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

The association between epidural labor analgesia and maternal fever remains somewhat controversial despite being supported by evidence in randomized controlled trials, observation and retrospective studies. Perhaps this is because maternal fever during labor itself is a complex and multi-factorial phenomenon, and many criticisms of the studies demonstrating the above association include selection bias, bias in obstetric practice, and faulty study design. Anesthesiologists are often tasked to explain the potential complications of epidural analgesia, and it behooves us to better acquaint ourselves with this often overlooked topic.

Randomized controlled trials comparing intravenous opioid or unmedicated labor to epidural analgesia show that the epidural arm is more likely to experience hyperthermia and overt clinical fever. The increase in temperature is gradual, with women who receive epidural analgesia earlier in labor experiencing greater increases. There is some degree of selection bias in observational studies, as those women who are more at risk for fever (e.g. longer labor, longer duration of ruptured membranes, more frequent cervical examinations) are also more likely to elect for epidural analgesia. However, the randomized controlled trials give stronger support to a causal relationship.

The mechanism is incompletely understood, as not all women who receive an epidural exhibit an increase in core body temperature – only about 20% do. The most consistently supported mechanism is that of noninfectious inflammation mediated by pro-inflammatory cytokines. Less popular theories include altered thermoregulation and avoidance of opioids, which may suppress fever.

The maternal consequences of fever during labor include elevation of heart rate, cardiac output, oxygen consumption and catecholamine production. Shivering and antibiotic exposure are more common in febrile women. Frequently obstetric management is altered, with a higher associated incidence of operative vaginal and cesarean delivery. It is unclear whether the labor pattern is altered by the fever, or it simply influences obstetric decision making in respect to fears of maternal or fetal complications of delaying delivery.

Maternal fever also has fetal effects as well, including fetal hyperthermia. This in turn may be associated with low fetal tone, lower Apgar scores, advanced airway management, cardiopulmonary resuscitation, and neonatal seizure.

Treatment of maternal fever, whether or not associated with epidural analgesia, is therefore important. However, treatment options are limited given the unclear etiology of the fever. Acetaminophen is not effective in suppressing epidural-related maternal fever. High dose methylprednisolone, is effective, however it is impractical given the risk of increased neonatal bacteremia. Therapeutic effects of systemic opioids have also been weak, and carry the complication of possible neonatal respiratory depression.

There is a need for further research into the etiology, prevention and treatment of epidural related maternal fever. In the meantime, anesthesia providers can provide patients with what is known on the topic to help them make an informed decision.

References

Arendt KW, Segal BS. The association between epidural labor analgesia and maternal fever. Clin Perinatol. 2013 Sep;40(3):385-98. doi: 10.1016/j.clp.2013.06.002. Epub 2013 Jul 19.

Segal, S. Labor epidural analgesia and maternal fever. Anesth Analg. 2010 Dec;111(6):1467-75. doi: 10.1213/ANE.0b013e3181f713d4. Epub 2010 Sep 22.

The Centers for Medicare and Medicaid Services (CMS) has released two rule updates that will heavily impact anesthesiology providers in 2018. As previously discussed, CMS is a government agency that administers governmental health programs, providing guidelines for pricing and reimbursement at the state level for Medicare Centers of Excellence and other Medicare/Medicaid-serving providers. Anesthesiology providers, including anesthesiologists and Certified Registered Nurse Anesthetists (CRNAs) are subject to such guidelines. Furthermore, CMS as an agency is trending towards providing more specific diagnosis and reimbursement codes for surgical procedures, highlighting the specific anesthesia procedures. The most recent round of Rule Updates supports the trend.

As of Jan 1, 2018, CMS has pronounced that anesthesia for endoscopies are to be affected by a new reimbursement scheme. The decision was driven by a meeting of key stakeholders, that included the Medicare Payment Advisory Commission, the American Society of Anesthesiologists (ASA), and the American Medical Association.

In sum, the rule changes will change services rendered as follows:
1. Endoscopic retrograde cholangio-pancreatography (ECRP) is now a unique code. As such, ECRPs will be reimbursed at a greater base unit as compared to prior to this ruling, at a rate of 6 units versus 5 units. For reference, one unit is roughly 8 minutes to 22 minutes of provider time.
2. Colonoscopies and screening for colonoscopies has been reduced. These procedures will now receive 3-4 units per procedure.

The American Society of Anesthesiologists is particularly active in the CMS space and has advocated heavily for appropriate and equal reimbursement of anesthesiology services. In response to the above Rule Updates, the ASA has released a public statement criticizing the undervaluation of endoscopies. The ASA, after conducting market research among its membership, is assured that these procedures should achieve at least 4 units. While the difference in one unit may seem negligible, in terms of reimbursement it can have grave implications. Sum reimbursement is dependent on the CMS-determined conversion factor; for 2018, CMS has concluded that the anesthesia conversion factor will be 22.1887 USD (a rise from 2017’s 22.0454 USD value), in comparison to an overall resource-based conversion factor of 35.9996 USD. Therefore, to conduct a simple thought exercise, one could imagine 1000 endoscopy procedures occurring per year in an endoscopy suite. At a rate of 5 units per procedure, the net annual reimbursement would equate to 1000 procedures * 5 units per procedure * 22.1887 conversion factor = 110,943.50 USD. However, at the updated CMS rate, this net annual reimbursement would change to 1000 procedures * 3 units per procedure * 22.1887 conversion factor = 66, 566.10 USD, a dramatic decrease. In combination with the fact that many physicians will continue to devote the same amount of time to the procedure, the decreased unit allocation could lead to a severe undervaluing of the physician’s time. Conversely, if the physician or physician’s office aims to achieve reimbursement parity, they must require that physicians minimize the number of minutes they spend per procedure per patient, which can lead to medical error and lapses in safety. From the perspective of the ASA, rule changes which decrease unit allocation for routine procedures is dangerous for the provider, the patient, and the healthcare system as a whole.

The anesthesia space will continue to be impacted by rapid changes in CMS governance. Anesthesiologists, CRNAs, and healthcare administrators must be kept knowledgeable of such changes to keep pace with the rapid innovation present in the American healthcare system.

Sources:
https://www.asahq.org/advocacy/fda-and-washington-alerts/washington-alerts/2017/11/cms-releases-final-rule-for-2018-medicare-physician-fee-schedule
https://www.federalregister.gov/documents/2017/11/15/2017-23953/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions
https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-11-02.html