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  • Inside Track
    December 02, 2015

    Right-to-Try and Right-to-Die: Moving Toward Patient Empowerment

    In this article, attorney Tyler Wilkinson explains how legal developments, including “right-to-try” and “right-to-die” laws, could accelerate the healthcare industry’s move towards greater patient empowerment and engagement in their own care.

    Tyler Wilkinson

    woman on deathbedDec. 2, 2015 – Now more than ever, patients and consumers are taking control of their health-related decisions. States, including Wisconsin, continue to consider laws that allow terminally ill patients to try non-approved treatments or end their own suffering, and technology is driving innovations in healthcare delivery and personal well-being.

    For instance, patients can now visit doctors “virtually” through live Internet streams, and track their exercise, sleeping, or dietary habits through “medical apps.” These advances correspond to the technological innovation taking place in the healthcare sphere.

    A number of legal developments may accelerate the healthcare industry’s move towards greater patient empowerment and engagement in their own care.

    This article discusses legal developments in four areas: laws that give patients a “right-to-try” non-FDA approved treatments or a “right-to-die” through doctor-assisted suicide; advancements in tele-healthcare; and regulation of medical apps for mobile devices.

    Right-to-Try Laws

    Patients with terminal illnesses may not always have conventional medical options. As a result, patients in this situation often look to alternatives, including experimental medications that are not yet proven or publicly available. But potentially life-saving drugs are not always available to people most in need of those drugs.

    To address this problem, more than 20 states, including Wisconsin, have introduced “right-to-try” laws in the past year in the hope of providing terminally ill patients access to experimental medications. Here’s how the proposed laws work:

    Under current FDA regulations, a drug company must obtain regulatory approval to use experimental drugs on humans in clinical trials. The regulations strictly control who is given access to the experimental drug to ensure that the drug is used safely and to monitor side effects. One exception to the strict rules on who can use experimental drugs is the “compassionate use” exemption. Under this exemption, the FDA can allow drug companies to give experimental drugs to terminally ill people outside of the clinical trial. In short, the FDA gives drug companies permission to choose to give the experimental drug to terminally ill patients outside of the controlled clinical trial.

    “More than 20 states, including Wisconsin, have introduced ‘right-to-try’ laws in the past year in the hope of providing terminally ill patients access to experimental medications.”

    However, the FDA does not order the drug company to give the drug; it gives them permission to do so. Ultimately, the drug company makes the decision whether to allow a patient access to an experimental drug. Drug companies may be hesitant to give an experimental drug to a terminally ill patient before the drug has been tested through a robust clinical trial process. Drug companies fear that expanded use of an untested drug can cause adverse effects for the patient, which ultimately could derail the regulatory process or lead to a lawsuit.

    This is where the right-to-try laws come into play. These laws provide a limitation of liability under state law to drug companies, drug manufacturers, pharmacists, and physicians who are involved in helping a qualified patient obtain an experimental drug.

    A patient is eligible under the law if the patient is terminally ill, has considered all conventional treatment options, has received a recommendation for the experimental drug from his doctor and has given written informed consent for the use of the experimental drug. Contrary to the title, the right-to-try laws do not give the patient a right to use the experimental drug; it only removes some fear of liability for the drug companies.

    Tyler K. WilkinsonTyler K. Wilkinson (U.W. 2011) is an attorney with Axley Brynelson LLP, Madison. He advises healthcare providers on risk management and administrative issues, litigation and government investigations. Reach him by email or by phone at (608) 257-5661.

    Wisconsin’s proposed law has popular and bipartisan support, but it is not without criticism. Commenters argue that these laws empower terminally ill patients and provide them with choices when it comes to end-stage diseases.

    Others are not so sure, and question the ethics of a drug company deciding whether to allow access to an experimental, but potentially life-saving, treatment. Healthcare providers also question the safety of giving untested drugs to the most vulnerable patients. Still others fear that these laws create false hope for terminally ill patients who obtain a compassionate use exemption but who are denied by a weary drug company.

    The nationwide push for right-to-try laws is another example of how patients are becoming more empowered to take control of their healthcare and treatment.

    Right-to-Die

    As the baby boomers age and begin to face their own mortality, many are starting to think about where they will pass, whether it be in a nursing home, hospice care, or at home. A smaller group of people are debating how people should die.

    There are currently laws in Oregon, Washington, and Vermont that give certain patients a limited “right” to choose to take affirmative steps to die. This “right-to-die” legislation is growing in popularity; recent polls show that between 68 and 74 percent of people support these laws. In 2015, over 25 states, including Wisconsin, will have considered laws that allow certain people to “die with dignity.” In fact, California recently passed an “End of Life Option Act,” effective in 2016, which is modeled on the Oregon law.

    So how would a right-to-die law change Wisconsin law? Currently, Wisconsin law allows a person to refuse life-saving treatment in one of four ways:

    1. A competent adult can refuse any medical treatment, even if it would save or sustain their life.

    2. A person can execute an “advance directive” authorizing the withholding or withdrawal of life-sustaining procedures or of feeding tubes when the person is in a terminal condition or is brain-dead.

    3. Certain persons can execute a “do-not-resuscitate” order which directs medical personnel to forgo CPR on them if they are choking or suffering a heart attack and CPR will exacerbate other conditions.

    4. A guardian may agree to withhold life-sustaining procedures for a person who is brain-dead.

    In other words, Wisconsin law allows a person to refuse treatment, but does not allow a person to take affirmative actions to end his or her life.

    The proposed law would change that and allow a competent but terminally ill adult to request life-ending medication from a physician. The proposed law requires agreement from both a treating and a consulting physician that the patient is terminally ill. The proposed law also builds in a “waiting period” to allow patients to change their minds.

    “Wisconsin law allows a person to refuse treatment, but does not allow a person to take affirmative actions to end his or her life.”

    Research in Oregon, which enacted a “death with dignity” law almost 20 years ago, shows that just over 1,300 people have requested prescriptions for lethal medications, but only one-third of those requesting actually used it. For many patients, simply having control over the illness and over one’s end is good enough.

    There is little chance that Wisconsin will enact a right-to-die law anytime soon. But these proposed laws provide another example of how recent changes in healthcare seek to empower patients to take control of their own health and treatment.

    Telehealth

    The most visible development is the growing acceptance and use of “telehealth.” Broadly defined, telehealth is the delivery of healthcare services through communication technologies rather than through in-person communication. Healthcare services can be provided to patients remotely through four modalities:

    • Live video where the patient and provider can interact in real-time.

    • Store-and-forward communications where a provider records a message for a patient to listen to or watch at a later time.

    • Remote patient monitoring, where the patient sends data (like blood glucose levels) to a provider and the provider monitors that data over time.

    • Mobile health, where providers send health information and educational materials through mobile apps on cell phones and tablets.

    Telehealth has been around for years, but it continues to grow in patient, provider, and payer acceptance and use. This trend should continue as healthcare providers become more adept at delivering services to remote patients and as patients become more comfortable interacting with their providers virtually or remotely.

    Three legal developments will likely accelerate the use of telehealth services. First, last July, Congress introduced the Medicare Telehealth Parity Act of 2015 (Telehealth Act).

    Currently, federal law only allows reimbursement for telehealth services if provided in a qualifying rural area. The federal Telehealth Act proposes changes to current Medicare telehealth payment methodologies and expands coverage to include both rural and urban areas. The proposed Telehealth Act has bipartisan support and should gain momentum in the next few months.

    “Telehealth has been around for years, but it continues to grow in patient, provider, and payer acceptance and use.”

    Second, 29 states plus Washington D.C., have enacted commercial payment parity laws that require commercial health plans to cover medical services provided via telehealth to the same extent they cover medical services provided in-person. This means that health plans are required to provide the same coverage for care whether it is delivered in-person or remotely.

    Finally, a number of states are considering the adoption of an Interstate Physician Licensure Compact. This proposed compact will create an alternative, voluntary and expedited path for physicians with a medical license in one state to obtain licenses in other states that have adopted the compact. This means that a physician in Wisconsin could easily and quickly obtain a license to practice medicine in other states that have adopted the compact and thus provide services to patients in those other states through telehealth. This proposed law has broad bipartisan support in Wisconsin.

    These legal developments should make telehealth a safer and more appealing investment for healthcare providers. Based on the growing acceptance of telehealth and the legislative steps mentioned above, one financial analyst estimates the telehealth industry will be valued at $34 billion by 2020.

    Medical Applications

    If you heard cheers from San Francisco, Austin, and Madison last winter, they were probably from “hoodied” coders working to create medical applications for mobile devices. In January and February 2015, the Food and Drug Administration (FDA) issued guidance to medical app developers indicating that it did not intend to regulate large segments of the medical and mobile application fields. The FDA’s decision should make it much easier and cheaper for medical app developers to bring products to market.

    Patients and healthcare providers nationwide are using mobile technology to improve patient health and the overall delivery of healthcare. Certain companies and products are already publicly available and well-known. For instance, mobile apps and wearable devices from companies like Fitbit and Jawbone can help people manage their own health and wellness. Websites like MyFitnessPal.com can help people count calories and share data with providers. Apple and Epic Systems are working together to provide HealthKit, a data repository which collects information from various devices (connected scales, fitness trackers, food diaries, etc.) and shares it with providers.

    For every large company identified above, there are countless mobile medical app start-ups trying to develop the next hit product.

    “The FDA’s decision should make it much easier and cheaper for medical app developers to bring products to market.”

    The promise of these medical apps was tempered by the dreaded development process. In layman’s terms, the development process is an FDA-required process to determine whether medical devices are safe and effective. It can involve extensive clinical trials and FDA review, a potentially long, arduous, and expensive process.

    That’s why it was big news when the FDA announced that it would not regulate certain medical applications. In January 2015, the FDA issued draft guidance on “low-risk products that promote a healthy lifestyle” and indicated it does not intend to examine them to determine whether they are “devices” subject to regulation.

    Health and activity monitors similar to those produced by Fitbit and Jawbone fell into this category and will not be subject to review. Last February, the FDA announced it would not regulate mobile medical applications that pose low risks to the public, such as mobile apps that help patients maintain positive behaviors, use GPS location to alert patients to environmental conditions, implement video games to motivate patients to exercise, and apps that track asthmatic attacks.

    In short, the FDA removed a large hurdle for many medical app developers to take their products to the public. App developers will need to carefully review the FDA guidance before deciding their product is not subject to FDA review. Developers should also be mindful of privacy laws as they may create apps subject to HIPAA or state privacy laws.

    The FDA’s decision to forego regulatory review of certain products and mobile medical apps was great news for clusters of developers in cities like San Francisco and Madison. It’s also great news for consumers and patients looking for new ways to monitor their health and to engage with their physician.

    This article was adapted from a Health Law Update presentation Attorney Tyler Wilkinson gave at the State Bar of Wisconsin PINNACLE’s® annual Health, Labor and Employment Law Institute in August 2015.



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