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Science Policy Around the Web – July 7, 2017

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By: Leopold Kong, PhD

Food Policy

Food and Microbiota in the FDA Regulatory Framework

More and more probiotic food products, or microbiota-directed foods, claiming to “improve” the body’s microbiota have been hitting the shelves, with sales valuing over US$700 million in the US alone and US$36.6 billion globally this past year. However, there is little framework regulating their ingredients or guaranteeing the scientific accuracy of their health claims that has resulted in costly legal action. For example, in September 2009, Dannon settled a US$35 million consumer class action suit challenging the claimed health benefits in their ads. A similar class action suit against Procter & Gamble’s Align probiotic has been certified and set for Oct. 16, 2017. A paper recently published in the journal Science calls for greater clarity in policy regulating probiotic products. Importantly, the authors urge that probiotics should be clearly classified as a dietary supplement, a medical food, or a drug. If classified as a dietary supplement, probiotics can make claims on nutrient content and effect on health, but not on treatment, prevention or diagnosis of disease. If classified as a medical food, probiotics must contain ingredients that aid in the management of a disease or condition, with “distinctive nutritional requirements”, that is scientifically recognized. Finally, if classified as a drug, probiotics will require clinical trials to prove its medical claims. An alternative, and perhaps cheaper, way forward is to regulate probiotics as a kind of over-the counter medical food, requiring testing only for their active ingredients that can be used in a variety of products. (Green et al., Science)

Antibiotic Resistance

Untreatable Gonorrhoea on the Rise Worldwide

Over 78 million people are infected with gonorrhea each year, a sexually transmitted disease that has traditionally been treated effectively with anti-microbials. However, recently published data from 77 countries show that antibiotic-resistant gonorrhea is getting more pervasive and harder to cure. “The bacteria that cause gonorrhea are particularly smart. Every time we use a new class of antibiotics to treat the infection, the bacteria evolve to resist them,” said Dr. Teodora Wi, Medical Officer, Human Reproduction, at the WHO. The data found widespread resistance to ciprofaxacin, azithromycin, and even to the last-resort treatments, oral cefixime and injectable ceftriaxone. New drugs are under development, including a phase III trial of a new antibiotic, zoliflodacin, launched by the non-governmental organization Drugs for Neglected Diseases Initiative and Entasis Therapeutics, a biotech company in Waltham, Massachusetts. Better prevention through education on safer sexual behavior and more affordable diagnostics will also be needed moving forward. (Amy Maxmen, Nature News)

Maternal Health

U.S. has the Worst Rate of Maternal Deaths in the Developed World

A recent six-month long investigation by NPR and ProPublica has found that more women in the US are dying of pregnancy related complications than any other developed country. Surprisingly, this rate is increasing only in the US, which stood at ~ 26.4 deaths per 100,000 births in 2015, translating to nearly 65,000 deaths annually.  This is three times worse than for women in Canada, and six times worse than for women in Scandinavian countries. Reasons include older new mothers with more complex medical histories, unplanned pregnancies, which are the case half the time in the US, greater prevalence of C-sections, and the fragmented health system. This is in contrast with progress in preventing infant mortality, which has reached historic levels in the US. Better medical training for maternal emergency and more federal funding for research in this area may improve the situation for American mothers. (Nina Martin and Renee Montagne, NPR)

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How Easy is it to Access Health Care in the US?

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By: Rachel F Smallwood, PhD

Source: pixabay

         Access to health care has been a concern as long as there has been health care, and it is one of the hot-button issues of health care policy debates. The recent repeal of the Affordable Care Act and passing of the American Health Care Act (AHCA) in the House of Representatives has again brought this debate front and center. The Congressional Budget Office’s analysis of the first iteration of the AHCA indicated that it would result in 24 million less people having health insurance by 2026. It would also place more of the financial burden on people making less than $50,000 per year. However, substantial changes were made to parts of the bill before it passed in the House, and there will likely be more if it is to be passed in the Senate. There is much debate and dissension on what level of access to health care should be provided by the government and whether health care is a right versus a privilege. In addition to that debate, there are other facets of the United States’ health care system that need examination and work to ensure access to health care.

There are many reasons a person may not have access to health care – not having health insurance is just one. To measure access to health care, one must first define it. Is there some quality standard that must be met for treatment to be considered health care? How do we determine whether one person’s health care is equivalent to another’s? With health care measures that range from necessary, recommended but not dire, to completely elective, even these differences can be difficult to quantify. Most institutions collecting data on health care use a working definition like that set by the Institute of Medicine in 1993: access to health care means a person is able to use health care services in a timely manner to achieve positive health outcomes. This implies that a person can enter the health care system, physically get to a place where they can receive health care, and find physicians whom they trust and who can provide the needed services.

Indeed, there are differing opinions on what constitutes “access”, and this heterogeneity is further compounded by the multiple barriers to access. For example, with the recent AHCA proposal, many representatives spoke about separating the concepts of health care coverage and health care access, while others believe that the two are not separable. There are at least four factors that limit a person’s access to healthcare. The first barrier is the availability of health services; if the necessary health care is not provided within reasonable traveling distance of a person seeking services, none of the other factors matter. The other three factors are personal barriers such as a person’s perceptions, attitudes, and beliefs about their own health and health care, organizational barriers such as referrals, waiting lists, and wait times, and financial barriers such as inability to afford insurance, copays, costs beyond deductibles, and lost wages.

The current policy in the United States is the Affordable Care Act, put into place under the Obama administration. One of the most contentious points of the law is its requirement that every person have health care coverage or pay a penalty. A 2015 survey released by the National Center for Health Statistics indicated a substantial drop in the percentage of the US population without insurance over the previous few years. There was a slight increase in the percentage of people with a usual place to go for health care (i.e. a primary care provider or clinic for regular check-ups), and a decrease in the number of people who failed to obtain needed health care due to cost, but simply requiring everyone to purchase health insurance did not induce a commensurate rise in people gaining access to health care, in accordance with the steps and measures discussed by the Agency for Healthcare Research and Quality. Additionally, there have been substantial increases in premiums, which means that those consumers still have a significant financial barrier to health care.

The numbers and policies referenced above address the country as a whole, but statistics vary widely across regions of the United States. US News ranked states on their access to health care using six metrics: child wellness and dental visits, adult wellness and dental visits, health insurance enrollment, and health care affordability. Some examples of the ranges seen between states in these measures are that 20% of adults do not have regular checkups in the highest ranked states, while around 40% do not have regular checkups in the lowest ranked states. In the highest ranked state for affordability, the fraction of people who needed to see a doctor but could not because of cost was around 7%, while in the lowest ranked state this percentage was just under 20%. While some of this is due to the differing demographics and living conditions from state to state, the discretion and freedom that states have in applying health care laws also factor in.

When comparing to other similar (high-income) nations, the United States falls short on access to health care. Although the Affordable Care Act improved access to health insurance, the US is still lagging when it comes to its residents receiving actual care. This is partially due to fewer physicians practicing general medicine in the US. In 2013, the US ranked below all other Organization for Economic Co-operation and Development countries, except for Greece, for the density of general practitioners per 1,000 people. A related measure showed that the US also had a lower percentage of physicians choosing general practitioner/primary care as their specialty than all other 35 countries. These countries are all World Bank-categorized high-income countries except for Mexico and Turkey, which are upper middle-income (and had better stats than the US). This disparity has been noted in the US and is driven by many factors including physician salaries, patient loads, and medical education emphasis (or lack thereof) on primary care. This shortage also disproportionately affects rural areas, likely contributing to some of the state-to-state variability noted above.

The United States is struggling when compared with similar nations to provide health care access to its citizens. The reasons for this struggle are multifaceted, including access to health insurance, financial barriers, and lack of primary care physicians. The political tensions and opposing principles held by individuals can also be barriers to working toward a more accessible health care system. We should be focused on developing a health care system where all can reasonably obtain health insurance, where health care costs are not prohibitively expensive, and medical education should emphasize the importance of primary care in our nation’s health and communicate the need for practitioners in under-served areas. Shedding light on these areas for improvement will allow people to work together to address our weaknesses and create a system that improves and sustains the health of our nation.

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Written by sciencepolicyforall

May 19, 2017 at 10:16 am

Science Policy Around the Web – May 16, 2017

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By: Sarah L Hawes, PhD

Source: pixabay

Preventative Medicine

Fresh Foods a Day Keep Disease and Deficit Away

If you have recently shopped for health insurance, you likely encountered incentives for self-maintenance, such as discounted gym membership, or reimbursement for a jogging stroller. These incentives are motivated by the enormous ticket price of failing health. The CDC estimates that over $500 billion is spent annually on direct medical expenses to treat chronic diseases, which can be prevented or postponed through lifestyle practices – including heart disease, obesity, and diabetes.

The Geisinger health care system reports encouraging results from the first year of a lifestyle-modification program called Fresh Foods Pharmacy, piloted in central Pennsylvania. This program provides patients with Type 2 diabetes nutrition counselling, hands-on classes in healthy cooking techniques, and a weekly prescription for five days’ worth of fresh food – fillable for free at a hospital based “food pharmacy.” This means patients are not just advised to eat better; they are comprehensively enabled to eat better.

David Feinberg, president and CEO of Geisinger, reports that all 180 participants in the pilot group have made substantial improvements in their health, including reductions in blood pressure and body weight, and that many have seen a several-point reduction in a blood marker used to diagnose and monitor their disease, called A1C. A1C reduction means that blood sugar levels are being better controlled, which also means fewer costly diabetic complications for patients down the line. Feinberg calls the program “life changing,” adding that participants “won’t go blind; [they] won’t have kidney disease, amputations.”

Many Fresh Foods Pharmacy participants are low-income, so there is powerful financial incentive to ‘follow doctors’ orders’ and eat the free, healthy food. But what does supplying a person with nutritional counsel and weekly fresh foods cost?

Geisinger spends approximately $1,000 per year on each Fresh Foods Pharmacy patient. Meanwhile, a mere one-point drop in A1C levels saves Geisinger roughly $8,000 per year. Feinberg says that many participants trimmed about 3 points off their A1C level in the first year, saving roughly $24,000 on a $1,000 investment. “It’s a really good value” says Feinberg, who is already working to expand the program to additional sites.

Improved patient health and medical cost-cutting in the first year of this program are independently exciting. In addition, the value of engendering better patient health through comprehensive dietary support is very likely to extend beyond patient and provider. Patients who are enabled to engage in healthful food preparation will share a healthier diet and food-culture with their families, enhancing program benefits in as-yet unmeasured dimensions. (Allison Aubrey, NPR)

Research Funding

Climate Science Policy Lessons from Down Under

Pretend for a moment that everyone firmly believes that climate change is real, and is a real threat. Is this enough to safeguard basic climate science research? Recent events in Australia give us our answer – no.

Australia is the most active contributor to climate science in the Southern Hemisphere. As such, Australian researchers provide a truly international service. Public appreciation of this fact, together with public activism, recently saved funding for Australian climate science.

In 2015, Dr. Larry R. Marshall was appointed to lead Australia’s national scientific agency (CSIRO). Dr. Marshall planned to champion initiatives motivated by his faith in climate science. He wanted to develop technologies to respond to inescapable climate change, and to mitigate damage through reduced emissions. Paradoxically he proposed to fund these by laying off droves of basic climate researchers.

Dr. John A. Church was a climate scientist at CSIRO, having published highly regarded studies indicating accelerated sea level rise paralleling greenhouse gas emission. On catching wind of Marshall’s plan, Church reached out to his contacts in the media and wrote an open letter to Marshall in defense of basic science. Public marches, hearings, and protests from thousands of international scientists ensued.

Ultimately, the rally of public voices instigated by Dr. Church and others like him was effective. Far fewer layoffs occurred than were initially slated to occur. Dr. Church was among those let go by CSIRO, but was rapidly recruited by the University of New South Wales to continue his climate research.

Bear in mind that Dr. Marshall was no climate change denier. He showed great willingness to use scientific findings to guide policy, which is admirable. He addressed an Australian Senate committee saying that the climate “absolutely is changing,” and “we have to do something about it.” In a recent interview, he summarized his reasons for wanting to lay off scientists saying this: “Unfortunately, with a finite funding envelope, you’ve got to make choices where you fund.”

Australia’s example shows us that even in a political environment with great faith in science, reverence for basic research is a separate issue, and merits independent attention and protection. Staying abreast of science policy matters. And for those of us who believe there is no shortage of natural complexity, and no end to the fruitful pursuit of knowledge, it pays to speak out in defense of basic research. (Justin Gillis, The New York Times)

 

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Science Policy Around the Web – May 5, 2017

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By: Thaddeus Davenport, PhD

Healthcare Policy

House Passes Bill to Repeal and Replace the Affordable Care Act

Thomas Kaplan and Robert Pear reported for the New York Times yesterday that Republicans in the US House of Representatives voted to pass a bill that would undo a number of central elements of the Affordable Care Act. Only six weeks ago, House Republicans failed to gather enough support to even vote on the first version of this bill, which was predicted to eliminate insurance coverage for twenty-four million Americans over the next decade. Since that time, Republican lawmakers have modified the so-called American Health Care Act (AHCA) bill to appeal to the more conservative members of the House – including provisions that would limit federal support of the Medicaid program, allow states to opt out of requiring that insurance cover services like maternity and emergency care, and also enable states to apply for waivers that would let insurance companies charge higher premiums for some individuals with pre-existing conditions. Like the first version, the bill that passed the House on Thursday does away with the ‘individual mandate’, which imposes a tax on people who can afford to buy insurance but do not – an aspect of the Affordable Care Act that was relatively unpopular but critical to ensure sustainability of the insurance markets. It also replaces government-subsidized insurance plans with tax credits between $2,000 and $4,000, depending on age. Other provisions in the bill would stop federal funding to Planned Parenthood for one year as well as eliminate taxes on high-income individuals, insurance companies, and pharmaceutical companies that helped to fund the Affordable Care Act. Yesterday, 217 Republicans voted in favor of the revised AHCA bill that will certainly  not provide healthcare insurance for everyone, without waiting for a non-partisan Congressional Budget Office analysis of the bill’s impact on the federal deficit or on the American people. These representatives’ haste reveals that they care little about how the AHCA will actually affect their constituents’ lives, and Democrats are counting on voters remembering this in upcoming elections. (Thomas Kaplan and Robert Pear, The New York Times)

Science Funding

NIH Funding Changes to Support More Early Career Investigators

The NIH budget has gradually declined over the last fourteen years, from $40 billion in 2003 to about $32 billion in 2017. Given that a proposed budget from the Trump administration for fiscal year 2018 would further cut funding for NIH by $5.8 billion, it is unlikely that funding for the NIH will increase dramatically in the coming years. To address these budget limitations, and in an attempt to do more with less, Jocelyn Kaiser reported for ScienceInsider this week that the National Institutes of Health will impose a cap on the number of grants awarded to investigators. In an open letter announcing the decision, NIH director, Francis Collins, writes that 40% of NIH funding is concentrated in the hands of 10% of NIH-funded investigators. He notes that this is not inherently problematic, except that many studies indicate that there are diminishing scientific returns on each additional dollar that is granted to any individual investigator. Under the new guidelines, investigators will be limited to a maximum of three R01-equivalent grants in order to support approximately 1,600 more grants to early career and mid-level researchers, who have been particularly affected by the declining NIH budget. While it is difficult to quantify scientific impact, the NIH decision is admirable for its intent to support diversity and efficiency in funding research. (Jocelyn Kaiser, ScienceInsider)

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Science Policy Around the Web – April 25, 2017

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By: Eric Cheng, PhD

Photo source: pixabay.com

FDA

FDA Nominee Gottlieb Tackles Vaccines, Trial Design at Hearing

The President’s nominee to head the FDA, Scott Gottlieb, MD, sat before lawmakers for his confirmation hearing before the Senate’s health committee. Gottlieb, a hospitalist and former FDA official, was questioned on many controversial topics on health.  On the topic of vaccines and autism, Gottlieb said, “I think we need to come to the point where we can accept ‘No’ for an answer, and come to the conclusion that there is no causal link between vaccinations and autism.”

On the topic of double-blind randomized trials as the “gold standard” for medical treatment research, Gottlieb was more cautious. He believed that there are more “opportunities to modernize how we do clinical trials in ways that aren’t going to sacrifice on the gold standard of safety and effectiveness. Perhaps there are ways to think of clinical trial constructs that don’t require the tight randomization that current clinical trials do.” What this suggests is a push towards more adaptive trials that would allow researchers to review results before a study’s endpoint and would allow changes to treatment groups in a study, which is in contrast to traditional randomized controlled trials.

Another less controversial but popular topic in the hearing was on opioid abuse. Gottlieb believed that opioid abuse is “a public health emergency on the order of Ebola and Zika” and that bolder steps will be needed to address this issue.

The committee will vote on whether to move Gottlieb’s nomination to the Senate floor after the Senate returns in late April from a 2-week recess. (Joyce Frieden, MedPage Today)

Healthcare Policy

Trump Administration Still Plans to Undo Parts of the ACA, Tom Price Testifies

Health and Human Services Secretary Tom Price made one thing clear during his testimony to the House appropriations committee: “The administration is still intent on dismantling parts of the Affordable Care Act even if Republicans lack the votes to rewrite it.”

Price discussed how, as the Health and Human Services Secretary, his department could scale back several federal mandates that include “essential benefits” in coverage to make insurance plans cheaper. He did not say if the administration will continue to provide cost-sharing subsidies for insurers, which has been a topic of discussion on items to change in the Affordable Care Act. However, removing subsidies will bring “significant premium increases,” said Michael Adelberg, a health-care principal at FaegreBD Consulting. He predicts that the removal of these subsidies will cause some insurers to drop out while the remaining insurers will seek rate increases to compensate.

Regardless of these discussions, the individual mandate remains in place with Price telling the panel, “So long as the law’s on the books, we at the department are obliged to uphold the law.” (Juliet Eilperin and Mike DeBonis, Washington Post)

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Written by sciencepolicyforall

April 25, 2017 at 9:53 am

Healthcare Policy – What’s in Store for Our Future Healthcare Needs?

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By: Emily Petrus, PhD

       There’s no question that the US spends too much on healthcare – in 2015 it cost 18% of its GDP, equivalent to $3.2 trillion dollars. In fact, we spend more on healthcare to cover just 34% of our population via Medicare and Medicaid than other countries who cover their entire population with universal healthcare. Most people assume that this higher spending equals better health, but unfortunately this isn’t the case.

According to a 2015 Commonwealth Fund survey, the US has the highest infant mortality and obesity rates and the lowest life expectancy of the top 13 Organisation for Economic Co-operation and Development (OECD) countries. In addition, we have the highest rates of prescription drug use, amputation due to diabetes mismanagement, and the second highest death rate from ischemic heart disease. Our relatively small percentage (14.1%) of people over age 65 also have the highest rate of at least two chronic illnesses per person. These numbers are estimated to increase as baby boomers age, so the outlook isn’t good when considering how many elderly people we can expect to suffer from chronic health issues.

However, it’s not all doom and gloom – we are in the top 3rd for surviving cancer, boast the lowest smoking rates, and have the highest access to diagnostic imaging services (such as MRI and CT scans). In this light, it makes sense that we spend more, have better access to expensive technology, and use more expensive prescription drugs. Another way to slice the data paints a different picture. The sickest 5% of the population accounts for 50% of medical spending, and accounts for 60% of spending on prescription drugs. Together these data indicate that the US could be in better shape if we had a healthier population.

How could we make the population healthier? Let’s consider that the determinants for health are 30% genetics, 70% behavior, environment and social factors, only 10% is mediated by healthcare. Other OECD countries spend significantly more on social services such as supportive housing, employment programs, retirement and disability programs. Social services are especially beneficial for people in lower income brackets, who incidentally have the poorest health in the US. The life expectancy for the poorest Americans is about 13 years less than the wealthiest. Racial disparities also contribute to gaps in healthcare outcomes for Black, Hispanic, Asian and American Indians/Alaskan Native Americans, all of whom experience worse medical care. The parameters measured included access to care, effective communication with medical staff, and a specific source of ongoing medical care, such as a primary care physician. It is estimated that these disparities amount to billions of dollars in economic loss – $35 billion in excess health care expenditures – for example, a trip to the emergency room for something that could be treated by better access to a primary care physician. Expanding Medicaid would increase medical access to poor and disadvantaged minority groups, for example, Blacks in the south. However, many states thatch have high at-risk populations decided not to expand Medicaid. Spending more on social services aimed at improving people’s health seems to be working in other OECD countries, and the National Academy of Medicine recommends the US increase spending in these areas.

Social services are unlikely to gain support from conservatives, so spending in this area is unlikely to be supported by the current administration. However, there are other areas in healthcare that can gain bipartisan support. 30% of medical expenses are considered wasteful – meaning they are for unnecessary services, fraud, and sky high pharmaceutical or administrative costs. Medicare has already saved billions of dollars by reducing overpayments to private insurers and tying medical provider payments to quality of care. Overall a goal of those involved in healthcare reform should seek to follow this example of prioritizing value over volume of care, which will translate to better outcomes at lower costs for patients and taxpayers.

So what did the Affordable Care Act (ACA, also known as Obamacare) achieve since it was passed in 2010? In the time leading up to the ACA, 82% of the American public wanted healthcare reform. Private insurance premiums were rising 10% per year, and insurance didn’t have to cover expensive benefits, so many plans came without services like mental health or maternity care. Maternity care is not just a women’s issue, healthier pregnancies result in healthier babies who become part of our population. Before the ACA, 50 million (17%) of the population was uninsured; by 2016 20 million people had gained health insurance, leaving only 10% of our population uninsured. Women and people with pre-existing conditions can’t be denied coverage or charged more by insurance companies. Lifetime spending caps were removed, meaning if you were a sick baby in the ICU you can’t be denied coverage for the remainder of your life. The most popular part of the bill allows young adults to stay on their parents’ insurance until age 26, which reduced the uninsured rate for young adults by 47%. Finally, tax credits made health insurance through exchanges more affordable for those at or below 400% of the federal poverty line.

Those are the good parts about the ACA – here’s the bad news.  High deductible plans have increased from 10% of plans offered in 2010 to 51% of plans in 2016, meaning people buying insurance can expect to pay at least the first $1,000 per year out of pocket. If it seems that premiums are jumping, they are: they rose 20% from 2011 to 2016. It’s easy to blame the ACA for rising premiums, but if we consider that premiums rose 10% per year before the ACA, 20% in 5 years doesn’t sound so bad. Some specific states are expecting huge increases, for example Oklahoma will see a 42% increase in 2016. Part of the reason premiums are rising is because healthcare gets more expensive each year – it outpaces inflation and wages. Insurance companies are also losing money because they have enrolled more sick, expensive people than they expected to when they set prices. The ACA attempted to mediate the sticker shock for insurance companies by setting up “risk corridors” to help shoulder the burden, but that part of the bill was scuttled for political reasons, and now insurance companies are passing the buck to consumers. Regarding taxes, under the ACA, those without insurance will face a penalty fee double that of the 2015 amounts.

A central campaign promise of Trump and Republicans was to repeal the ACA and provide better and more affordable coverage for all.  The American Health Care Act (AHCA) proposed several weeks ago by Republicans was a repeal and replace bill which was unpopular from the start. The AHCA was unpopular with conservatives for not going far enough to repeal the ACA, while moderates worried about the 20 million people, including their constituents, being denied or outpriced from insurance due to some elements of the bill. The AHCA removed the mandates requiring insurance companies to provide essential health benefits. This could lower premiums but insurers could also reduce services, leading to “junk plans”. Additionally, tax credits for people buying insurance would be significantly lower than current levels, making insurance too expensive for many middle-income people. Medicaid coverage was also proposed to shrink, resulting in less coverage for poor Americans. Finally, eliminating the community rating of the ACA would enable insurance companies to charge older and sicker people higher premiums, essentially pricing those who need insurance the most out of the market. The AHCA proposed to ameliorate this problem by providing larger tax credits to older individuals and setting up pools of high risk people subsidized by the government.

It is safe to assume that the Republican controlled House, Senate and the White House will try again to present bills that modify the ACA. However, it remains to be seen if they will try a bipartisan effort to fix certain parts of the bill that are flawed, or repeal and replace the ACA with something completely new.

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Written by sciencepolicyforall

April 14, 2017 at 9:22 am