Dramatic changes in the U.S. health care system over the past several decades have affected clinicians’ professional responsibilities and workplace experiences in profound ways. In this chapter the committee examines economic (or market), regulatory, and social factors in the external environment that affect health care organizations (HCOs) and contribute to workplace stress and greatly diminish clinicians’ professional well-being. The external environment is the third level of the committee’s systems framework for clinician burnout and professional well-being (see Figure 6-1). As
1 Excerpted from the National Academy of Medicine’s Expressions of Clinician Well-Being: An Art Exhibition. To see the complete work by Edi Matsumoto, visit https://nam.edu/expressclinicianwellbeing/#/artwork/220 (accessed January 30, 2019).
described in Chapter 2, the external environment influences the structure and performance of HCOs directly and, through them, the frontline care delivery level. Clinicians’ experiences of external environmental demands is influenced by HCOs’ interpretations of regulatory and administrative requirements and decisions about work processes. (See Chapter 4 for the work system factors under the control of HCOs that influence clinician burnout and well-being and Chapter 5 for more about HCO actions and decisions affecting the clinical work system and the care team.)
This chapter focuses on the available evidence related to the ways that three external environment factors contribute to clinicians’ workplace stress: (1) structural changes in the U.S. health care industry, including the growth of large, health care corporations; (2) the laws, regulations, and standards for the oversight of U.S. clinicians; and (3) changing societal
values and the clinician–patient relationship. The chapter discusses health information technology (IT) in the context of some of the policies associated with clinical documentation, prescription drug monitoring, prior authorizations, and information privacy and security. Chapter 7 takes a broader view of the role of health IT in clinical practice, its effects on clinicians, and the innovations under development.
HEALTH CARE INDUSTRY
Efforts to improve the quality of health care and reduce its cost have led to the unprecedented changes that are ongoing in today’s health care system. These changes, however, are occurring within a highly fragmented health care system that is characterized by a vast array of complex interrelationships among those who receive, provide, finance, and regulate care. The many different stakeholders often have divergent interests and expectations, which complicates efforts to improve the system (Altman and Frist, 2015; Moses et al., 2013). Clinicians and the work environment are affected by the shifts toward the industrialization of health care delivery, toward greater accountability and transparency through measurement, and toward new care delivery and payment models.
The practice of medicine, once considered a cottage industry practiced by individuals or small partnership groups, started transitioning toward multi-specialty groups and corporations in the 1990s (Maloney, 1998). Ongoing structural changes in the health care industry, including the horizontal and vertical integration of insurers, hospitals, pharmacies, and physician and dental practices, are leading to an increasing number of clinicians being employed by large corporations. These changes are also bringing about the wider application of industrial-type operational strategies by HCOs designed to deliver care more efficiently, such as greater divisions of labor and reliance on unskilled labor, standardization of roles and tasks, and the creation of corporate managerial structures (Casalino, 2017; Moses et al., 2013; Rastegar, 2004). One analysis estimated that the number of health care administrators increased 3,200 percent between 1975 and 2000, thus, underscoring the nature of the structural changes occurring in the industry (Cantlupe, 2017).
Corporate employment can provide various advantages to physicians, such as freedom from the business demands of operating a practice, negotiating leverage with health insurers over payment rates, and, potentially, more control over their work schedules (Casalino, 2017). At the same time, the managerial hierarchy in health care corporations can have control over many domains that affect clinicians, including the
application of clinical algorithms, practice guidelines, standardization of procedures, cost-control measures that affect care directly (such as choice of orthopedic prostheses and implantable cardiac devices), quality improvement programs, and supply of clinical information required by insurers. (Moses et al., 2013, p. 1957)
Care delivery strategies such as standardization, cost controls, and productivity targets can create schisms between individual clinicians’ values and expectations and those of the organization as well as declines in the clinicians’ sense of control, flexibility, and autonomy and a potential erosion of professional values (Casalino, 2017; Moses et al., 2013; Rastegar, 2004). These tensions between HCOs and clinicians can contribute to work stress, job dissatisfaction, and burnout (Gregory and Menser, 2015; Linzer et al., 2017; Rothenberger, 2017). See Chapter 3 for the consequences of burnout and Chapter 4 for details on the work-related sources of clinician burnout.
LAWS, REGULATIONS, AND STANDARDS
Mirroring the complex organization of the U.S. health systems and the major changes in care delivery and financing, the U.S. regulatory landscape for the oversight of the health professions includes a multitude of ever-changing regulatory and oversight bodies that define and influence many aspects of a clinician’s responsibilities and actions. Health care laws and regulations are promulgated by federal, state, and local governments and affect institutional providers as well as individual clinicians. Additionally, private organizations supplement the work of governmental regulators by issuing standards, such as those that are used to accredit health professions schools, administer licensing examinations, and certify specialists (Field, 2008). Also, health professional organizations and societies have had a longstanding role in self-regulation (authority over certain legal, economic, and institutional aspects of the profession) (Havighurst, 1983), although the authority of each organization varies greatly (Madara and Burkhart, 2015).
The myriad laws and regulations as well as the many accreditation and other professional standards are intended to support the health care system, for example, by engendering public confidence in the competence of physicians through licensure requirements (Field, 2008). However, despite areas of overlap, oversight bodies at times operate without coordination (Field, 2008), which is contributing to growing concerns about the burden of administrative requirements on clinicians (a contributory factor to burnout; see Chapter 4). Policy makers often fail to assess the impact of new regulations or requirements before they are implemented (Lee et al., 2019a).
A 2017 survey of members of a multi-specialty academic faculty in New England found that the average time spent by a physician on administrative duties was nearly 28 percent of the physician’s work week, and this appears to have increased since 2014. Prior authorizations, specialty recertifications, and compliance regulations related to opioid prescribing were the duties for which required faculty engagement had increased the most over the 3-year study period (Del Carmen et al., 2019).
Growing administrative requirements, many of them discussed in this chapter and in Chapters 4 and 7, can interfere with the care experience of patients and “drain time and morale” from clinicians (Berwick et al., 2017, p. E1). In response to the negative effects of administrative burden on patient care and on clinicians, clinician-led efforts have begun to focus attention on the problem. In 2018 six medical professional organizations representing 560,000 physician and medical student members called upon U.S. Congress, the administration, payers, vendors, and other stakeholders to expand and accelerate efforts to reduce administrative burden. The six organizations issued joint principles calling for the simplification of clinical documentation requirements, improved performance measures, and the streamlining or elimination of prior authorization forms. These organizations also encouraged better leveraging of health IT to improve usability and clinical workflows and called for continuous evaluations of regulations and administrative tasks on clinicians and patients (AAFP, 2018). In addition to this call to action, the American College of Physicians’ Patients Before Paperwork initiative is identifying and prioritizing the most burdensome administrative tasks faced by clinicians, developing policy recommendations to address these administrative tasks, and engaging in ongoing outreach and stakeholder engagement efforts with external sources of administrative and regulatory burden (ACP, 2018a). Chapter 5 discusses an approach some HCOs are taking to modify or eliminate administrative rules that contribute little or no value to patient care (Berwick et al., 2017).
In the sections that follow, the committee discusses various laws and regulations that define payment schemes for clinician services and that shape the requirements, policies, and procedures for medical records documentation and coding, quality measurements and reporting, prescription drug monitoring, privacy rules, and prior authorization forms. (Laws and regulations related to electronic health records and other technologies are discussed in Chapter 7.) In the latter part of this section, the committee addresses professional licensure, board certification, and professional liability.
Health Care Reform and Payment Policies
The Patient Protection and Affordable Care Act of 20102 initiated a significant federal interest in value-based health care. The more recent Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 20153 (MACRA) (in particular, the new payment options under the MACRA Quality Payment Program [CMS, 2019b]), along with initiatives in the private sector (Health Care Transformational Task Force, 2017) are accelerating the value movement. These initiatives include linking payment to value by using alternative payment models, increasing care integration and coordination to improve population health (i.e., the medical home model), and using information technology to improve patient care. A goal is to substantially change incentives to promote the delivery of higher value care by clinicians and HCOs.
Figure 6-2 shows eight federal value-based programs that have been implemented over the past decade. Most recently, under MACRA, the U.S. Department of Health and Human Services (HHS) set a goal of having 90 percent of Medicare fee-for-service payments linked to quality or value by 2018 (HHS, 2015). In 2019 MACRA introduced a two-track Quality Payment Program for participating Medicare clinicians. Under the Merit-Based Incentive Payment System, participating clinicians receive performance-based payment adjustments, and under alternative payment models such as accountable care organizations, clinicians have additional incentives to provide high-quality and cost-efficient care (CMS, 2019b).
In addition to the payments they receive from participating in federal value-payment programs, HCOs and clinicians are, of course, reimbursed for their services and procedures by multiple commercial insurers and consumers. Payment structures can vary from fee-for-service to newer value-based models. Each payer has its own set of rules and regulations with different levels of complexity (Gottlieb et al., 2018). For example, there is variation in practice requirements (e.g., credentialing); variation in the conditions, tests, and treatments that are covered and the associated coding rules (i.e., Current Procedural Terminology [CPT] and the International Classification of Diseases, Tenth Revision [ICD-10]); variation in the payment-related incentives and penalties employed; and variation in the quality measures required to be reported (see the section on quality reporting below).
There are many reports in the literature concerning how the existing federal and commercial payment schemes have created a confusing and onerous environment for clinicians. Managing multiple payment systems with complex rules, processes, metrics, and incentives that may frequently change is a
2 Public Law 111-148, 124 Stat. 119.
3 H.R. 2, Public Law 114-10.
source of considerable burden for clinicians (Casalino et al., 2016; Cohen et al., 2018; Wynne, 2016). As private insurance plans continue to follow the Centers for Medicare & Medicaid Services’ (CMS’s) lead and expand the use of risk-sharing contracts (Health Care Transformational Task Force, 2017; Hsu et al., 2017), one result could be greater clinician burden because of the variations across payers in terms of programmatic goals, documentation and performance measurement requirements, and uncertainty about the evolution of payment models (Hsu et al., 2017). One study of clinical hospital pharmacists found that uncertainty regarding health care reform is a risk factor for burnout (Jones et al., 2017).
To the extent that payment policies and requirements are causing substantial administrative burden, financial pressures, or other negative effects on clinicians to the point that they are leaving their practices, the very success of health care reform may be threatened (Dyrbye and Shanafelt, 2011) and create barriers to patient care. For example, third-party reimbursement policies under Medicare Part D have been reported to contribute to community pharmacists’ financial stress (Gabay, 2017) and the closing of community pharmacies, which may reduce access to care, particularly in rural communities where there may be only one community pharmacy and the pharmacist may be the only local health care provider (Ullrich et al., 2017).
Medical Records Documentation and Coding Requirements
Medical records documentation facilitates several functions, including the recording of pertinent information regarding a patient’s health history, the planning and evaluation of a patient’s treatment, the monitoring of a patient’s health over time, communication among providers involved in the patient’s care, billing, carrying out reviews of usage and quality of care, liability protection, and data collection for research. Myriad federal and state laws and regulations impose specific documentation requirements on health care providers.4 For example, the Medicare conditions of participation state that “[t]he medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services” and provides further detailed requirements to meet this standard.5 Additionally, the federal Meaningful Use program has expanded medical records documentation requirements to include specific information pertaining to payer quality measures6 and to serve as a vehicle for sharing health information with patients, families, and caregivers.7Appendix B provides examples of the clinical documentation and coding requirements of the Medicare Program, for accreditation by The Joint Commission, and of the ICD-10.
State medical boards also may require certain clinical documentation requirements, for example, with respect to a telehealth encounter.8 Other stakeholders have placed additional requirements on the clinical documentation process for quality reporting, physician report cards, reimbursement,
4 See, e.g., Illinois Administrative Code, Title 77 Public Health, Chapter 1: Department of Public Health, Subchapter b: Hospitals and Ambulatory Care Facilities, Part 250 Hospital Licensing Requirements, Subpart L: Records and Reports, Section 250.1510(b)(2) Medical Records; Commonwealth of Massachusetts, Division of Health Care Facility Licensure and Certification, Hospital licensure, 105 CMR 130.
5 See 42 CFR § 482.24 (C).
6 See, e.g., 42 CFR § 495.20—Meaningful use objectives and measures for eligible professionals, eligible hospitals, and critical access hospitals before 2015.
7 See 42 CFR § 495.24—Stage 3 meaningful use objectives and measures for eligible professionals, eligible hospitals, and critical access hospitals for 2019 and subsequent years.
8 See, e.g., Section 13: Medical Records, Telemedicine Standards of Practice, Board of Licensure in Medicine and Board of Osteopathic Licensure, Maine Department of Professional and Financial Regulation. (“A licensee who uses telemedicine in providing health care shall ensure that complete, accurate and timely medical records are maintained for the patient when appropriate, including all patient-related electronic communications, records of past care, physician-patient communications, laboratory and test results, evaluations and consultations, prescriptions, and instructions obtained or produced in connection with the use of telemedicine technologies. The licensee shall note in the patient’s record when telemedicine is used to provide diagnosis and treatment.”)
public health data, and disease tracking and trending. Moreover, hospital bylaws and rules and regulations typically address the content of medical records9 and impose their own sets of requirements, based on organizational goals, values, and the interpretation of external expectations. These multiple sources of clinical documentation requirements lead to duplicative and inconsistent requirements (AHA, 2017) that are burdensome and time consuming. The American Hospital Association reports that hospitals are required to comply with 341 mandatory regulatory requirements, at an estimated annual cost of $7.6 million per community hospital, on average. Larger hospitals can spend up to an estimated $19 million annually. Fulfilling these demands requires 59 full-time staff per hospital, more than one-fourth of which are doctors or nurses who could otherwise be providing direct patient care (AHA, 2017). To fulfill the requirements, short cuts, such as use of copy-and-paste functions and check boxes, are commonly employed, but they may result in an increased risk of poor-quality notes, contradictions in the history, and inadequate documentation (Dimick, 2008). Another increasingly popular strategy to help clinicians complete documentation is the use of medical scribes. (Chapters 5 and 7 discuss the evidence associated with the use of scribes.) Excessive paperwork and documentation is also a stressor for other professions. For example, Schommer and colleagues (2018) identified higher levels of reported time stress among community pharmacists than among hospital pharmacists; doing excessive paperwork or documentation (i.e., third-party work) was found to be one of seven items that may contribute to time stress (Schommer et al., 2018).
Clinical Documentation Redesign
As a result of the many reports that have examined the burden associated with clinical documentation and other clerical tasks (Arndt et al., 2017; Baumann et al., 2018; Shanafelt et al., 2016; Sinsky et al., 2016; Tai-Seale et al., 2017) (see Chapter 4 for details), there have been multiple calls for a significant redesign of clinical documentation (ACP, 2018b; Haas et al., 2019; Ommaya et al., 2018).
Federal actions to reduce the effort and time required to record health information include the development of a draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHR (ONC, 2018) released by the HHS Office of the National Coordinator for Health Information Technology (ONC) in 2018, as directed by
9 The Joint Commission Standard, Medical Staff (MS); MS.01.01.01, EP 16 mandates that requirements for completing and documenting medical histories and physical exams in accordance with state law and hospital policy must be included in the medical staff bylaws.
U.S. Congress under the 21st Century Cures Act.10 In response to ONC’s proposed strategy, the American Medical Informatics Association (AMIA) called for HHS to adopt a long-term electronic health record (EHR) strategy that uses informatics tools and methodologies to gather information from care documentation and apply it to clinical decision support and improving performance (Fridsma, 2019). In AMIA’s view, efforts to improve clinical documentation and reduce clinician burden should focus on clinically purposeful documentation and not just on reduced documentation (Fridsma, 2019).
In addition, CMS’s Patients over Paperwork initiative, launched in 2017, has made a number of changes in an attempt to simplify Medicare documentation requirements in order to reduce the amount of time clinicians spend on claims documentation (CMS, 2019a). In June 2019, CMS announced that it is actively soliciting public feedback to shape Patients over Paperwork’s next steps and future progress in tackling unnecessary clinician burden (CMS, 2019a).
10 Public Law 114-255.
Quality Measurement and Reporting
Documenting and reporting quality measures is of paramount importance to improving health care. Two Institute of Medicine reports, To Err Is Human: Building a Safer Health System (IOM, 2000) and Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001), powerfully brought the public’s attention to significant gaps in health care quality and safety and to the importance of measuring system performance. Since then a growing number of employers, payers, and regulators have required the reporting of quality and safety information (e.g., Healthcare Effectiveness Data and Information Set®11 clinical measures, Consumer
11 Healthcare Effectiveness Data and Information Set (HEDIS®) is a registered trademark of the National Committee for Quality Assurance.
Assessment of Healthcare Providers and Systems®12 patient experience measures, and Leapfrog hospital survey data) from health plans, hospitals, and health systems. At the same time, published comparative score cards and rankings (e.g., Hospital Compare [CMS, 2000], Quality Compass®13) based on these performance data have emerged as key drivers for improved accountability, transparency, and increased value in health care.
Value-based payment models require measures of quality, patient experience, and efficiency, which is contributing to a proliferation of performance measures and reporting requirements, with a commensurate increase in the burden on clinicians who are recording and collecting the data (NQF, 2019). Although many of the performance measures provide useful information, there are many that do not (because they are duplicative, not clinically relevant, have poor methodological design, etc.) and are thus not effective in improving the performance of the health system (Berwick, 2016; IOM, 2015; MacLean et al., 2018). The current mandatory measurement requirements, which include measures that are not important to patient health (Berwick, 2016; Dunlap et al., 2016; IOM, 2015; Panzer et al., 2013; Safran and Higgins, 2019), contribute to the perception that current quality measures detract from meaningful clinical activity and deprofessionalize the clinician (Khullar et al., 2018; Pronovost et al., 2018), as well as adding a substantial burden to the workload of clinicians (Casalino et al., 2016; Sinsky et al., 2016) (see Chapter 4), even with the use of current health information technology (Cohen et al., 2018).
Multi-stakeholder efforts to decrease the burden associated with quality measurement are ongoing. For example, the Measure Applications Partnership (MAP), convened by the National Quality Forum (NQF), guides HHS on the selection of performance measures for federal health programs. In its 2017 guidance (NQF, 2017), MAP called for a reduction in the number of measures in federal programs as well as better feedback from frontline clinicians to ensure that measures are driving improvement and not causing negative consequences (e.g., burnout) on clinicians. In addition, the Core Quality Measure Collaborative (CQMC), involving America’s Health Insurance Plans, CMS, and NQF, as well as national physician organizations, employers, and consumers, promotes the coordination of measure use and collection across public- and private-sector payers. In developing core sets of performance measures, CQMC aims to “reduce the burden of measurement by eliminating low-value metrics, redundancies, and inconsistencies in measure specifications and quality measure reporting requirements across
12 Consumer Assessment of Healthcare Providers and Systems (CAHPS®) is a registered trademark of the Agency for Healthcare Research and Quality.
13 Quality Compass® is a registered trademark of the National Committee for Quality Assurance.
Prescription Drug Monitoring Program Requirements
Currently, 49 states, the District of Columbia, and one U.S. territory (Guam) have authorized a prescription drug-monitoring program (PDMP). PDMPs are state-operated data repositories that collect, monitor, and analyze electronically transmitted patient-specific prescribing and dispensing data submitted by pharmacies and dispensing practitioners with the goal of reducing prescription drug abuse and diversion. When prescribers or pharmacists query the database for a patient’s prescription history, they can see prescription information regarding the dose, supply, and prescriber of scheduled drugs the patient has filled. Clinicians can use this information to inform their prescribing decisions, avoid polypharmacy, and refrain from supplying opioids to patients exhibiting drug-seeking behavior. The circumstances under which a clinician is required to access the database, however, vary from state to state.
As of January 2019, at least 43 of the 49 states with PDMPs (plus Guam) now legally mandate prescribers—and 20 mandate pharmacists—to query the system prior to writing or dispensing a prescription for controlled substances with recognized potential for abuse or dependence (PDMP TTAC, 2019). While this policy is well intended and serves the need to curb prescription drug abuse, requiring clinicians across care settings to query PDMPs can be burdensome (Haffajee et al., 2015). In querying PDMPs, prescribers have experienced difficulty in obtaining logins, encountered system downtime, and noted that information is not integrated into clinical workflow with often incomplete data (Haffajee et al., 2015). According to a 2018 JAMA Surgery study, clinicians without PDMP databases built directly into their EHR systems (i.e., one-click access) spend an average of 13 minutes per patient to complete PDMP queries, opioid risk calculator processes, and required institutional informed consent processes (Stucke et al., 2018).
To increase the use of PDMPs, the Substance Abuse and Mental Health Services Administration funded projects in nine states from fiscal years 2012 to 2016 through its PDMP Electronic Health Records Integration and Interoperability Expansion (PEHRIIE) program (CDC, 2017). Ensuring that prescribers have one-click access to state PDMP data is one strategy to reduce administrative burden on clinicians by eliminating the need for prescribers to manually log into PDMP’s website separately. EHR integration of PMDP data is becoming increasingly common across the country (Monica, 2018a,b) and will likely accelerate with the emergence of new
private-sector initiatives facilitating clinician access to prescription drug information at the point of care (DrFirst, 2019).
CMS has also taken action to reduce the burden associated with PDMPs. In 2018 CMS called on state Medicaid programs to improve EHR integration of PDMP data to enhance appropriate and safe prescribing, reduce provider burden, and allow HCOs to more easily track patient information related to opioid use (Hill, 2018). In its guidance to states, CMS stated,
This integration removes the requirement for providers to log in to a separate system, manage a separate login and disrupt their workflow to query the PDMP. Single sign-on interoperability between EHR and PDMP, such that PDMP results are displayed when the EHR indicates a controlled substance is prescribed, could be supported, as an example. (Hill, 2018, p. 2)
In addition, under Medicare Part D, CMS has implemented a voluntary prescription drug benefit that makes e-prescribing optional for physicians and pharmacies but requires drug plans that participate in the prescription benefit to support electronic prescribing (CMS, 2014).
Maintaining Privacy and Security Compliance
Federal and state laws and regulations impose obligations on HCOs and clinicians to maintain the privacy and security of health information. For example, the goal of the Health Insurance Portability and Accountability Act (HIPAA) privacy standards is to protect the integrity, confidentiality, and availability of health data. Similarly, the purpose of the HIPAA Security Rule is to establish national standards for the protection of electronic protected health information (PHI). The steps required by clinicians to comply with federal and state privacy and security laws and regulations concerning health information along with related organizational policies and procedures add to the administrative burden on clinicians. For example, the HIPAA Privacy Rule requires that an authorization contain either an expiration date or an expiration event that relates to the patient or the purpose of the use or disclosure.14 Some HCOs require patients to execute written authorization for the use and disclosure of PHI on an annual basis. Such a requirement results in clinicians searching the EHR to find the most recent authorization, making sure that it has been signed within the past year and, if not, obtaining a new form from the patient. Additionally, two commentators have noted that misapplications of the HIPAA requirements have unnecessarily resulted in restricting the exchange of clinical information
14 45 CFR § 164.508(c)(1)(v).
between treating clinicians and have led to rules against posting patients’ names in clinical areas to facilitate finding or identifying the patient and also rules against family members or loved ones reviewing medical records and clinical information even with the patient’s permission (Berwick and Gaines, 2018).
Another example of HCOs’ influence on the implementation of privacy and security laws and regulations and the effects on clinician burden relates to patient communications, including e-mail, text messaging, or Web-based messaging platforms, all of which are subject to the HIPAA privacy and security standards (HHS, 2019; Liederman et al., 2005). In order to comply with the HIPAA security standards, access to a clinician’s e-mail and the HCO’s EHR or other Web-based messaging platforms must be password protected. The HIPAA security standards require covered entities to have procedures for creating, changing, and safeguarding passwords.15 In implementing such procedures, HCOs typically use stringent password management requirements (e.g., number of characters, symbols, capitalization, and frequency of change) that clinicians must meet. Dealing with user logon and authentication procedures can be time consuming. For example, in one study of family medicine physicians (n = 142), clinicians were found to have spent nearly as much time on system security as on reading or editing the problem list each day (Arndt et al., 2017). Challenges are amplified for clinicians who use more than one EHR and communication platform, as each requires its own password and software (Gellert et al., 2017; Liu et al., 2019; Luxton et al., 2012).
Prior Authorization Process
Payers often require clinicians to obtain prior authorization for medications, other forms of treatment, diagnostic procedures, and referrals. The intent of prior authorization is to deter patients from getting unnecessary medical care and to direct prescribers to less costly treatment options where appropriate (and thus reduce the cost of care); however, these requirements can also create hassles for patients and add to clinicians’ burden (Jacobson and Neuman, 2018). Different prior authorization rules by different payers require inconsistent workflow processes and the submission of additional information through manual processes (eHealth Initiative, 2019). Pre-authorization processes, which have to be completed annually even for medications for chronic conditions, are resource-intensive and pose barriers to providing optimal patient care (Brown and Brown, 2018; Del Carmen et al., 2019). In a recent study of physicians at an academic medical center, pre-authorization was the most onerous administrative task
15 45 CFR § 164.308 (a)(5)(ii)(D).
(Rao et al., 2017). Similarly, a national study of community pharmacists found that prior authorization was a top concern among pharmacists with Medicare Part D, with pharmacists reporting that they spent the most time on prior authorization, followed by reimbursement and formulary issues (Spooner et al., 2017).
Among the advocacy initiatives to reform prior authorization and reduce the burden on clinicians and patients is a consensus statement from the American Medical Association (AMA), America’s Health Insurance Plans, and other stakeholder organizations (AHA et al., 2018). These stakeholders identified five areas for improving the prior authorization process: the use of criteria for the selective application of prior authorization requirements; regular review of the list of medical services and prescription drugs that are subject to prior authorization; enhanced communications among health plans, health care providers, and patients; continuity of patient care; and widespread industry use of standard electronic prior authorization processes.
At the federal level, more than 100 members of U.S. Congress sent a letter to the CMS administrator in 2018 expressing concern about Medicare Advantage plans’ use of prior authorization and the associated administrative burden placed on clinicians (Roe et al., 2018). They asked CMS to collect data on the scope of prior authorization practices, prepare a report describing CMS oversight of pre-authorization policies, and engage stakeholders to improve the prior authorization process for patients and clinicians.
Health care professionals in the various disciplines are required to be licensed and must meet certain standards to maintain their licenses. Licensing occurs at the state level, and the requirements vary from state to state. Clinicians practicing in multiple states and those using telehealth technologies have additional requirements (FSMB, 2019a). For example, telehealth and telepharmacy require appropriate licensure in all of the jurisdictions where a clinician’s patients receive care, resulting in clinicians needing to meet yearly or every-other-year licensure requirements in multiple states. Although licensure requirements vary, common requirements include completing medical licensure applications and engaging in continuing medical education, including mandated programs in drug prescribing, child abuse, pain management, and other topics specified by state laws, and maintaining an active physician drug monitoring program profile (to detect over-prescribing of controlled drugs). Recent efforts to streamline licensing have attempted to expedite medical licensure applications for multistate practice (FSMB, 2014; Interstate Medical Licensure Compact, 2019) and simplify physician licensure applications across multiple states with the use of a
Web-based uniform application (FSMB, 2019b). There are similar efforts in place to streamline the nursing licensure process (NCSBN, 2019). The National Association of Boards of Pharmacy adopted an online state license transfer process in 2018 (NABP, 2019). The requirements of each individual state must also be met.
State Licensing Board Questions on Mental Health Status
Applicants for state licensure in a variety of health professions typically are required to answer questions relating to their physical and mental health status, including any substance use disorders, in both initial and renewal applications. Such questions reflect a responsibility among state medical boards to ensure clinicians are not impaired and that they can meet their statutory duty to promote patient safety. Unfortunately, many medical and nursing license application questionnaires include overly intrusive personal health questions that can be a barrier to clinicians seeking treatment for treatable illnesses (Dyrbye et al., 2017; Halter et al., 2019).
While this issue affects a number of licensed health care professionals, state medical licensing board questions relating to the mental health status of physicians have received the most attention in the literature. In a 2016 review of initial and renewal medical license application forms from 48 medical licensure boards, 50 percent were found to have included overly broad questions about physicians’ mental health that were inconsistent with the AMA, the American Psychiatric Association (APA), and the Federation of State Medical Boards (FSMB) policies and recommendations (Dyrbye et al., 2017). A 2017 analysis of state medical board applications for physicians seeking first-time licensure found that 84 percent asked about mental health conditions and 92 percent asked about substance use. Of the states that did ask about mental health, only 53 percent limited those questions to conditions that cause functional impairment, and 86 percent included questions about past mental health conditions (Gold et al., 2017). In nursing, Halter and colleagues (2019) report that 30 nurse licensing boards ask questions about mental illness on their applications, 22 of which ask questions that focus on specific diagnoses, examine historical data in the absence of current impairment, or require the applicant to predict future impairment (Halter et al., 2019).
There is also some evidence that these requirements discourage honest disclosure and also inhibit treatment seeking among physicians who are struggling with mental health issues. In a survey of 5,829 U.S. physicians, physicians who worked in a state that had overly broad questions on mental health were found to be 20 percent more likely to be reluctant to seek formal care for a mental health condition because of concerns about repercussions to their medical licensure (Dyrbye et al., 2017). A survey of
female physicians (n = 2,106) found that only 6 percent of physicians with a mental health diagnosis or who had sought mental health treatment reported it to their state licensing board (Gold et al., 2016).
Some analyses have concluded that many state medical and nursing licensing board questions about past, rather than current, histories of mental illness and substance abuse are likely in violation of the Americans with Disabilities Act (ADA) of 1990 (Halter et al., 2019; Polfliet, 2008; Schroeder et al., 2009). Protection of the public from impaired professionals is a critical function of state licensing boards for medicine, dentistry, pharmacists, nursing, lawyers, and other regulated professions. This public safety function, however, is in tension with another important public policy objective of avoiding discrimination against persons with disabilities. These competing societal goals have come into conflict with respect to the content of application questions for certain professional licensing boards, and this has led to litigation in both the medical and the legal professions under Title II of the ADA. Title II provides that “no qualified individual with a disability shall, by reason of such disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of a public entity, or be subjected to discrimination by any such entity.”16 Title II of the ADA further requires state and local government agencies to operate programs so that they are “readily accessible to and usable by individuals with disabilities.”17
Certain judicial rulings have held that licensing boards are subject to Title II of the ADA because they are empowered by state governments to provide benefits, services, and programs.18 For example, in Medical Society of New Jersey v. Jacobs et al.,19 the New Jersey State Board of Medical Examiners sought information about an applicant’s status as a person with a disability instead of focusing on any behavioral manifestations of disabilities that might impair the individual’s ability to practice medicine. The U.S. District Court for the District of New Jersey examined the licensing board’s inquiry, “Have you ever suffered or been treated for any mental illness or psychiatric problem?” and concluded that questions regarding applicants’ diagnosis of and treatment for psychiatric illness or condition are unnecessary, where the medical examiners could “formulate a set of effective questions that screen out applicants based only on their behavior and capabilities.”20 Since the Jacobs case, several federal district courts
16 42 U.S.C. § 12132 (Title II) (1994).
17 42 U.S.C. § 12148(a)(1) (1994).
18 See, e.g., Theriault v. Flynn, 162 F.3d 46 (1st Cir., 1998); Burke v. State Bar of Cal., No. C 06-06950 WHA, 2007 WL 39397 (N.D. Cal., Jan. 4, 2007).
19 See Medical Society of New Jersey v. Jacobs et al., 1993 WL 413016 (D.N.J., 1993).
20 Id. (section 7).
have ruled on mental health inquiries by state licensing boards.21 Although many of these cases involved questions relating to state bar applications,22 the common issue with medical licensure is the balance of an applicant’s right to privacy with the protection of the public.
The FSMB and the APA have noted that a history of mental illness or substance use does not reliably predict a future risk to the public (APA, 1984, 2018; FSMB, 2018). In 2018, the FSMB issued 10 recommendations related to the state medical board licensing process that were intended to reduce the stigma associated with mental health issues and encourage treatment seeking (FSMB, 2018). Several recommendations address the necessity of including questions about the mental health of physicians on applications for medical licensure or renewal as well as addressing the appropriate phrasing of such questions, including focusing only on current impairment
21 See Hason v. Medical Board of California et al., 279 F.3d 1167, 1168 (9th Cir. 2002) (Following denial of an application for medical license on the basis of mental illness, rather than on actual functional impairment, the physician filed a pro se complaint in federal district court alleging discrimination based on his disability in violation of his rights under the U.S. Constitution and Title II of the ADA, which was dismissed. The Ninth Circuit Court of Appeals ruled that the lower court erred in its interpretation of Title II of the ADA, noting that “[t]he act of licensing involves the Medical Board (i.e., a ‘public agency’) providing a license (i.e., ‘providing a service’) to an applicant for a medical license” and thus falls within the purview of the Act.).
22 See, e.g., Bartlett v. New York State Board of Bar Examiners, 226 F.3d 69 (2d Cir. 2000) (The Board denied an applicant’s request for testing accommodations, such as extended time and alternative ways to answer questions. The U.S. Court of Appeals for the Second Circuit concluded that if the applicant had a disability, then she was entitled to the requested accommodations because the Board was subject to Title II of the ADA. On remand, the U.S. District Court for the Southern District of New York found the Board’s failure to accommodate the plaintiff’s reading impairment was a substantial factor contributing to her failure to pass the bar and that she was entitled to reasonable accommodations when taking the bar exam.); Clark v. Virginia Bd. of Bar Examiners, 880 F. Supp. 430, 436-440 (E.D. Va. 1995) (the U.S. District Court for the Eastern District of Virginia found a question reading, “Have you, within the past five years, been treated or counseled for any mental, emotional or nervous disorders?” to be overly broad, unproven in its necessity, and potentially discriminatory; the Clark court determined that only questions concerning an applicant’s conduct are permissible in assessing the applicant’s current level of competence. Additionally, the Clark court held that even if open-ended questions are limited in time, there was no evidence of a correlation between past psychiatric treatment and current functional impairment. Although it invalidated the bar examiners’ question, the Clark court indicated that the ADA would permit some form of mental health inquiry); Ellen S. v. Florida Board of Bar Examiners, 859 F. Supp. 1489, 1493-94 (S.D. Fla. 1994) (Applicant for admission to the bar sued the Florida Board of Bar Examiners claiming that application questions pertaining to an emotional disorder violated the Title II of the ADA, and the U.S. District Court for the Southern District of Florida held that a defendant need not have knowledge of the plaintiff’s disability in order to violate Title II of the ADA and that questioning the applicant as to whether she had ever sought treatment for a nervous, mental, or emotional disorder or had been diagnosed as having such a condition violated the Act.).
when state medical boards decide to include these types of questions. The FSMB also encouraged state medical boards “to advance a positive cultural change that reduces the stigma among and about physicians seeking treatment for mental, behavioral, physical or other medical needs of their own” (FSMB, 2018, p. 2).
Similarly, in 2018, the AMA confirmed its stance that physicians should be able to seek the care they need for burnout, anxiety, depression, and substance-related disorders without fear of punitive treatment, discover-ability in malpractice litigation, or licensure and career restrictions (AMA, 2018). Several states recently have adopted, or are actively considering, the recommendations of the FSMB and the AMA, including the state medical boards of Florida (Freeman, 2019), North Carolina (Ellis, 2016), Ohio (Ohio Academy of Family Physicians, 2016), and Washington (Fordham, 2018).
Certification boards have the goal of ensuring the competence of physicians and other clinicians completing postgraduate specialty training and throughout their careers (Baron, 2015). In medicine, board certification is a process whereby professional peers set standards for designation as “board-certified specialists” by 1 of the 24 boards of the American Board of Medical Specialties. Board certification requirements include completion of an accredited residency or fellowship program, maintaining a current and unqualified license to practice, and successfully passing a secure examination of knowledge specific to that specialty. Certification has evolved from an initial, one-time event to a program of ongoing education and assessment (recertification) to help physicians stay current with medical knowledge and skills. The Board of Pharmacy Specialties addresses similar issues in pharmacy.
Recertification programs, known as “maintenance of certification” (MOC) or, more recently, as “continuing certification” programs (Vision for the Future Commission, 2019), have been a source of dissatisfaction among physicians. Physicians have strong concerns over the burden, cost, and relevance of MOC programs (Cook et al., 2016; Del Carmen et al., 2019; Teirstein and Topol, 2015; Vision for the Future Commission, 2019). Meeting MOC requirements adds a substantial burden that is typically handled after work, contributing to stress and difficulties with work–life balance. A survey involving national cross-specialty random sample of licensed U.S. physicians found no association between attitudes toward MOC and burnout (Cook et al., 2016). In 2018 an independent commission (Vision for the Future Commission) was formed to address key issues related to continuing certification programs, and it recently issued its final
report with conclusions and recommendations to enhance these programs (Vision for the Future Commission, 2019).
Similar to medical licensure, obtaining professional liability insurance often requires completing forms that include questions inquiring about past and current mental health concerns, presenting yet another barrier to appropriate treatment seeking. Professional liability policies are a response to a litigious society. A 2004 study found widespread discontent among physicians practicing in high-liability environments (Mello et al., 2004). As discussed in Chapter 3, malpractice lawsuits are common (Mello et al., 2004) and are associated with increased stress (Jones et al., 1988) and risk of burnout as well as personal consequences for physicians (Balch and Shanafelt, 2011). The stressors involved in being named in a medical malpractice action may be heightened if the use of emerging technology is involved, particularly given the uncertainty of how current theories of legal liability will apply to claims involving new technology, such as an artificial intelligence (AI) diagnostic tool. Traditionally, medical malpractice is based on negligence, which is defined as any act or omission by a clinician during the treatment of a patient that deviates from the accepted norms of practice and causes injury to the patient. The standard of care in medical malpractice actions, usually a national or community-based standard relating to what is customary practice among physicians in the same specialty in similar settings, generally is established through expert witness testimony.23 In contrast, if a medical device or piece of equipment is responsible for the patient’s injury, then the principles of product liability apply, with its strict liability standard for manufacturing defects, design defects, and failure to warn of such defects.
As discussed in Chapter 7, the use of AI tools that are reliable and embedded smoothly in the workflow may help reduce the stress of practice, but they may also place new demands on clinicians. As the use of emerging
23 Jurisdictions differ as to the expected standard of care in a medical malpractice action. The national standard of care requires a doctor to use the degree of skill and care of a reasonably competent practitioner in his field under same or similar circumstances. The community-based or locality standard requires a physician to have the reasonable caliber of skill and knowledge that is generally possessed by surgeons and physicians in the locality where he or she practices. The respectable minority rule provides that where the physician did not follow the same course of therapy that other doctors would have followed, he can show that his course is accepted by a respectable minority of practitioners. Given the implementation of national standards for medical education and the universal availability of online guidance and evidence, there has been increasing support for a shift to a national standard of care. See Lewis et al. (2007).
technologies becomes more common, the standard of care in medical malpractice actions likely will change because certain technologies, such as an AI-based diagnostic tool, may supplant rather than support a clinician’s professional judgment or function. In determining legal liability, it is presently unclear whether the use of new technologies in patient care that results in injury to a patient will be evaluated under the traditional negligence standard applied in medical malpractice claims or by the product liability doctrine (Bennett and Habte, 2018).
As the regulation of digital health technologies continues to evolve, the evolution may affect whether a negligence standard or product liability will apply in a medical malpractice claim. Moreover, establishing whether the clinician who employed the AI diagnostic tool or the health IT vendor or the developer is at fault in the event of harm to a patient and then determining the degrees of comparative negligence among the three will be complicated, given the myriad functionalities and the blurring of boundaries between the tasks that are performed by the clinician and the extent to which the AI diagnostic tool is substituting for a clinician’s professional judgment or function. As AI algorithms improve and clinicians increasingly use this technology for diagnosis and decision making, the traditional malpractice standard of negligence may become more difficult to apply.
Not only do lawsuits add economic burden for organizations and clinicians, but the fear of malpractice can led to lower quality care (Forster et al., 2002). Medical malpractice reform is back on the federal policy agenda, but there is little available evidence that currently proposed medical liability reforms will be effective, with the possible exception of safe harbors and administrative compensation (Mello et al., 2017).
Societal Values and the Clinician–Patient Relationship
Over the past several decades, societal values and norms have been shifting away from the traditional paternalistic model of health care (“Doctor knows best”) (Bhopal, 2015; Kilbride and Joffe, 2018) toward a more patient-centered model (Gusmano et al., 2019; Weil, 2019). Currently, this shift places value on a more therapeutic and balanced relationship between clinicians and patients, shared decision making (Montori, 2019; Montori et al., 2019), and a more collaborative care experience. Technology and the Internet are allowing wider access to information about health conditions, treatments, quality, safety, and costs, which benefits patients wanting greater participation in the health care they receive (Gusmano et al., 2019).
At the same time, some of these same societal changes seem to be contributing to the erosion of patients’ trust in clinicians and the health care system (Blendon et al., 2014; Lee et al., 2019b; Levey, 2015; Lynch, 2018). Factors reported to be undermining public trust in clinicians and the
health care system include the growth in the variety of information sources, perceptions that health care is a business like any other, health care advances and changes to patient care recommendations, quality problems and medical errors, and cost-containment strategies (Lynch, 2018). The 2018 American Board of Internal Medicine Foundation Forum on [Re]Building Trust elaborates the role of trust among and between various stakeholders, including patients, clinicians, health care delivery organizations, payers, and regulators (Lynch, 2018).
While several strategies exist to improve the trust between clinicians and patients (Lee et al., 2019b), the committee’s review of the literature suggests that more needs to be known about the various system factors influencing the clinician–patient relationship, such as federal policies, market forces, new technologies, health information on the Internet, and organizational policies and practices. A systems approach to supporting and strengthening the clinician–patient relationship would focus on the design and implementation of policies, rules, and management actions that demonstrate a commitment to patient values and preferences and at the same time support and sustain the professional well-being of clinicians. As articulated in the committee’s conceptual framework, this process relies on using feedback, learning, and improvement principles (see Figure 2-1).
The clinician information available on health care rating websites is but one example of an opportunity to balance what consumers value (accurate information to inform health care choices) and what clinicians value (an accurate assessment of the care they provide). As discussed in the beginning of the chapter, the structural organization of the health care industry is shifting, giving HCO administrators greater control over the practices, policies, and procedures governing many aspects of frontline care delivery, while relying on clinicians’ professional ethics to go above and beyond requirements if patient well-being demands it (Ofri, 2019). There is concern that health care rating websites targeting patients are not accurately reflecting these structural changes in care delivery. That is, health care rating websites report information on aspects of care that are out of the direct control of clinicians (Burn et al., 2018; Lester et al., 2019), such as office staff friendliness, wait times, and ease of parking. In a study of community pharmacy ratings, for example, wait time was most frequently associated with a low rating, and friendliness and helpfulness of staff was most frequently associated with a high rating (Lester et al., 2019). If clinician assessments include factors attributable to the HCO and not to the individual clinician or direct patient encounter, patients may not be getting an accurate view of the patient experiences with the individual clinicians, in which case the information is not useful. Because these assessments can have adverse effects on a clinician’s professional reputation, patient recruitment, and revenue, they are an important source of clinician stress. These
implications for patients and clinicians suggest that taking a systems look at how clinician assessment approaches may be influencing the clinician–patient interactions in various ways is warranted.
An array of factors within the external health care environment perpetuate the complex landscape of legal, regulatory, standards requirements, and expectations that influence the everyday work of clinicians. While there is little published research that examines how compliance with these requirements directly affects clinicians, it is reasonable to conclude that the combination of the additional clinical workload, the disruptions to workflow, and the time and stress associated with fulfilling the requirements described in this chapter diverts clinician attention away from providing patient care and may contribute to clinician burnout. A better balance between important HCO and societal goals and maintaining clinician wellbeing is needed.
A number of stakeholders have called for reforming these evolving regulations and (at times) redundant and conflicting requirements and expectations. While some efforts to simplify federal regulations have been initiated, it is too early to know if these changes will reduce the burden on clinicians in a meaningful way. What is clear is that further coordinated efforts from a variety of stakeholders are needed to address the issue and to help optimize clinician professional well-being and prevent and mitigate burnout.
AAFP (American Academy of Family Physicians), American Academy of Pediatrics, American College of Obstetricians and Gynecologists, American College of Physicians, American Osteopathic Association, and American Psychiatric Association. 2018. Joint principles on reducing administrative burden in healthcare. https://www.acponline.org/acp_policy/statements/joint_principles_administrative_burden_2018.pdf (accessed July 20, 2019).
ACP (American College of Physicians). 2018a. Patients Before Paperwork initiative. Philadelphia, PA: American College of Physicians. https://www.acponline.org/system/files/documents/advocacy/where_we_stand/patients_before_paperwork/two-pager-handout-pb4p-2018-updated.pdf (accessed February 9, 2019).
ACP. 2018b. Physician well-being and professional satisfaction. https://www.acponline.org/practice-resources/physician-well-being-and-professional-satisfaction (accessed July 3, 2018).
AHA (American Hospital Association). 2017. Regulatory overload: Assessing the regulatory burden on health systems, hospitals, and post-acute care providers. Chicago, IL: American Hospital Association.
AHA, America’s Health Insurance Plans, American Medical Association, American Pharmaceutical Association, Blue Cross Blue Shield Association, and Medical Group Management Association. 2018. Consensus statement on improving the prior authorization process. https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/arc-public/prior-authorization-consensus-statement.pdf (accessed July 20, 2019).
Altman, D., and W. H. Frist. 2015. Medicare and Medicaid at 50 years: Perspectives of beneficiaries, health care professionals and institutions, and policy makers. JAMA 314(4):384–395.
AMA (American Medical Association). 2018. Access to confidential health services for medical students and physicians, H-295.858. https://policysearch.ama-assn.org/policyfinder/detail/Access%20to%20Confidential%20Health%20Services%20for%20Medical%20 Students%20and%20Physicians?uri=%2FAMADoc%2FHOD-295.858.xml (accessed May 31, 2019).
APA (American Psychiatric Association). 1984. Position statement on confidentiality of medical records: Does the physician have a right to privacy concerning his or her own medical records? American Journal of Psychiatry 141(2):331–332.
APA. 2018. Position statement on inquiries about diagnosis and treatment of mental disorders in connection with professional credentialing and licensing. https://www.psychiatry.org/File%20Library/About-APA/Organization-Documents-Policies/Policies/Position-2018-Inquiries-about-Diagnosis-and-Treatment-of-Mental-Disorders-in-Connection-with-Professional-Credentialing-and-Licensing.pdf (accessed July 20, 2019).
Arndt, B. G., J. W. Beasley, M. D. Watkinson, J. L. Temte, W. J. Tuan, C. A. Sinsky, and V. J. Gilchrist. 2017. Tethered to the EHR: Primary care physician workload assessment using EHR event log data and time-motion observations. Annals of Family Medicine 15(5):419–426.
Balch, C. M., and T. Shanafelt. 2011. Combating stress and burnout in surgical practice: A review. Thoracic Surgery Clinics 21(3):417–430.
Baron, R. J. 2015. Professional self-regulation in a changing world: Old problems need new approaches. JAMA 313(18):1807–1808.
Baumann, L. A., J. Baker, and A. G. Elshaug. 2018. The impact of electronic health record systems on clinical documentation times: A systematic review. Health Policy 122(8):827–836.
Bennett, S., and L. Habte. 2018. Artificial intelligence in health care: Welcome to the machine. AHLA Connections 22(5):16–20.
Berwick, D. M. 2016. Era 3 for medicine and health care. JAMA 315(13):1329–1330.
Berwick, D. M., and M. E. Gaines. 2018. How HIPAA harms care, and how to stop it. JAMA 320(3):229–230.
Berwick, D. M., S. Loehrer, and C. Gunther-Murphy. 2017. Breaking the rules for better care. JAMA 317(21):2161–2162.
Bhopal, A. 2015. Attitude and the 21st century doctor. Lancet Global Health 3(3):e126–e127.
Blendon, R. J., J. M. Benson, and J. O. Hero. 2014. Public trust in physicians—U.S. medicine in international perspective. New England Journal of Medicine 371(17):1570–1572.
Brown, G. C., and M. M. Brown. 2018. Preauthorization. Current Ophthalmology Reports 6(3):181–190.
Burn, M. B., D. M. Lintner, P. E. Cosculluela, K. E. Varner, S. R. Liberman, P. C. McCulloch, and J. D. Harris. 2018. Physician rating scales do not accurately rate physicians. Orthopedics 41(4):e445–e456.
Cantlupe, J. 2017. The rise (and rise) of the healthcare administrator. AthenaInsight. November 7. https://www.athenahealth.com/insight/expert-forum-rise-and-rise-healthcare-administrator (accessed July 20, 2019).
Casalino, L. P. 2017. The Medicare Access and CHIP Reauthorization Act and the corporate transformation of American medicine. Health Affairs (Millwood) 36(5):865–869.
Casalino, L. P., D. Gans, R. Weber, M. Cea, A. Tuchovsky, T. F. Bishop, Y. Miranda, B. A. Frankel, K. B. Ziehler, M. M. Wong, and T. B. Evenson. 2016. U.S. physician practices spend more than $15.4 billion annually to report quality measures. Health Affairs (Millwood) 35(3):401–406.
CDC (Centers for Disease Control and Prevention). 2017. Integrating & expanding prescription drug monitoring program data: Lessons from nine states. https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf (accessed July 20, 2019).
CMS (Centers for Medicare & Medicaid Services). 2000. Hospital compare: A quality tool for adults, including people with Medicare. Washington, DC: U.S. Department of Health and Human Services.
CMS. 2014. E-prescribing. https://www.cms.gov/Medicare/E-Health/Eprescribing/index.html (accessed May 31, 2019).
CMS. 2017. Core measures. https://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/QualityMeasures/Core-Measures.html (accessed May 31, 2019).
CMS. 2019a. CMS seeks public input on Patients over Paperwork initiative to further reduce administrative, regulatory burden to lower healthcare costs. https://www.cms.gov/newsroom/press-releases/cms-seeks-public-input-patients-over-paperwork-initiative-further-reduce-administrative-regulatory (accessed July 20, 2019).
CMS. 2019b. Value-based progams. https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/value-based-programs.html (accessed May 31, 2019).
CMS. 2019c. Quality payment program. https://qpp.cms.gov (accessed July 2, 2019).
Cohen, D. J., D. A. Dorr, K. Knierim, C. A. DuBard, J. R. Hemler, J. D. Hall, M. Marino, L. I. Solberg, K. J. McConnell, L. M. Nichols, D. E. Nease, Jr., S. T. Edwards, W. Y. Wu, H. Pham-Singer, A. N. Kho, R. L. Phillips, Jr., L. V. Rasmussen, F. D. Duffy, and B. A. Balasubramanian. 2018. Primary care practices’ abilities and challenges in using electronic health record data for quality improvement. Health Affairs (Millwood) 37(4):635–643.
Cook, D. A., M. J. Blachman, C. P. West, and C. M. Wittich. 2016. Physician attitudes about maintenance of certification: A cross-specialty national survey. Mayo Clinic Proceedings 91(10):1336–1345.
Del Carmen, M. G., J. Herman, S. Rao, M. K. Hidrue, D. Ting, S. R. Lehrhoff, S. Lenz, J. Heffernan, and T. G. Ferris. 2019. Trends and factors associated with physician burnout at a multispecialty academic faculty practice organization. JAMA Network Open 2(3):e190554.
Dimick, C. 2008. Documentation bad habits. Shortcuts in electronic records pose risk. Journal of AHIMA 79(6):40–43; quiz 45–46.
DrFirst. 2019. Cerner to work with DrFirst to connect to state prescription drug monitoring programs. https://www.drfirst.com/news/cerner-to-work-with-drfirst-to-connect-to-state-prescription-drug-monitoring-programs (accessed May 31, 2019).
Dunlap, N. E., D. J. Ballard, R. A. Cherry, W. C. Dunagan, W. Ferniany, A. C. Hamilton, T. A. Owens, T. Rusconi, S. M. Safyer, and P. J. Santrach. 2016. Observations from the field: Reporting quality metrics in health care. Discussion paper. National Academy of Medicine. https://nam.edu/wp-content/uploads/2016/07/Observations-from-the-Field-Reporting-Quality-Metrics-in-Health-Care.pdf (accessed July 20, 2019).
Dyrbye, L. N., and T. D. Shanafelt. 2011. Physician burnout: A potential threat to successful health care reform. JAMA 305(19):2009–2010.
Dyrbye, L. N., C. P. West, C. A. Sinsky, L. E. Goeders, D. V. Satele, and T. D. Shanafelt. 2017. Medical licensure questions and physician reluctance to seek care for mental health conditions. Mayo Clinic Proceedings 92(10):1486–1493.
eHealth Initiative. 2019. Prior authorization: Current state, challenges, and potential solutions. https://www.ehidc.org/resources/prior-authorization-current-state-challenges-and-potential-solutions (accessed July 20, 2019).
Ellis, E. 2016. NC medical board adopts new approach on licensee medical, mental health issues. North Carolina Medical Society. November 30. http://www.ncmedsoc.org/nc-medical-board-adopts-new-approach-on-licensee-medical-mental-health-issues (accessed July 20, 2019).
Field, R. I. 2008. Why is health care regulation so complex? Pharmacy and Therapeutics 33(10):607-608.
Fordham, E. 2018. State medical board has a simple solution to help amid physician mental health crisis. https://dailycaller.com/2018/09/15/doctor-suicide-rates-licensure (accessed July 20, 2019).
Forster, H. P., J. Schwartz, and E. DeRenzo. 2002. Reducing legal risk by practicing patient-centered medicine. Archives of Internal Medicine 162(11):1217–1219.
Freeman, L. 2019. Florida medical board may curtail asking doctors about past mental illness on applications. Naples Daily News, March 17. https://www.naplesnews.com/story/news/health/2019/03/17/committee-slated-discuss-doctor-application-change-april/3143230002 (accessed July 20, 2019).
Fridsma, D. B. 2019. Letter to ONC and CMS. Bethesda, MD: American Medical Informatics Association. https://www.healthit.gov/sites/default/files/webform/reducing_burden_report/amia-response-to-onc-hit-burden-reduction-strategy_vfinal.pdf (accessed July 8, 2019).
FSMB (Federation of State Medical Boards). 2014. Interstate medical licensure compact ready for consideration by states: Federation of State Medical Boards. http://www.fsmb.org/site-assets/advocacy/news-releases/2014/fsmb-statement-on-final-compact-final.pdf (accessed November 23, 2018).
FSMB. 2018. Physician wellness and burnout report and recommendations of the FSMB Workgroup on Physician Wellness and Burnout. Journal of Medical Regulation 104(2):37–48.
FSMB. 2019a. Uniform application (UA) for licensure. http://www.fsmb.org/uniform-application (accessed July 20, 2019).
FSMB. 2019b. Telemedicine policies: Board by board overview. http://www.fsmb.org/siteassets/advocacy/key-issues/telemedicine_policies_by_state.pdf (accessed July 20, 2019).
Gabay, M. 2017. Direct and indirect remuneration fees: The controversy continues. Hospital Pharmacy 52(11):740–741.
Gellert, G. A., G. S. Conklin, and L. A. Gibson. 2017. Secure clinical texting: Patient risk in high-acuity care. Perspectives in Health Information Management 14(Winter):PMC5430112.
Gold, K. J., L. B. Andrew, E. B. Goldman, and T. L. Schwenk. 2016. “I would never want to have a mental health diagnosis on my record”: A survey of female physicians on mental health diagnosis, treatment, and reporting. General Hospital Psychiatry 43:51–57.
Gold, K. J., E. R. Shih, E. B. Goldman, and T. L. Schwenk. 2017. Do U.S. medical licensing applications treat mental and physical illness equivalently? Family Medicine 49(6):464–467.
Gottlieb, J. D., A. H. Shapiro, and A. Dunn. 2018. The complexity of billing and paying for physician care. Health Affairs (Millwood) 37(4):619–626.
Gregory, S. T., and T. Menser. 2015. Burnout among primary care physicians: A test of the areas of worklife model. Journal of Healthcare Management 60(2):133–148.
Gusmano, M. K., K. J. Maschke, and M. Z. Solomon. 2019. Patient-centered care, yes; patients as consumers, no. Health Affairs 38(3):368–373.
Haas, D. A., J. D. Halmaka, and M. Suk. 2019. 3 ways to make electronic health records less time-consuming for physicians. Harvard Business Review, January 10. https://hbr.org/2019/01/3-ways-to-make-electronic-health-records-less-time-consuming-for-physicians (accessed July 20, 2019).
Haffajee, R. L., A. B. Jena, and S. G. Weiner. 2015. Mandatory use of prescription drug monitoring programs. JAMA 313(9):891–892.
Halter, M. J., D. G. Rolin, M. Adamaszek, M. C. Ladenheim, and B. F. Hutchens. 2019. State nursing licensure questions about mental illness and compliance with the Americans with Disabilities Act. Journal of Psychosocial Nursing & Mental Health Services, April 11:1–6 [Epub ahead of print].
Havighurst, C. C. 1983. The doctors’ trust: Self-regulation and the law. Health Affairs 2(3):64–76.
Health Care Transformational Task Force. 2017. Health Care Transformation Task Force announces substantial increase in value-based payments. https://hcttf.org/2017-member-transformation-progress-report (accessed May 31, 2019).
HHS (U.S. Department of Health and Human Services). 2015. Better, smarter, healthier: Delivery system reform. https://www.healthit.gov/sites/default/files/facas/Joint_DSR_slides_2015-10-06.pdf (accessed July 20, 2019).
HHS. 2019. HIPAA FAQs. https://www.hhs.gov/hipaa/for-professionals/faq/health-information-technology/index.html (accessed May 15, 2019).
Hill, T. 2018. Letter to state Medicaid directors: Leveraging Medicaid technology to address the opioid crisis. Baltimore, MD: Centers for Medicare & Medicaid Services. https://www.medicaid.gov/federal-policy-guidance/downloads/smd18006.pdf (accessed July 20, 2019).
Hsu, J., C. Vogeli, M. Price, R. Brand, M. E. Chernew, N. Mohta, S. K. Chaguturu, E. Weil, and T. G. Ferris. 2017. Substantial physician turnover and beneficiary “churn” in a large medicare pioneer ACO. Health Affairs 36(4):640–648.
Interstate Medical Licensure Compact. 2019. Interstate Medical Licensure Compact: A faster pathway to medical licensure. https://imlcc.org (accessed July 20, 2019).
IOM (Institute of Medicine). 2000. To err is human: Building a safer health system. Washington, DC: National Academy Press.
IOM. 2001. Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academy Press.
IOM. 2015. Vital signs: Core metrics for health and health care progress. Washington, DC: The National Academies Press.
Jacobson, G., and T. Neuman. 2018. Prior authorization in Medicare advantage plans: How often is it used? https://www.kff.org/medicare/issue-brief/prior-authorization-in-medicare-advantage-plans-how-often-is-it-used (accessed May 31, 2019).
Jones, G. M., N. A. Roe, L. Louden, and C. R. Tubbs. 2017. Factors associated with burnout among U.S. hospital clinical pharmacy practitioners: Results of a nationwide pilot survey. Hospital Pharmacy 52(11):742–751.
Jones, J. W., B. N. Barge, B. D. Steffy, L. M. Fay, L. K. Kunz, and L. J. Wuebker. 1988. Stress and medical malpractice: Organizational risk assessment and intervention. Journal of Applied Psychology 73(4):727–735.
Khullar, D., D. Wolfson, and L. P. Casalino. 2018. Professionalism, performance, and the future of physician incentives. JAMA. November 26 [Epub ahead of print].
Kilbride, M. K., and S. Joffe. 2018. The new age of patient autonomy: Implications for the patient–physician relationship. JAMA 320(19):1973–1974.
Lee, P. V., D. Berwick, and C. A. Sinsky. 2019a. Building trust between the government and clinicians: Person to person and organization to organization. JAMA 321(18):1763–1764.
Lee, T. H., E. A. McGlynn, and D. G. Safran. 2019b. A framework for increasing trust between patients and the organizations that care for them. JAMA 321(6):539–540.
Lester, C. A., M. Wang, and V. G. V. Vydiswaran. 2019. Describing the patient experience from Yelp reviews of community pharmacies. Journal of the American Pharmacists Association 59(3):349–355.
Levey, N. N. 2015. Medical professionalism and the future of public trust in physicians. JAMA 313(18):1827–1828.
Lewis, M. H., J. K. Gohagan, and D. J. Merenstein. 2007. The locality rule and the physician’s dilemma: Local medical practices vs. the national standard of care. JAMA 297(23):2633–2637.
Liederman, E. M., J. C. Lee, V. H. Baquero, and P. G. Seites. 2005. Patient–physician Web messaging. The impact on message volume and satisfaction. Journal of General Internal Medicine 20(1):52–57.
Linzer, M., C. A. Sinsky, S. Poplau, R. Brown, and E. Williams. 2017. Joy in medical practice: Clinician satisfaction in the healthy work place trial. Health Affairs (Millwood) 36(10):1808–1814.
Liu, X., P. R. Sutton, R. McKenna, M. N. Sinanan, B. J. Fellner, M. G. Leu, and C. Ewell. 2019. Evaluation of secure messaging applications for a health care system: A case study. Applied Clinical Informatics 10(1):140–150.
Luxton, D. D., R. A. Kayl, and M. C. Mishkind. 2012. mHealth data security: The need for HIPAA-compliant standardization. Telemedicine Journal and e-Health 18(4):284–288.
Lynch, T. 2018. 2018 ABIM Foundation forum background paper. https://abimfoundation.org/wp-content/uploads/2018/07/2018-ABIM-Foundation-Forum-Background-Paper.pdf (accessed July 20, 2019).
MacLean, C. H., E. A. Kerr, and A. Qaseem. 2018. Time out–Charting a path for improving performance measurement. New England Journal of Medicine 378(19):1757–1761.
Madara, J. L., and J. Burkhart. 2015. Professionalism, self-regulation, and motivation: How did health care get this so wrong? JAMA 313(18):1793–1794.
Maloney, F. P. 1998. The emerging medical/industrial complex. The industrialization of medicine. Physician Executive 24(2):34–38.
Mello, M. M., D. M. Studdert, C. M. DesRoches, J. Peugh, K. Zapert, T. A. Brennan, and W. M. Sage. 2004. Caring for patients in a malpractice crisis: Physician satisfaction and quality of care. Health Affairs (Millwood) 23(4):42–53.
Mello, M. M., A. Kachalia, and D. M. Studdert. 2017. Medical liability—Prospects for federal reform. New England Journal of Medicine 376(19):1806–1808.
Monica, K. 2018a. Minnesota enables EHR integration of PDMP data for safe prescribing. EHR Intelligence. https://ehrintelligence.com/news/minnesota-enables-ehr-integration-of-pdmp-data-for-safe-prescribing (accessed May 31, 2019).
Monica, K. 2018b. NC Department of Health enabling EHR integration of PDMP data. EHR Intelligence. https://ehrintelligence.com/news/nc-department-of-health-enabling-ehr-integration-of-pdmp-data (accessed May 31, 2019).
Montori, V. M. 2019. Turning away from industrial health care toward careful and kind care. Academic Medicine 94(6):768–770.
Montori, V. M., I. Hargraves, R. J. McNellis, T. G. Ganiats, J. Genevro, T. Miller, R. Ricciardi, and A. S. Bierman. 2019. The care and learn model: A practice and research model for improving healthcare quality and outcomes. Journal of General Internal Medicine 34(1):154–158.
Moses, H., 3rd, D. H. Matheson, E. R. Dorsey, B. P. George, D. Sadoff, and S. Yoshimura. 2013. The anatomy of health care in the United States. JAMA 310(18):1947–1963.
NABP (National Association of Boards of Pharmacy). 2019. Licensure transfer. https://nabp.pharmacy/programs/licensure-transfer (accessed July 20, 2019).
NCSBN (National Council of State Boards of Nursing). 2019. Nurse licensure compact. https://www.ncsbn.org/nurse-licensure-compact.htm (accessed June 20, 2019).
NQF (National Quality Forum). 2017. Maximizing the value of measurement: Map 2017 guidance. Washington, DC: National Quality Forum.
NQF. 2019. Core Quality Measures Collaborative. https://www.qualityforum.org/cqmc (accessed May 31, 2019).
Ofri, D. 2019. The business of health care depends on exploiting doctors and nurses. New York Times, June 8. https://www.nytimes.com/2019/06/08/opinion/sunday/hospitals-doctors-nurses-burnout.html (accessed July 20, 2019).
Ohio Academy of Family Physicians. 2016. State medical board removes objectionable question from licensure application. Weekend Family Medicine Update, July 26. https://www.ohioafp.org/wfmu-article/state-medical-board-removes-objectionable-question-licensure-application (accessed July 20, 2019).
Ommaya, A. K., P. F. Cipriano, D. B. Hoyt, K. A. Horvath, P. Tang, H. L. Paz, M. S. DeFrancesco, S. T. Hingle, S. Butler, and C. A. Sinsky. 2018. Care-centered clinical documentation in the digital environment: Solutions to alleviate burnout. NAM Perspectives. Washington, DC: National Academy of Medicine. https://nam.edu/ care-centered-clinical-documentation-digital-environment-solutions-alleviate-burnout (accessed July 20, 2019).
ONC (The Office of the National Coordinator for Health Information Technology). 2018. Strategy on reducing burden relating to the use of health it and ehrs: Draft issued for public comment. Washington, DC: U.S. Department of Health and Human Services. https://www.healthit.gov/topic/usability-and-provider-burden/strategy-reducing-burden-relating-use-health-it-and-ehrs (accessed July 20, 2019).
Panzer, R. J., R. S. Gitomer, W. H. Greene, P. R. Webster, K. R. Landry, and C. A. Riccobono. 2013. Increasing demands for quality measurement. JAMA 310(18):1971–1980.
PDMP TTAC (Prescription Drug Monitoring Program Training and Technical Assistance Center). 2019. PDMP mandatory query by prescribers and dispensers. http://www.pdmpassist.org/pdf/Mandatory_Query_20190115.pdf (accessed May 31, 2019).
Polfliet, S. J. 2008. A national analysis of medical licensure applications. Journal of the American Academy of Psychiatry and Law 36(3):369–374.
Pronovost, P., M. M. E. Johns, S. Palmer, R. C. Bono, D. B. Fridsma, A. Gettingger, J. Goldman, W. Johsnon, M. Karney, C. Samitt, R. D. Sriram, A. Zenooz, and Y. C. Wang. 2018. Procuring interoperability: Achieving high-quality, connected, and person-centered care. Washington, DC: National Academy of Medicine.
Rao, S. K., A. B. Kimball, S. R. Lehrhoff, M. K. Hidrue, D. G. Colton, T. G. Ferris, and D. F. Torchiana. 2017. The impact of administrative burden on academic physicians: Results of a hospital-wide physician survey. Academic Medicine 92(2):237–243.
Rastegar, D. A. 2004. Health care becomes an industry. Annals of Family Medicine 2(1):79–83.
Roe, D. P., A. Bera, A. Harris, and N. P. Dunn. 2018. Letter from representatives in Congress to Administrator Verma. Washington, DC: U.S. Congress. https://www.aans.org/-/media/Files/AANS/Advocacy/PDFS/Medicare-Advantage-Prior-Authorization-Letter-to-CMS--Signed.ashx (accessed December 21, 2018).
Rothenberger, D. A. 2017. Physician burnout and well-being: A systematic review and framework for action. Diseases of the Colon and Rectum 60(6):567–576.
Safran, D. G., and A. Higgins. 2019. Getting to the next generation of performance measures for value-based payment. Health Affairs blog. https://www.healthaffairs.org/do/10.1377/hblog20190128.477681/full (accessed May 31, 2019).
Schommer, J. C., C. A. Gaither, W. R. Doucette, D. H. Kreling, and D. A. Mott. 2018. Associations between work activity and work setting categories and dimensions of pharmacists’ quality of work life. Pharmacy (Basel, Switzerland) 6(3):62.
Schroeder, R., C. M. Brazeau, F. Zackin, S. Rovi, J. Dickey, M. S. Johnson, and S. E. Keller. 2009. Do state medical board applications violate the Americans with Disabilities Act? Academic Medicine 84(6):776–781.
Shanafelt, T. D., L. N. Dyrbye, C. Sinsky, O. Hasan, D. Satele, J. Sloan, and C. P. West. 2016. Relationship between clerical burden and characteristics of the electronic environment with physician burnout and professional satisfaction. Mayo Clinic Proceedings 91(7):836–848.
Sinsky, C., L. Colligan, L. Li, M. Prgomet, S. Reynolds, L. Goeders, J. Westbrook, M. Tutty, and G. Blike. 2016. Allocation of physician time in ambulatory practice: A time and motion study in 4 specialties. Annals of Internal Medicine 165(11):753–760.
Spooner, J. J., H. Spotts, and S. Khan. 2017. A nationwide study of pharmacists’ perception of the impact of Medicare Part D on the pharmacist–patient relationship. Consultant Pharmacist 32(10):629–644.
Stucke, R. S., J. L. Kelly, K. A. Mathis, M. V. Hill, and R. J. Barth, Jr. 2018. Association of the use of a mandatory prescription drug monitoring program with prescribing practices for patients undergoing elective surgery. JAMA Surgery, August 22 [Epub ahead of print].
Tai-Seale, M., C. W. Olson, J. Li, A. S. Chan, C. Morikawa, M. Durbin, W. Wang, and H. S. Luft. 2017. Electronic health record logs indicate that physicians split time evenly between seeing patients and desktop medicine. Health Affairs (Millwood) 36(4):655–662.
Teirstein, P. S., and E. J. Topol. 2015. The role of maintenance of certification programs in governance and professionalism. JAMA 313(18):1809–1810.
Ullrich, F., A. Salako, and K. Mueller. 2017. Issues confronting rural pharmacies after a decade of Medicare Part D. Rural Policy Brief no. 2017-3. https://rupri.public-health.uiowa.edu/publications/policybriefs/2017/Issues%20confronting%20rural%20pharmacies.pdf (accessed July 20, 2019).
Vision for the Future Commission. 2019. Continuing board certification: Vision for the Future commission. https://visioninitiative.org/wp-content/uploads/2019/02/Commission_Final_Report_20190212.pdf (accessed March 15, 2019).
Weil, A. R. 2019. Patients as consumers. Health Affairs (Millwood) 38(3):343.
Wynne, B. 2016. For Medicare’s new approach to physician payment, big questions remain. Health Affairs (Millwood) 35(9):1643–1646.
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