In 2016, more than 6 million women in the United States gave birth, transforming daughters into mothers and relationships into families.¹ All patients are strongly encouraged to receive routine antepartum care with an obstetrician after pregnancy is confirmed. This includes laboratory tests, ultrasound and monitoring of the baby’s growth and activity, supportive measures to optimize nutrition and maternal comfort, and preventative therapy (including immunizations, smoking and alcohol cessation) to avoid untoward medication exposures and ensure a safe pregnancy.

A common question that arises relates to the safety of anesthesia and surgery during pregnancy. In general, all elective surgical procedures are typically postponed until at least several weeks after giving birth, to decrease both the risk to the mother as well as the unborn baby. Regardless, more than 75,000 pregnant females undergo surgery every year.² Related risks can be broken down into 3 categories:

Risk to mother: Starting at week 6, significant changes in the maternal physiology occur in order to compensate for the baby’s developing circulatory system and nutritional needs. Increased blood volume leads to the heart working harder and faster. The lungs need to supply enough oxygen to meet the metabolic demands of a growing womb in an increasingly limited space. As the plasma or “water” component of the blood increases, the complex reactions that activate and eliminate our medications also change. The anesthesiologist must take these factors into account when planning an anesthetic for an emergency or urgent procedure.

Still, maternal risk for non-obstetric surgery is minimal and not significantly different than that of the general population. In a systematic review of more than 12,000 patients, a single death was reported.³ However, every patient should receive a thorough evaluation for factors related to “high-risk pregnancy,” characterized by significant cardiovascular, metabolic or other systemic changes that put the mother at risk during or immediately after pregnancy.

Risk to fetus: Between weeks 3 and 8, the baby’s organs start to develop from embryonic tissue implanted in the uterus. This is a critical stage with an intricate, orchestrated sequence of events, and any interruptions can lead to birth defects. A classification system exists to determine the safety of medications in pregnancy.⁴

Anesthetic medications have been studied extensively in pregnant females, with the vast majority of studies showing no difference in the incidence of birth defects compared to the general “background” risk of 3-5% after the first trimester.⁵ These same studies emphasize the importance of limiting exposure to the shortest possible duration, avoiding repetitive dosing, and waiting until after the first trimester. Prolonged exposure to anesthetic adjuncts such as benzodiazepines and nitrous oxide can lead to defects, and opioid medications such as fentanyl can lead to dependence and abstinence syndromes after the baby is born. All patients are strongly encouraged to discuss potential medication additions or changes with their obstetrician or primary care provider.

Risk to pregnancy: Even after the organs have formed and first heartbeat is heard, there is a slight increase in the incidence of ectopic pregnancy, miscarriage, and pre-term labor with pregnant patients receiving an operation. The rate of miscarriage is 5.8% after surgery, which is increased to 10.5% if surgery is performed during the first trimester.³  Severe changes in blood pressure, hypoxia (low oxygen), acidosis, and presence of infections are the most immediate causes associated with adverse outcomes.

For this reason, surgery is recommended to be performed in the 2^nd trimester. Below are some precautions that are taken for female patients that are pregnant, or suspected to be pregnant, upon admission to the hospital:

1. Determination of necessity and urgency: While elective surgery is postponed, urgent and emergent procedures are needed to ensure maternal well-being, which takes a priority over the fetus in the case of medical or surgical emergencies. For example, appendectomies (i.e. removal of the appendix due to infection and inflammation) are performed because the risk of severe infection (e.g. sepsis) or rupture would threaten the mother and fetus. Trauma and the resulting changes in blood pressure and sympathetic system activation can also compromise circulation to the fetus, and thus surgery must occur.

Anesthetic choice is relevant to avoid unnecessary exposure of narcotics to the mother and fetus, and a regional anesthetic (e.g. epidural, nerve block, local skin infiltration) can help achieve minimal risk.

2. Routine pre-operative pregnancy tests: All female patients of childbearing age are typically required to take a urine pregnancy test as part of the pre-operative evaluation. If positive, a sample from the blood is taken to confirm pregnancy and estimate conceptual age.
3. Fetal monitoring: Starting in the 2^nd trimester, special electrodes and pads can be used to monitor the mother’s baby’s heart rate during surgery. In hospital settings, an obstetric consultant or team will be present to monitor fetal well-being and intervene if the pregnancy is deemed to be at risk.
4. Emergency Protocol: Although CPR and similar life support measures are extremely rare, a strict protocol is followed for all pregnant female patients with unstable vital signs. The patient is tilted slightly to the left (“left uterine displacement”) to decrease the pressure exerted by the womb on the major blood vessels returning blood from the legs to the heart. If the patient is unable to breathe independently, airway access is obtained and supplemental oxygen is administered. In critical cases, intentional pre-term delivery of the baby can be undertaken to improve the outcomes of CPR.

References:

1. https://www.guttmacher.org/united-states/pregnancy
2. Goodman S. Anesthesia for nonobstetric surgery in the pregnant patient. Semin Perinatol 2002;26:136–145.
3. Cohen-Kerem R, Railton C, Oren D, Lishner M, Koren G. Pregnancy outcomes following non-obstetric surgical intervention. Am J Surg. 2005;190:467-73.
4. Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (Federal Register/Vol. 73, No. 104/Thursday, May 29, 2008)
5. Hoyert DL, Mathews TJ, Menacker F, et al. Annual summary of vital statistics: 2004. Pediatrics 2006;117:168–83.

Opioid usage and subsequent abuse has led to a crisis of epidemic proportions in the United States. According to the CDC, 91 Americans die every day as a result of opioid overdose with the total number of overdose deaths quadrupling since 1999. In addition to the morbidity and mortality, the opioid epidemic costs the United States nearly $75B annually, and that number is growing yearly driven by an ever-increasing number of prescriptions from physicians. Considering all the consequences of our national dependency on opioids, physicians need to begin to retake control of how pain is managed in the United States and one of the first places that change can occur is in the location where acute pain is most commonly first managed- the emergency room.

While historically opioids have been the first line in treating pain in the emergency room and for prescription at discharge, advances in technology have now provided physicians an entirely different modality in which to address acute pain- Point of Care Ultrasound nerve blocks (PoCUS). Ultrasound guided nerve blocks were first described in anesthesiology literature in 1978 and as ultrasound technology has matured over the subsequent twenty years the number of clinical applications has multiplied for the ultrasound machine. Ultrasound now serves as both a means for direct intervention as well as a modern extension of the physical exam. With this in mind, PoCUS is a powerful tool that when extended to the emergency room, empowers physicians on the front line of acute pain to have a means to treat pain without having to turn to opioids. Equipped with PoCUS, emergency room physicians are now able to perform targeted nerve blocks for procedures that otherwise would have required high doses of narcotics such as Fentanyl and Morphine to control pain. ER physicians are now able to perform procedures such as shoulder dislocation reduction under ultrasound guided interscalene brachial plexus block, hand laceration repair under axillary nerve block, extremity fracture stabilization with supraclavicular/femoral/sciatic nerve blocks, and even go so far as rib fracture pain management with intercostal nerve blocks. In addition to acute pain secondary to trauma, ER physicians often encounter patients experiencing acute pain exacerbations secondary to chronic pain. These medically complex patients have traditionally been given prescriptions for opioids and discharged to the care of their pain physicians, but now thanks to nerve block interventions made possible by PoCUS, patients with acute on chronic pain can now be stabilized with minimal to no opioid until they are able to see their pain physician the following day.

All the applications allow not only for superior pain control when compared to opioids, but also limit their usage in the acute phase of pain, usage in a patient’s hospital stay, and heavily reduce the need for ER physician opioid prescriptions. Physicians who utilize PoCUS can take pride in knowing that they are not only treating their patients more effectively, but also doing their part in fighting the national opioid epidemic.

In 2018 so far, the United States has already reported several critical data breaches of healthcare data, such as breaches in UnityPoint Health System, Florida Medicaid, and Hancock Health. The systems were hacked in several ways. The most common mechanism that hackers used to gain illegal entry into the data system was sending phishing emails to healthcare system employees. Phishing emails are designed to mimic those sent from official system email addresses. Moreover, hackers also gained entry to heavily protected health systems by capitalization on unsecured Wi-Fi networks or misconfigured servers, reflecting the lack of a current focus on data security in the U.S. healthcare system.

The United States government has intensified its punitive measures on data breaches specific to health-based personal information. However, a soon-to-be enacted European Union (EU) legislation will impact this objective. The General Data Protection Regulation (GDPR) Act of 2016 is intended to advocate for consumer ownership of individual personal information by implementing specific procedures for ensuring data security at the institutional level. As per the language of the act, personal data will encapsulate data on one’s personal, private, and/or professional life and could include health information, social media, bank details, or one’s computer IP address. Healthcare information is evidently a topic of interest to the public, as this will heavily influence how sensitive health data is managed post-2018 at the global level.

The EU and the U.S. often influence each other, particularly concerning regulation. Once the majority of EU-serving companies begin to be held to the GDPR law, it may encourage an entrance of similar legislation in the United States. In this event, healthcare practices would be held to a much higher standard of data privacy and information security. For example, the concept of patient consent would be strengthened. In effect, the patient would have to provide explicit and unambiguous consent to each stage of the data processing. Healthcare organizations would thus have to implement higher quality methods for obtaining consent from patients. This could include a method as simple as multiple check-boxes on the patient’s electronic medical record, or a more complex measure such as requiring the patient to author and sign a declarative statement affirming consent for all forms of data processing, such as data storage on a cloud, international data transfers, transfers within healthcare institutions, etc.

Furthermore, under a GDPR-type legislation, patients would have certain expedited rights to their data. For example, under the GDPR individuals have a right to Data Portability, also known as the right for patient to have their data sent to them immediately; the Right to Be Forgotten, a more extensive way of stating the patient’s right for the data to be erased; and the Subject Access Right, which dictates that the patient’s data can be made free and must be addressed within one month upon request. Such expedited rules would likely be aligned with a U.S. transition to a GDPR model.

The high-level goal of data regulations is transparency and security – ensuring that patients have the right to their personal data, knowing that their sensitive health information is secure. Come May 25, 2018, a large proportion of U.S. healthcare companies and practices will become subject to GDPR if they serve EU residents. To achieve the goals of data security, practices will have to work with a data protection officer, an expert tasked with controlling and managing the data, including the provisions of pseudonymity or anonymity, along with sanctioning offenses should rules not be followed. Moreover, as the trend of highly controlled data management spreads to nations outside the EU, it is highly likely that a GDPR-type legislation will reach the U.S, impacting those groups not already held to GDPR. Healthcare companies, practices, and administrators should prepare for the impending global trend, investing pre-emptively in strategic and powerful systems for data security.

References

https://www.whitepapers.em360tech.com/wp-content/uploads/GDPR-Implications-of-the-GDPR-in-Healthcare-042717-d1.pdf

https://hitconsultant.net/2018/03/21/healthcare-organizations-gdpr/

http://www.healthcareitnews.com/news/europes-gdpr-privacy-law-coming-heres-what-us-health-orgs-need-know

https://pink.pharmaintelligence.informa.com/PS122336/Planning-Ahead-In-The-EU-The-Impact-Of-The-GDPR-On-Clinical-Trials-And-Research

https://www.natlawreview.com/article/does-gdpr-regulate-clinical-care-delivery-us-health-care-providers

In a previous post, we wrote about how the field of anesthesiology has a rich history of engaging with ethical issues that arise in medical practice. But what are the ethics of anesthesiology practice? What defines an ethical anesthesiologist?

There are two major dimensions to consider when discussing ethics. First and foremost are the ideals that inform our definitions and understandings of ethical issues. These are concepts and principles that animate the discussions around professional ethics, and are fundamental to whatever case we may be focused on. Then, there is also the pragmatic dimension of ethics: what ought to be done in complicated situations? What are the on-the-ground questions and problems faced by anesthesiologists, and what do our ideals prompt us to answer? Universal ethical principles help to shape an approach that we can then apply to the day-to-day ambiguities that arise.

Like most medical specialties, anesthesiology has a code of ethics defined through rigorous discussion and consensus among leaders in the field. They fall under the broader Principles of Medical Ethics as defined by the American Medical Association. Those principles include the familiar “do no harm,” as well as other general values that most physicians share. Particular to anesthesia are a set of compelling guidelines that all patients may expect when under the care of an anesthesiologist.

Anesthesiologists have an ethical responsibility towards not only their patients, but also the facilities where they practice, their clinical colleagues, and to themselves. This means supporting a patient’s self-determination and including them in the choices around their care when appropriate. Anesthesiologists must treat all patients indiscriminately, employing respect and adhering closely to safety protocols. Among colleagues, anesthesiologists are committed to collaborating thoughtfully to improve quality, effectiveness and efficiency of medical care. Importantly, anesthesiologists must also take good care of themselves to ensure their own physical and mental health to perform in this often demanding job.

According to their code of ethics, anesthesiologists also share an ethical responsibility to society as a whole. This means participating in activities that serve and improve their communities, and acting as a positive representation of their profession in any capacity.

As you can see, anesthesiology does not exist in isolation—the ethical practice of anesthesiologists is defined in relation to many levels: their patients, colleagues, communities, and to themselves. This central framework, when applied to the issues in the field, encourage problem-solving that looks holistically at every actor, not just the individual.

Thinking pragmatically, anesthesiologists face many complicated and current questions in this time of innovation and growth. The unique issues at play can be organized into three central categories: preoperative, intraoperative, and post-operative. Preoperatively, anesthesiologists may sometimes find their expert consultation on a patient’s fitness for surgery to be at odds with the surgeon or other physicians. They may also encounter questions around the informed consent process, and whether it adequately assesses a patient’s understanding and acceptance of the procedure. Intraoperatively, anesthesiologists may find themselves in a unique position to advocate for a patient to be treated with respect and modesty. This engages complex dynamics and roles between different clinicians involved with surgery, but no one understands better than an anesthesiologist the particularly vulnerable position of a patient who is under. Post-operatively, anesthesiologists may face challenges ensuring that a patient is transitioned well to their treatment and recovery plan.

The anesthesiologist holds a very unique position, both in the operating room and in the medical field generally. Their roles, expertise, and experiences are particular to the specialty and accordingly follow specific principles to guide the ethical practice of their work. This ensures not only their efficacy on a case-by-case basis, but also an integrated effort across many cooperating clinicians to create a safe and high-quality environment of care.

References

Hariharan, Seetharaman. “Ethical issues in anesthesia: the need for a more practical and contextual approach in teaching.” Journal of anesthesia 23.3 (2009): 409-412.

GUIDELINES FOR THE ETHICAL PRACTICE OF ANESTHESIOLOGY, Committee of Origin: Ethics (Approved by the ASA House of Delegates on October 15, 2003, and last amended on October 22, 2008)

The Center for Medicare and Medicaid Services (CMS) is constantly progressing its policies, particularly concerning its value-based care programs. Of these programs, MACRA, the Medicare Access and CHIP Reauthorization Act, represents a highly innovative legislative measure to encourage quality care among CMS-reimbursed physicians. Signed into law in 2016, MACRA created distinct payment pathways for physicians such as the Merit-Based Incentive Payment System (MIPS) and the Alternative Payment Models (APMs) program. The following article will discuss 2018 updates to MACRA and MIPS specifically, with an emphasis on how such updates will affect providers and practices at-large.

For individual clinicians, reporting requirements under MACRA will dramatically increase in 2018. To begin, a physician or practice’s score is calculated utilizing various quantitative measures for quality. In order to have a score included in the total score, CMS requires physicians to satisfy specific data submission requirements by utilizing a data completeness measure. Data completeness is defined as the percentage of potential data that the physician submits to CMS upon reimbursement request. In 2017, the threshold for data completeness was set at 50%, however in 2018 CMS has increased this threshold to 60%. This increase reflects the shift at CMS to integrate claims data from a variety of healthcare institutions.

In addition to more rigorous data reporting requirements, CMS will begin to assess cost measures for CMS institutions, a dramatic shift from the previous policy. Initially, the inclusion of cost measures in MACRA/MIPS evaluations was set to occur in 2019, however CMS accelerated this timeline by including it in 2018. For MIPS scoring purposes, cost will account for 10% of the total score. Furthermore, points for cost will be calculated by measuring Medicare Spending Per Beneficiary (MSPB) and cost per capita. Once the data is submitted, CMS will perform cost calculations in order to minimize potential institution biases. CMS is setting the level of contribution of cost to the total score at a conservative 10%, with the aim to double this contribution by 2019. In essence, 2018 will serve as a pilot year of sorts for CMS to test the methodologies and processes around measuring, evaluating, and applying cost to scoring.

Lastly, CMS has made a concerted effort to account for the wave of natural disasters that plagued the United States in 2017 (Hurricane Irma, Hurricane Harvey, Hurricane Maria). Physicians and practices that are located in those areas that are MIPS-affiliated may submit a hardship exception application to account for a dearth of data or reporting requirements. Moreover, these physicians and practices will not be subject to late penalties.

In sum, the MACRA and MIPS changes for 2018 are significant in progressing the cost and quality agenda of CMS, while also remaining cognizant of the influential impact of the environment on healthcare over the past year. Future updates will continue to streamline evaluation processes, ensuring that value is at the center of the U.S. healthcare system.

Sources:

1. https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/QPP-Year-2-Executive-Summary.pdf
2. https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/QPP-Year-2-Final-Rule-Fact-Sheet.pdf
3. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/QPP-MIPS-Quality-and-Cost-Slides.pdf