News From ACFAS

---

Rooms for ACFAS 2019 in New Orleans are filling fast! Reserve your hotel room safely and securely with onPeak now before housing closes on January 15.

When you book with onPeak, you receive the lowest guaranteed rate for your room and also protect yourself from unauthorized companies that may promise you a discounted room but then leave you hanging.

Visit acfas.org/neworleanshousing to reserve your room now so you don't miss out! Need new solutions to the day-to-day issues affecting your practice? Then visit the HUB theater from February 14–16, 2019 in the ACFAS 2019 Exhibit Hall for honest, clear-cut advice you can put to use as soon as you return to the office.

Get comfortable in the HUB’s casual atmosphere and engage in candid conversations and lively Q&A with presenters and your fellow attendees. A new slate of hourly HUB sessions will include:

• Boosting Your Practice Revenue
• Being Part of a Team
• RVUs and YOU
• Streamlining Your Day: Strategies for Efficiency
• And more!

Freely share your ideas and personal experiences in the HUB and leave with a ready supply of practical tips and tools to help you in your practice.

Visit acfas.org/neworleans to download the ACFAS 2019 program for the complete HUB schedule. ACFAS wants to raise national awareness of the valuable work you do every day to improve your patients’ lives. If you have a patient success story to share, please contact Melissa Matusek, CAE, ACFAS Marketing and Communications director, at melissa.matusek@acfas.org so we can include it as part of our ongoing public relations campaign.

Let us know how you:

• Helped a patient get his or her life back through the use of a new surgical procedure
• Got an athlete back in the game
• Restored hope in a patient who felt his or her foot or ankle condition could not be treated
• Changed the lives of those in your community

Send us your stories now, and watch ACFAS publications for updates on how the College is working to promote you.

Foot and Ankle Surgery

---

A systematic review and meta-analysis were conducted to determine outcomes obtained with conservative and surgical management of isolated tibialis anterior tendon rupture. Twenty-four references, which included 155 cases, were identified, with conservative management associated with poorer outcomes due to pain and functional limitations related to ankle dorsiflexory weakness. Surgical intervention had better odds for good outcome, while the best postoperative outcomes resulted from use of an ipsilateral split/turn-down ipsilateral tibialis anterior tendon graft, semitendinous autograft or direct repair. The worst outcomes were associated with extensor hallucis longus autograft. The most frequent postoperative finding was objective mild dorsiflexory weakness, which did not lead to subjective functional limitation. Good functional outcomes happened regardless of patient age at the time of intervention. The results imply that surgical intervention yields better functional outcomes than conservative management.


A study was conducted to explore the clinical outcomes of a large cohort of patients with unicortical medial malleolar fixation. A total of 461 ankle fractures were detected among patients who underwent unicortical medial malleolar fixation between 2011 and 2017, with a mean follow-up of 11.4 months. The number of patients with an isolated medial malleolar fracture was 211, with eight excluded for not following up with the treating surgeons following the procedure. The primary result was radiographic union. Two asymptomatic nonunions were observed, along with one delayed union that healed via an external bone growth stimulator and two malunions of the medial malleolus, with one asymptomatic. The other patient exhibited posttraumatic osteoarthritis but has not yet required further surgery. None of these patients required revision medial malleolar surgery, and the union rate using unicortical medial malleolar fixation was 99 percent.


The purpose of this study was to assess the correlation between the preoperative hindfoot valgus deformity and calcaneal osteotomy angles and the postoperative calcaneal displacement. Weightbearing CT scans obtained pre- and postoperatively were retrospectively analyzed for 16 patients. Corresponding three-dimensional bone models were used to measure valgus deformity pre- and postoperatively, inclination of the osteotomy and displacement of the calcaneus. Linear regression was conducted to assess the relationship between these measurements. On average, the hindfoot valgus changed from 13.1° (±4.6) preoperatively to 5.7° (±4.3) postoperatively. A mean inferior displacement of 3.2 mm (±1.3) was observed along the osteotomy with a mean inclination of 54.6° (±5.6), 80.5° (±10.7) and -13.7° (±15.7) in the axial, sagittal and coronal planes, respectively. A statistically significant positive relationship was found between the preoperative valgus, the axial osteotomy inclination and the inferior displacement. This study shows that the degree of preoperative hindfoot valgus and the axial osteotomy angle are predictive factors for the amount of postoperative inferior displacement of the calcaneus.

Practice Management

---

Consistent review of revenue cycle management metrics is crucial to identifying collection slowdowns, productivity declines and potential risk issues before they become aggravated. Among the financial indicators that practice leaders or administrators should review and discuss on a monthly basis is gross collection percentage, a comparison of the total payments received during the period, net of refunds, to the total amount of charges billed. Another key metric is net collection percentage, which quantifies the practice's success collecting "collectible" dollars by evaluating collection team performance.

The third metric consists of days in accounts receivable (A/R) to grade the average number of days it takes for an account to be paid. The percentage of A/R over 90 days old also requires assessment, and successful practices strive for 20 percent or less of total A/R in this category. The fifth metric concerns work relative value units (wRVUs), and the optimal productivity measure is benchmarking a provider's wRVUs against published figures for their specialty. The sixth metric is credit balances, with practices obligated to refund plan and patient credit balances.


Many doctors struggle with the demands of the prior authorization (PA) process. According to a 2017 AMA Prior Authorization Physician Survey, a medical practice completes an average of 29.1 PA requests per physician per week, which takes an average of 14.6 hours to process. The impact on patient care is significant: most physicians report that the PA process delays patient access to necessary care and can lead to a patient abandoning the recommended course of treatment.

Practices struggling with the PA process may consider conducting an assessment and examining the approaches available to help meet the challenge. First, look at the factors affecting the scope of the PA challenge at your practice, such as how often prescriptions are denied coverage because a PA is required, or whether patients' managed care plans frequently change the criteria for approving coverage for your prescribed medications. Next, assess the current burden on your practice's staff in managing PAs, including how many hours are spent hunting for the correct PA form, completing the forms and spending time on the phone with managed care plans.

Finally, consider your PA process options. The first option is to go it alone, which may require dedicating a staff member to focus solely on PAs. Another option is a form-based service, which provide electronic access to forms from most plans for most products, either through a web portal or delivered from pharmacy. The final option is a full-service provider, which manages the PA process for the practice, including electronic submission of PA clinical information on common format, tracking down the patient's prescription plan identification, follow-up calls to the plan and appeals support.


The Office of the National Coordinator for Health Information Technology reported the most common reason for not using information received electronically from outside the hospital system is problems integrating information into the electronic health record (EHR) system. The biggest obstacle to sending information via electronic exchange is difficulty locating providers' addresses. Nearly 60 percent of hospitals in 2017 noted challenges exchanging patient health information across different vendor platforms, up from 50 percent in 2016.

Meanwhile, hospitals that engaged in all four interoperability domains—sending, receiving, finding and integrating—increased by 41 percent since 2016, and they were more than three times more likely to have information electronically available than hospitals that only send and receive summary of care records. Close to 30 percent of small, rural and Critical Care Access hospitals (CAHs) could send, receive, find and integrate summary of care records in 2017. Moreover, small, rural and CAHs boosted their rates of engagement in the four interoperability domains by 50 percent during 2016 and 2017 and lagged their counterparts across all four domains.

Health Policy and Reimbursement

---

Health policy experts predict that major health reform faces slim odds of getting through a divided Congress next year. Nevertheless, plenty of opportunity for change exists at the state and industry level. One health policy trend that experts foresee taking center stage in 2019 is the Affordable Care Act (ACA). A ruling from a federal judge finding the law unconstitutional has cast uncertainty on the future of the nation's healthcare system and has reframed national debate on health reform ahead of the 2020 elections.

Another 2019 priority will be the U.S. Centers for Medicare and Medicaid Services (CMS) waiver guidance. Armed with a majority, House Democrats are poised to investigate how the Trump administration has handled the ACA during the last two years, including interpretation of the statute that allows states to reform their own insurance markets by using waivers to promote short-term plans or implement work requirements. Drug-pricing policy is also expected to continue dominating health priorities in 2019, although it will be a long road from bipartisan commitment to reducing prices to bipartisan consensus on how best to do so. Drugmakers are preparing for smaller but significant regulatory changes, such as increased approval of biosimilars and mandates to include price information in direct-to-consumer advertisements.

Meanwhile, increasing pressure on hospitals could drive a shift toward value-based payment models next year. Finally, digital therapeutics and e-health initiatives stand to finally emerge in the industry and transform care delivery. In 2019, the U.S. Food and Drug Administration's Digital Health Software Precertification Program, designed to expedite the approval process for digital health products, is expected to begin greenlighting software-based medical devices.


The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a final rule that will require accountable care organizations (ACOs) in the Medicare Shared Savings Program to take on financial risk sooner. Under the new rule, called Pathways to Success, lower revenue or physician-led ACOs can remain in no-risk programs for three years, while new ACOs for two years and existing ACOs get just one year. Then all must take accountability for healthcare spending.

CMS has set the shared savings rate at 40 percent for ACOs not assuming risk for healthcare costs and 50 percent for ACOs at all levels of risk. ACOs also have new obligations to patients. The rule requires them to provide beneficiaries with a written notice in person or electronically that they are participating in a new approach to care delivery, and it must also explain what participating in an ACO means for their care. Finally, to ensure financial benchmarking, CMS is incorporating regional spending factors in establishing an ACO's target spending during all agreement periods, providing a more accurate point of comparison for evaluating ACO performance.


A new measure from Sen. Elizabeth Warren (D-MA) seeks to lower drug prices by enabling the government to manufacture select generic drugs. Her bill would establish a new U.S. Department of Health and Human Services (HHS) office that could manufacture generic drugs itself and sell them at fair prices, if no one is already making the product, or if only a few companies are making the drug and prices rise suddenly.

"In market after market, competition is dying as a handful of giant companies spend millions to rig the rules, insulate themselves from accountability and line their pockets at the expense of American families," Warren said. While others have introduced ideas to lower drug prices recently, Warren's bill targets generic drugs, which are often considered inexpensive. However, her office said the generic drug market is "broken" and lacks competition, noting an investigation into a huge price-fixing scheme in the generic pharmaceutical market.

Medicine, Drugs and Devices

---

From a transition to the global standard for quality management systems (QMS) to the revamping of premarket review pathways in the United States, the medical device industry can expect to see at least some regulatory initiatives that 2018 set in motion come to fruition in 2019. The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has released its list of guidances indicating which topics will take precedence for 2019 policy clarifications, while FDA's new rulemakings agenda is out as well. In the meantime, 2018 themes indicate the direction these plans are likely headed.

Regulatory harmonization and modernization took center stage this year, speaking to the measures of success in CDRH's three-year policy roadmap from January and its recently updated medical device safety action plan. CDRH projects centered on harmonization and pursued over the course of 2018 involve the International Medical Device Regulators Forum and the International Organization for Standardization, among others. Regulatory modernization was another major theme during 2018, with the shift being largely underpinned by real-world evidence, total product lifecycle reviews and least burdensome principles.

CDRH also released a string of proposals in recent months to revamp several of its premarket review pathways as part of the modernization push. Whether the proposals will yield the intended results and become set programs remains to be seen as some proposals in the premarket review space have already raised concerns among industry experts. Plans around 510(k)s and de novos to watch during 2019 include the new Quality in 510(k) Review Program that CDRH launched in September. In addition, a rule in the de novo space was finalized in December to create efficiencies by clarifying FDA's device classification processes.


The United States Preventive Services Task Force (USPSTF), which routinely draws up guidelines for disease prevention, has drafted a plan for research to identify evidence-based strategies that could lower the likelihood of addiction developing out of opioid prescriptions. The draft is open for public comment until mid-January. "This is a new preventive service we’re looking at," said Alex Krist, MD, a professor of family medicine at Virginia Commonwealth University and USPSTF vice-chair. "And we’re proposing to evaluate evidence around that preventive service. We’re looking for public input as we want to make sure we’re looking at the right kinds of evidence." The draft focuses on strategies that can be implemented in primary care settings to reach teens and adults with short-term or chronic pain who are not currently using opioids. The panel hopes to settle on a list of interventions that can then be researched for evidence of success. Special attention would be focused on groups believed to be particularly vulnerable, such as those with mental health problems along with pain and those with prior histories of substance use disorders.


The U.S. Drug Enforcement Administration (DEA) and opioid distributors failed to halt the flow of millions of the drugs into rural West Virginia despite warning signs that the drugs were being diverted for abuse, according to a new congressional report from the majority staff of the House Energy and Commerce Committee. The committee found that distributors failed to conduct proper oversight of their customers by not questioning suspicious activity and not properly monitoring the quantity of opioids that were being shipped to individual pharmacies.

The committee also found that DEA did not properly use a database that aims to monitor the flow of opioid analgesics from manufacturers to sellers, something that could have allowed federal agents—in real time—to notice that millions of drugs were being sent to pharmacies in West Virginia. The 324-page report shows how mistakes and lack of oversight led to a massive influx of drugs there, much of which ultimately fueled the black market sale and illegal abuse of opioids, including oxycodone. "Taken altogether, the committee's report outlines a series of missteps and missed opportunities that contributed to the worsening of the opioid epidemic in West Virginia," the report says. "While focused on a narrow part of West Virginia, the report raises grave concerns about practices by the distributors and DEA nationwide."