Category: Blog

By: Alexis Rose

Ransomware attacks have become an increasing plague on a number of industries, but there is special concern for the targeting of hospitals and other healthcare providers. Ransomware is a type of malware that infects computers and networks, typically through infected e-mails or advertisements. The malware locks users out of key files or an entire network and the infected computer will display a screen with a ransom demand. The owner of the system is told the network can only be unlocked with a key that must be provided by the hacker, and the key can only be acquired once the ransom is paid. The high value of healthcare files and the vulnerability of hospital computer systems makes the healthcare industry an increasing target for ransomware attacks.

A number of hospitals have paid ransom demands and the demands are only getting bolder. The largest ransom paid was on February 5^th by the Los Angeles area hospital, Hollywood Presbyterian Medical Center, which paid $17,000 in bitcoin (a type of online currency that allows cyber criminals to demand larger untraceable amounts of money) to have its system unlocked. The attack on Hollywood Presbyterian was the beginning of a slew of ransom attacks through the months of March and April. In March, three hospitals were hit by ransomware attacks within a few days of each other and in early April MedStar’s system was hit, putting at risk its ten-hospital network. On May 23^rd, Kansas Heart Hospital was hit with the boldest attack yet, when the hackers demanded a second ransom. The Wichita-based hospital was hacked and paid a “small amount” of ransom, according to the hospital’s president. However, after the ransom was paid the hospital was not provided with the key to unlock their data. Kansas Heart did not pay the second ransom, but it makes clear a frightening fact that these attacks will likely get worse before a comprehensive cyber-security solution can be found.

The large uptick of ransomware attacks has sparked concern amongst many security experts and the government. The Senate Judiciary Committee held a hearing on May 28^th about the broader issue of ransomware attacks across industries, but the discussion was largely focused on the healthcare industry. Adam Meyers, an expert who has worked in the cyber-security field for over fifteen years, testified in front of the Committee and urged the medical industry to train its personnel in spotting suspicious e-mails and links. He also highly encouraged hospitals to have a separate back-up network, which allows the hospital to more easily recover files that may otherwise be lost forever.

The College of Healthcare Information and Management Executives (CHIME) also provided a statement to the Committee with their recommendations for combatting ransomware attacks.  In the statement made by CHIME, the group pointed out that much of the IT money and resources in the medical industry have focused on HIPPA regulations and patient file privacy, rather than network security. CHIME recommended that policymakers give the health industry incentives that will encourage investment in IT. CHIME also recommended that Congress reduce the complexity of the regulation that commands the healthcare industry. By having more uniformed and less complicated security regulations healthcare providers can spend more time and money monitoring against daily threats. Alisa Walker, a partner at Baker Donelson, a top health law firm, wrote last month about the importance of a comprehensive preparedness plan. She recommends that hospitals (as well as other industries) treat ransomware threats similar to any other physical security threat.

It is clear that ransomware attacks will continue to climb and both the healthcare industry and lawmakers will have to make significant changes in how these threats are handled. Lawmakers have to create serious cyber-security regulations and the healthcare industry will have to use significant time and resources to comply.

NAS Study on GMOS: End of Debate?

Agricultural biotechnology (commonly referred to as “GMOs,” “genetic engineering,” or “biotech”) has been the topic of much debate over the past few years, and most of the discussion has been about whether companies should be required to label products containing GMOs. Congress is currently working to create bipartisan legislation that would require mandatory nationwide labeling, fixing the issue of patchwork individual state labeling laws, such as the one going into effect in July in Vermont, which requires labels on products containing genetically engineered ingredients. The Vermont law – Act 120 –will take effect July 1, 2016. Consumers and legislators have pushed for a GMO label on foods made through biotechnology due to fear of unknown health and environmental effects and the right to know what is in our food, such as infertility or cancer in humans and resistance in plants.

In order to address some concerns and rhetoric around biotechnology, the National Academy of Sciences (NAS) released a report, “Genetically Engineered Crops: Experiences and Prospects,” on May 17. The NAS conducted a retrospective examination of the alleged positive and adverse effects of biotech crops in order to anticipate what emerging genetic-engineering holds for the future. The NAS panel, which was comprised of 200 independent experts with no direct ties to the agriculture industry, reviewed 900 studies comparing the US and EU and found that there is no evidence to suggest  GMOs pose any adverse risks to human health or the environment. The report discusses several uncertainties about the economic, agronomic, health and safety impacts of biotech crops and food, while also making recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GMO technology.

While the NAS found no adverse environmental or health risks, the study is not meant to end the discussion about biotechnology or its effects on the environment and human health. While there are a couple of varieties of GMOs currently in the marketplace, such as corn, soybeans, and papayas, many biotech traits have not yet left the laboratory. The NAS study stated that, “available in fewer than 10 crops as of 2015, varieties with G.E. herbicide resistance, insect resistance, or both were grown on about 12 percent of the world’s planted cropland.”  The NAS, Food and Drug Administration (FDA), US Department of Agriculture (USDA), and other research agencies will need to continue to conduct and review studies regarding the health impact of food biotechnology, as well as its impact on the ecosystem.

As the world population and obesity continue to increase and water supply and farmable land further decrease, researchers and companies will look towards science to help us solve some of these monumental issues. However, it is essential that systems and regulations are put in place to help us continue to assess the safety of scientific innovations, such as food biotechnology, and help consumers better understand what is in their food and help them make informed choices.

In 1994, the state of Ohio convicted Warren Keith Henness for aggravated murder.  The Ohio Supreme Court later set an execution date for Henness for January, 2015.  However, the Ohio Department of Rehabilitation and Corrections has pushed Henness’ execution date and the dates of many others, because they have been unable to obtain the necessary drugs to carry out the executions.  This problem is not limited to Ohio. More than 20 states will face great difficulty obtaining the specific drugs in the future.  As of January 1, 2016, there were 2,943 death row inmates in the United States.  The number of executions completed in 2015 was the lowest in 25 years, and half of the stays of execution were due to states’ inability to obtain the necessary drugs.

On May 13, 2016, Pfizer, an American global pharmaceutical corporation, announced that it will now enforce a distribution restriction on the specific drugs which are included as part of the lethal injection protocols.  Lethal injection procedures vary by state, but several use a one, two, or three-drug protocol, which requires an anesthetic or sedative, typically followed by pancuronium bromide to paralyze the inmate and potassium chloride to stop the inmate’s heart.  There are seven specific drugs that will now only be distributed to certain wholesalers, distributors and direct buyers, and all are required to agree to not resell the drugs to prisons.  The seven drugs: propofol, pancuronium bromide, midazolam, hydromorphone, rocuronium bromide, vecuronium bromide, and potassium chloride, are FDA-approved drugs used every day in efforts to treat illnesses and save lives.  Companies like Pfizer believe that these products should no longer be used for capital punishment.

Pfizer’s move is the last step in closing off the remaining FDA-approved manufacturers of drugs used in executions as all of the major pharmaceutical companies in the United States now stand together on this issue.  While the announcement is probably partly a public relations move and partly a business decision, Pfizer, along with other drug makers, say that their products are supposed to be used to save lives, not take them.  The companies believe that drugs have a certain value, but if associated with death due to the use in capital punishment, those drugs will lose that value.

Pfizer’s decision poses many questions for states that use lethal injection.  States may continue to search for the drugs needed to administer executions.  However, the 31 states that still impose lethal injection as capital punishment will possibly end their search by violating the law.  Some states have already looked to state-regulated compounding pharmacies that mix individual ingredients in the strength and dosage required to perform the procedure.  Though these compounding pharmacies distribute drugs for lethal injection, they often do not want their identities known to avoid lawsuits for contractual liability.  Few states allow methods such as electrocution, and even fewer states allow the gas chamber, hanging, and firing squad, but with the position taken by pharmaceutical companies, more states could resort to such procedures.  For example, Tennessee said in 2014 that if the drugs for lethal injection are unavailable, the state can use the electric chair.  A year later, Utah reintroduced firing squads.  Though it is difficult now to say how much of an impact Pfizer’s decision will have, states that use lethal injection will have to start looking for alternatives.

On March 31, the Health Law and Justice Society hosted its spring symposium “Drug Promotion in the 21^st Century: Off-Label Marketing and First Amendment Concerns.”

Although the Food and Drug Administration (FDA) approves drugs for specific medical purposes, many treatments approved for one use are also effective for other diseases and conditions. The FDA has traditionally prohibited the promotion of medical products for uses other than those approved by the agency and reflected in the labeling. This restriction, however, has recently been weakened by successful legal challenges based on the First Amendment guarantee of freedom of speech. The symposium provided an overview of these issues and assessed recent legal developments, including several important cases decided in the past year. The panelists also discussed the implications of expanding the right to off-label promotion for the FDA, the drug industry, and medical practice. Professor Lewis Grossman, Professor of Law at American University Washington College of Law and food and drug law scholar, introduced and moderated the panel.

 

The speakers for the symposium were 1) Allison Zieve, J.D., Director, Public Citizen Litigation Group; 2) Richard Samp, J.D., Chief Counsel, Washington Legal Foundation; 3) Adriane Fugh-Berman, M.D., Associate Professor and Director of PharmedOut, Georgetown University Medical Center; and 4) Anne K. Walsh, J.D., Director, Hyman, Phelps & McNamara, P.C.

 

Ms. Zieve offered an illustrative history of how FDA’s authority over drugs has evolved. Her comments focused on the FDA’s requirements of safety and efficacy for new drugs before approval for sale on the market and balancing that with what is considered “truthful” speech. She emphasized that laypeople may not be able to properly evaluate truthful scientific statements in terms of safety and efficacy for human use. Furthermore, she stated that allowing industry to successfully use the First Amendment to discuss truthful statements about off-label uses of drugs could potentially have severe consequences for the public.

Mr. Samp’s comments focused on truthful speech, and regulations of commercial speech. He emphasized that the current trend in courts is to apply closer First Amendment scrutiny to restrictions on non-misleading commercial speech.

Ms. Fugh-Berman brought a physician’s and academic perspective on this issue. Among many things, she discussed the fact that while off-label uses of drugs can sometimes be rational and inevitable, most of the time, it is not. She focused on scientific support for off-label uses of drugs. She said that industry controls what information and studies the public sees and that companies usually have a great deal of information regarding off-label uses of their drugs.

Finally, Ms. Walsh’s comments discussed the interplay between the Federal Food, Drug, and Cosmetic Act, and the False Claims Act.

The symposium was an incredible event with truly esteemed speakers. The AUWCL community was incredibly lucky to have such knowledgeable speakers come and offer their expertise. To watch the event and hear further details, please visit: http://media.wcl.american.edu/Mediasite/Play/5a8de06dc577415b84aee30771df3e111d.

On March 30^th, the Blue Cross and Blue Shield Association released a report on their study of those who were newly insured in the private market thanks to ACA reforms – and found that they were sicker, and costlier, than previous enrollees. The report was used by Blue Cross and Blue Shield to explain the premium increases they have asked for, and which many insurance commissioners have approved.  Those offering Blue Cross plans are also asking for certain other aspects of the ACA, such as special atypical enrollment periods, to disappear so that insurance companies can better control when and who signs up for coverage.  It should be no surprise that Blue Cross and Blue Shield companies should want increased premiums and more predictable enrollment periods – 23 of those companies reported a collective $1.9 billion decline in earnings in the first three quarters of 2015 as a result of their inclusion in the ACA national exchanges.

The report analyzed health insurance for 4.7 million Americans across all 50 states that were newly enrolled in 2014 and 2015.  One aim of the study was to find out if the ACA provisions not allowing insurance companies to disqualify people for pre-existing conditions in fact resulted in a sicker group of insureds.  The study found, in fact, newly enrolled insureds had higher rates of high blood pressure, diabetes, depression, coronary artery disease, H.I.V. and hepatitis C.  Diabetes and hepatitis C, in particular, were found to be twice as common among new enrollees, and H.I.V. was more than three times as common.  However, even Blue Cross and Blue Shield recognized that the prevalence of these diseases will shrink in new enrollees as those diseases are treated or even prevented through the insureds’ new healthcare options.  Programs to prevent and treat diseases more effectively are already paying dividends as such programs see fewer hospital admissions, readmissions, and hospital infection rates.  Blue Cross and Blue Shield is using the report not only to justify its premium increases, but to espouse the need for better care management such as making sure those with chronic diseases continue to take their medicine, or that people take advantage of preventative care, like flu shots,  to prevent illnesses that require more expensive treatments.

Another aim of the report was focused on costs and medical service usage.  Among new enrollees, visits to doctors and other medical professionals was 26 percent higher and hospital admissions rates were 84 percent higher.  The increased medical service usage the study observed may also be a result of the policies being more comprehensive, another requirement for private marketplace policies under the ACA.  It could also be the result of new enrollees having put off medical care and making up for it upon being enrolled, which could mean the service usage could flatten out over time.  On the whole, medical costs for new enrollees were 19% higher than employer-based group members in 2014 and 22 percent higher in 2015.

However, increased cost, usage, and pre-existing condition prevalence may be a sign that the ACA is working.  Administration officials, for example, have stated that these figures are signs that healthcare is now reaching vulnerable populations that it had not before, which was the intent of the ACA.  Although costly, the ACA reforms have decreased the number of uninsured citizens and helped close the health insurance gap between lower and higher income Americans.

On March 29, 2015, SB 234 was signed into law making Utah the first and only state in the nation to require that doctors administer anesthesia or analgesic for women who are undergoing abortions at 20 weeks and later in order to prevent fetal pain. In 2015, Montana Governor, Steve Bullock, vetoed a very similar measure.

Those in favor of the law say that the regulation prevents fetuses from suffering during abortions. However, at the center of the debate in the legislature was the scientifically disputed notion that a fetus can feel pain during the procedure. Doctors in Utah and across the United States say there is no proof that fetuses are able to feel anything at that point in the pregnancy. Literature reviews from the Journal of the American Medical Association and the American Congress of Obstetricians and Gynecologists state that fetal pain is unlikely before the third trimester which begins at 28 weeks. Doctors opposing the law further say that sedating a woman during an abortion procedure puts the woman at risk for complications, and that it will interfere with the relationship between a physician and patient.

Senator Curt Bramble, the bill’s sponsor and a CPA with no known medical background, says the purpose of the bill is to protect those who have no voice. Bramble, who originally wanted to ban abortions after 20 weeks, further says that if abortions are going to be at all legal, then doctors must take steps to alleviate pain to the unborn child. However, an OB-GYN and abortion provider in Utah, Dr. Leah Torres, has since emailed the governor because she does not understand what the law is requiring her to do. As ‘fetal anesthesia’ does not exist in standard medical practice, the law does not specify how doctors are supposed to administer anesthesia or analgesic in these situations. When the Montana Legislature proposed a similar law, which was later vetoed, physicians asked similar questions as those doctors were also unsure what exactly was being asked of them.

How safe is anesthesia for the mother? There are three main types of anesthesia: local, regional, and general, though the Utah legislature did not specify which type or how it should be administered. Doctors tend to avoid general anesthesia except in cases where they find it to be absolutely necessary. Dr. Esplin, a Utah doctor who testified at the committee hearing for this law, said, “women having abortions will either be placed under general anesthesia – meaning they’re unconscious and hooked up to a breathing tube – or sedated with a heavy dose of narcotics.” Those opposing the law say that not only is there no benefit for the woman in administering an anesthetic, but it adds an additional risk to the woman’s health.

Based on inconclusive evidence, women in Utah are now mandated to undergo anesthesia to have an abortion at 20 weeks and later, where previously, women were given a choice whether or not they wanted to be anesthetized. Fetal pain is a complicated and controversial topic in science, but the ability to feel pain at that specific point in gestation is, for now, unproven. In absence of scientific evidence proving fetal pain, perhaps such a bill is simply another way to limit abortion access for women.