electronic health record.

Ten Years After Hurricane Katrina: Progress And Challenges Remain For US Emergency Preparedness

Ten years ago, the nation watched in shock as Hurricane Katrina devastated the city of New Orleans. Katrina was followed closely by Hurricane Rita, impacting Western Louisiana, and these storms collectively have become synonymous with systemic failure of disaster preparedness, response, and recovery policy. They provided a wake-up call to government agencies, politicians, and community agencies alike.

That following year, Congress created, among other things, an Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS), with a mandate to reach across government sectors and coordinate federal efforts to prevent, prepare for, and respond to the adverse health effects of public health emergencies and disasters. While we mark this 10-year anniversary with remarkable progress, we must acknowledge an ever growing obstacle: a national attention deficit.

The following blog post highlights the progress we have made and the challenges that remain.

Developing A National Response Capability

At the time of Hurricane Katrina, the public health, health care, and emergency management communities along the Gulf Coast were poorly integrated and lacked the systems, mechanisms, and plans to coordinate an effective, cross-jurisdictional response.

Today, our national approach to preparing for health emergencies is guided by a National Health Security Strategy, which recognizes that disasters require coordinated actions on the part of all stakeholders, governmental and non-governmental alike. It also recognizes that strong, day-to-day systems, ranging from public health surveillance to a well-functioning trauma and emergency care system, are critical to disaster response.

A National Response Framework informs a unified, multi-sector national approach to providing information to a broad coalition of community organizations during emergencies and disasters. Incident command systems are used not only by traditional first responders, but also by virtually every health department and a majority of hospitals in the country, improving coordination during disasters. Basic capabilities that public health and medical care systems must have to be disaster ready are clearly articulated, and federal guidance and funding supports states and health care entities in achieving these capabilities.

When disasters strike, ASPR coordinates the federal medical and public health aspects of the response across HHS and the rest of the United States government. The response to Superstorm Sandy, the largest natural disaster since Katrina, demonstrated progress and remaining gaps in this national response capability. Although far from perfect, there was better coordination between governmental components, the private sector, and emergency responders. The National Disaster Medical System and U.S. Public Health Service teams responded in hours, rather than days, to requests for assistance.

At times, the health sector and emergency managers lacked sufficient understanding of one another’s needs and challenges. For example, fuel shortages and restricted transportation into New York City meant that critical health care facility generators couldn’t refuel and their personnel, including those who provided substantial amounts of home health care, could not get to work or reach their patients, thus causing many more people to require evacuation to hospitals and shelters.

Strengthening Health Care System Preparedness

When Hurricane Katrina struck, many health care facilities in affected areas lacked the plans and resources to care for their patients through the disaster, especially as resources became scarce. Many facilities lacked basic evacuation plans, redundant communications infrastructure, electronic medical records, or backup generators. Thus, when hospitals lost power during the storm, they were unable to evacuate patients, their medical equipment stopped working, they were cut off from emergency managers who might have been able to provide help, and they were unable to transfer important health information because their paper-based records were destroyed.

We now recognize that all health care facilities, not just hospitals, must plan for disasters, have the basic equipment necessary to sustain operations and be able to allocate scarce resources fairly, and that such planning must take place with the recognition that each facility does not exist in a vacuum. The nation has invested significantly in public health and health care system preparedness and in strengthening these day-to-day systems through electronic health records, equipment such as generators and temporary hospitals, and through training and exercising, building resilience at the local, state, and federal levels.

The investments enhance the ability of communities and states to handle larger disasters without emergency federal assistance such as that provided through the National Disaster Medical System (NDMS). At the same time, the NDMS is stronger and its teams are able to deploy more quickly to support a broader array of needs when needed. A growing number of health care coalitions—increasingly comprised of most of the health care entities in a community—are better able to coordinate their local medical response during disasters.

For example, after both the 2013 Boston Marathon Bombings and the 2015 Philadelphia Amtrak crash, when casualties needed to be addressed within a few hours, coalitions, which had been developed with federal support, helped direct patients to specific hospitals so that no one facility was overwhelmed. The benefits of this broader community-based approach were evident during Superstorm Sandy, when hospitals were able to effectively implement their evacuation plans and safely transfer patients to other facilities while maintaining continuity of care.

In contrast, many nursing homes, adult care facilities, and some dialysis centers had not sufficiently planned how to care for patients if facilities flooded or lost power, and many patients needed to be evacuated to shelters or other facilities and receive care there. This shortcoming highlighted the need for sustained focus on community-wide disaster planning. Because of the extent of the damage and displacement of populations, the local health care system did require federal support; the National Disaster Medical System deployed teams and was operational within about four hours of the request for assistance.

In addition, electronic health records (EHRs) can provide support for accessing a patient’s health records during a disaster. Following Hurricane Katrina, the Office of the National Coordinator for Health Information Technology stepped in to support the development of a makeshift electronic health record to provide pharmacy and other information for evacuated residents. Funding from the HITECH Act subsequently offset the cost of adopting electronic health records in practice and supported community infrastructure to build information exchange platforms that can allow data to move with people, everyday and in disaster. After a tornado struck Joplin, Missouri in 2011, medical personnel working out of a temporary mobile hospital accessed patients’ electronic health records using remote support, and then transferred those records upon the patients’ move to other facilities. Many community health centers and physicians without EHRs never reopened.

The HHS Office of the National Coordinator for Health Information Technology has prioritized the need for individuals’ health data to follow them in times of disaster; remotely hosted and cloud back-up are making this increasingly possible. Unfortunately, interoperable EHRs are not yet a reality in many communities, but they should be. By sustaining emergency preparedness and continuing to strengthen our health data system, we can continue to improve response and ensure continuity of care during disasters.

Making Behavioral Health Part Of A Health Response

Following Hurricane Katrina, many individuals with chronic mental illness were displaced and unable to access care, resulting in an increase in suicides and mental health crises in the areas immediately affected by the storm as well as in neighboring states that absorbed displaced residents. Those without a history of mental illness were also severely affected, with some studies finding that the prevalence of mental illness among New Orleans residents doubled in the months following the storm. Emergency responders, who were exposed at high levels to significant death and destruction, experienced behavioral health challenges at even higher rates than the rest of the affected population.

Today, behavioral health is incorporated into the formal federal disaster response, addressing the needs of survivors and responders. Following the Sandy Hook shootings and the Boston Marathon bombings, HHS deployed mental health response teams to help affected communities along with first responders who, in the acute aftermath of the tragedy, provided services until the community could implement its own plans.

After the Deepwater Horizon Oil Spill, Substance Abuse and Mental Health Services Administration launched a national Disaster Distress Line for individuals in areas affected by disasters to access help or psychological support. The Distress Line often is publicized in communities affected by disasters, even those that do not require additional federal support.

Further, psychological first aid training and tools have been developed and made available so every community can better anticipate and address the behavioral needs of responders throughout the response and recovery phases. To sustain preparedness, both residents’ and responders’ behavioral health needs must be considered in community response and recovery plans.

‘Whole Community’ Approach To Disaster Planning

The failure to anticipate the profound health and social needs of the Katrina-affected population was avoidable. Numerous federal data sets that detailed population characteristics and their health status were widely available; the response system should not have been surprised that the population had high rates of chronic disease, and poverty was rampant.

Now, a mapping platform is used to aggregate and map information about populations (e.g. demographics, language spoken), community resources (e.g. location of health care facilities), and vulnerabilities (e.g. chronic disease status, electricity-dependent populations, flood-prone zones). Federally deployed teams, such as those of the National Disaster Medical System (NDMS), can be purposely amplified to include providers whose language skills match those of the affected population to enhance communication and better address their health care needs.

More recently, ASPR and the Centers for Medicare and Medicaid Services developed a way to identify individuals who have electricity-dependent durable medical equipment, are on dialysis, receive home health care services—or are oxygen-dependent; this information can now be used to inform local community disaster planning. In an emergency, additional information, such as addresses of individuals with particular access and functional needs, can be made available to a health department official in a HIPAA-compliant fashion to facilitate live-saving emergency response.

Up-to-date, accurate, de-identified information is now available to state public health agencies and responders for just-in-time planning with every approaching major storm anywhere in the U.S., and can be used to help prioritize areas for power restoration in the immediate aftermath of an event. Given the shift from hospital to home-based care, such real-time awareness of population-level needs, and the ability to respond to them, not just during disasters, but day to day, is critical. It allows health departments to plan for population health needs, emergency managers to more effectively deploy resources where they are needed most, and community organizations to better understand potential needs and offer additional support.

Looking Forward

While the progress in health care and public health emergency preparedness in the last decade supports more timely, seamless, and holistic responses to disaster, there is more that must be done. Federal funding for state and local health preparedness declined by 38 percent from 2005 to 2012 and has continued to do so, placing communities at risk. Policymakers, like the public, seem to forget that disaster preparedness is critical, or subscribe to the view that preparedness can be ‘bought’ with a one-time purchase of equipment and supplies.

State and local agencies, as well as health care facilities, need to continually train and practice to respond to public health emergencies. Health information technology systems, though significantly advanced in the past few years, must become fully interoperable to support a coordinated and effective response to a catastrophic disaster or emergency. And, we must understand that recovery is as much a part of response as preparedness is, recognizing the broad scope of health recovery.

While Katrina was a local tragedy of national consequence, an even greater tragedy would be for communities across our nation to forget the importance of a trained, ready, nimble, and coordinated public health emergency preparedness system able to care for individuals and communities in the wake of disaster, including those who are most vulnerable.

Building sustained preparedness into the day-to-day decisions that enhance health care, public health, and emergency management must become the cultural norm. This will require continual planning, sustained funding, and attention among all sectors of society — including individuals and communities, governments, non-governmental organizations, and the business community. Doing so is vital to ensuring that all communities across the nation are prepared to respond to and recover from future public health disasters and fulfill our collective promise to never again repeat the chaos, disorder, and despair that followed Hurricane Katrina.

Authors’ note

From Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC (N.L., K.F.); Office of the Assistant Secretary for Health, US Department of Health and Human Services, Washington, DC (K.D.) The views expressed are those of the authors, and not necessarily those of the US Department of Health and Human Services.

High Blood Pressure During Pregnancy May Reappear Later in Life: Study

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Quality Improvement: ‘Become Good At Cheating And You Never Need To Become Good At Anything Else’

The Centers for Medicare and Medicaid Services (CMS) has trumpeted the recent drop in hospital readmissions among Medicare patients as a major advance for patient safety. But lost amidst the celebration is the fact that hospitals are increasingly “observing” patients (or treating returning patients in the emergency department) rather than “readmitting” them. But while re-labeling helps hospitals meet CMS’ quality standards (and avoid costly fines), it probably signals little real quality gain and often leaves patients worse off financially.

Observation Status

Debate over the seemingly arcane subject of “observation status” has blossomed in recent years because billions of Medicare payment dollars are at stake. What is “observation status?”

According to MedPac (page 57):

If a Medicare patient does not initially meet the criteria for inpatient admission but the attending physician concludes the patient should be observed in the hospital for a period of time before being sent home, the patient can remain in the hospital in observation status. Observation stays are billed as outpatient services rather than inpatient admissions.

In most cases, observation patients receive care in a regular inpatient unit, and get treated just like other inpatients. And in many cases, observation stays stretch out to several days: in 2012, 26 percent lasted two nights and 11 percent at least three. But from Medicare’s point of view, this is outpatient care, which leaves patients responsible for more of the bill, and ineligible for Medicare-paid rehab or skilled nursing care.

Hospitals started designating more stays as “observation” after Medicare’s auditors began disallowing the entire payment for some brief hospital “admissions.” Even though “observation stays” pay less than inpatient admissions, hospitals took a better safe than sorry approach, classifying many brief stays as “observation.” Between 2006 and 2013, observation stays increased by 96 percent, accounting for more than half of the apparent decline in total Medicare admissions during that seven-year period (see page 55).

Observation Classification

Medicare’s recent adoption of penalties for readmissions offered hospitals a new incentive to shift some patients returning within 30 days of their discharge to observation status. A patient stay labeled “observation” doesn’t count as a readmission, allowing hospitals that might otherwise be fined for having too many readmissions to skirt the penalty.

Recent data indicates that such gaming isn’t just a theoretical possibility.

About 10 percent of all hospital stays occurring within 30 days of discharge are now classified as “observation;” a quarter of hospitals classified 14.3 percent or more of all repeat stays as “observation.” Moreover, analysis of time trends in observation stays makes it clear that they account for a significant chunk of the reduction in readmissions. Between 2010 and 2013, 36 percent of the claimed decrease in readmissions was actually just a shift to observation stays.

Emergency Department Use

And it’s not just observation stays that have been on the increase. More of the recently discharged patients are being treated in emergency departments (EDs)—without being admitted—as well.

Factoring in the 0.4 percent increase in ED visits within 30 days of discharge, the fall in the percent of discharged patients returning to hospitals for urgent problems is only 0.3 percent over the past three years — less than one-third of the improvement that CMS claims. And even this 0.3 percent overall fall may be partly an artifact of hospitals’ “upcoding” (exaggerating the severity of patients’ illnesses), which boosts diagnosis-related group (DRG) payments, and could also corrupt the formula used to risk-adjust expected readmission rates.

For patients discharged after heart attacks, the urgent return rate has actually risen slightly; the reported 1.8 percent fall in readmission is more than offset by a 0.7 percent increase in observation stays and a 1.2 percent increase in ED visits.

These aggregate figures surely hide vast differences among hospitals. Some hospitals have undoubtedly reduced readmissions by doing the hard work of fully stabilizing fragile patients prior to discharge, improving communications with outpatient providers, assuring diligent follow-up, etc.

But others appear to be hitting their readmission targets mostly by gaming the system — re-labeling rather than re-designing care. Medicare rewards both approaches equally, but for hospitals, re-labeling is probably far cheaper (and more profitable) than re-designing.

Medicare’s readmission penalties are among the growing number of pay-for-performance (P4P) and value-based purchasing initiatives that offer bonuses to high performers and/or penalize the laggards. We previously pointed out that the evidence for this carrot and stick approach is unconvincing. More recently, a long-term follow-up of the English hospital P4P program found that P4P generated no improvement in patient outcomes, damping the enthusiasm generated by the rosy short-term findings, and reinforcing the need for skepticism.

Adopting unproven everywhere P4P strategies that have been proven nowhere risks quality failure on a monumental scale. It pressures hospitals to cheat, saps doctors’ and nurses’ intrinsic motivation to do good work even when no one is looking, and corrupts the data vital for quality improvement.

As the graffiti artist Banksy once said: “Become good at cheating and you never need to become good at anything else.”

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Implementing Health Reform: New Guidance On Reenrollment Of 2015 Enrollees (Updated)

August 28 update: On August 27, 2015 the Centers for Medicare and Medicaid Services (CMS) published a notice that it is seeking emergency clearance from the Office of Management and Budget (OMB) for modifications to an information collection request currently approved by the OMB for collecting information from insurers under the medical loss ratio and risk corridor programs.

CMS claims that additional and more detailed information is necessary to validate data that insurers have already submitted to CMS, to resolve significant discrepancies in the 2014 benefit-year submissions, and to address a number of common errors that may lead to submissions that do not comply with CMS guidelines. Without this information, CMS states that it will be unable to verify the accuracy of submissions and validate the data needed to operate the risk corridor program.

All qualified health plan insurers that submitted risk corridor data will be required complete a risk corridor checklist that will be available at the CMS Paperwork Reduction Act website. If a company cannot verify the accuracy of its submitted MLR/risk corridor data on the checklist, it must resubmit accurate data by September 8 or 14 as instructed by CMS.

In addition, companies that are requested to do so by August 31, 2015 must complete a risk-corridor discrepancy worksheet. Both reports must be submitted online. The discrepancy reporting worksheet relates to discrepancies between the MLR/risk corridor report and the reports that were submitted for the reinsurance program.

One issue that CMS seems to be focused on is companies that had an unusually high number of claims that were submitted in 2014 but not paid by March 31, 2015. Dollar figures submitted by insurers with respect to premiums and claims are expected to be accurate to one quarter of one percent.

It is perhaps not surprising that implementation of a program as complex as the risk corridor program would have led to complications in its first year of operation. The final deadline for approval of qualified health plan rates by state insurance departments, however, was August 25, 2015, and without information on the risk corridor contributions and payments of particular insurers, states cannot be certain that the rates they are approving are appropriate.

CMS has not yet to my knowledge publicly announced how it will deal with this issue.

August 27 update: On August 24, 2015, the Centers for Medicare and Medicaid Services (CMS) released a Guidance Regarding Training, Certification, and Recertification for Navigator Grantees and Certified Application Counselors (CACs) in the Federally Facilitated Marketplaces (FFMs).

CMS regulations require all navigators in FFMs to complete Department of Health and Human Services (HHS)-approved training and pass a certification examination before being certified, and to be certified or recertified on an annual basis, Navigators must also meet permissible state licensure or certification standards.

Certification for navigator staff and volunteers who completed training during the 2014-2015 grant period expires on September 15, 2015. In order to continue to perform as a navigator after September 15, FFM navigators must either complete the entire 2016 navigator training program or, depending on the circumstances, the 2016 recertification training program.

Navigators working for organizations that received a no-cost extension continuing after September 15, 2015, but are not awarded a navigator grant for the 2015-2018 project, will lose their certification when the no-cost extension ends and may not hold themselves out as navigators after that point. Navigators with programs that have applied for a 2015-2018 grant, but do not have a no cost-extension from 2014-2015, are advised to hold off until navigator program awards are announced early in September.

Navigators who were certified for 2014-2015 and not decertified and who are still with the same organization can be recertified by taking an abbreviated 2016 training program consisting of two modules, one on “SHOP Marketplace Assistance” and the other on “Privacy, Security, and Fraud Prevention Standards.” These modules are updated from last year.

Recertified navigators may continue to perform their duties if their organization receives a 2015-2018 grant or a no-cost extension. Navigators who have not yet been certified or who were certified during the 2014-2015 period, but were either decertified or have become affiliated with a different organization than the one with which they were affiliated for 2014-2015, must take the entire 2016 certification training program, which consists of 15 modules and takes about 20 hours to complete.

Certified application counselors must also take marketplace-approved training programs, pass the CAC certification examination, and meet permissible state licensure or certification requirements. The CAC training consists of six modules and takes five to 10 hours to complete. CACs may also complete additional navigator training modules if they choose to do so.

CACs are certified by their organizations for one year and must be recertified by their CAC organization within one year of their initial certification. CAC organizations are encouraged to have their CACs complete the 2016 training before the 2016 open enrollment period begins even if the CAC is not due for recertification.

CACs must take the full CAC certification training — there is no abbreviated CAC recertification training available. CAC training was not available between June 15, 2015 and August 26, 2015 so CAC organizations with CACs who were not recertified during this time period will not be considered out of compliance with HHS requirements if they complete training by September 30, 2015.

CAC organization agreements renew automatically each year unless the organization or CMS terminates or fails to renew the agreement. CACs are not required to enter into new agreements with their CAC organization, but CAC organizations must ensure that all their CACs are in compliance with HHS requirements and that the certification of their CACs is current.

CAC organizations must disclose to their CACs any non-disqualifying conflicts of interest that they have so that the CACs may further disclose the conflict to consumers. CACs are not required to inform CMS as to which CACs they have or have not certified or recertified.

New Guidance On Reenrollment Of 2015 Enrollees

Original post: On August 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released on its REGTAP website a guidance for insurers on reenrollment of 2015 enrollees through the federally facilitated marketplace (FFM) for 2016. The guidance is quite technical and includes little non-technical information that has not already been released, in particular in CMS’s April 22, 2015 reenrollment guidance. The August 25 guidance, however, presents a particularly detailed roadmap of how the 2016 open enrollment period will work for qualified health plan (QHP) insurers, and is thus worthy of a description here.

Defining Reenrollment

First, some definitions. Reenrollment is the process though which the FFM ensures that an insurer continues an enrollee’s QHP coverage from one plan year to the next. Reenrollment may be in the same product or in a different product if the original product in which an enrollee was enrolled is no longer available. Renewal is reenrollment in the same product. Active enrollment occurs when an enrollee returns to the FFM to submit an application and select a plan for the next year. Passive enrollment or auto-enrollment is reenrollment initiated by the FFM for current enrollees who do not return to the FFM to submit an application and select a plan by December 15, 2015.

Enrollees who do not actively reenroll by December 15, 2015 will have their eligibility redetermined for 2015 based on the most recent income information available on the FFM regarding the enrollee and on updated Federal Poverty Tables and benchmark plan premium information. The FFM will send current 2015 enrollees not scheduled for termination a notice prior to the open enrollment period describing the annual redetermination and reenrollment process, their obligation to update their information with the FFM, and the process the FFM will follow to update advance premium tax credit and cost-sharing reduction (CSR) eligibility for those who fail to actively reenroll.

Enrollment Notices

Particular notices will be sent to three groups of individuals:

• The Opt-Out Group who have not authorized the FFM to access their tax data, for whom eligibility updating will not be possible unless they actively return to the FFM;
• The Special Notice group whose tax information reflects an income of more than 500 percent of the federal poverty level, who must reestablish eligibility with the FFM for APTC or CSR; and
• The Failure to Reconcile Group, who have did not file taxes or reconcile their 2015 advance tax credits for 2014, and who must be terminated from coverage if they fail to do so before the end of 2015.

The third group promises to be quite large. Individuals in these groups will generally be reenrolled in coverage for 2016, but will not receive tax credits or cost-sharing reductions unless they actively reenroll, and for the failure to reconcile group, file their taxes and reconcile their 2014 tax credits.

Guidance For Insurers

Insurers will get a list of their enrollees that fall into one of these three groups, although it will just be a single list not broken down into the three categories. The guidance includes talking points that insurers can use to reach out to the enrollees on this list, advising them how to address each of the potential issues that may affect them. Of particular importance is getting individuals who have not yet filed form 8962 to reconcile their 2014 tax credits to file their taxes and the form. Once they have done so, they must return to the FFM after open enrollment begins on November 1, 2015, to update their 2016 application, as the FFM will not have a record of their filing their taxes if they have only just done so.

The FFM will passively auto-enroll 2015 enrollees who continue to be eligible for coverage for 2016 and do not actively enroll, if their QHP insurer has provided the FFM with a 2016 reenrollment crosswalk template to indicate in what plan the 2015 enrollees will be reenrolled. 2015 enrollees may also actively reenroll for 2016 between November 1, 2015 and December 15, 2015 for coverage beginning January 1, 2016, even if their 2015 coverage was terminated prior to December 31, 2015, for instance for non-payment. The FFM will provide returning 2015 enrollees with a pre-populated application that they can use to update their eligibility.

The FFM will send passive reenrollment transactions to insurers in two waves, one beginning around October 15, 2015 and the other beginning around December 16, 2015. Most reenrollees will be included in the first round, giving insurers time to prepare reenrollment notices to those who are passively reenrolled. Enrollees will not be given any indication that they are being reenrolled, however, until December 16, 2015 to encourage them to return to the FFM before that date to actively reenroll. Insurers will not inform enrollees that they have been passively reenrolled until the insurer sends out the January billing notice.

The second wave of passive reenrollments will include newer enrollees who began enrollment after the first wave of passive reenrollments were executed as well as enrollees who for whatever reason, including pending data-matching issues, needed additional time to complete an action before they could be reenrolled. Enrollees who are still in the 90/95 day grace period for resolving data-matching issues at the end of the 2015 plan year will be reenrolled passively for 2016, with a set date in 2016 for their coverage to expire if the issue is not resolved.

The guidance describes in detail the transactions that will be exchanged between the FFM and insurers and the codes that will be used for those transactions during the reenrollment period. Active reenrollments that result in a plan change will result in an 834 transaction being sent both to the losing and gaining plans. Most 2015 enrollees will be passively reenrolled by the start of open enrollment, so active enrollments that result in changes of plan will result in a cancellation by the plan in which the individual has been passively reenrolled. Active reenrollment in the same plan will also result in an active reenrollment transaction.

If an individual actively reenrolls after December 15, 2015, the FFM will terminate the passive reenrollment the day before the actively selected plan becomes effective. Agent/broker National Producer Numbers (NPNs) will be sent on passive reenrollments and pre-populated for 2016 reenrollment, but can be removed or edited by the applicant and will be superseded by any NPN entered through a reenrollment application. Information on assisters who are not agents or brokers will not be included for passive reenrollments but will be sent on active reenrollments.

Beginning in early November and daily through December 22, 2015, the FFM will send insurers “switch files,” which will cumulatively list the insurer’s current subscribers who have switched to another insurer but were not passively reenrolled. It will not include subscribers who were passively reenrolled and then switched (who will be covered by a cancelled passive reenrollment 834 transaction) or enrollees who actively reenroll in a 2016 plan offered by their 2015 insurer.

Passive Reenrollment

In exceptional circumstances, a passive reenrollment may be cancelled because the enrollee’s coverage terminates before the end of 2015, for example for nonpayment. A passive enrollment may also be cancelled if a current enrollee actively reenrolls opening a new account rather than using the FFM’s pre-populated application, thus creating a duplicate enrollment.

At any time during open enrollment (up until January 31) an enrollee can change plans, resulting in a cancellation of any plan in which the enrollee is actively or passively reenrolled. If an enrollee reports a life change, such as the addition of a baby or spouse, before December 15, it will be reflected in a passive reenrollment. An individual passively reenrolled in the October 15 wave may be reenrolled again passively in the December 16 wave if life changes are reported in the interim.

Enrollees who are passively reenrolled during the first wave will have pre-populated application forms available at Healthcare.gov if they choose to update their eligibility information and reenroll. Their account will not reveal their passive reenrollment prior to December 15, but the plan in which they are passively reenrolled will be in “saved plans” in Plan Compare. The 2015 tobacco rating status will remain the same for 2016 passive reenrollments unless it is changed by the enrollee.

If an insurer receives neither an active nor passive reenrollment for a current year enrollee, and the enrollee is not on the switch file and does not have a late current year termination, the insurer should search to see if the enrollee has enrolled with a new FFM-assigned identification or as a dependent of another enrollee. If the enrollee cannot be found enrolled under a different number, the insurer should attempt to contact the enrollee. If the insurer locates the enrollee and the enrollee wishes to continue coverage, or if the enrollee continues to pay his or her premium, the insurer should advise the enrollee to contact the FFM to straighten things out and in the interim the insurer should continue coverage based on the most recently available information as to tax credit and cost-sharing reduction eligibility.

Insurers are not required to collect a binder payment from enrollees who are reenrolled in the same product or in a new product because the original product is no longer available. If an enrollee fails to pay the premium for the first month of 2016, the reenrollee is entitled to a 90-day grace period before termination. Binder payments are required to effectuate coverage for enrollees who change products, for new enrollees, and for returning enrollees who did not have continuous coverage with the insurer.

After December 15, 2015, the FFM will send 2015 enrollees information about their 2016 enrollment, indicating if they were passively reenrolled and whether financial assistance was applied. If the individual was not passively reenrolled, the FFM will encourage him or her to contact the FFM to actively reenroll. Insurers must also send enrollees notice as to products they are discontinuing or renewing in accordance with earlier guidance.

Despite Pockets of Resistance, Most U.S. Kids Getting Vaccinated

Health officials call the finding heartening, but worry about lingering opposition to inoculations

Many Parents Unaware of Dangers E-Cigarettes Pose to Little Kids: Survey

Users should store liquid nicotine where small children can't find it, researchers say

Can We Tame The Wild West of Health Care Pricing?

By TORBEN NIELSEN

Health care pricing is like the Wild West and it is only a matter of time before it catches up with us. In July, the Centers for Medicare & Medicaid Services (CMS) confirmed what many consumers, employers and health plans already knew: there is no cost and quality standard in the American health care system.

Improving our system starts with driving payers and consumers to high value providers. But first, we must know who is charging what. Price transparency tools offer that important information, enabling people to actually comparison shop for their health care services.

In early July, CMS released a proposed rule aiming to address price variation by starting with joint replacements. According to CMS, there were more than 400,000 Medicare inpatient joint procedures, resulting in more than $7 billion in hospitalization costs in 2013. The average Medicare expenditure for surgery, hospitalization and recovery ranged from $16,500-$33,000 depending on geography, with widely varying rates of infection and implant failure post-surgery.

To address this variation, CMS outlined a new payment model that would make some hospitals accountable for the costs and quality of care from the time of surgery through 90 days after. Based on their performance on cost and quality metrics, participating hospitals would either earn a reward or be required to repay some of the Medicare costs.

This is a step in the right direction, but policies that target only one program, like Medicare, ignore trouble spots in other areas, including the employer and commercial markets.

CMS’ proposed rule on joint replacements, for example, does not address broader issues with price variation that impact our system as a whole. As indicated below in Figure 1, HealthSparq’s data shows that hip replacements are more costly in the commercial market than in Medicare, with costs ranging from $26,000 – $49,000 in 2013. California, Texas and parts of the Northeast are at the upper end of the cost spectrum, while parts of the Midwest and Mountain region are at the lower end.

Figure 1. Cost Variation for Hip Replacements in Commercial Market

In addition to higher overall costs in the commercial market, data shows that hip and knee replacements are increasing exponentially among patients 45 to 64 years old, many of whom receive health insurance coverage from their employer or a commercial plan. When combined with higher costs, the increased service volume among this population suggests that the total costs associated with joint replacements in the commercial market may exceed costs in the Medicare market.

Given the challenges we’ve discussed, consumers are using price transparency data in the commercial market to fend for themselves. Working with over 70 health plans and reaching a total of 72 million beneficiaries, HealthSparq has unique insight into consumer shopping behaviors and the types of information consumers are using for health care decision-making.

Our data on joint replacements shows:

• Consumers want to know how much their joint replacements will cost. Viewing of cost estimates related to hip/knee replacements are in the top five of more than a thousand different searches viewed by consumers on our cost estimator over the last year.
• Consumers know that prices may vary across facilities. Approximately 54 percent of the hip/knee replacement cost estimates requested by consumers also included a request for facility-specific information.
• Consumers are using price data to compare prices at different facilities. Approximately 38 percent of patients requesting a facility-specific estimate did so for more than one facility. This is evidence of shopping behavior.

To tame the Wild West and improve the health care system, payers and consumers must use all of the tools at their disposal, including health care shopping tools. Transparency helps consumers better navigate health care, while allowing plans, providers, and employers to identify and steer patients toward opportunities for savings when medically appropriate. It also helps consumers understand quality, timeline and more.

Let’s use health care shopping tools to put the days of pricing duels and shootouts behind us. Consumers deserve a better health care system.

Torben Nielsen is SVP of Product and Strategy, HealthSparq

What Should Public Health Officials Be Doing About E-Cigarettes?

Are electronic cigarettes a safer alternative to combustible cigarettes, or are they a new gateway to a lifetime of nicotine addiction? In the past month, the editors of The New York Times noted the opposite conclusions from the British agency Public Health England that reported e-cigarettes can reduce the health risks of smoking by 95 percent, compared to a study in the Journal of the American Medical Association, which showed that ninth graders who tried e-cigarettes were far more likely to then use regular combustible tobacco within a year.

In a step that may help resolve this controversy, the Food and Drug Administration (FDA) is soon expected to pass federal e-cigarette “deeming” regulations, which are so named because the Family Smoking Prevention and Tobacco Control Act of 2009 grants the agency oversight authority for additional tobacco products that it “deems to be subject” to the Act.

But while the debate they have ignited is new, electronic cigarettes themselves are not. The patent for their first prototype was issued in 1963, and the tobacco industry was approached decades ago with this technology as an alternative to cigarettes. Not until nearly a decade after the 1998 Tobacco Master Settlement Agreement did the tobacco industry become interested in e-cigarettes, best displayed by their recent acquisition of many of the smaller e-cigarette manufacturers.

This delay leaves some to wonder: why didn’t Big Tobacco champion e-cigarettes much earlier if they truly believed them to be “harm reduction” devices? In the following blog post, I suggest five key steps that policymakers, regulators, and public health advocates should take on e-cigarettes.

E-Cigarettes And The Ongoing Public Health Battle On Smoking

The public health effort regarding e-cigarettes has evolved in the reverse order of most other medical interventions. Framed as an innovation, e-cigarettes entered the American marketplace in 2007 touted as a possible smoking cessation tool, without being subject to the rigorous clinical safety and efficacy evaluation that are required before FDA approval of a new medication or device.

Breaking the addiction to nicotine is difficult, even with the assistance of the nicotine patch, gum, or prescription medication, which is why preventing Americans from becoming addicted to nicotine in the first place has been and should continue to be a top public health priority. Only about 6 percent of smokers stop smoking each year with existing smoking cessation aids, and several research studies have shown that e-cigarettes are not particularly more effective, with a low quit rate of only around 7 percent.

There may be a silver lining, however, in that patients treated with placebo e-cigarettes without nicotine were nearly 60 percent as successful at quitting as those given e-cigarettes containing nicotine, suggesting that the removal of the nicotine in e-cigarettes (as has been done in other nations) could be a future public health strategy in America.

In 13 countries worldwide, e-cigarettes have been banned, in part due to their potential for promoting drug abuse in addition to nicotine addiction, since marijuana and other illicit substances can be vaped as well. In New Zealand, it is illegal to sell any e-cigarette that contains nicotine, and e-cigarettes containing placebo only are sold primarily in pharmacies. Perhaps the FDA can also incorporate these insights gleaned from the worldwide experience with e-cigarettes into the final deeming regulations?

In 2015, many unanswered questions remain regarding the dangers of e-cigarettes, both to smokers and those around them, but some initial myths have also been dispelled. Two initial claims by e-cigarette proponents: that there are not any carcinogens in e-cigarettes, and that the secondhand vapor does not contain nicotine or other toxic chemicals, have both been proven incorrect.

Scientific studies have characterized the toxicity of e-cigarettes, particularly in the exposure to propylene oxide, metals, and formaldehyde. As a novel innovation, e-cigarettes also pose unique health hazards not associated with traditional cigarettes. Calls to poison control centers by concerned parents have dramatically increased across America after the accidental ingestion of liquid nicotine by children, and other users have inadvertently instilled the e-cigarette fluid into their eyes after mistaking the storage bottles for eye drops.

The consequences and toxicity of direct contact of liquid nicotine on skin need to be better understood. Malfunctioning e-cigarette batteries and accidental activation of the heating element have spontaneously ignited fires in homes, on airplanes, and in high school gymnasiums, which prompted the issuance of a 2015 Federal Aviation Administration (FAA) Safety Alert recommending a ban on e-cigarettes in checked baggage. New research will characterize the potential effects of e-cigarettes on surgical patients, and explore the combined effect of inhaled propylene glycol, acetaldehyde, and metal particles upon perioperative anesthetic and respiratory outcomes.

A Safer Product Is Not Necessarily Safe

The claim that e-cigarettes are safer than traditional combustible cigarettes should thus be approached with caution, as safer is not the same as safe. Combustible cigarettes remain one of the most lethal products for sale in America — more than 10 times as many U.S. citizens have died from cigarettes than in all the wars fought in American history. Since the first Surgeon General’s report on tobacco in 1964, over 20 million Americans have succumbed to tobacco’s deadly toll, and countless more lives and families have been harmed. In many industries, the identification of a safer alternative to a dangerous product would trigger a recall, and discontinuation of the manufacture and sale of the more dangerous item.

In the fall of 2014, the tobacco industry voluntarily decided to place dire warning labels on e-cigarettes regarding their health risks and potential for promoting nicotine addiction. This action was reminiscent of the sudden shift in the tobacco industry’s stance towards combustible cigarettes after the 1998 Tobacco Master Settlement, and perhaps reflects the recognition by tobacco industry scientists of the new hazards posed by e-cigarettes and related legal liability?

The tobacco industry has asserted that e-cigarettes are not a tobacco product and therefore not subject to either regulation or taxation under the Tobacco Master Settlement, though the World Health Organization (WHO) has reported that 22 nations worldwide regulate e-cigarettes as a tobacco product. Some perceive the tobacco industry’s current efforts in State Capitols as seeking to ensure that e-cigarettes are not defined as a tobacco product in American legislation and to bypass FDA regulation a second time.

A new federal definition of “tobacco products” to include e-cigarettes might be an appropriate action to standardize the variable definitions by states across America. Funding the research and development endeavors to answer the unresolved questions about e-cigarette safety and efficacy is both costly and time consuming, and the burden of proof should have been required of manufacturers before their introduction into the marketplace.

The number of grant applications about e-cigarettes to California agencies, such as the University of California’s Tobacco-Related Disease Research Program that allocate grant dollars raised by taxes on combustible cigarettes, have increased significantly. A direct tax on e-cigarette companies could help fund the ongoing research into these unanswered questions about e-cigarettes.

Finding Common Ground

As ongoing research further characterizes the public health hazards of e-cigarettes, tobacco control advocates and Big Tobacco should identify areas they can agree on. One such area is not imperiling youth to the harm of cigarettes and nicotine addiction. Marketing of e-cigarettes to children, through product placement in film, television, and magazine advertisements that portray e-cigarettes as hip and cool, and using cartoon characters once used by Big Tobacco to attract young smokers, should end.

Use of e-cigarettes tripled among middle and high school students from 2013 to 2014, along with a significant increase in the use of hookah. While the share of high school students who smoke traditional cigarettes fell to 9 percent, the concern is that about a quarter of all high school students, and 8 percent of middle school students reported using a tobacco product in 2014, representing the first increase in years.

Another area that should be agreed upon is the need to exercise caution to safeguard the health and safety of the public. Over the past years, anti-smoking advocates have become concerned that the expansion of e-cigarettes risks renormalization of cigarettes, potentially reversing decades of success in tobacco control.

To protect the health of the public, clean indoor-air laws should not be weakened by allowing the increased use of e-cigarettes in public areas where conventional smoking is prohibited. The FAA is also currently considering a complete ban on the use of e-cigarettes on airplanes, both to improve air quality and avoid accidental fires during flights.

E-Cigarettes And The Path Forward

Moving forward, policymakers, regulators, and public health advocates should take five key steps on e-cigarettes with the health and safety of the public in mind:

1. Public health organizations, such as the American Cancer Society, American Lung Association and American Heart Association must work together to organize the scientific evidence to assist the FDA Commissioner to finalize the FDA deeming regulations.

2. In advance of the release of the FDA regulations, Congress should prepare a legislative plan to supplement any gaps in the agency’s authority and resources. In March 2015, Congresswoman Jackie Speier (D-CA) submitted H.R. 1517 “Stop Selling and Marketing to Our Kids E-Cigarettes Act (the SMOKE Act)” to give the FDA the added authority to regulate e-cigarettes as tobacco products, require warning labels and child proof packaging, and prohibit advertising to minors. Congresswomen Rosa DeLauro (D, CT) and Elizabeth Esty (D, CT) later proposed H.R. 3042 to close loopholes in the sales of e-cigarettes to minors, particularly online. These bills can provide the foundation for companion legislation to be submitted this fall.

3. The smaller e-cigarette companies should follow the lead of Big Tobacco and place a warning label on their products both in America and worldwide.

4. The FDA should change who sits on its Tobacco Products Scientific Advisory Committee, and reducing the number of tobacco industry representatives should be considered.

5. Finally, the White House Office of Management and Budget should be prepared to score new legislation seeking to tax e-cigarettes, with the revenue directed towards scientific research, and to offset the costs associated with ongoing oversight and law enforcement. Minnesota and North Carolina have led the way by imposing taxes upon single use e-cigarettes and liquid cartridges (e-juice). Just this month, a 30-percent excise tax on the wholesale price of e-cigarettes went into effect in Montgomery County, Maryland. The opportunity exists to separately tax each of the key components of a reusable electronic cigarette, such as the refillable delivery device and the liquid nicotine. The greatest tool to discourage smoking over the decades has been taxes on traditional cigarettes. This success should now be extended through taxes on e-cigarettes to help defray the health care costs of those e-cigarette users who become addicted to nicotine through their use, and to fund ongoing investigations into e-cigarette safety.

The debate over the dual nature of electronic cigarettes will be answered with time. In the final analysis, e-cigarettes will likely be proven to be a smoking cessation aid for some. But this benefit must be balanced with the fact that other adults and children who never previously smoked will be first introduced to nicotine via an e-cigarette rather than a traditional combustible cigarette, and others will use both e-cigarettes and regular cigarettes in a “dual-use” fashion. Therefore, any efforts to disseminate electronic cigarettes as a potential smoking cessation tool by Big Tobacco should also be combined with a coordinated strategy to reduce, and perhaps even phase out the sales of traditional combustible cigarettes in America over the years.

Tobacco control advocates should take comfort that a wave of e-cigarette regulation to prohibit e-cigarette use indoors has swept through City Halls in New York, Chicago, Los Angeles, San Francisco, and nearly 100 cities across America. More than 40 states have banned e-cigarette sales to minors. These efforts have been joined by the Attorney Generals of 40 states, the Senate and the Senate HELP committee, the World Health Organization, and the American Heart Association in the call for oversight into these nicotine delivery devices.

Building on these efforts, model legislation should be developed by policymakers in collaboration with tobacco control advocates to catalyze the rapid adoption of new laws in City Halls and State Capitols to regulate and tax e-cigarettes across the nation to promote the health and safety of the public.