Monday, February 29, 2016

Jack and the Green Sprouts, Inc. is Voluntarily Recalling Alfalfa and Alfalfa Onion Sprouts - FDA Safety Alerts & Drug Recalls

State health and agriculture officials are investigating an outbreak of food borne illness. Retailers and restaurants should not sell or serve alfalfa sprouts and consumers should not eat them at this time.

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CMS Acting Administrator Andy Slavitt’s Comments before the Federation of American Hospitals - CMS Blog

Welcome to Washington! I could tell you stories… Not long ago I was where you were– in the private sector attending conferences. Now, after a lot of years in health care, I ended up here where I find myself focused on the role CMS can play to be a productive and simplifying force at a time when all of us in health care are going through substantial and dramatic changes. Newly eligible consumers … different payment models … technology advances … more care integration … new requirements. Even change we welcome represents new challenges and the sheer volume of change has driven us all into implementation mode. From the not-so-distant past, I remember how CMS often felt opaque to me and I probably said more than once how helpful it would be to know CMS’s agenda rather than divining them by poring through an often intricate set of regulations so my commitment to you is to talk straight and engage in real dialogue. In my time left at CMS, likely under a year, I’d like to focus our culture on closing the gulf between the transformative policy agenda that happens here and the realities of care delivery in the real world. We can do that only by listening and continually improving what we do. And in the midst of this, I see it as a great time for hospitals to not only advocate for what you want, but strategically plan for the changes we see ahead.

So today, I’ll lay out our 2016 agenda specifically as it relates to our work with the hospital community in three parts.

  • first is how hospitals can participate with us in what I will call the “retailization” of health care;
  • second is how we can advance our care delivery payment initiatives in ways that really advance the ball on care;
  • and third, and perhaps as important as anything, is how CMS can be a better, more responsive partner to you by listening and simplifying.

The agenda starts with our shared priority: understanding how we receive care today in America where the consumer is more diverse, more mobile and more demanding than ever before. The consumers CMS serves represent our country’s needs as a whole– 140 million Americans– most on fixed or low incomes in every type of care situation–

–the Medicare patient leaving the hospital with five prescriptions to fill and 2 appointments to book,

–the marketplace customer who will have coverage for the first time and finally be able to have his wife’s chronic fatigue looked at,

–the daughter who has made the difficult decision to move her mother in a nursing home,

–the Medicaid patient waiting for her kidney transplant and managing to make it to dialysis for most appointments,

–the cancer patient who has decided he wants to be treated at home in more comfort.

–the family with a child with disabilities on Medicaid that requires 24 hour care and is watching every dollar and interviewing every home care worker.

These are the people we serve every day and these are the people I wake up every day thinking about. Since my email address is available to the public, I’ve now learned that many of them wake up every day thinking about me too.

As I read the many emails beneficiaries send me, I see that even in a wide diversity of circumstances, everyone is hoping for the same basic things from the health care system: to get care they can afford, to keep their family well taken care of, to have some understanding of what comes next, and when they’re sick, they want nothing more than to get them home and return them to as productive and healthy life as possible.

1.Retailization

Many hospitals have led the tremendous, nationwide effort to enroll people in new Marketplace or Medicaid coverage. And I thank you and congratulate you. Covering over 17 million newly insured Americans over the last few years is as profound a change as most of us have seen in our careers. Health care coverage says a lot about who we are as a country and is not only a more financially sensible way to get people care, but I know I speak for many that it provides a more moral and humane underpinning to how we feel about our industry. 

New coverage must only be the start of things. We have the opportunity to change health in America like we did 50 years ago at the dawn of Medicare and Medicaid, back when 1/3 of seniors lived in poverty to a time, now, when less than 10 percebt of seniors live in poverty. When people have insurance, their lives change in profound ways– from being able to access preventive care to being able to afford the prescription drugs for their chronic condition, or no longer worrying about the financial threat that would accompany a cancer diagnosis. And there are of course the economic effects – like reducing uncompensated care and hospital bad debt – which I will come back to in a moment.

But as I thank you, I want to openly discuss the next opportunities in a retail world. We are all used to living in a wholesale world where employers and health plans sit on the other side of the table from you to negotiate for better prices and new types of contracts. But what if we were all of the sudden living in a world where millions and millions of consumers carried that clout as their own agents and could ask for the things that were right for them and their families? In other words, are you ready to respond to a fully retail world?

Do you see this shift? Well, it’s already happening. Consumers on the exchange are every day allowing you to see the most valuable commodity of all– the voice of your customer. Here’s what I mean. Consumers are already now selecting their plans not by looking at the plan first– but first selecting a hospital or physician or prescription they want . . . then looking at which health plan offers them. 3.6 million times this happened in the last 3 months in just the 38 Federal marketplace states. They are shopping for their health care, not their health coverage.  And it’s only a matter of time before the price of the hospital service and the quality score is known to them when making this decision. And even more compelling, 70 percent of renewing consumers on the Federal exchange– seven-zero— came back to the exchange to actually choose a plan at renewal instead of accepting automatic enrollment. These are millions of opportunities for consumers to find you every open enrollment.

What do they want? Consumers are screaming that affordability matters more to them than it does to employers when they act as their agents. 90 percent of people have selected bronze or silver plans. This compares with fifteen percent as the highest anyone has seen in traditional employer markets. And consumers typically want affordability– those who switched plans saved over $500/month. So if consumers want savings, what do they appear to be willing to compromise on? According to a Kaiser Family Foundation report last May, consumers would much prefer a narrower network to a higher deductible or higher premium. This means we all need to be a part of reducing premiums– governments with subsidies, health plans with MLR limits, and you as you respond to their direct feedback.

So one important decision for many hospitals is how to participate and what is the right pricing strategy. One approach is a “just say no” approach and treat exchange consumers like any other managed care negotiation. The other approach is to create a more aggressive “retail strategy.” Part of a retail strategy begins with acknowledging that unlike what most of us assumed– the exchange market developed alongside of, not in place of, the employer market. Many hospitals set their rates as if the Marketplace would be replacement business, not an additional market. Revisiting that assumption I believe gets you to a more marginal pricing approach for Marketplace business befitting the lower-income individuals who are 80 percent plus of the exchange population.

A retail strategy calls on you to imagine you are negotiating directly with a cash paying consumer who used to be a source of bad debt– except one who now has the wherewithal to pay for services and wants to build a relationship where they can also find elective, outpatient and wellness services. A retail strategy offers you the opportunity for innovation to meet the customer need. It may mean taking less and seeing more patients in response to their affordability preferences. It may mean partnering with smaller plans or offering your own exchange plans or other strategies you think of to build your retail business. Ultimately, consumers will reward providers who want their business and have a strategy to get it. Sounds like how retail markets work.

But retail won’t stop there. Consumers will want better service and fairer service, and will likely be less tolerant of things that don’t work well for them. When the auto mechanic tells you that your $3000 estimate turned out to be $10,000, you probably won’t go back. Hidden charges, for things that happen in the ER or when the anesthesiologist is out of network and has separate charges, won’t be tolerated. The promising news is that leaders always emerge– and I am beginning to have conversations with hospitals and physicians who want to lead the charge so there are no more consumer surprises in their hospitals. Those that make that promise can expect to be rewarded by consumers. The retail world is emerging and with it, there is new opportunity.

2. Delivery system reform

Access is one thing, but unless that access is to a better quality health care system, we are not going to succeed. So let me talk about our agenda for advancing new payment models that reward for quality and value. A year ago, we committed that by 2018 we will reach a point where over 50 percent of Medicare FFS payments will be in new models like ACO. Many CEOs and CFOs tell me that the “tipping point signal” is helpful. Living in a fee-for-service world today while preparing for a payment system that rewards more coordinated, more value-oriented care that is emerging is challenging. This commitment from us should help galvanize your organizations in the right direction. Change often boils down to practical decisions on where to invest and we aim to make the case that the investments you are making in a quality programs and population health will carry a greater return than another expensive MRI machine or a new wing in the hospital.

We see payment models not as an end, but rather as a tool to help you increase communication, coordination and improve patient care. On April 1, we are launching a large scale pilot to connect and coordinate care for patients having joint replacement surgery. We are excited about how many hospitals are redesigning care and focusing on whole patient episodes of care. Already hospitals and surgeons are telling us of new communication and data sharing relationships with post-acute facilities. This speaks not only to better care but also retail health care centered on the patient. We also just announced both the expansion and advancement of new ACO models. There are now over 475 total ACOs with 30,000 participating physicians and 8.9 million beneficiaries around the country. And, 64 representing 1.6 million people, are in 2-sided or full risk models, up from 19 just last year and zero before the Affordable Care Act.

Where do we go from here? We have been bringing a focus on outcomes to every area where a consumer or beneficiary of CMS seeks care– from the physician’s office to the hospital to home health. In 2016, the implementation of the bi-partisan MACRA legislation will touch more and more specialties and create more incentives for to join alternative payment models. One area still largely untouched is pharmaceuticals. How we bring this same thinking on value into the development and prescribing of medications is on the agenda in 2016. We have received a lot of input as we have laid out the need as a country to be able to drive innovation and new cures but also promote access to medication for all patients who need them.

3. Listen to what’s happening on the ground 

The third part of our agenda is about our commitment to improving the lines of communication that allow us to close the gap between policy making and the realities of frontline care delivery.

CMS has significant responsibility for implementing new laws which must intersect with an already complex system with many demands. And so good policy must be ultimately informed by the impact it has at the kitchen table of the American family and in the clinic or office where they seek care.

We have several important initiatives:

–We will focus specifically on policies that impact rural health and have established the Rural Health Council which will have three areas of focus in policy coordination and strategy: access to care issues, the economics of rural health care, and promoting innovation across rural America. The council will host a Rural Health Open Door forum call every six weeks to update you on new CMS policy and initiatives, and at one of our upcoming sessions, the Council will seek input into our very important 2016 agenda.

–We will continue our commitment to iteratively improving the new care delivery models we release. Our newly launched Next Generation ACO model is a good example. It contains the features you have told us would best enable you to coordinate care, including innovative options like telemedicine, home visits, and direct patient incentive and engagement options. We also clearly heard that hospitals want us to fundamentally re-think the benchmarking and rebasing methodologies in our Shared Savings ACO models. We published a proposed rule that reflected a lot of the input we received, and we are now receiving comments.  While these models will never perfectly represent the best way to capture the quality and cost performance of a hospital, they should be the early generation tools that can act as the change management opportunities to move towards more coordinated care in your community.

–To be truly responsive, we must lead a simplification kick to reduce burden and give physicians back more time to spend with patients. Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over five years on burden and regulatory reduction. But we are barely scratching the surface. The work we’ve done recently over the 2 Midnight policy reflects the result of receiving significant feedback and is intended to create more discretion for care providers and move the RAC program from a “gotcha” feeling to a more educational and partner-oriented approach using QIOs. We will watch the results from these changes closely in hopes that we can demonstrate that collaboration will lead to better results without driving up inappropriate costs.

–On the technology front, tonight Secretary Burwell will be speaking at HIMSS about the role of technology in improving care delivery and tomorrow night, I will be joined by Karen Desalvo, of ONC, to talk about how we are working together to push initiatives to promote interoperability, simplify requirements, and usher in a new wave of technology improvements. The implementation of the bi-partisan MACRA regulations in the next several months gives us the first opportunity to focus on the physician office incentives and we will look for opportunities to address these critical areas in the hospital setting as well. We want to move back to a world where doctors can focus on patient outcomes and technology is a helpful tool, not a hindrance. And it will take all of us– government, care providers, and innovators– to get there. Over the next day, we will talk about our approach and principles as we approach the MACRA regulations.

Conclusion

Before I close, I want to thank those of you that are demonstrating your commitment to health equity, especially by treating Medicaid patients and the dually eligible. I recognize the challenge this can add to your system and I want you to know that we have released several proposals both in Medicare and Medicaid intended to focus on improving reimbursement levels for lower socioeconomic status and higher need populations. And we are committed to looking at what more there is we can do. But I know that no matter what we do, that our lowest income and hardest to treat citizens won’t get the same high quality of care that others do without your commitment as part of your role in the medical community to provide high quality care for all patients. I thank you for it and I ask that you know our commitment to health equity will not waver.

I want to close by repeating the theme I hope you’ve heard from me today as I laid out a very candid look at our agenda. Success for us is helping build a better health care system for all Americans, with smarter spending, and resulting in healthier people. We are at early stages of a system where we cover more people and also change how we integrate and work together to provide for a more value-based system. I know this transformation creates challenges as it plays out every day– all progress does. As we move forward, we need to listen and stay close to the realities on the ground and work together with you to create new generations of solutions that work better and are simpler. We thank you for all the constructive engagement and look forward to working with you in the coming months and years.


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FDA takes additional action to better understand safety of Essure, inform patients of potential risks - FDA Press Releases

The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for particular women and draft guidance with labeling recommendations including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients. Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. The new actions announced today take additional steps and follow the agency’s careful evaluation of available information.

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FDA takes additional action to better understand safety of Essure, inform patients of potential risks - FDA Press Releases

The U.S. Food and Drug Administration announced today two actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. These actions include a new, mandatory clinical study for Essure to determine heightened risks for particular women and draft guidance with labeling recommendations including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients. Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. The new actions announced today take additional steps and follow the agency’s careful evaluation of available information.

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FDA providing $2 million in new grants for natural history studies in rare diseases - FDA Press Releases

The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval. This will be the first time the FDA will provide funding through its Orphan Products Grants to conduct these types of studies for rare diseases.

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A systematic review and critical assessment of incentive strategies for discovery and development of novel antibiotics - Journal of Antibiotics

A systematic review and critical assessment of incentive strategies for discovery and development of novel antibiotics

The Journal of Antibiotics 69, 73 (February 2016). doi:10.1038/ja.2015.98

Authors: Matthew J Renwick, David M Brogan & Elias Mossialos



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Isolation and structure elucidation of new phthalide and phthalane derivatives, isolated as antimicrobial agents from Emericella sp. IFM57991 - Journal of Antibiotics

Isolation and structure elucidation of new phthalide and phthalane derivatives, isolated as antimicrobial agents from Emericella sp. IFM57991

The Journal of Antibiotics 69, 89 (February 2016). doi:10.1038/ja.2015.85

Authors: Tetsuya Saito, Takeshi Itabashi, Daigo Wakana, Hisashi Takeda, Takashi Yaguchi, Ken-ichi Kawai & Tomoo Hosoe



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Zincmethylphyrins and coproporphyrins, novel growth factors released by Sphingopyxis sp., enable laboratory cultivation of previously uncultured Leucobacter sp. through interspecies mutualism - Journal of Antibiotics

Zincmethylphyrins and coproporphyrins, novel growth factors released by Sphingopyxis sp., enable laboratory cultivation of previously uncultured Leucobacter sp. through interspecies mutualism

The Journal of Antibiotics 69, 97 (February 2016). doi:10.1038/ja.2015.87

Authors: Mohammad Nazrul Islam Bhuiyan, Ryogo Takai, Shinya Mitsuhashi, Kengo Shigetomi, Yasuhiro Tanaka, Yoichi Kamagata & Makoto Ubukata



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Three new milbemycins from a genetically engineered strain S. avermitilis MHJ1011 - Journal of Antibiotics

Three new milbemycins from a genetically engineered strain S. avermitilis MHJ1011

The Journal of Antibiotics 69, 104 (February 2016). doi:10.1038/ja.2015.90

Authors: Jun-jie Pan, Xu Wan, Hui Zhang, Zhen Chen, Jun Huang, Bo Yang, An-liang Chen & Ji-dong Wang



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Phenolic compounds from the fungus Inonotus obliquus and their antioxidant properties - Journal of Antibiotics

Phenolic compounds from the fungus Inonotus obliquus and their antioxidant properties

The Journal of Antibiotics 69, 108 (February 2016). doi:10.1038/ja.2015.83

Authors: Byung Soon Hwang, In-Kyoung Lee & Bong-Sik Yun



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Two rare quinone-type metabolites from the fungus Septofusidium berolinense and their biological activities - Journal of Antibiotics

Two rare quinone-type metabolites from the fungus Septofusidium berolinense and their biological activities

The Journal of Antibiotics 69, 111 (February 2016). doi:10.1038/ja.2015.84

Authors: Güner Ekiz, Elif Esin Hameş, Ayşe Nalbantsoy & Erdal Bedir



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Verrulactones D and E with unprecedented skeletons, new inhibitors of Staphylococcus aureus enoyl-ACP reductase, from Penicillium verruculosum F375 - Journal of Antibiotics

Verrulactones D and E with unprecedented skeletons, new inhibitors of Staphylococcus aureus enoyl-ACP reductase, from Penicillium verruculosum F375

The Journal of Antibiotics 69, 114 (February 2016). doi:10.1038/ja.2015.86

Authors: Nyung Kim, Mi-Jin Sohn, Hiroyuki Koshino & Won-Gon Kim



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Structure and activity relationships of the anti-Mycobacterium antibiotics resorcinomycin and pheganomycin - Journal of Antibiotics

Structure and activity relationships of the anti-Mycobacterium antibiotics resorcinomycin and pheganomycin

The Journal of Antibiotics 69, 119 (February 2016). doi:10.1038/ja.2015.88

Authors: Yasushi Ogasawara, Koichi Ooya, Michiko Fujimori, Motoyoshi Noike & Tohru Dairi



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RQN-18690A (18-deoxyherboxidiene) targets SF3b, a spliceosome component, and inhibits angiogenesis - Journal of Antibiotics

RQN-18690A (18-deoxyherboxidiene) targets SF3b, a spliceosome component, and inhibits angiogenesis

The Journal of Antibiotics 69, 121 (February 2016). doi:10.1038/ja.2015.94

Authors: Hideaki Kakeya, Daisuke Kaida, Hiromi Sekiya, Koji Nagai, Minoru Yoshida & Hiroyuki Osada



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Streptanoate, a new anticancer butanoate from Streptomyces sp. DC3 - Journal of Antibiotics

Streptanoate, a new anticancer butanoate from Streptomyces sp. DC3

The Journal of Antibiotics 69, 124 (February 2016). doi:10.1038/ja.2015.95

Authors: Saisattha Noomnual, Nopporn Thasana, Pareenart Sungkeeree, Skorn Mongkolsuk & Suvit Loprasert



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New cytotoxic spectinabilin derivative from ant-associated Streptomyces sp. 1H-GS5 - Journal of Antibiotics

New cytotoxic spectinabilin derivative from ant-associated Streptomyces sp. 1H-GS5

The Journal of Antibiotics 69, 128 (February 2016). doi:10.1038/ja.2015.99

Authors: Shuang-he Liu, Mei-dong Xu, Hui Zhang, Huan Qi, Ji Zhang, Chong-xi Liu, Ji-dong Wang, Wen-sheng Xiang & Xiang-jing Wang



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Sunday, February 28, 2016

Abbott Issues Voluntary Safety Notice on MitraClip® Delivery System Deployment Process - FDA Safety Alerts & Drug Recalls

Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company received a small number of reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system. Presently, there are 3,534 devices on the market (1,288 in the United States and 2,246 outside the United States). Abbott has received nine Medical Device Reports of malfunction.

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Saturday, February 27, 2016

Patient Priority–Directed Decision Making and Care for Older Adults with Multiple Chronic Conditions - Geriatrics

Older adults with multiple conditions receive care that is often fragmented, burdensome, and of unclear benefit. An advisory group of patients, caregivers, clinicians, health system engineers, health care system leaders, payers, and others identified 3 modifiable contributors to this fragmented, burdensome care: decision making and care focused on diseases not patients; inadequate delineation of roles and responsibilities and accountability among clinicians; and lack of attention to what matters to patients and caregivers (ie, their health outcome goals and care preferences). The advisory group identified patient priority–directed care as a feasible, sustainable approach to addressing these modifiable factors.

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Maytag Dairy Farms Expands Voluntary Recall Of Blue Cheese Products Due To Possible Health Risk - FDA Safety Alerts & Drug Recalls

Maytag Dairy Farms is expanding its voluntary recall of Maytag Blue blue cheese wedges, wheels and crumbles because they have the potential to be contaminated with Listeria monocytogenes. The organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Friday, February 26, 2016

Federal judge approves consent decree with Florida dietary supplement distributor, Viruxo - FDA Press Releases

A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes.

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Wednesday, February 24, 2016

The New Special Enrollment Confirmation Process - CMS Blog

Kevin Counihan, Health Insurance Marketplace CEO and Shantanu Agrawal, M.D., CMS Deputy Administrator and Director, Center for Program Integrity

As the Marketplace continues to grow and mature, we continue to monitor the health of the Marketplace and are looking for ways to make improvements – whether that’s creating new decision support tools to help consumers choose the right plan, strengthening risk adjustment, or clarifying the rules of the road for special enrollment periods, as we did several weeks ago.

Today, we are announcing another step that will enhance program integrity and contribute to a stable rate environment and affordability for consumers: a new Special Enrollment Confirmation Process in the 38 states using the HealthCare.gov platform. Under the new process, all consumers applying through the most common special enrollment periods will need to submit documentation to verify their eligibly to use an SEP. This represents a major overhaul of the SEP process. You can read more about the Special Enrollment Confirmation Process here:

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Special enrollment periods are an important way to make sure that people who lose health insurance during the year or who experience qualifying life changes have the opportunity to enroll in coverage. We are committed to making sure that special enrollment periods are available to those who are eligible for them. But it’s equally important to avoid misuse or abuse of special enrollment periods.

This change in HealthCare.gov’s special enrollment period process does not restrict anyone’s access to a special enrollment period who is rightfully able to enroll in coverage. But consumers will need to be sure to provide sufficient documentation to establish their eligibility. If an individual doesn’t respond to our notices, they could be found ineligible to enroll in Marketplace coverage and could lose their insurance.

As we begin work to implement the new process, CMS will solicit feedback from consumer advocates, insurers and other stakeholders over the next few weeks on verification requirements, processes and acceptable documentation. We welcome feedback and suggestions, which can be sent to SEP@cms.hhs.gov.

As we head into the third year of Marketplace coverage, we are pleased with the results of Open Enrollment and confident that the Marketplace will continue to thrive for years ahead. Making sure that the rules around special enrollment periods are clear and enforced is just one step we are taking to help make sure that consumers and insurers will continue to benefit from an attractive, competitive and growing Marketplace.


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Lessons Learned: Reflections on CMS and the Successful Implementation of ICD-10 - CMS Blog

by Acting Administrator Andy Slavitt

It was early 2015 and we had just gotten through a second successful season with HealthCare.gov, the turnaround that originally brought me into government, when the articles and letters started flying on our next big implementation – one that would affect nearly every physician and hospital in the country. And, anxiety levels were high.

On October 1, 2015, the U.S. health care system transitioned the way patient visits are coded from ICD-9 to the next version ICD-10, a system which sets the stage for meaningful improvements in public health. If people know about ICD-10 at all – and chances are they don’t – it’s probably from press reports about the more colorful diagnostic codes like “other contact with shark” or “burn due to water-skis on fire, subsequent encounter.” More seriously, for people in the health care industry, it was being compared to Y2K, a transition with the potential to create chaos in the health care system.

One representative from the physician community told me that he was concerned that half of physicians in the country wouldn’t be ready by the October 1 date. The thought of physicians in small, rural practices unable to run their practices had my complete attention. It also brought home that we are responsible for more and increasingly complex implementations – from HealthCare.gov to ICD-10 to new physician payment systems.

As I look to the future, great implementation is even more central to life at CMS.

In my time in D.C., I’ve come to see our role as implementing policies in a way that bring them to the kitchen table of the American family and to the clinics and facilities where they receive care. Implementation in this context is a vital responsibility. And there are millions of Americans that count on us to do it well: the senior filling his prescription; the trustee of the community hospital; the parents of a child with disabilities in need of home resources; the doctor who drives for miles to take care of her patients in several rural communities.

Implementation Success: 4 Lessons

It was clear that CMS had an enormous opportunity – after everything we learned from HealthCare.gov – to take the lead in smoothly implementing this new policy. The ICD-10 implementation had all the hallmarks of how CMS could drive a successful implementation and aim for excellence. The approach we took, which has become our doctrine for getting things done, had four major elements:

Lesson 1: Be Customer Focused

We believe we must always start from the perspective of the real-world needs of the people who live with the results of our implementation at the center of our work. And in the case of ICD-10, listening and learning about the issues small physician practices were facing helped us understand their resource and technical assistance needs, as well as their concerns over claims payment and cash flow.

In response, we launched “The Road to 10” aimed specifically at smaller physician practices with primers for clinical documentation, clinical scenarios, and other specialty-specific resources to help with implementation. CMS also released provider training videos that offered helpful ICD-10 implementation tips and a wealth of other material on CMS.gov/icd10. Finally, Medicare offered an unprecedented level of external testing with its three periods of voluntary end-to-end testing for physicians and other clinicians.

Lesson 2: Be Highly Collaborative

Because health care is still fragmented, CMS can’t work alone in implementing major changes. If it wasn’t for our close partnerships with the American Medical Association (AMA), the American Hospital Association, the American Health Information Management Association, state medical societies, physicians and other clinicians, billing agencies, equipment suppliers, and a variety of stakeholders, the ICD-10 implementation would not have gone as smoothly as it did. Because we listened to and collaborated with our partners, we were able to address concerns and multiply our ability to get resources to physicians. Several physician groups went from being very concerned about our approach to leading the charge on implementation. As AMA said, “We appreciate that CMS is adopting policies to ease the transition to ICD-10 in response to physicians’ concerns that inadvertent coding errors or system glitches during the transition to ICD-10 may result in audits, claims denials, and penalties under various Medicare reporting programs.”

Lesson 3: Be Responsive and Accountable

At CMS, we recognize that challenges happen and our efforts must be to anticipate them, make them visible, and be accountable for solving them. In the case of ICD-10, the potential for challenges weren’t only in our own systems, but in the systems of any physician office, hospital, or state Medicaid plan. At the suggestion of physician groups, we named an ICD-10 Ombudsman. Just as importantly, we committed to a three-business-day turnaround for every question or concern that came in from a provider. In the first month of implementation, we received approximately 1,000 inquiries and responded to 100 percent of them within three business days. We will never achieve perfection, but we will be visible and hold ourselves accountable for solving problems.

Lesson 4: Be Driven by Metrics

It’s not glamorous, but daily spreadsheets and scorecards keep complex implementations on track. Once we hit October 1, there were critical metrics to track. If doctors were sending us fewer claims, more claims than usual were denied, or a particular state was having trouble processing Medicaid claims, we needed to know as soon as possible.

Rather than waiting for the phone to ring, the CMS team created a scorecard and heat map to locate and track issues as they occurred. We launched an ICD-10 Coordination Center to handle any issues as they arose. A few days after ICD-10 launched, I received a call from a large physician organization representative asking me how things were going. I pulled out a version of the table below and read him the data. “This really is a new CMS,” he told me.

Final 2015 ICD-10 Claims Dashboard Medicare Fee-for-Service Metrics

Metrics Historical Baseline Q4 CY 2015
Total Claims Submitted 4.6 Million per day 4.6 Million per day
Total Claims Rejected 2% of total claims submitted 1.9%
Total ICD-10 Claims Rejected 0.17% of total claims submitted 0.07%
Total ICD-9 Claims Rejected 0.17% of total claims submitted 0.07%
Total Claims Denied 10% of total claims processed 9.9%

 

*NOTE: Metrics for total ICD-9 and ICD-10 claims rejections were estimated based on end-to-end testing conducted in 2015 since CMS has not historically collected this data. Other metrics are based on historical claims submissions.

Moving Forward

For thousands of physicians and other clinicians around the country, the change to ICD-10 was a big undertaking, requiring time, planning, and a period of adjustment. But on October 1, proper execution and good implementation made all the difference. On the big day, the ICD-10 Coordination Center was packed, and the CMS teams and our partners were geared up and ready to make sure that any burden on physicians could be minimized and concerns quickly addressed.

The ICD-10 Coordination Center

blog ICD

With preparation, planning, a focus on the customer, collaboration, clear accountability, and metrics, the dire Y2K fears didn’t come to pass. Instead, ICD-10 became like what actually occurred on Y2K, an implementation and transition most people never heard about.

With good implementations, we never declare victory and are still at the ready to continually improve. For those who still need help, CMS continues to provide technical support and respond to inquiries. For more information, visit www.cms.gov/ICD10.

The magnitude of CMS’s big, complex implementations have accelerated in recent years. And over the next several years, we will be a part of implementing big and important changes that spend our health care dollars more wisely and keep people healthier – from how we pay for care to collecting and publishing data on how care is paid for to building consumer websites evaluating nursing homes to protecting beneficiary privacy and security. Because these changes impact consumers and physicians and other clinicians’ daily lives, CMS is responsible to the American people to make health care work better for the consumer and better on the front lines of health care.


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FDA Statement on Senate Confirmation of Dr. Robert M. Califf - FDA Press Releases

FDA Statement on Senate Confirmation of Dr. Robert Califf

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Aedes mosquitoes and Zika virus infection: an A to Z of emergence?

Aedes mosquitoes and Zika virus infection: an A to Z of emergence?

Emerging Microbes & Infections 5, e16 (February 2016). doi:10.1038/emi.2016.37

Author: Colin R Howard



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Moxifloxacin and gatifloxacin for initial therapy of tuberculosis: a meta-analysis of randomized clinical trials

Moxifloxacin and gatifloxacin for initial therapy of tuberculosis: a meta-analysis of randomized clinical trials

Emerging Microbes & Infections 5, e12 (February 2016). doi:10.1038/emi.2016.12

Authors: Qiaoling Ruan, Qihui Liu, Feng Sun, Lingyun Shao, Jialin Jin, Shenglei Yu, Jingwen Ai, Bingyan Zhang & Wenhong Zhang



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Genetic features of Mycobacterium tuberculosis modern Beijing sublineage

Genetic features of Mycobacterium tuberculosis modern Beijing sublineage

Emerging Microbes & Infections 5, e14 (February 2016). doi:10.1038/emi.2016.14

Authors: Qingyun Liu, Tao Luo, Xinran Dong, Gang Sun, Zhu Liu, Mingyun Gan, Jie Wu, Xin Shen & Qian Gao



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Tuesday, February 23, 2016

Lipari Foods Issues Allergy Alert on Dark Chocolate Covered Coffee Bean Products Due to Undeclared Almonds - FDA Safety Alerts & Drug Recalls

Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds). People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume these products.

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Rucker's Wholesale & Service Co. Issues Allergy Alert on Undeclared Peanut Ingredient in Uncle Bucks & Cabela's Classic Candies Maple Nut Candy Peg Bags - FDA Safety Alerts & Drug Recalls

Rucker's Wholesale and Service Co. of Bridgeport, IL is voluntarily recalling all of Uncle Bucks and Cabela's Classic Candies Maple Nut candy peg bag, due to the presence of an undeclared peanut ingredient. People who have an allergy to peanuts run the risk of serious or life threatening allergic reaction if they consume this product.

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CMS Acting Administrator Andy Slavitt’s Comments before the National Association of Health Underwriters - CMS Blog

Below are the comments as prepared for delivery of CMS Acting Administrator Andy Slavitt at the National Association of Health Underwriters 2016 Capitol Conference in Washington, D.C. on February 23, 2016.

Thanks for the introduction. I appreciate the opportunity to be here to talk about the major priorities for the Health Insurance Marketplace in 2016. Kevin Counihan is going to be here tomorrow to talk specifically about the role of agents and brokers. But talking today as I am to many of the builders of this Marketplace, I want to provide my broad reflections on how far we’ve come, take a look at what’s around the corner, and spend a little bit of time on near term steps we will take to get there as we move through the early years of a long-term journey to provide affordable, stable coverage to millions of Americans.

Health care coverage says a lot about who we are as a country and what we want for our people. Covering over 17 million newly insured Americans over the last few years is as profound a change as most of us have seen in our careers. When people have insurance, their lives change in profound ways besides just having a card in their wallets– from being able to afford preventive care to accessing prescription drugs for their chronic condition, or no longer worrying about the financial threat that would accompany a cancer diagnosis. But there are less obvious things that change – parents with insurance coverage who finally allow their kid to play on the sports team because they no longer fear injury and entrepreneurs and contractors who can more comfortably leave their jobs to pursue their passions or a better job. And there are of course the economic effects – like reducing uncompensated care and hospital bad debt – costs that are borne by everyone. Studies have shown no reduction in employer sponsored coverage and that there has been continuous and significant job growth during these early years of coverage expansion. Importantly all of this has been accomplished below the CBO cost estimates. We cannot declare victory – but I would call all of this a good base to build from.

In the last two years, we have participated in the opening of a brand new market for health insurance – one that has added to, not replaced employer coverage. Just like the launch of the Medicare Advantage markets and Part D markets over 10 years ago, the new Health Insurance Marketplace is filling a new need by bringing consumers together with private sector health insurers to create a new affordable set of benefits for consumers – and a new business opportunity for health insurers as the move to make health care more retail business, driven by the consumer, is on. And just like the Medicare marketplaces, the first years of health insurance exchanges are filled with both successes and important lessons. So it’s important that we continually assess the data from the first few years and address and adjust to challenges as they occur. Consumers must do this. Health plans must do this. Insurance commissioners must do this. And those that operate marketplaces must do this.

This assessment informs our 2016 priorities. 1- Continuing to build a market attractive to both consumers and health plans; 2- ensuring market rules are fair and promote rate stability; and 3- looking at the Marketplace not just for what it does today, but how it serves as a stepping stone to what I will call a “fully retail” health care system. 

Marketplace Attractiveness

The Marketplace is still in the early stages. Consumers are still getting educated and health plans are experimenting with the right product and network designs and price points. Even as the market meets today’s needs and signs millions of new consumers up in record numbers, we are starting to move from a startup stage to a more mature stage.

We are fortunate to have an experienced team of operators and actuaries from the exchange world, the private sector and from our Medicare Advantage and Part D operation. The team listens to input, studies the data and meets regularly with stakeholders and takes a strategic view to determine what adjustments are warranted – whether in the form of consumer improvements or the regulations and operations of the Marketplace. Our experience tells us three things are necessary to make any marketplace attractive – it must be an attractive place for consumers to come and shop; it must be attractive to health plans to connect to and build relationships with desirable consumers; and it needs a predictable set of underwriting and other rules that compensate fairly for risk and keep the risk pool stable and balanced.

 

It would be easy enough to say that the tax credits that have finally made health care affordable to low- and fixed-income individuals have created an attractive market for consumers and it has. Eight in 10 people in the Marketplace can now get covered for $100 a month or less. But it’s more than that. The choice, competition and innovation that make any market work are fueling an attractive market for consumers who are by all accounts satisfied that they now have a market that is set up for them. 90% of consumers have an average of 3 insurance companies to choose from, translating into 50 plan options. And even at this early stage, innovations are taking hold to respond to consumer demands. Consumers can now pick a plan based upon the insurance their doctor accepts or the drug they are looking for. And, in a promising sign of products being designed around market need, the vast majority of consumers are getting direct services like primary care and generic drugs outside their deductible. A truly retail market with these type of organic innovations is important because it should attract even more consumers, including higher income and healthier individuals who will be attracted to better experiences and better services available on the Marketplace.

 

We are also seeing the characteristics of an attractive market for health plans to serve; a growing market; a growing base of new young consumers; and high levels of consumer engagement and responsiveness to new offerings. Over 12.7 million people signed up for a 2016 health insurance plan in this Open Enrollment period. And we’ve seen a significant influx of new consumers making it clear there is still a large untapped market to serve. There were over 4 million new consumers who gained coverage in this Open Enrollment period just on the Healthcare.gov platform. And the tax penalty is bringing more young and healthy consumers into the market.

 

We used a large portion of our marketing resources to make sure that consumers were aware of the increasing fee for people that go without insurance and our data tells us that drove significant enrollment – a potentially good sign for the risk pool. And 43% of all new consumers in HealthCare.gov states this Open Enrollment are under 35, compared to 40% a year ago. There are also unprecedented levels of consumer engagement – as 70% of renewing Marketplace consumers returned to make active decisions about their health insurance choices.

 

From what used to be a slow growing and highly selective individual insurance market before the ACA, competitors can win and grow meaningful market share with the right set of offerings. And while companies will set their own strategies and approaches, we, along with the state departments of insurance, are also committed to making sure there are opportunities for reasonable margins in this market.

 

Marketplace Rules

 

With a continually growing membership, a replenished risk pool, and an active set of consumers, this market represents a growing attractive segment for health plans, right alongside Medicaid, Medicare and Commercial segments. Now we know that individual markets are also designed to serve people who have transitional coverage needs as they move between employers. We also know that both healthy people and people with illnesses will enter the market, both during Open Enrollments and Special Enrollment Periods. And that’s OK – so long as the market operates as it’s supposed to, risk adjustment works, and health plans receive the data they need to act on. Based on our first two years of operation, there are three areas where we are taking action.

 

SEP

 

First, we think it is critical for us to enforce the integrity of the Special Enrollment eligibility process so that it serves those consumers who are eligible for them, not those who want to wait to buy insurance until they’re sick. SEPs play an important role for consumers who lose employer sponsored coverage or have another qualifying event. But, we are both reducing the number of SEPs available and overhauling the process to make sure Special Enrollment Periods meet their intended purpose. We will announce some specific changes later this week, which will include opportunities for market participants, consumer advocates and other stakeholders to have some input into our approach.

 

Risk adjustment

 

Next, we are committed to making sure that risk adjustment continues to work as it is intended and improves based on the most recent data and accounts for new trends that emerge like higher cost drugs. Later next month, we will publicly release our newest risk adjustment white paper, in which we will outline a number of topics we’re looking hard at in preparation for a public risk adjustment conference on March 31. At the conference, we will bring together market participants, actuaries and stakeholders to review the risk adjustment methodology so we can build in changes based on the first several years of experience. We have the tools to make certain the proper incentives exist to insure sicker populations.

 

Better Information

 

Third, we’re committed to getting health plans better information earlier so that this can inform their care management approach, their network strategy and their pricing. This year, we will be providing early estimates of health plan specific RA calculations everywhere we have enough submissions from health plans. We also launched backend automation functionality and policy specific payments January 1. This should improve decision making and reduce operating costs for plans participating in the exchange and allow them to offer better care management, customer service and the tools to build better relationships with consumers.

 

We have also announced that the reinsurance program, which paid out $7.9 billion for 2014, at a 25% higher level than expected, will pay out up to $7.7 billion for 2015.  Just as that program has been a stabilizing force to date, the one-year moratorium on the Health Insurance Tax, of $13.9 billion will also help stabilize premiums next year as the transitional reinsurance program phases out.

 

I’m confident these focal areas – in our SEP approach, our risk adjustment, the technology and information wiring we’ve built, as well as the added stabilization – will lead directly to a lower and more stable rate environment for consumers now and in the future.

 

 

Health Insurance as a Retail Market

 

The launch of the Health Insurance Marketplace is happening at a time when health insurance is finally becoming a true retail market where you must sell, service and renew based on the consumer’s opinion of your value – and this is unmistakably happening across government, individual, and employer markets. I have had a number of conversations with health plan CEOs who see the Marketplace as part of the opportunity to transform for this more retail world, where building a trusted brand with consumers can be expected to extend throughout their health care lives – from Medicaid managed care, to the Marketplace, to Medicare Advantage and Part D – as these worlds become increasingly linked together throughout people’s lives.

 

Building brand and relationships with consumers is complicated by the fact that the market is new and requires experimentation. Companies are searching for the care management approaches, consumer engagement approaches, network approaches, product designs, loyalty strategies and price points that will work best for them in this Marketplace. We are already seeing companies experiment with innovative new consumer approaches for the exchange – staff model clinics, capitation, telemedicine, medical homes, and intensive case management –  all designed for Marketplace use. Some companies have found niches and strategies that work and others are still adjusting.

 

But how companies treat consumers in this process is an important part of their ability to build the right brand in a fully retail health care world. Those that treat customers well – and make changes gradually and with clear explanations will build loyalty among consumers that could have lifetime value. Those that make sudden announcements, frequent changes that they don’t explain, or enter and exit markets sporadically will likely find that brands are built by consumers who have long memories. Watch the Health Insurance Marketplace. Great companies, products, consumer successes and brands will be built over the next several years and that holds great potential for how health insurance works for people.

 

Conclusion

 

Let me close by recapping the themes in our 2016 Marketplace agenda. It’s an exciting year that will be built on a great start but will continue to improve, with some important areas of focus that I’ve outlined that we are giving near term emphasis to. We think we are at the beginning of a big change in health care where the consumer becomes more and more empowered in a retail world and all of us must pay attention, invest, watch the data, learn and adapt. There will be new challenges and new opportunities as the market changes. It is thanks to you all, the agents and brokers, who take the time to invest in consumer needs and meet people where they live, that insurance coverage is a reality for so many people. I am excited to work with the many people who have gotten this started to see through this continued evolution of the Marketplace as it matures and thrives in meeting the needs of consumers.


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CMS Acting Administrator Comments before the American Medical Association - CMS Blog

Below are the comments as prepared for delivery of CMS Acting Administrator Andy Slavitt at the American Medical Association’s National Advocacy Conference in Washington, D.C. on February 23, 2016.

***

Thanks for the introduction and the opportunity to be here. You know, last year I began every speech talking about my first year on the job and our big plans for CMS in playing our part in moving the health system forward. All of the sudden, come January, I find myself thinking that it’s in all probability my last year, and focusing on what that means.

And my reflections aren’t that different than last year. We have a busy year and a lot to do. I think about our agenda not only in terms of how it impacts life for patients and their physicians and caregivers today, but also in how CMS can set a tone to work constructively with you for years to come.

Today, I’d like to lay out our 2016 agenda as it relates to our work with the physician community. And there are really three parts to that agenda that I want to discuss. The first sounds simple enough. It’s how we listen better to physicians, keep lines of communication open, and get a better and more direct feel for what is happening on the front lines of care delivery. The second, which I think follows fairly directly from there, is how we simplify things. And the third relates to our payment reform agenda of improving care outcomes and spending. Throughout the conversation this morning, I will touch on implementation the bi-partisan MACRA and MIPS programs.

We know that new programs bring changes to the real world of medicine. So I will talk a little bit about our philosophy towards payment reform generally and even more about our approach to this very complex implementation.

***

I always start with our shared priority: your patients, the consumers of the Medicare, Medicaid, CHIP, and Marketplace programs. Our charge at CMS is clear, meeting the evolving needs of 140 million Americans, most with low- or fixed-incomes, whether they are living with a disability, trying to afford a prescription, or are in need of coverage as they look for a better job.

These are the people we serve every day and these are the people I wake up every day thinking about. Since my email address is available to the public, I now know many of them wake up every day thinking about me too.

As I read the many emails beneficiaries send me, I realize that even in a wide diversity of circumstances, everyone is hoping for the same basic things from the health care system: to get care they can afford, to keep their family well taken care of, and when they’re sick, they want nothing more than to get them home and to lead as productive and healthy life as possible.

As society ages with 10,000 people joining Medicare every day, the challenge to all of us increases. We need to invest in all the things that keep people healthy and at home like primary care, prevention, chronic disease management, medication management, care coordination and all the transitions where people get lost. We need to do all of this, while at the same time striving to find new ways to care for and interact with patients we don’t see every day in a world of more information and better technology.

While fostering a future of sharable and wearables and telemedicine is undoubtedly some part of the answer, at its most fundamental level, we cannot devalue the most important and precious element of health care: the time a patient has with their physician. The moments when a patient’s course can be most effectively changed for the better. Getting patients the care they need is why our agenda is so important.

***

This is why our first priority for 2016 is opening the lines of communication and listening to the physicians and other clinicians who provide care to our beneficiaries. CMS has significant responsibility for implementing new laws which must intersect with an already complex system with many demands. I’m a believer in the maxim that it is almost always 90 percent about implementation.

And so good policy must be ultimately informed by the impact it has at the kitchen table of the American family and in the clinic or office where they seek care. The EHR Incentive Program, ICD-10, MIPS, ACOs and medical homes, bundled payments, 2 Midnights. These are just the recent crop of implementations CMS has been charged with. And it is clear from listening to physicians there is fatigue – with change, with measurement, with new requirements that come from the outside and aren’t simple to implement.

As we hear this feedback, it tells us we must provide more tools and support and be as flexible as possible to the needs of physician practices, even while we push for a health care system that is better connected, more coordinated and produces better outcomes.

Our working relationship with the AMA has been an important and very positive model for us in listening. One of the first rules of building a learning organization is to listen to people most directly impacted by, and sometimes most critical of, our work. In the case of ICD-10, we reached an important turning point when we heard and responded to the very reasonable fears of physicians on their readiness, on cash flows and on potential penalties, particularly for small practices.

We doubled down on technical resources like the “Road to 10” and other support, provided more opportunities to test a practice’s readiness and we made adjustments to reduce needless penalties. And, to provide direct communications with front line physicians, we named an ICD-10 Ombudsman, set up a full-time command center and committed to 3 business day turnaround on any physician question and concern. We used a model for implementation first tested with the turnaround of healthcare.gov that we are now replicating in other implementations. It’s about responsiveness, collaboration, being publicly accountable and transparent, and being metric driven.

We’ve embraced this approach as we’ve implemented new payment models. Our newly launched Next Generation ACO model is a good example. It contains the features physician groups around the country have told us would best enable them to coordinate care, including innovative options like telemedicine, home visits, and direct patient incentive and engagement options. And as I will talk about in a moment, we are soliciting an unprecedented amount of direct physician input as we work to implement the MIPS payment models.

This will be a journey for all of us. One that requires a trusted partnership underpinned by honest, productive dialogue that helps each of us meet our common goal of better patient care.

I’m optimistic that our first objective of listening better to what happens in daily practice is not just a passing idea, but will make real lasting change to how we do things at CMS far beyond my tenure.

When I ask people at CMS to describe their best moments, they haven’t been spent behind a desk making policy in D.C. It is when they are out in communities across the country, helping beneficiaries, meeting with hospitals and physician practices, in nursing homes and PACE centers, talking to innovators, and working with many care providers who are on the front line of improving care for people.

Connecting to what happens in daily patient care is vital to our policy-making as we seek a better, smarter healthier system.

***

The second agenda item is to simplify. I visited with a physician in suburban Massachusetts a month or so ago. Small busy practice, two docs. I asked the physician to take me through a typical day and his interactions with technology and measurement and how it helped and hindered his interactions with patients.

He was very pleased to have technology in his office, but it didn’t do the thing he needed most like give him feedback on referrals he made, and it required a fair amount of effort from him that took time but didn’t add a lot to patient care. He also discussed his interactions with various commercial health plans and with CMS and with payment model changes and administrative burden. The visit painted a vivid picture of the gulf that can exist between public policy, even good public policy, and what it feels like on the front line of practice.

We must reduce burden and give physicians back more time to spend with patients. Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over five years. But we are barely scratching the surface. We have a strategic effort this year designed to reduce burden and create efficiencies in the physician’s office.

Last week with AMA’s help, we announced the alignment of quality measures used by CMS and commercial payers so that everyone measures quality the same way across many areas of medicine.

Consistency is vital to simplicity. And we have also launched an initiative around the country to streamline how we provide data to physician practices so that CMS and commercial payers can provide it in a form that is practice ready and encompasses all patients the same way.

I visited with a physician practice in Denver where this has been fully implemented and heard first-hand how collaboration and simplicity were allowing them to deliver better care. Patient centered care means being practice centered as well. 

We are also pushing on administrative simplification and standards, and this year will launch a public framework for creating new standards and a tool for physicians to help us enforce health plan compliance with existing standards.

On the technology front, with the passage of the bi-partisan MACRA legislation, Congress has clearly recognized that technology is an important part of the solution. It obviously holds great promise to connect us to one another, to improve our productivity, and to create a platform for a next generation of innovations that we can’t imagine today.

As we move forward and implement MACRA, we must refocus on how to simplify the program so that technology can help get us where we need to go, not slow us down. We will be sharing details and inviting comment as we roll out our proposed regulations, but our work will be guided by several principles:

  • Rewarding providers for the outcomes technology helps them achieve with their patients, not for using technology alone.
  • Allowing providers the flexibility to customizegoals to their individual practice needs. This should cause technology vendors to become more user-centered and support physician needs.
  • Leveling the technology playing field to promote innovation, including for start-ups and new entrants, by unlocking electronic health information through open APIs, technology tools that underpin many consumer applications.  This way, new apps, analytic tools and plug-ins can be connected, and we can address the lock that early EHR decisions have created for some practices.
  • Prioritizing interoperability by implementing interoperability standards and focusing on real-world uses of technology, like ensuring continuity of care during referrals or finding ways for patients to engage in their own care. And we will not tolerate data blocking, business models that prevent or inhibit the data from flowing around the needs of the patient.

As you may know, the MACRA legislation applies to physician office care, not hospital care, so we are also exploring ways to align hospital incentives with these principles as well.

All of these principles won’t change things overnight. It will take physicians and innovators time to build a better future, but this is the right place to start.

***

The third priority area I will cover is the transformation of how we pay for care to reward for the delivery of high quality care. What we all want is a better system that spends money smarter, and keeps people healthier. How care is paid for is one element of that.

When we announced a year ago that more than 50 percent of our Medicare FFS payments will be linked to quality and value through alternative payment models by 2018, we were sending an important signal that we will soon reach a tipping point.

We know that to do this requires change from many parts of health care, and that actual change is hard. We know the challenge physicians and other clinicians face living in the fee-for-service world today while preparing for a payment system that rewards more coordinated, more value-oriented care that is emerging.

So, we committed to a $650 million-plus investment to over 140,000 physicians to support them in their aim to transform their practices to get paid for quality.  We are partnering with organizations and physician specialty societies across the country to help support these physicians to use data, technology, and quality measurement to improve care for their patients.

I’ve spoken about the implementation of the bipartisan MACRA legislation. It is a major priority for us this year and at its most fundamental level, is a program that brings pay for value into the mainstream through the Merit-based incentive program. The program compels us to measure physicians on four categories: quality, resource use, the use of technology, and practice improvement.

Over the next several months, we will be rolling out details for public comment, but I will say that the team is approaching the implementation by working with front-line physicians from the beginning. We started with a four day session with physicians and technology companies and through an RFI to garner direct feedback on the right measures for each specialty and how to implement the program most simply.

We are now conducting eight physician focus groups in four separate markets – none of them Washington, D.C.  Now everyone in CMS will a chance to hear directly from physicians. The AMA has provided significant input and we will be engaging closely with members of Congress who are also deeply committed to improving value-based care.

We are committed to building a program that is as flexible as possible and adapts around the goals of a provider’s individual practice and patient population. But even with all this work, I expect we will need to rely on significant input into how it works in reality, both positively and negatively so that, within the constraints of the law, we can improve it. If you commit to continually providing the input, we will commit to continually improving it.

I want to mention one other important element in how we are paying for care. Last year, with the active support from the AMA, we began paying for advanced care directive conversations.  While this was seen as big news and a step forward in dealing with an area with lots of strong views, there is other news I hope you take away as well. And that’s the value we place on conversations between the patient and their doctor.

Whether it’s this work, care coordination visits, or models like our oncology payment pilot, we believe we need to move back to a place where we are paying for doctors to talk to patients about their health, not just paying for new technology, devices, surgeries and prescriptions that have certainly been dominant drivers over the last number of years.

We have a ways to go here, but this is a direction that Patrick Conway, our Chief Medical Officer and a practicing physician, and I are passionate and excited about and are pushing to take root across the work coming out of CMS.

***

Before I close, I want to thank those of you that are demonstrating your commitment to health equity, especially by treating Medicaid patients and the dually eligible. I recognize the challenge this can add to your practices and I want you to know that we have released several proposals both in Medicare and Medicaid intended to focus on improving reimbursement levels for lower socioeconomic status and higher need populations.

But I know, no matter what we do, that our lowest income and hardest to treat citizens won’t get the same high quality of care that others do without your commitment as part of your role in the medical community to provide high quality care for all patients. I thank you for it and I ask that you know our commitment to health equity is primary.

I want to close by repeating the theme I hope you’ve heard from me today: Success for us is helping build a better health care system for all Americans, with smarter spending, and resulting in healthier people.

We are at early stages. I know the challenge of this transformation as it plays out every day in practice creates challenges. All progress does. But the transformation to better care will only come from you and your patients. And as we move forward, we need to listen and stay close to the realities on the ground and work together with you to create new generations of solutions that work better and are simpler.

We thank you for all the constructive engagement and look forward to working with you in the coming months and years.

###


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Marathon Ventures, Incorporated Announces Voluntary Recall of Raw Macadamia Nuts Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Marathon Ventures, Inc. announced today that it is voluntarily recalling various retail and bulk packages containing raw macadamia nuts as a precautionary measure because the product may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, nausea, vomiting, diarrhea (which may be bloody), and abdominal pain.

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Monday, February 22, 2016

Wilderness Family Naturals Issues Allergy Alert on Undeclared Milk in Organic Coconut Milk Powder And Products Containing Organic Coconut Milk Powder - FDA Safety Alerts & Drug Recalls

Wilderness Family Naturals of Silver Bay, MN, is voluntarily recalling its Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this ingredient due to potential milk contamination. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.

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Best Foods Inc. Issues Allergy Alert on Undeclared Peanuts in Deer Brand Cumin Powder 7 Ounce and Deer Brand Cumin Powder 14 Ounce - FDA Safety Alerts & Drug Recalls

Best Foods Inc. 30 Saw Mill Pond Rd,. Edison, NJ is recalling its 7 ounce packages and 14 oz. packages of Deer brand Cumin Powder because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Data Transparency and the Extension of Temporary Provider Enrollment Moratoria (CMS 6059-N4) - CMS Blog

By Shantanu Agrawal, M.D., CMS Deputy Administrator and Director, Center for Program Integrity

As part of our efforts to improve care delivery through the sharing and utilization of information, the Centers for Medicare & Medicaid Services (CMS) has released two new public data sets. A new public file provides information on the availability and use of services provided to Medicare beneficiaries by ambulance and home health agencies (HHAs), a second data set provides the list of all approved providers and suppliers in Medicare’s fee-for-service operations. Both data sets are available at https://data.cms.gov

The Affordable Care Act provided CMS with new opportunities and resources to combat fraud, waste, and abuse in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).  CMS used authority provided by the Affordable Care Act to impose temporary enrollment moratoria for the first time on July 30, 2013 (Phase I) and for the second time on January 30, 2014 (Phase II).  CMS extended these six-month phases of the moratoria on July 29, 2014; January 29, 2015; July 29, 2015 and most recently on January 29, 2016. The moratoria temporarily halted the enrollment of new home health agencies (HHAs) and ground ambulance suppliers in certain geographic areas, and giving CMS the opportunity to analyze and monitor the existing provider and supplier base, as well as further focus additional fraud prevention and detection tools in these areas.

Today, as part of our efforts to share information, CMS released a Moratoria Provider and Supplier Services and Utilization Data Tool. The tool uses ambulance and HHA paid claims data within CMS systems for Medicare fee-for-service beneficiaries. The data, which do not contain any individually identifiable information about Medicare beneficiaries or their providers, cover the period from October 1, 2014 to September 30, 2015, and are updated quarterly.  The tool includes interactive maps and a dataset that shows national-, state-, and county-level provider and supplier services and utilization data for selected health service areas. For this first release, the data provide information on the number of Medicare ambulance suppliers and HHAs servicing a geographic region, with moratoria regions at the state and county level clearly indicated, and the number of Medicare beneficiaries who use one of these services. Users of the tool can also find the degree to which use of these services is related to the number of providers and suppliers servicing a geographic region. Provider and supplier services and utilization data by geographic regions are compared easily using the interactive maps. Future releases may include comparable information on additional health service areas.

CMS’ continued commitment to strengthening program integrity also extends to supporting the provider and supplier community through increased transparency about those enrolled in the Medicare program. As part of this effort, CMS is publishing Public Provider Enrollment Files that list all providers and suppliers enrolled in Medicare. The continued growth of programs that require provider and supplier enrollment in Medicare fee-for-service as a prerequisite has steadily increased, as has the demand for information from the healthcare industry. This public provider data allows users, including other health plans, and researchers the ability to access Medicare data.

The Public Provider Enrollment Files consist of individual and organizational enrollment information on all providers and suppliers nationwide who are approved to bill Medicare. This includes key unique identifiers, enrollment type and state, names, National Provider Identifier (NPI), specialty, and limited address information (City, State, Zip code). This data also identifies reassignment relationships between individuals and groups. The information in the file will be updated quarterly and extracted directly from the Provider Enrollment, Chain, and Ownership System (PECOS), which is the official system of record for Medicare fee-for-service enrollment. The information can only be updated through submission of updates to enrollment information via PECOS. Providers and suppliers will need to make enrollment updates by contacting their respective Medicare Administrative Contractor (MAC), or by going to http://ift.tt/1mykviy. Updates will be shown with the next release of the file.

The long-term goal of this initiative is to continue to expand data elements available in the files, and eventually consolidate other existing public lists of provider information, such as the Ordering and Referring File, Part D Prescribing File, and Revalidation Lists. CMS believes the release of the enrollment data provides a clear and transparent way for providers, suppliers, state Medicaid programs, private payers, researchers, and other interested individuals or organizations to leverage Medicare Provider Enrollment information.

To view a fact sheet on the Ambulance and HHA data set, visit: http://ift.tt/1LCKEan  The utilization tool is available through the CMS website at: http://ift.tt/1L6wjbh

To view a fact sheet on the Public Provider Enrollment file, visit:  http://ift.tt/1LCKGim   This data set is available through a series of .csv files that will be updated quarterly and published at http://ift.tt/1L6wljt.

Questions regarding the Public Provider and Supplier Enrollment files or the Ambulance and HHA data set should be sent to the Office of Communications at the Office of Communication, 7500 Security Blvd., Baltimore, MD 21244-1850.


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CMS strengthens provider and supplier enrollment screening - CMS Blog

By Shantanu Agrawal, M.D., CMS Deputy Administrator and Director, Center for Program Integrity

CMS is strongly committed to protecting the integrity of the Medicare program, including making sure only qualified providers and suppliers are enrolled in Medicare. The Affordable Care Act provided tools to enhance our ability to screen providers and suppliers upon enrollment and identify those that may be at risk for committing fraud, including the use of risk-based screening of providers and suppliers.  In addition to implementing the tools provided by the Affordable Care Act, we are strengthening our strategies designed to reinforce provider screening activities by increasing site visits to Medicare-enrolled providers and suppliers, enhancing and improving information technology (IT) systems, and implementing continuous data monitoring practices to help make sure practice location data is accurate and in compliance with enrollment requirements.

We have the authority to conduct site visits on all enrolling and enrolled providers and suppliers, and the Affordable Care Act gave us tools to enhance our ability to screen and identify those that may be at risk for committing fraud.  A recent Government Accountability Office (GAO) report, which identified areas for improvement in our Provider Enrollment, Chain, and Ownership System (PECOS) – the IT system for Medicare enrollment – regarding verification of provider or supplier practice locations, helped CMS target our efforts to further enhance our provider screening activities. We appreciate the GAO’s work in this area and are using the GAO’s findings to support our broader provider screening enhancements

When enrolling in Medicare, providers and suppliers (including physicians and non-physician practitioners) are required to supply on their application the address of the location from which they offer services. As a result of our continuous review of policies, we have put into practice four tactics to strengthen strategies designed to reinforce provider and supplier screening activities:

Increase the number of site visits to Medicare-enrolled providers and suppliers. CMS has the authority, when deemed necessary, to perform onsite review of a provider or supplier to verify that the enrollment information submitted to CMS or its agents is accurate and to determine compliance with Medicare enrollment requirements (42 C.F.R. 424.517). Under this authority, CMS has increased site visits, initially targeting those providers and suppliers receiving high reimbursements by Medicare that are located in high risk geographic areas.

Enhance address verification software in PECOS to better detect vacant or invalid addresses or commercial mail reporting agencies (CMRAs). Starting this year, CMS will replace the current PECOS address verification software with new software that includes Delivery Point Verification (DPV) in addition to the existing functionality. This new DPV functionality will flag addresses that may be vacant, CMRAs or invalid addresses. In most cases, CMRAs are not permitted in the Medicare program. These verifications will take place during the application submission process and may trigger additional ad hoc site visits.

Deactivate providers and suppliers that have not billed Medicare in the last 13 months. Beginning March 2016 and on a monthly basis, CMS will run analysis on enrollment data to deactivate providers or suppliers meeting specific criteria that have not billed Medicare in the last 13 months. Providers and suppliers that may be exempted from the deactivation for non-billing include: those enrolled solely to order, refer, prescribe; or certain specialty types (e.g., pediatricians, dentists and mass immunizers (roster billers)). This approach will remove providers and suppliers with potentially invalid addresses from PECOS without requiring site visits. 

Monitor and identify potentially invalid addresses on a monthly basis through additional data analysis by checking against the U.S. Postal Service address verification database. CMS has started to continuously monitor and identify addresses that may have become vacant or non-operational after initial enrollment. This monitoring is done through monthly data analysis that validates provider and supplier enrollment practice location addresses against the U.S. Postal Service address verification database.

If you are a provider or supplier, you can help us protect the integrity of the Medicare program by informing us promptly of any changes to your enrollment, as required.

We are committed to protecting the integrity of the Medicare program. Increasing site visits, improving IT systems, and conducting continuous data monitoring will strengthen the integrity of the Medicare program while minimizing burden on the provider and supplier community.


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Sunday, February 21, 2016

Fresh Creative Foods Issues Allergy Alert on Undeclared Fish (Anchovy) in H-E-B Tartar Sauce - FDA Safety Alerts & Drug Recalls

Fresh Creative Foods is recalling 8oz containers of H-E-B Tartar Sauce due to an undeclared fish (anchovy) allergen. Some plastic tubs have the correctly labeled Cocktail Sauce lid with a container labeled as Tartar Sauce when the actual contents are Cocktail Sauce.

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Saturday, February 20, 2016

Health Matters America Inc. Issues Nationwide Recall of Sprouted Flax Seed Powder and Sprouted Chia & Flax Seed Powder Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Health Matters America of Cheektowaga, NY, is recalling specific lots of Organic traditions SPROUTED FLAX SEED POWDER and Organic traditions SPROUTED CHIA & FLAX SEED POWDER because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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Anticoagulation in Older Adults with Multimorbidity - Geriatrics

The number of patients with atrial fibrillation (AF) who are of advanced age or have multiple comorbidities is expected to increase substantially. Older patients with AF generally gain a net benefit from anticoagulation. Guidelines typically recommend anticoagulation. There are multiple challenges in the safe use of anticoagulation in frail patients, including bleeding risk, monitoring and adherence, and polypharmacy. Although there are options for chronic oral anticoagulation, clinicians must understand the unique advantages and disadvantages of these medications when developing a management plan. This article reviews issues surrounding the appropriate use and selection of anticoagulants in complex older patients with AF.

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Maytag Dairy Farms Voluntarily Recalls Blue Cheese Products Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Maytag Dairy Farms is voluntarily recalling 5 lots of "Maytag Blue" blue cheese wedges and wheels and 15 batches of blue cheese crumbles because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Friday, February 19, 2016

Country Life Natural Foods Recalls Raw Pistachios Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Country Life Natural Foods of Pullman, MI is recalling shelled raw pistachios, sold in 2 lb bags and 30 lb boxes, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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Maytag Dairy Farms Expands Voluntary Recall of Blue Cheese Due to Food Safety Concern - FDA Safety Alerts & Drug Recalls

Maytag Dairy Farms in Newton, IA today announced a voluntary recall of lot number 150482 of Maytag Raw Milk Blue Cheese due to possible contamination with Listeria monocytogenes. This follows the recall of lot number 150481 that was announced this past weekend.

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Maytag Dairy Farms Issues Voluntary Recall of Blue Cheese Due to Food Safety Concern - FDA Safety Alerts & Drug Recalls

Maytag Dairy Farms in Newton, IA today announced a voluntary recall of lot number 150481 of Maytag Raw Milk Blue Cheese due to possible contamination with Listeria monocytogenes.

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Wild Blue Yonder Foods Issues Recall for Chappaqua Crunch Granola with Blueberries and Bananas Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

WBY Foods of Marblehead, MA, is recalling its Chappaqua Crunch Simply Granola with Blueberries and Bananas, in 13 ounce packages, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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FDA approves Briviact to treat partial onset seizures - FDA Press Releases

The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.

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Thursday, February 18, 2016

Peking Food LLC Issues Allergy Alert For Undeclared Egg in Assorted Chef Hon Brand Steamed Buns - FDA Safety Alerts & Drug Recalls

PEKING FOOD LLC of BROOKLYN, NY, is recalling Chef Hon brand STEAMED BUNS WITH SEAFOOD & VEGETABLE and STEAMED BUNS WITH SEAFOOD MARINATED IN XO-SAUCE, because they contain undeclared eggs. People who have an allergy to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

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Advance Care Planning and Goals of Care Communication in Older Adults with Cardiovascular Disease and Multi-Morbidity - Geriatrics

This article provides an approach to advance care planning (ACP) and goals of care communication in older adults with cardiovascular disease and multi-morbidity. The goal of ACP is to ensure that the medical care patients receive is aligned with their values and preferences. In this article, the authors outline common benefits and challenges to ACP for older adults with cardiovascular disease and multi-morbidity. Recognizing that these patients experience diverse disease trajectories and receive care in multiple health care settings, the authors provide practical steps for multidisciplinary teams to integrate ACP into brief clinic encounters.

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Multiple Chronic Conditions in Older Adults with Acute Coronary Syndromes - Geriatrics

Older adults presenting with acute coronary syndromes (ACSs) often have multiple chronic conditions (MCCs). In addition to traditional cardiovascular (CV) risk factors (ie, hypertension, hyperlipidemia, and diabetes), common CV comorbidities include heart failure, stroke, and atrial fibrillation, whereas prevalent non-CV comorbidities include chronic kidney disease, anemia, depression, and chronic obstructive pulmonary disease. The presence of MCCs affects the presentation (eg, increased frequency of type 2 myocardial infarctions [MIs]), clinical course, and prognosis of ACS in older adults. In general, higher comorbidity burden increases mortality following MI, reduces utilization of ACS treatments, and increases the importance of developing individualized treatment plans.

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