Published 10/1/2016

Second Look—Advocacy

These items originally appeared in AAOS Headline News Now, a thrice-weekly enewsletter that keeps AAOS members up to date on clinical, socioeconomic, and political issues, with links to more detailed information. Subscribe at www.aaos.org/news/news.asp (member login required)

Safety summit recommendations
Work groups convened as part of a 2-day event sponsored by AAOS and the American College of Surgeons (ACS) have released a series of recommendations designed to develop surgical care and surgical education curricula standards and encourage efforts into safety research. The recommendations include the creation and adoption of standardized surgical safety education programs and simulation-based safety training modules for the entire surgical team, as well as the following:

  • Teamwork training that begins during undergraduate medical education and continues through postgraduate training and maintenance of certification
  • Shared decision making practices
  • Patient-centered surgical consent processes
  • Standardized surgical site marking and identification policies
  • A common data collection system to measure and improve patient safety outcomes

MIPS path under MACRA
An article in Modern Healthcare on payment options under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) notes that many physicians still have questions about the new system and are not ready to assume the downside risk of alternative payment models (APMs). The writer explains that under MACRA, physicians will be reimbursed for Medicare patients under the Merit-based Incentive Payment System (MIPS) or an Advanced APM. Under MIPS, providers will be graded on quality, resource use, clinical practice improvement, and meaningful use of certified electronic health records technology. According to the article, about 90 percent of physicians are expected to choose the MIPS path. Under the Advanced APM path, physicians will receive lump-sum incentive payments and higher annual provider payments and will be exempt from MIPS reporting measures; however, they will also bear an increased financial risk, making it a more difficult path for the average physician.

Medicare ACO savings
The U.S. Centers for Medicare & Medicaid Services (CMS) has announced 2015 performance year results for the Medicare Shared Savings Program and the Pioneer Accountable Care Organization (ACO) Model. The agency reports that, in 2015, Medicare ACOs produced a combined total program savings of $466 million. ACOs that reported in both 2014 and 2015 improved on 84 percent of the quality measures that were reported in both years. In addition, all 12 participants in the Pioneer ACO Model improved their quality scores from 2012 to 2015 by more than 21 percentage points, and overall quality scores for 9 Pioneer participants were more than 90 percent during 2015.

CMS fee schedule
CMS has released the annual Medicare Physician Fee Schedule proposed rule that addresses changes to the physician fee schedule and other Medicare Part B payment policies. The proposed rule also includes proposals related to the Medicare Shared Saving Program as well as to the release of certain pricing data from Medicare Advantage bids and medical loss ratio reports from Medicare health and drug plans. Among other things, the proposed rule reminds Medicare providers that federal law prohibits them from collecting Medicare Part A and Medicare Part B deductibles, coinsurance, or copayments from beneficiaries enrolled in the Qualified Medicare Beneficiaries (QMB) program—a Medicaid program that helps certain low-income individuals with Medicare cost-sharing liability.

MedPAC comments
The Medicare Payment Advisory Commission (MedPAC) has submitted comments on a CMS proposed rule covering, among other things, hospital outpatient prospective payment and ambulatory surgical center (ASC) payment systems, quality reporting, and electronic health record (EHR) incentive programs. MedPAC notes that CMS has proposed to increase the conversion factor in the ASC payment system by 1.2 percent during 2017. However, MedPAC recommends that Congress eliminate that increase, based on "indicators of payment adequacy for ASCs, which are positive, and the importance of maintaining financial pressure on providers to constrain costs." In addition, MedPAC supports the establishment of a value-based purchasing program for ASCs in which high-performing ASCs would be rewarded and low-performing facilities would be penalized. Finally, the agency outlines concerns regarding CMS's meaningful use approach of paying hospitals and clinicians to purchase EHRs, and about requirements for hospitals and clinicians to report information demonstrating that they use the EHRs. "We are not convinced it benefits patients or improves health outcomes if CMS defines and measures meaningful use of EHRs," MedPAC states. "A better approach, in the Commission's view, is to ensure that the payment system itself creates a business case for the use of EHRs and encourages vendors to market products that improve care and interoperability."

Surgeon specialization
Data from a study published in The BMJ (online) suggest that surgeon specialization may be a stronger of measure of quality than the number of times a particular procedure is performed. The research team reviewed Medicare data on 25,152 surgeons in the United States who performed at least one of eight procedures (carotid endarterectomy, coronary artery bypass grafting, valve replacement, abdominal aortic aneurysm repair, lung resection, cystectomy, pancreatic resection, or esophagectomy) on 695,987 patients. They found that, for all four cardiovascular procedures and two out of four cancer resections, a surgeon's degree of specialization was a significant predictor of surgical mortality, independent of the number of times the surgeon performed that procedure. In addition, for five procedures, the relative risk reduction from surgeon specialization was greater than that from surgeon volume for that specific procedure. The research team notes that surgeon specialization accounted for 9 percent to 100 percent of the relative risk reduction otherwise attributable to volume in that specific procedure.

Reps in the OR
Findings published in PLOS ONE (online) suggest ethical concerns regarding the reliance of surgeons on manufacturer representatives for education and surgical assistance. The researchers conducted a qualitative, ethnographic study of the relationships among surgeons, medical device representatives, and industry involvement in surgeon education. They conducted two focus groups, including one with hospital-based attending orthopaedic surgeons, as well as individual interviews with three former or current medical device representatives, a director of a surgical residency program at an academic medical center, and a medical assistant for a multiphysician orthopaedic practice. The researchers write that, although "surgeons view themselves as indisputably in charge, device reps work hard to make themselves unobtrusively indispensable in order to establish and maintain influence, and to imbue the products they provide with personalized services that foster a surgeon's loyalty to the reps and their companies."

Whistleblower suit
STAT reports on a whistleblower lawsuit in which Medtronic is accused of promoting its VERTE-STACK spine device for off-label use. The writer notes that the device was approved by the U.S. Food and Drug Administration (FDA) for use in the thoracic and lumbar spine, and specifically labeled that it is not for cervical spine use. However, an email obtained by attorneys shows a manufacturer sales representative stating that "many surgeons choose to use it in the cervical spine," and one observer notes that the device is sized more appropriately for use in the neck than the lumbar spine. A spokesperson for the company states that the device "comes in a variety of sizes to accommodate the unique anatomies of different-sized patients."

Adverse events
According to a study in Clinical Orthopaedics and Related Research (online), third-party reviewers may identify more minor adverse events than surgeons. The researchers compared adverse-event reporting by six surgeons and two independent clinical reviewers using the Spine Adverse Events Severity System Version 2 and the Orthopaedic Surgical Adverse Events Severity System in elective orthopaedic procedures. They collected adverse event data on 164 patients (48 spine surgery, 51 hip surgery, 34 knee surgery, and 31 shoulder surgery patients). The researchers write that surgeons captured 14 adverse events and the reviewers captured 99 adverse events. They note that surgeons adequately captured major adverse events, but failed to record minor events that were captured by the reviewers. Overall, 93 of 99 (94 percent) adverse events reported by reviewers required only simple or minor treatment and had no long-term adverse effect, while three patients experienced adverse events that resulted in use of invasive or complex treatment that had a temporary adverse effect on outcome.

Physician-owned hospitals
A study published in Health Affairs (online) claims that restrictions under the Affordable Care Act (ACA) may have effectively eliminated the formation of new physician-owned hospitals. The researchers reviewed data on 106 physician-owned hospitals in Texas and found significant increases in formation, physician ownership, and physical capacity of physician-owned hospitals following passage, but prior to implementation, of the ACA. After ACA provisions took effect, they noted improved use of hospital assets to generate increased levels of services, revenue, and profits. The researchers found no evidence that existing physician-owned hospitals had stopped accepting Medicare to avoid ACA restrictions, "although some investors adopted a seemingly unsuccessful strategy of not accepting Medicare at physician-owned hospitals formed after implementation of the ACA."

Medicaid expansion
According to a study in Health Affairs (online), hospitals in states that chose to expand Medicaid programs under the ACA have seen a reduction in uncompensated care. The researchers reviewed data on uncompensated care costs at 1,249 U.S. hospitals between 2011 and 2014. They found that, in states that expanded Medicaid, uncompensated care costs decreased from 4.1 percentage points to 3.1 percentage points of operating costs. Further, they estimate that uncompensated care costs would have decreased from 5.7 percentage points to 4.0 percentage points of operating costs in nonexpansion states if those states had expanded Medicaid.

Ancillary services
Survey data in The Journal of Arthroplasty (August) suggest that many patients believe surgeon ownership of orthopaedic-related businesses to be an ethical practice and feel comfortable receiving care at such a facility. The research team surveyed 280 consecutive patients at two centers regarding three surgeon ownership scenarios: owning a surgery center, providing in-office physical therapy (PT), and owning advanced imaging facilities. Among patients who responded (n = 214), 73 percent agreed that it is ethical for a surgeon to own a surgery center, 77 percent supported physician ownership of a PT practice, and 77 percent said it would be ethical to own an imaging facility. In addition, 67 percent indicated that surgeon ownership of such a business would have no effect on their trust of the provider. However, many respondents agreed that surgeon owners might perform more surgery (47 percent), refer more patients to PT (61 percent), or order more imaging (58 percent).

Medical errors
An opinion piece in The New York Times argues that some estimates of death rates associated with medical errors may be artificially inflated. The writer argues that some studies have failed to take into account patients' underlying medical conditions as a factor. "Doing research in this area is very difficult," he writes. "When someone dies in a car accident, it's clear what caused the death. … But when an 86-year-old with dementia and cancer dies and also had been given a drug in a slightly-too-high dose a few weeks earlier, is it the error that killed her or the underlying disease and age?"

Opioid letter
A letter sent to physicians from U.S. Surgeon General Vivek H. Murthy, MD, MBA, requests the assistance of the healthcare community in fighting the opioid epidemic. "Nearly two decades ago, we were encouraged to be more aggressive about treating pain, often without enough training and support to do so safely," the letter reads. "This coincided with heavy marketing of opioids to doctors. Many of us were even taught—incorrectly—that opioids are not addictive when prescribed for legitimate pain." Dr. Murthy notes that nearly 2 million people in the United States now have a prescription opioid use disorder, which has contributed to increased heroin use and the spread of various communicable diseases.

Readmission penalties
Kaiser Health News reports that CMS will withhold more than half a billion dollars in hospital payments over the next year due to readmission penalties. Overall, CMS will penalize 2,597 hospitals based on 30-day readmissions for six common conditions, including hip and knee arthroplasty. Although approximately the same number of hospitals were penalized last year, the average penalty will increase from 0.61 percent to 0.73 percent of Medicare payments.

UDI deadline
Survey data released by Loftware, Inc. and USDM Life Sciences suggest that few medical device manufacturers may be prepared to meet an upcoming FDA deadline for compliance with unique device identification (UDI) rules. The Sept. 24 deadline stipulates that labels and packages of Class II medical devices bear UDI barcode labels with correctly formatted dates, and data for Class II devices must be submitted to the FDA Global Unique Device Identification Database. The researchers polled approximately 120 medical device industry professionals and found that only 15 percent are currently compliant with the next phase of regulation and "are in need of a sustainable labeling solution, which would allow them to make the necessary adjustments to achieve compliance across their enterprise and be prepared for ensuing phases of the regulation."

OR attire
ACS has released guidelines for appropriate operating room (OR) attire based on professionalism, common sense, decorum, and available evidence. Recommendations include:

  • Soiled scrubs and/or hats should be changed as soon as feasible, and prior to speaking with family members after a surgical procedure.
  • Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.
  • Masks should not be worn dangling at any time.
  • OR scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover up, and never worn outside the hospital perimeter.
  • During invasive procedures, mouth, nose, and hair should be covered to avoid potential wound contamination.
  • Earrings and jewelry worn on the head or neck should be removed or appropriately covered during procedures.
  • Clean appropriate professional attire (not scrubs) should be worn during all patient encounters outside the OR.

ACS states that, "As stewards of our profession, we must retain emphasis on key principles of our culture, including proper attire, since attention to such detail will help uphold the public perception of surgeons as highly trustworthy, attentive, professional, and compassionate."