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Science Policy Around the Web – May 11, 2018

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By: Mohor Sengupta, PhD

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source: Max Pixel

Drug prices

Why Can’t Medicare Patients Use Drugmakers’ Discount Coupons?

With high drug prices, affordability of specialized medicines is a matter of concern for many individuals, especially those on life-saving brand-name drugs.

Manufacturers of brand-name medicines provide discount coupons to people with private health insurance. Such discounts are denied for people with federal healthcare plans such as Medicare or Medicaid. For example, for one patient on Repatha (a cholesterol reducing drug), the co-payment is $618 per month with the Medicare drug plan, but it is only $5 for patients with commercial insurance plans. This discrepancy has resulted in a “double standard” because arguably, the discount is denied to the people who need it most, that is the retired population subscribing (compulsorily) to federal healthcare programs.

Drug manufacturers have an incentive to offer discounts on branded medicines as they increase the likelihood of purchase and results in greater access to and demand for the products. While these discount coupons are immensely beneficial for life-threatening conditions for which generic drugs are not available, a 2013 analysis has shown that lower cost generic alternative and FDA approved therapeutic equivalent was available for 62% of 374 brand-name drugs.

The federal government has argued that with the discount coupons, patients might overlook or be discouraged from buying cheaper variants of the brand-name drug. Even if a patient chooses to use a brand-name drug with a discount coupon over cheaper alternative, their health insurance plan still has to pay for the drug. That amount maybe more than Medicare or Medicaid may be willing to pay. This has resulted in the federal anti-kickback statute which prohibits drug manufacturers to provide “payment of remuneration (discounts) for any product or service for which payment may be made by a federal health care program”.

One important question is why do drug makers sell the brand-name drugs at a much higher price bracket when generic, cheaper options are available? In the present scenario, insurance companies should make the judgement about whether they are willing to cover such brand-name drugs for which generic alternatives are available. Often doctors prescribe brand-name drugs without considering their long-term affordability by patients. It is the responsibility of doctors and insurance providers alike to determine the best possible drug option for a patient.

Taking in both sides of the picture, use of discounts must be exercised on a case basis. It must be enforced for specialized drugs against which generic alternatives are not available and which are usually used for severe or life-threatening conditions. Currently for people with such conditions and on federal healthcare plans, affordability is a major challenge.

(Michelle Andrews, NPR)


EPA standards

EPA’s ‘secret science’ rule could undermine agency’s ‘war on lead’

Last month the Environmental Protection Agency (EPA) administrator, Scott Pruitt issued a “science transparency rule” according to which studies that were not “publicly available in a manner sufficient for independent validation” could not be used while crafting a regulation. This rule is at loggerheads with Pruitt’s “war on lead” because a majority of studies on lead toxicity are observational, old and cannot be validated without consciously exposing study subjects to lead.

Lead is a potent neurotoxin with long term effects on central nervous system development. It is especially harmful to children. There are several studies showing lead toxicity, but many do not meet the inclusion standards set by the EPA’s the new science transparency rule. Computer models developed to assess lead toxicity, which played important role in EPA’s regulations on lead in the past, have amalgamated all these studies, including the ones that cannot be validated. If the science transparency rule is retroactive, it would mean trashing these models. An entire computer model can be rendered invalid if just one of its component studies doesn’t meet the transparency criteria.

Critics say that the transparency measure will be counter-effective as far as lead regulations are concerned. “They could end up saying, ‘We don’t have to eliminate exposure because we don’t have evidence that lead is bad’”, says former EPA staffer Ronnie Levin. Another hurdle is the proposed data sharing requirement. Lead based studies tend to be epidemiological and authors might be unwilling to share confidential participant data.

Bruce Lanphear of Simon Frazer University in Canada is skeptical of EPA’s intensions because the agency has not imposed similar transparency measures for chemical companies like pesticide producers.

Finally, this rule could set different standards for lead safely levels in different federal agencies. Currently Center for Disease Control and Prevention (CDC) and Department of Housing and Urban Development (HUD) consider 5 micrograms per milliliter of lead in blood as the reference level. The EPA rule could lead to a new reference level, leading to discrepancies when complying with agencies across the U.S. government.

(Ariel Wittenberg, E&E News)


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Written by sciencepolicyforall

May 11, 2018 at 10:24 pm

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

Science Policy Around the Web – February 4, 2015

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By: Jennifer Seedorff, Ph.D

photo credit: Synapse journal via photopin cc

Global Warming

On Monday, the United Nations’ World Meteorological Organization, WMO, joined the National Aeronautics and Space Administration, NASA, the National Oceanic and Atmospheric Admiration, and the Japan Meteorological Agency in concluding that 2014 was the hottest year on record.  The only major science agency that has not explicitly agreed with 2014 being the hottest year on record, was the Hadley Center in Britain which concluded “the uncertainty ranges mean it’s not possible to definitively say which of several recent years was the warmest.” The World Meteorological Organization also noted “the difference in temperature between the warmest years is only a few hundredths of a degree – less than the margin of uncertainty.”  These record temperatures were achieved despite the absence of an El Nino event, which typically temporarily increase temperatures. WMO Secretary-General Michel Jarraud noted, “The overall warming trend is more important than the ranking of an individual year.”  Although experts may disagree on which particular year was the warmest on record, it is striking that 14 of the 15 hottest years on record have been in the 21st century, and we are only 14 years into this century.  (Chris Mooney, The Washington Post)


Public Health – Precision Medicine

Details have begun to emerge on President Obama’s Precision Medicine Initiative, first announced during his State of the Union Address.  On January 30th, President Obama rolled out the initiative in the East Room. Precision medicine refers to tailoring medical treatments to an individual, including their specific genetic makeup, disease mutations, microbiome, etc.  Francis Collins, director of the NIH, and Harold Varmus, head of the National Cancer Institute, recently described the Precision Medicine Initiative in the New England Journal of Medicine, “The proposed initiative has two main components: a near-term focus on cancers and a longer-term aim to generate knowledge applicable to the whole range of health and disease.” They further commented that this initiative “will also pioneer new models for doing science that emphasize engaged participants and open, responsible data sharing. Moreover, the participants themselves will be able to access their health information and information about research that uses their data.” Funding for this $215 million initiative still needs to be approved by Congress. Jo Handelsman, associate director for science in the White House Office of Science and Technology Policy, referred to precision medicine as a “game changer” that “holds the potential to revolutionize the way we approach health in this country and ultimately around the world.” (Jocelyn Kaiser, ScienceInsider and Francis Collins and Harold Varmus, The New England Journal of Medicine)


Public Health – Medicare Reform

Medicare is in the process of reforming how it pays for medical care. It is planning a transition from a fee-for-service system that pays providers based on the quantity of services provided to a system that rewards providers, instead, for the quality of the services provided.  This transition has intensified the debate over how to measure the “quality” of a service.  Currently, quality is being measured in terms of process, how many patients with a given diagnosis are being given a specific intervention, for instance how many back pain patients are being advised against bed rest or how many chest pain patients in the ER are being given aspirin.   On January 30th, a nonprofit advisory group, the National Quality Forum, submitted to Health and Human Services recommendations on 199 performance metrics for consideration.  Christine Cassel, president of the National Quality Forum, said that many of their recommendations seek to replace narrow process metrics with “measures that matter” to patients. The Center for Medicare and Medicaid Services is publicly releasing many quality metrics on its Hospital Compare and Physician Compare websites, although comparing complication rates between physicians is not yet available.  Beck reports that some doctors have criticized tying physician reimbursements to these outcome-based measurements arguing that whether a patient gets better is often out of their control. The transition to quality-based measurements has had its successes, including reducing the rate of central-line blood stream infections by 50% since hospitals were required to report them. According to Scott Wallace, a visiting professor at Dartmouth, “Measurement fatigue is a real problem in hospitals.  But, to me, the only metric that matters is, did you get better?” (Melinda Beck, The Wall Street Journal)



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Written by sciencepolicyforall

February 4, 2015 at 10:22 am

Science Policy Around the Web – November 28, 2014

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By: Varun Sethi, Ph.D

photo credit: El Bibliomata via photopin cc

Interdisciplinary Science

Gut-brain link grabs neuroscientists

Gut bacteria benefit mental health. Do they? This is what companies selling probiotics have long claimed. Though traditionally skeptical to the theory, many neuroscientists are becoming interested in the clinical implications of the gut microbiome. The National Institute of Mental Health spent more then US$ 1 million this year, on research aimed at studying the microbiome-brain connection. Studies presented at the recent SFN meeting in DC reported this as a paradigm shift in neuroscience. Bifidobacterium and Lactobacillus are genera that have been reported to show beneficial effects on anxiety and depression related behavior. Gut bacteria and bacterial waste products may regulate stress, anxiety and cognition, especially in early life. Mechanisms and therapeutic potential of these associations are the focus of research in the field. The interaction between the gut associated immune system, enteric nervous system and gut based endocrine system has led to intriguing speculations about the impact of the bi-directional signaling between the mind, brain and gut. Are psychobiotics and melancholic microbes going to be the prescription to happiness? Though majority of the studies are in rodent models, the implications of microbiota in our intestines is being increasingly looked at with interest. There maybe some science in the use of the term ‘gut feeling’ after all! (Sara Reardon, Nature)


Health Care Policy

Medicare’s Chronic Care Management Payment — Payment Reform for Primary Care

A fee-for-service system, wherein payments for primary care are restricted to office based visits, is unable to provide good support for the core activities of primary care outside the office visit. These include tasks such as patient care co-ordination, patient communication, medication refill and care provided via electronic or telephonic channels. In 2015, the Centers for Medicare and Medicaid Services (CMS) will be introducing a non-visit-based payment for chronic care management (CCM). This is an important and broadly applicable change to primary care payment and reflects an investment in creating a value-oriented healthcare system. The system will allow a practices to receive a monthly fee of $40 for beneficiaries with two or more chronic conditions, that are expected to last at least 12 months and confer a significant risk of death, decompensation or functional decline. Practices will have to use electronic health records (EHR), provide round the clock availability to staff able to access EHR and maintain a designated practitioner amongst other things. The implementation of this policy will, however, have to deal with many challenges. Beneficiaries will be expected to pay a 20% co-insurance for CCM, a fee for a service they have so far received free. They will have the choice to consent, and in the event that they refuse, how will the practice continue to care for such patients ? Smaller practices with limited resources may have trouble meeting the requirements and may perhaps be rendered ineligible. The details of the implementation are unclear as yet. While the payment will provide additional resources to the primary care system, it may not achieve the transformation in practice as per the patient-centered medical home (PCMH) initiatives. (Samuel T. Edwards, Bruce E. Landon, New England Journal of Medicine)


Translational Science

Changing the Mindset in Life Sciences Toward Translation: A Consensus

Basic discoveries in biomedical science continue to a fast pace, however, the translation of this knowledge into clinical use lags behind significantly. Biomedical translation is challenged with scientific, financial and political speed-breakers. In May 2014, Translate, a meeting in Berlin, brought together stakeholders from around the world with the common goal of improving biomedical translation. Infrastructure, funding and de-risking issues in biomedical technology were major factors identified as barriers in biomedical translations. An appalling 80 to 90% research projects fail before they are tested in humans, and those that do proceed require up to 15 years to find a clinical use. A multidisciplinary approach involving clinical scientists, researchers, patent agents, industrial partners and regulatory authorities is required to create expert professional translators, who have the expertise to capture those discoveries that have the potential to make it to the clinical market. A change in academic funding and education is warranted. Academic reward systems should focus on not only the publication quality, number and journal impact factor, but also on tangible impacts of research on medical treatments and patient benefits. Cross-talk between scientists from different specialties, with different ideas, perspectives and expertise needs to encouraged and facilitated. The importance of professionalizing translation was emphasized at the meeting. Adequate economic incentives and market forces are essential in driving and directing successful translation. While industry is eager to take over projects beyond phase 2, funding for early phase development is complicated by larger risks and remains an uphill task. This paper discusses the role of a translational researcher in recognizing these challenges and invoking the industry, networking to form partnerships that are essential to collect market data and find solutions. A change in scientific mindset with a greater emphasis on interactive and collaborative relationships is needed. In future articles of this series, funding barriers and derisking will be discussed. Biomedical translation, is not a passive process and is a very crucial step in improving the value of health care, health outcomes and the quality of patient life. (Duda et al., Science Translational Medicine)



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November 28, 2014 at 3:50 pm

Science Policy Around the Web – November 30, 2012

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photo credit: aloshbennett via photopin cc

By: Jennifer Plank

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Tobacco Companies Are Told to Correct Lies About Smoking
A recent ruling by Judge Gladys Kessler of the United States District Court for the District of Columbia requires tobacco companies to publish corrective statements admitting that they lied about the dangers of smoking. Each corrective advertisement must include a statement that a federal court has ruled that tobacco companies “deliberately deceived the American public about the health effects of smoking.” The tobacco companies opposed this ruling; however, Judge Kessler maintains that all of the statements are backed by specific findings of the court. (The Associated Press)

A Huge Pay Cut for Doctors is Hiding in the the Fiscal Cliff – On January 1, a 30 percent pay cut for doctors treating Medicare patients is set to take effect. This pay cut has been looming for a decade. Each year, doctors increase the amount they bill for services and procedures. Therefore, in 1997, Congress adapted a solution to this problem to reduce rising costs to Medicare- if doctors’ fees increased too much per patient per year, Medicare would pay a little less for services. For example, in 2002, using the formula developed by Congress, Medicare was to cut 4 percent from the amount paid to doctors. However, that year, doctors complained resulting in complaints to Congress from Medicare patients, and ultimately, Congress passed a bill to ignore the pay cuts. This pattern repeated itself yearly resulting in a cumulative cut of about 30 percent. This reduction in pay for doctors is one component of the fiscal cliff negotiations. (Channa Joffe-Walt)

Smith Wins Chair of U.S. House Science Committee – Leaders in the House of Representatives recommended that Lamar Smith of Texas become the new chair of the House Committee on Science, Space, and Technology. Representative Smith is about to begin serving his 14th term in Congress and has served on the House science committee for 26 years. While Representative Smith maintains some conservative ideals- including being skeptical of government action on climate change, he has also been successful at working in a bipartisan manner. Many lobbyists for universities and science organizations are happy with the selection. (David Malakoff)

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Written by sciencepolicyforall

November 30, 2012 at 11:47 am