Monthly Archives: February 2016

Proposed ordinance would require tobacco manufacturers to clean up its own street litter

See that cigarette butt on the street? Tobacco manufacturers could be cleaning up after their own cigarette litter in California under a model ordinance proposed by ChangeLab Solutions of Oakland, California.

The model ordinance is designed to help local counties and cities curb tobacco litter in their communities. Under the model ordinance, producers of filtered tobacco products, including cigarettes, are prohibited from selling their products unless they agree to one of the following two choices: 1) participate in a tobacco disposal program or 2) pay an annual in-lieu fee. Depending on which entity has the most control over the sale of tobacco in a respective community, “producers” can be defined to encompass manufacturers, importers, distributors, wholesalers and/or retailers.

Changelab Solutions released the model ordinance earlier this February 2016. The document spans twenty-two pages, and at its heart is the idea that tobacco producers can be incentivized to create a tobacco litter waste program. The model ordinance encourages counties and cities to set their own parameters for the litter program. One potential model would be a litter clean-up system jointly operated by a group of producers, and the producers could hire a third-party waste management company to conduct the actual waste control. The scope of the waste management could be as simple as situating ash trays or ash cans throughout the city. It may also be more extensive by providing a collection service of tobacco waste from residential areas, commercial areas, and public spaces. The model ordinance also requires participants to prepare an annual report summarizing the impact of the program.

Producers that decide against participating in the litter program can instead pay an optional in-lieu fee, which is collected annually to cover the reasonable costs of tobacco waste mitigation. Under the model ordinance, the in-lieu fee is calculated to reflect the amount of filtered tobacco products that are sold by the non-participating tobacco producer.

The model ordinance is the first of its kind in the country. Although intriguing, the ordinance rests upon interests that may not be as immediately compelling. The fight against tobacco litter may be subsumed in favor of other battles against the tobacco industry, such as federal cigarette taxes to mitigate overall smoking rates. That, compounded with the influential tobacco lobby, would likely stymie the momentum that the tobacco waste model ordinance would gain from the early stages of its adoption.

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CDC Drinking and Pregnancy Recommendations Draw Ire from Those It Is Meant to Help

A press release from the Centers for Disease Control and Prevention (CDC), a federal agency under the Department of Health and Human Services, is making national headlines for all of the wrong reasons.  The release, entitled “More than 3 million US women at risk for alcohol-exposed pregnancy,” appeared to have the best of intentions – proposing a number of best practices to help women prevent fetal alcohol spectrum disorders (FASDs) in their potential pregnancies.  In particular, the report notes that “Sexually active women who stop using birth control should stop drinking alcohol,” due to the fact that drinking while unknowingly pregnant can cause damage to the fetus.  However, many women viewed the report as insulting and another instance of the federal government having too much to say about women’s health choices.

The report starts by defining their at-risk population (which numbers 3.3 million) as women between 15 and 44 years old engaging in three practices: drinking, being sexually active, and not using birth control to prevent pregnancy. The report is not specifically about women who are actively trying to have a child, though the report notes that 3 of 4 women actively trying to have children also continue drinking.  The report is more about women who may become accidentally pregnant, and thus would unknowingly expose a fetus to alcohol.  From here, a number of contentions arise.

One contention is that the CDC is suggesting complete abstention from alcohol while the effects of limited drinking on fetuses is not a settled debate.  One response notes that it would be very difficult to do a study on the effects of alcohol on pregnancy because it would be unethical to conduct a double-blind experiment on pregnant women.  Furthermore, when limited studies have been done, there has been no link found between one to two drinks a week and fetal issues. Therefore, the recommendation of full abstention comes off as a pretense to otherwise try to control women’s behavior.

Another contention is that among the risks of alcohol consumption listed, the CDC included “injuries/violence” and “sexually transmitted disease.” As another response notes, there is a missing step in logic when one suggests alcohol consumption leads to violence and STDs. To say that puts all the onus on the woman for leaving herself open to such abuse, and not on those who would take advantage of someone who had been drinking.  There is no similar claim that men should also abstain from alcohol, whether actively using birth control or not.

Both responses recognize the ultimate goal of the report was noble – prevent FASDs. Furthermore, the report was lauded by some including the American College of Obstetricians and Gynecologists for its message of preventing FASDs. But by reducing women down to nothing but potential child-bearers, and saying nothing of the role men play in unwanted pregnancies or violence and STD spread, the CDCs ultimate point was lost on many.

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Electronic Health Record Interoperability Not as Close as Hoped According to GAO

A September report from the Government Accountability Office (GAO) found that while progress is being made in terms of electronic health records (EHR) interoperability, healthcare providers in the United States are still far away from full implementation.  Interoperability is the idea that different EHR systems would be able to pass information to each other.  The study primarily looked at 18 initiatives currently being engaged in by nonfederal stakeholders, although the study recognized the necessity of the federal government in EHR implementation.  In examining these programs, GAO found five challenges: “(1) insufficiencies in health data standards, (2) variation in state privacy rules, (3) accurately matching patients’ health records, (4) costs associated with interoperability, and (5) the need for governance and trust among entities, such as agreements to facilitate the sharing of information among all participants in an initiative.”  The study also found that a key to moving EHR interoperability forward will be the recognition by health care providers that it is a valuable tool for improving clinical care.

EHR implementation was mandated in 2009 by the Centers for Medicare and Medicaid Services (CMS) and the Office of National Coordinator for Health IT.  The initiative CMS began, known as “meaningful use,” was a three-phase-in-five-years program started in 2011 to encourage healthcare providers to begin using EHR.  The first stage focused on getting Medicare eligible healthcare providers to eliminate manila folders and replace them with standardized, electronic formats, which patients would have access to through an online portal.  In the second stage, Medicare eligible providers needed to meet a quota of 5% of patients being on EHR if that health care provider wished to qualify for the EHR Incentives Program (which is managed by CMS).  In 2014, when the second phase was supposed to end, 48% of Medicare eligible professionals and 65% of Medicare eligible hospitals met the phase 2 quota.  Due to the low numbers, the 5% quota has been extended until 2017, and in 2018 the quota will rise to 10%.

Additionally, there have been issues getting doctors and patients to accept EHR.  Patients who are relatively healthy are not all that interested in monitoring their health, and the programs are not overly consumer friendly for patients and doctors alike – often containing long drop down menus and producing documents up to 70 pages long. These issues are also impacting daily life for doctors.  In general, it takes much longer to input data into the system than it would a normal written record.  Doctors also worry that having their patients input their information into computer systems, rather than through discussions with doctors, could weaken interpersonal relationships between doctors and their patients.

Even in places where EHR implementation appears to be succeeding, like Massachusetts (which boasts over 80% acceptance among physician practices), other issues such as a multitude of EHR programs being available – and thus no standardization across healthcare providers – causes frustrations.  One healthcare provider noted a setup cost of $84,000 for their EHR system and related IT systems.  Some improvements are happening naturally.  In Massachusetts for example, 80% of healthcare providers are using one of seven EHR programs whereas before, there were as many as twenty.  Hopefully as the GAO report suggests, as the meaningful use program moves into the third phase in the coming years, interoperability becomes more of a focus.

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Election 2016 and the Fate of the Affordable Care Act

Election 2016 and the Fate of the Affordable Care Act

As the 2016 presidential race looms on, candidates, on both sides of the isle, have provided prospective voters with ideas of how health care in America will fair under their presidency. Candidates have adopted policies ranging from complete and utter repeal of every provision of the Affordable Care Act (ACA) to proposed single payer systems. Depending on the outcome this coming November, Americans may see an end to the insurance exchange or changes to established programs like Medicaid and Medicare. Below are brief summaries of Senator Sanders and Senator Cruz’s proposed health plans.

Senator Bernie Sanders: Senator Sanders’ health plan, Medicare For All: Leaving No One Behind, would provide health care coverage to all Americans in a “federally administered single-payer health care program.” Senator Sanders projects that this plan, which would cover the breadth of health care services from preventative care, primary care services and specialty long-term care, will cost an estimated 1.38 trillion dollars a year, according to Sanders’ campaign site. The health care program would be funded primarily by a progressive tax scheme with additional funding from employers and limited premiums for certain households. Sanders suggests that his health care plan will save most Americans $5,000 and will take away the anxiety of wondering if a service is covered or if a desired health care professional is in or out of network. Naturally, there are critics to Sanders’ plan claiming that the numbers proposed by his plan are too good to be true.

Senator Ted Cruz: It seems unclear whether Senator Cruz has officially offered a full health care plan; however, what is clear is that if Ted Cruz is elected president he will not rest until the ACA is repealed. Questioned about his health care plan in a recent Republic national debate, Ted Cruz highlighted three principles that would stand as the cornerstone of his perspective plan: 1) allowing citizens to purchase insurance across state lines; 2) expanding health savings accounts; and 3) severing health insurance from employment, making health insurance individualized and portable. During his debate response, Cruz did not indicate the costs his plan or proposed initiatives carry. Moreover, according to Slate.com, what was more noticeably missing from Cruz’s response was “[a]ny mention whatsoever of how patients with pre-existing conditions, who were routinely denied coverage by insurance companies prior to health reform, would be taken care of.” While removing restrictions of where Americans can purchase health insurance seems practicable; however, as of yet, Cruz has not mentioned how he would deal with the uninsured, underinsured or individuals that explicitly receive coverage because of the ACA. Critics to Cruz’s outlined principles seem to focus on the oversight mentioned by Slate.com, that Cruz’s “plan” does not account for many sectors of the population that the ACA specifically helped.

As the 2016 presidential race is sure to heat up in the coming months, it will be interesting to see how all the candidates plan to change America’s healthcare system.

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Three-parent Babies

On February 3, 2016, a panel consisting of elite scientists and bioethicists gave its approval to “go forward with caution” with a form of genetic engineering called Mitochondrial Replacement Therapy (“MRT”) as long as the process is carefully monitored and closely regulated.

The purpose of MRT is to prevent the passage or development of congenital diseases by using DNA from three parents. It would use a third party’s DNA to cut out the risk of certain disorders being passed on from parent to child by replacing the mother’s damaged mitochondrial DNA with healthy mitochondrial DNA of a donor. The ultimate goal is that parents can have healthy children that are genetically their own.

Although the panel did urge that the use of MRT be limited to male embryos because “the implications of a child growing up with donor mitochondrial DNA are not yet clear.” The panel argues that it is important to limit MRT’s use to males only, because males do not pass down mitochondrial DNA to their children. Since males do not pass mitochondrial DNA to their children it would prevent modified DNA from being passed down to multiple generations, which is incredibly important since the long term impact of modified DNA is still unknown. The Panel cautioned that the procedure should only be extended to female embryos once the long term effects are better understood. However, this decision differs from the United Kingdom’s approval of the technique in 2015 and its decision not to place any sex-based restrictions on the use of MRT.

The decision came from a committee that was created at the request of the Food and Drug Administration (“FDA”) to investigate the ethical implications of three-parent babies. First, there is a serious amount of concern that babies born as a result of MRT could have germline changes, which could be passed down for multiple generations. It also magnifies the slightest lab mistake into a problem that could be faced by people for decades to come. There is also a major concern about this technology being a tool to “play god,” which strengthens the argument for significant restrictions and regulations. Additionally, the technology poses several safety and regulation concerns.

However, this approval has hit the ultimate roadblock- the Congressional wall. The omnibus fiscal 2016 budget bill passed last year contained language that prohibits the government from using any federal funds to handle applications for experiments “in which a human embryo is intentionally created or modified to include a heritable genetic modification.” Therefore, the FDA is paralyzed and unable to move forward with MRT. As a result of this restriction families that could seriously benefit from MRT will not be able to take advantage of the technology anytime soon.

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