Legislative activities and informed consent

This month’s column highlights two important benefits of membership in the American College of Surgeons (ACS)—support for advocacy-related issues that are key to ACS members and an automated informed consent process. This column describes both of these benefits, specifically the efforts that the Division of Advocacy and Health Policy (DAHP), Washington, DC, carry out on the behalf of Fellows, and information on the College’s robust informed consent resources.

DAHP protects surgeons, surgical patients

The DAHP directs the College’s advocacy activities on behalf of practicing surgeons and surgical patients at both the federal and state levels on all aspects of socioeconomic, legislative, and regulatory issues that affect surgery.

Regulatory issues

The College plays many interconnected roles in advocating on behalf of ACS members. For example, the Regulatory Affairs team in June provided comments on the Centers for Medicare & Medicaid Services (CMS) proposed rule to implement the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act (MACRA) of 2015. Once finalized, the rule will establish the roadmaps for participation in the Merit-based Incentive Payment System, which will replace the current fee-for-service program, and alternative payment models. In addition to providing comments on the MACRA proposed rule, the College’s Regulatory Affairs team is meeting with CMS officials to ensure that members will be able to successfully participate in the new Medicare payment programs.

Legislative activities

MACRA was made possible in large part because of the advocacy efforts of the College’s Legislative Affairs team, which led a nearly 10-year campaign to repeal the sustainable growth rate (SGR) formula previously used to calculate Medicare physician payments. An ACS-led coalition of national surgical associations built bipartisan congressional support to pass MACRA in 2015, which included the SGR repeal. During the decade-long battle, the College played a leading role in blocking proposed Medicare payment cuts of more than 30 percent that would have resulted from the SGR formula.

The ACS Legislative Affairs team also is focused on other key policy initiatives, including the following: blocking CMS from disclosing raw Medicare physician claims data to third parties to protect surgeons from inaccurate performance ratings; requiring a study to designate general surgery health professional shortage areas; and removing barriers to colorectal cancer screenings. More information about the College’s legislative priorities is available in the July issue of the Bulletin.¹

State issues

State Affairs staff helps ACS chapters organize grassroots campaigns to advance state initiatives, such as tanning bed restrictions, expanded bariatric surgery coverage, and reciprocity between states allowing volunteer health care practitioners to provide assistance in another state during an emergency. Current examples of these initiatives include the Kansas Chapter of the ACS, which in 2016 successfully supported passage of a new law banning the use of indoor tanning devices by minors; the passage of the Uniform Emergency Volunteer Health Practitioners Act in Georgia; and other initiatives including the prevention of drastic increases in medical liability costs in New York, repeal of an ambulatory surgery tax in Connecticut, and maintaining the motorcycle helmet law in Tennessee.

Practice management

In addition to advocating before federal and state lawmakers and government agencies, the DAHP also helps members navigate practice management and coding issues through resources such as the ACS Coding Hotline and via regional workshops, which are offered throughout the year. As CMS finalizes the rule to implement MACRA, the College will provide the details surgeons need to know to protect their Medicare payments.

How to get involved

Ideas for getting involved in the College’s advocacy and health policy initiatives include the following:

• Become familiar with key legislative issues affecting surgeons and surgical patients on the ACS website
• Contact your members of Congress and respond to ACS calls to action through SurgeonsVoice (ACS member ID and last name required)
• Participate in the annual Leadership & Advocacy Summit as well as your local ACS chapter’s state advocacy day
• Build relationships with your lawmakers by attending in-district meetings and/or town halls or by inviting them to visit your surgical practice. Follow the steps outlined on the ACS website.
• Learn about the ACS Professional Association’s political action committee with SurgeonsPAC.

Automated informed consent process

Surgeons are responsible for obtaining informed consent from their patients and recognize it as a critical step in the course of care. Informed consent serves as a communication tool for ensuring that patients understand the realities and ramifications of treatment, but it also can help to reduce medical errors by outlining the details of scheduled procedures. At the same time, many surgeons concede that, as important as they are, efforts in this regard often fall short. Sometimes, obtaining informed consent is viewed as a document signing event, in particular when the signature form is either highly generic or simple fill-in-the-blank forms that either lack specific details or are at a level beyond the understanding of the average patient and their family.

Recognizing these inadequacies, health care payors and accreditation organizations are paying closer attention to the viability of today’s approach to informed consent. CMS and The Joint Commission are both clear in their expectations as to what entails an appropriate informed consent process (see Table 1 and Table 2). The CMS’ guidelines related to informing patients of the participation of different qualified medical providers and their respective roles is in precise alignment with the recently updated ACS Statements on Principles,² which will be published in full in the September issue of the Bulletin.

Table 1. CMS: Elements of a well-designed informed consent process

A description of the proposed operation, including the anesthesia to be used. The indications for the proposed procedure. Material risks and benefits for the patient related to the surgery and anesthesia, including the likelihood of each, based on the available clinical evidence, as informed by the responsible practitioner’s clinical judgment. Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity. Treatment alternatives, including the attendant material risks and benefits. The probable consequences of declining recommended or alternative therapies. Who will conduct the surgical intervention and administer the anesthesia. Whether physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines. For operations in which residents will perform important parts of the procedure, surgeon and patients are encouraged to discuss the following: That it is anticipated that physicians who are in approved postgraduate residency training programs will perform portions of the operation, based on their availability and level of competence That it will be decided at the time of the procedure which residents will participate and their manner of participation, and that this will depend on the availability of residents with the necessary competence; the knowledge the attending surgeon has of the resident’s skill set; and the patient’s condition That residents performing surgical tasks will be under the supervision of the attending Whether, based on the resident’s level of competence, the attending surgeon will be physically absent from the same operating room for some or all of the surgical tasks performed by residents Note: A “moonlighting” resident or fellow is a postgraduate medical trainee who is practicing independently, outside the scope of his/her residency training program and would be treated as a physician within the scope of the privileges granted by the hospital Whether, as permitted by state law, qualified medical practitioners who are not physicians will perform important parts of the operation or administer the anesthesia, and if so, the types of tasks each type of practitioner will carry out; and that such practitioners will be performing only tasks within their scope of practice for which they have been granted privileges by the hospital. Source: Centers for Medicare & Medicaid Services. State Operations Manual. Appendix A–Survey protocol, regulations and interpretive guidelines for hospitals. Rev. 151, November 20, 2015. §482.51(b)(2). Available at: www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf. Accessed July 5, 2016.

Table 2. TJC: requirements for informed consent

A complete informed consent process includes a discussion of the following elements: The nature of the proposed care, treatment, services, medications, interventions, or procedures Potential benefits, risks, or side effects, including potential problems that might occur during recuperation The likelihood of achieving goals Reasonable alternatives The relevant risks, benefits, and side effects related to alternatives, including the possible results of not receiving care, treatment, and services When indicated, any limitations on the confidentiality of information learned from the patient Source: The Joint Commission 2009 Requirements Related to the Provision of Culturally Competent Patient Centered Care Hospital Accreditation Program (HAP). Hospital Accreditation Standards. Oakbrook Terrace, IL: The Joint Commission. 2009. Standard RI.01..03.01. Available at: www.jointcommission.org/assets/1/6/2009_CLASRelatedStandardsHAP.pdf. Accessed July 5, 2016.

Patients also are playing a more active role in the informed consent process and are more willing to participate in decisions regarding their health care. A survey of 800 people conducted by the Foundation for Informed Medical Decisions found that more than 80 percent of the respondents felt that informed patients made better medical decisions.³

Accurate and useful content also is a patient safety issue. The Agency for Healthcare Research and Quality (AHRQ) has identified missed and incomplete or not fully comprehended informed consent as a significant patient safety opportunity. The AHRQ states that better informed patients are less likely to experience medical errors, providing another layer of protection. Patient-centered communication also increases patient and physician satisfaction, improves clinical outcomes, and decreases the likelihood of liability litigation.⁴

Survey reveals informed consent inadequacies

To obtain a clearer picture of where the surgical community stands in terms of its approach to the informed consent process, the ACS surveyed members in 2006 about their informed consent practices. Of the 1,183 surgeon and nurse respondents to the Patients as Partners in Surgical Care Survey, only 47 percent of physicians reported using printed consent materials.⁵ Of that number, just 15 percent met the specifications set forth in ACS and American Medical Association (AMA) guidelines, with gaps across the board. Among the survey respondents with consent forms in place, for example, only 41 percent covered procedural risks, 38 percent included information on diagnoses, and 23 percent presented the patient’s likely prognosis.

The ACS has long promoted the importance of comprehensive informed consent. In fact, the DAHP recommends that surgeons address additional concerns not recommended by the AMA, such as advancing a detailed and specific set of information, including diagnosis, prognosis, purpose, preparation, options, and benefits. Additionally, the College has designed a set of 10 questions that may be presented to patients to ensure they consider all factors related to their procedure.⁶

As part of the Patients as Partners in Surgical Care Survey, the ACS solicited comments from its members regarding how the College could enhance the patient consent process. Of those surveyed, 98 percent noted that it would be helpful or very helpful to have the College develop informed consent and patient education materials. Overall, surgeons said they would like to see a model that encourages dialogue with patients, as well as a system that would automate the process.

Vendor partnership

To address the issues raised in the survey, in 2006 the nine-member ACS Patient Education Committee reviewed multiple vendors of digital informed consents and selected Taylor Healthcare’s iMedConsent application. That software tool is available to ACS members on a 30-day free trial basis. Purchase and installation are offered at a 30 percent discount to ACS members. Details about “Procedure Specific Informed Consent” may be found on the ACS website.

Developed by a surgeon, the iMedConsent system offers a standardized approach to receiving consent and makes available more than 3,500 procedure-specific documents across 30 specialties. The application also features an image library that allows surgeons to not only inform their patients about what to expect, but show them as well. Pre- and postoperative patient education materials, including drug monographs and follow-up care instructions, are essential components of the system. The automated tool, including procedure-specific consent forms and patient education materials, presents a complete picture of an individual case, including diagnosis, surgery, and pre- and post-procedure considerations.

The ACS selected the iMedConsent application for a number of reasons. The breadth of procedure-specific informed consent documents was key to this decision. In addition, the committee was impressed that the iMedConsent application has been deployed for 12 years throughout the 158 Department of Veterans Affairs (VA) medical centers as the cornerstone of the VA’s Electronic Support for Patient Decisions initiative.

The automated system also addresses concerns shared by nurses in the Patients as Partners in Surgical Care Survey. Nurses noted that once patients hear the word “surgery,” they tend to forget everything else, making it challenging for patients to comprehend specific details about their case. Nurses also noted a degree of uncertainty about how to respond when patients ask specific questions about their planned procedure after the surgeon has conducted the informed consent process. The automated informed consent application, on the other hand, allows nurses to access a detailed, procedure-specific consent document and provide clarification for the patient.

The iMedConsent application is updated regularly with new procedures. For example, as new risks associated with computed tomography (CT) scans are revealed, procedure risks are updated to reflect current opinion.7 In addition, the application is regularly updated to reflect new regulatory language so that surgeons are always in compliance with federal and state statutes and guidelines. This capability is significant in an environment that is changing rapidly. In January 2009, for instance, the updated Joint Commission Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery took effect. As part of The Joint Commission’s overall 2009 National Patient Safety Goals, the protocol states that accredited institutions have “an accurately completed and signed procedure consent form…available and accurately matched to the patients,” both in the preoperative area for verification and again in the operating room for the time-out.8 Procedure-specific informed consents were a critical component identified in preventing wrong site surgery.⁹

The updated ACS template available within the iMedConsent application automatically populates the time-out guidelines and includes pre- and postoperative instruction, which is particularly helpful when more than 65 percent of all procedures in community hospitals are now done on an outpatient basis.¹⁰ This system supports efficiency, not only for patients and their families but also the medical team, as it ensures all forms are available as needed. An automated approach can simplify and streamline the informed process and provides the added value of bolstering the role of patient as partner and enhancing patient safety.

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References

1. Walter KR. Surgeons voice legislative priorities at 2016 Advocacy Summit. Bull Am Coll Surg. 2016;101(7):67-69.
2. Hoyt DB. Looking forward. Bull Am Coll Surg. 2016;101(6):8-11. Available at: bulletin.facs.org/2016/06/looking-forward-june-2016/. Accessed July 19, 2016.
3. Fowler FJ, Barry M. Through the eyes of the patient: The quality and safety imperative for informed medical decision making. 2008 National Patient Safety Foundation (NPSF) Annual Patient Safety Congress. May 14–16, 2008. Nashville, TN.
4. U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality. Guide to patient and family engagement in hosptial quality and safety. June 2013. Available at: www.ahrq.gov/professionals/systems/hospital/engagingfamilies/guide.html. Accessed June 23, 2016.
5. Heneghan K, Sachdeva AK, McAninch JW. Surgical patient education: Transformation to a system that supports full patient participation. Bull Am Coll Surg.2006;91(6):11-19.
6. American College of Surgeons. Education. Ten questions you should ask before an operation. Available at: facs.org/education/patient-education/patient-resources/prepare/10-questions. Accessed June 2016.
7. Brenner DJ, Hall EJ. Computed tomography: An increasing source of radiation exposure. N Engl J Med. 2007;357:2277-2284.
8. The Joint Commission. The Joint Commission 2009 requirements related to the provision of culturally competent patient-centered care hospital accreditation program (HAP). Available at: www.jointcommission.org/assets/1/6/2009_CLASRelatedStandardsHAP.pdf. Accessed July 5, 2016.
9. O’Leary CE, McGraw RS. Informed consent requires active communication. Anesthesia Patient Safety Foundation Newsletter. Spring 2008. Available at: www.apsf.org/newsletters/pdf/spring2008.pdf. Accessed July 5, 2016.
10. Wier LM, Steiner CA, Owens PL. Agency for Healthcare Research and Quality. Surgeries in hospital owned outpatient facilities, 2012. Statistical brief 188. February 2015. Available at: www.hcup-us.ahrq.gov/reports/statbriefs/sb188-Surgeries-Hospital-Outpatient-Facilities-2012.pdf. Accessed July 5, 2016.