Published 11/1/2016

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)

FDA boxed warning
The U.S. Food and Drug Administration (FDA) has announced it will require boxed warnings and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines—nearly 400 products in total—including information regarding serious risks associated with concurrent use of those medications. An FDA data review showed that physicians have been increasingly prescribing them together, and this has been associated with adverse outcomes. Based on data reviewed by the FDA, the agency concluded that from 2004 to 2011, the rate of emergency department visits involving nonmedical use of opioids and benzodiazepines increased significantly, with overdose deaths involving both drug classes nearly tripling during that time frame.

MACRA flexibility
The U.S. Centers for Medicare & Medicaid Services (CMS) has announced new flexibility in the implementation of Medicare's Quality Payment Program, which is called for under the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. In a blog post, CMS Acting Administrator Andy Slavitt outlines four options for reporting data under the Quality Payment Program, including options that enable physicians to submit "some data" and avoid a negative payment adjustment. The announcement comes after intense pressure from numerous physician groups, including the American Association of Orthopaedic Surgeons (AAOS), which urged greater flexibility in the implementation timeline. In a comment letter to CMS regarding the proposed rule, AAOS argued that it would be "burdensome, if not impossible, for physicians to get ready for the first performance year of 2017," and that "physicians who find this time frame too difficult to comply with may not participate in the MIPS [Merit-based Incentive Payment System] program at all." The final rule is expected to be released by Nov. 1, 2016.

Physician desk time
Findings from a study published in Annals of Internal Medicine (online) suggest that some physicians may spend as much as two-thirds of their work time on electronic health records (EHRs) and desk work. The researchers tracked the work habits of 57 physicians, 21 of whom also completed after-hours diaries. They found that during the office day, participants spent 27.0 percent of their total time on direct clinical face time with patients and 49.2 percent of their time on EHR and desk work. While in the examination room with patients, physicians spent 52.9 percent of the time on direct clinical face time and 37.0 percent on EHR and desk work. In addition, physicians who completed after-hours diaries reported 1 to 2 hours of after-hours work each night, devoted predominantly to EHR tasks. The researchers note that the study is descriptive and does not support formal statistical comparisons or projections.

Risk adjustment
Findings published in Health Affairs (September) suggest that, to avoid unfairly penalizing certain hospitals, CMS should include risk adjustment in bundled payment initiatives such as the Comprehensive Care for Joint Replacement (CJR) program. The research team applied payment models analogous to the CJR to Medicare claims for patients who underwent lower extremity joint replacement in Michigan from 2011 to 2013, and calculated the net difference in reconciliation payments with and without risk adjustment. They found that reconciliation payments were reduced by $827 per episode for each standard-deviation increase in a hospital's patient complexity, and estimated that risk adjustment could increase reconciliation payments to some hospitals by as much as $114,184 annually.

Cost decline
CMS has released its annual report on the Models 2, 3, and 4 of the Bundled Payments for Care Improvement (BPCI) initiative. BPCI is designed to reward awardees for adopting practices that reduce Medicare payments for the bundle of services in the episode relative to a target price that CMS determines based on the provider's historic payments for the same type of episode. The three models vary in definition and payment approach, with Model 2 being most widely adopted. The writers note that 74 percent of Model 2 episode initiators participated in major joint replacement of the lower extremity. The report finds that during the first year of BPCI, participating hospitals initiated 18,936 orthopaedic surgery episodes, of which approximately 90 percent were for major joint replacement of the lower extremity. Overall, average Medicare payments for the anchor hospitalization and the 90-day postdischarge period were estimated to have declined $864 (3 percent) more for orthopaedic surgery episodes initiated at BPCI hospitals than for orthopaedic surgery episodes initiated at comparison hospitals.

Bundled payments and quality
A study published in The Journal of the American Medical Association (Sept. 19) finds that adoption of a bundled payment system for joint arthroplasty procedures was associated with a reduction in reimbursement without a significant change in quality outcomes. The researchers reviewed data on lower extremity joint arthroplasty episodes from 176 hospitals voluntarily participating in the CMS BPCI initiative and 841 matched comparison hospitals. Among BPCI hospitals, they found that mean Medicare episode payments were $30,551 in the baseline period, declining to $27,265 in the intervention period; among comparison hospitals over the same period, payments declined from $30,057 to $27,938. The researchers state that overall, the mean Medicare episode payments declined by an estimated $1,166 more for BPCI episodes than for comparison episodes, primarily due to reduced use of institutional postacute care. They found no statistical differences between BPCI hospitals and comparison hospitals in claims-based quality measures, including 30-day unplanned readmissions, 90-day unplanned readmissions, 30-day ED visits, 90-day ED visits, 30-day postdischarge mortality, and 90-day postdischarge mortality.

Readmission rates and quality
An interview published in HealthLeaders Media discusses a research letter published in the September issue of The Journal of Hospital Medicine. The study team reviewed information from nearly 4,500 acute-care hospitals and found that hospitals with the highest readmission rates were more likely to show better mortality scores in patients treated for heart failure, chronic obstructive pulmonary disease, and stroke. After adjustment, the researchers found that patients treated at hospitals that had more readmitted patients had a fractionally better chance at survival than patients who were cared for at hospitals with lower readmission rates.

CMS and ACOs
An article in The New York Times looks at the issue of accountable care organizations (ACOs) under CMS rules. The writer notes that CMS has encouraged providers to form ACOs based on a model devised by researchers at Dartmouth College. However, Dartmouth itself has dropped out of the federal ACO program, citing financial losses. An evaluation of the Dartmouth ACO found that it had reduced Medicare spending on hospital stays, medical procedures, imaging, and tests, and achieved quality goals. However, the ACO failed to meet money-saving benchmarks set by federal officials and was subject to financial penalties.

MedPAC comments
The U.S. Medicare Payment Advisory Commission (MedPAC) has submitted comments on a CMS proposed rule regarding revisions to payment policies under the Physician Fee Schedule. Among other things, MedPAC notes that CMS has proposed a requirement that all practitioners who bill for global surgical services report claims for pre- and postoperative services, contending that a sample would not provide enough data to accurately value all surgical procedures. The agency agrees with those concerns, but recommends that CMS "design a survey that captures the most relevant information on services delivered during the global period, such as the number and level of pre- and postoperative visits, the setting, the length of time of each visit, the presence of postsurgical complications, and direct practice expense inputs," and stratify the sample by practitioner specialty, geography, setting, and types of services furnished.

ED trends
Two studies published in Annals of Emergency Medicine (online) examine ED trends in the wake of implementation of the Affordable Care Act (ACA). In the first study, researchers reviewed hospital administrative data from 2011 through 2015 for patients aged 18 to 64 years in 201 nonfederal Illinois hospitals. They found that average monthly ED visit volume increased by 5.7 percent after ACA implementation. They noted a large reduction in ED visits by uninsured patients was overcome by a large post-ACA increase in Medicaid visits and a modest increase in privately insured visits.

In the second study, a research team surveyed ED directors in Massachusetts in 2006, 2009, and 2015, and found increases in the following:

  • median number of annual ED visits per center—from 32,025 in 2005 to 42,000 in 2014
  • number of full-time attending physicians—from 11 to 12
  • number of full-time ED nurses—from 27 to 42

In adjusted models, they found significantly reduced odds of consultant availability in 2014 versus 2005 for general surgery, neurology, obstetrics/gynecology, orthopaedics, pediatrics, plastic surgery, and psychiatry.

Narrow ACA networks
The Wall Street Journal reports that some insurers plan to accelerate moves toward limited network plans offered on ACA exchanges. An analysis of regulatory filings for 18 states and the District of Columbia finds that 75 percent of insurer offerings on healthcare exchanges in 2017 will likely be health-maintenance organizations or exclusive provider organizations. Preferred-provider organizations (PPOs) would make up the remaining 25 percent. Across the filings examined by McKinsey & Co., about 15 percent of exchange-eligible consumers may have no PPOs to choose from.

"Low-value" services
A research letter in JAMA Internal Medicine (online) suggests that so-called low-value services (as defined by the Choosing Wisely initiative) may drive up healthcare spending in the United States. The research team reviewed claims information from a commercial insurer on 1,468,689 patients, and assessed predictors of disproportionate low-value spending using a two-part model that adjusted for patient and plan characteristics. They found that 114,732 patients (7.8 percent) received low-value services in 2013, accounting for $32.8 million in spending. The most commonly received low-value services included triiodothyronine measurement in hypothyroidism, imaging for nonspecific low back pain (LBP), and imaging for uncomplicated headache. Additionally, the treatments that accounted for the greatest proportion of spending were spinal injection for LBP ($12.1 million; 37.0 percent), head imaging for uncomplicated headache ($3.6 million; 11.0 percent), and imaging for nonspecific LBP (3.1 million; 9.4 percent).

Physician employment
According to information released by the nonprofit Physicians Advocacy Institute, the number of physician practices owned by healthcare systems increased 86 percent from 2012 to 2015, and by mid-2015, 38 percent of U.S. physicians were employed by hospitals and health systems. The researchers reviewed information from a database developed from biannual phone surveys of a wide range of physician practices. They found that, from 2012 to 2015, hospital employment of physicians rose approximately 59 percent in the South, 58 percent in the Northeast, 49 percent in Alaska and Hawaii, 44 percent in the Midwest, and 33 percent in the West. Over that same period, hospital ownership of practices rose approximately 118 percent in Alaska and Hawaii, 106 percent in the Northeast, 98 percent in the South, 82 percent in the West, and 72 percent in the Midwest.

Lower-quality hospitals
A study published in Health Affairs (September) suggests that surgery performed at lower-quality hospitals may cost more over time compared to procedures performed at high-quality institutions. The researchers reviewed data on hospital quality and information on Medicare fee-for-service claims for five surgical procedures, including hip arthroplasty, and evaluated the relationships between 30- and 90-day episode-based spending, patient satisfaction, and surgical mortality. They found that the difference in Medicare spending between low- and high-quality hospitals was driven primarily by postacute care, which accounted for 59.5 percent of the difference in 30-day episode spending, and readmissions, which accounted for 19.9 percent. The researchers write that the "findings suggest that efforts to achieve value through bundled payment should focus on improving care at low-quality hospitals and reducing unnecessary use of postacute care."

Team physicians bill
The U.S. House of Representatives has passed the Sports Medicine Licensure Clarity Act. If enacted, the Act would clarify medical liability rules to ensure team physicians and athletic trainers are properly covered by their professional liability insurance while traveling with athletic teams in another state. The bill proceeds to the U.S. Senate for consideration.

Star ratings
In a letter to the acting administrator of CMS, MedPAC has offered comments on hospital star ratings found on the agency's Hospital Compare website. Star rating is a summary score calculated using a weighted average of seven quality measure groups: mortality, readmissions, safety of care, patient experience, effectiveness of care, timeliness of care, and efficient use of medical imaging. The first four outcome groups are each weighted 22 percent of the summary score, while the last three groups are each weighted 4 percent. The agency found that, of 102 five-star hospitals, only 56 percent had a rating based on all four of the outcome groups, while of the 129 one-star hospitals, 98 percent were rated using all four of the outcome groups, suggesting that "a substantial share of the best-performing hospitals were not rated on a full set of outcome measures." In addition, MedPAC argues that there are too many "overlapping hospital quality payment and reporting programs, which creates unneeded complexity in the Medicare program." The agency encourages CMS to align star ratings as much as possible with existing CMS programs.

UDI and GUDID compliance date
The FDA has extended the compliance date for Unique Device Identifier (UDI) label and Global Unique Device Identification Database (GUDID) submission requirements for certain class II devices to Sept. 24, 2018. Included in this group are collections of two or more different class II (or class II and class I) devices packaged together in which each device in the package is not individually labeled with a UDI, and single-use devices, other than implants, all of a single version or model, provided they are distributed together in a single device package, intended to be stored in that device package until removed for use, and not intended for individual commercial distribution. The agency states that the extension does not apply to collections of devices that include one or more devices that are implantable, life-sustaining, or life-supporting.