Published: June 4, 2015

THE AAO-HNS VOICE COMMITTEE Demonstrated safety

For over two decades, otolaryngologists have treated spasmodic dysphonia (SD) patients using Botulinum toxin type A (Btx A) in a multiuse fashion from FDA-approved, 100-unit vials among multiple patients.

A recent multi-institutional study showed Botulinum toxin vials safe in multiuse fashion

vialBy Thomas L. Carroll, MD, Michael J. Pitman, MD, and Norman D. Hogikyan, MD

For over two decades, otolaryngologists have treated spasmodic dysphonia (SD) patients using Botulinum toxin type A (Btx A) in a multiuse fashion from FDA-approved, 100-unit vials among multiple patients. Recently, the Centers for Disease Control and Prevention (CDC) has recommended against this common practice. This action jeopardizes the delivery of appropriate, life-affirming medical care to thousands of patients. This recommendation differs from the typical practice pattern of clinicians who administer the drug in a multiuse fashion. Another controversy involving the use of BtxA surrounds the manufacturer’s purported decrease in efficacy beginning four hours after resuspension of the drug. Evidence and clinical experience suggest Btx A remains effective weeks or months after the vial is initially opened, as long as it is refrigerated for future use. (Liu A, et al. A. J Am Acad Dermatol 2012;67: 373–378) A recent multi-institutional study was undertaken to explore and potentially resolve these controversies, utilizing both retrospective and prospective observational data of patients receiving Botox (Allergan Corp., Irvine CA) for spasmodic dysphonia (SD). (Barrow EM, et al. Laryngoscope. 2014 Dec 4. doi: 10.1002/lary.25068. [Epub ahead of print])

Led by senior author Michael M. Johns III MD, the authors collected data from three high-volume academic laryngology practices (the Emory Voice Center, the University of Pittsburgh Voice Center, and the University of Texas Health Science Center’s Voice Center San Antonio) that all use Btx A vials in a sterile, multiuse fashion for SD: “Directly after reconstitution, predetermined amounts of BtxA are drawn up for subject use, using a new needle to puncture the vial with separate syringes for each subject. The needle is discarded after the Btx A is drawn up. The remaining reconstituted Btx A that is not used during the clinic time is refrigerated at 4ºC for use the following week.” The study also highlights that otolaryngologists are not alone in this practice by citing a recent survey of the American Society for Dermatologic Surgery. This survey assessed 1,000 physician-members regarding their dermatologic practice patterns, and experiences with single- versus multipatient-use of Btx A stating there were “no instances of local infections ever documented by this group despite using the vials on multiple patients.”

The authors used three methods to evaluate the safety of using Btx A vials in a multiuse fashion. All subjects were given Btx A from a vial that had been used in a multiuse fashion per routine clinical practice. First, 179 patients with a collective history of 3,423 Btx A injections from the three study sites were given a paper questionnaire at the time of their current injection asking them if they had ever experienced potential signs of infection following any past Btx A injection (pain, redness and/or swelling at the injection site, and/or fever). A final question asked if they had ever experienced an injection that did not provide effect. Of all injections given, 5.81 percent were reported to have resulted in at least one of the aforementioned findings. Most of the patient responses were swelling or redness at the injection site. Only one patient out of 179 reported a fever in the post-injection period. Failed injections were reported in 3.36 percent of all injections.

The second method of Btx A multiuse vial safety evaluation involved a prospective phone survey of the same subjects one week after the injection was performed. In the study, 174 subjects participated with 22 (12.64 percent) experiencing pain, redness, swelling, or fever after the procedure. In total, nine (5.17 percent) experienced redness, eight (4.6 percent) experienced pain, and four (2.3 percent) had swelling at the injection site after their most recent Btx A treatment. Only one of the 174 subjects (0.57 percent) experienced fever.

Finally, the Emory Voice Center performed a single-site, retrospective review of nearly 10 years of one-week follow-up phone survey data of injections performed using the multiuse vial technique. The 743 subjects underwent 6,216 Btx A injections. Not a single infection-related adverse event was identified, and there were no unscheduled clinic visits or admissions due to infection following these procedures.

This study specifically demonstrates the safety of reconstituted Btx A vials to be used in a multiuse, multipatient fashion as they have been for decades, without undue concern for increased infection risk as proposed by the CDC and the manufacturer. In laryngological applications, typically for SD, very small amounts (typically 0.625 to 5 units) are used for each patient event. If used according to guidelines, more than 90 percent of the 100-unit Btx A vial would be discarded with each use resulting in enormous waste and increased expense to the healthcare system. The authors of the study also cite prior studies demonstrating the general side effects of Btx A, including nausea, malaise, flu-like symptoms, and rashes, which a patient can report following injection elsewhere in the body. Finally, other cited studies demonstrated pain, redness, and swelling at the injection site at incidences no higher than placebo. Dr. Johns’ group concludes that their cohort likely experienced their symptoms due to the injection trauma itself rather than from infectious sequelae.

Although not the primary focus of the study, an indirect observation on efficacy of reconstituted Btx A lasting longer than the recommended four hours was made by the authors. The clinical practice of the three study sites is to store and refrigerate the unused portion of the vials for future use. With SD Btx A injection clinics happening weekly or biweekly at these centers, they report a 96.64 percent Btx A injection treatment efficacy rate. With this finding, efficacy beyond four hours is clearly demonstrated. Furthermore, the current study cites numerous other peer-reviewed papers that demonstrate preservation of both potency and duration of action for periods of a few weeks to six months.

The authors conclude the data they present demonstrates good evidence to support the use of Btx A vials in a multiuse fashion without concern for local or systemic infection. This paper’s findings, offered alongside prior studies that offer evidence in a similar strain, afford otolaryngologists another set of data to challenge the CDC and manufacturer recommendations. These recommendations, which have directed local institutional guidelines, have led to significant waste of Btx A, extra effort, and wasted time for clinicians in otolaryngology and pharmacy who must prepare the Btx A and an additional, unnecessary cost to the health system. There is currently a robust societal mandate for cost-effective healthcare, and physicians should be in the lead in defining areas where quality-based medicine can reduce costs appropriately and safely. Physicians must also take the lead when it is possible that a pharmaceutical manufacturer’s policy, i.e., single- versus multiuse of a vial, may in fact be rooted in projected sales figures rather than medical efficacy or patient safety. A conversation to challenge the CDC’s and manufacturer’s guidelines is necessary at every institution that prevents multiuse, multipatient use of reconstituted Btx A.

More from June 2015 - Vol. 34 No. 05
tinnitus-slider
Clip, copy, and share: Clinical practice guideline plain language summaries for patients
The AAO-HNSF clinical practice guideline (CPG) plain language summaries (PLS) are developed by the guideline development group (GDG), consumers, and AAO-HNSF staff, with final sign-off by the CPG leadership.
plans
Don’t get denied! Prepare now
ICD-10 is a few months away. Here’s what you can do to prepare Uncertainty related to implementation was one of the main reasons many providers postponed preparing for ICD-10. Now that political uncertainty has been all but eliminated, electronic health record (EHR) vendors, clearinghouses, and health plans are all moving forward with preparation for the ICD-10 transition. Otolaryngologists in group or small practices must follow this lead and focus on preparation efforts to ensure that practice revenues will not be interrupted come October 1. ICD-10 is a few months away, what can I do to prepare? Communicate with your payers/vendors One of the most effective things you can do at this point is communicate with all payers and vendors to ensure they are prepared and ask them what you need to do to further prepare. Below is a sample list of questions to ask your payers/vendors to receive ICD-10 information that could be crucial to your practice’s workflow after October 1. (This list is just a sample and is in no way all-encompassing nor should it be interpreted as legal advice): Does our license with you include ICD-10 regulatory updates on a moving-forward basis after the ICD-10 go-live date of October 1? Who are the ICD-10 contact people and what is their contact information? What modifications to my EHR must be made to accommodate ICD-10? Will there be any additional fees charged as a result of the ICD-10 upgrade? When will system upgrades for ICD-10 go into effect? Will there be any additional training provided as a result of the ICD-10 upgrade? Is there a charge associated with any additional training that is required? Besides system upgrades, what additional documentation and forms changes (matrices, clickable templates, etc.) will you provide? When can we see updated policy/edit/prior authorization changes for ICD-10? Will system upgrades for ICD-10 require additional hardware to support the software modifications? How will your products and services accommodate both ICD-9 and ICD-10 as we work with claims for services provided both before and after the transition deadline for code sets? What does testing mean to your organization and when will we be able to test ICD-10 claims/transactions? What are your post-implementation contingency plans to ensure accurate provider reimbursement? (e.g., Will you grant “advance payments” in the form of paper checks for risk mitigation purposes?) Improve documentation practices While you cannot submit actual ICD-10 codes and receive payment until the deadline has arrived, you can submit detailed documentation for your claims as a form of practice in anticipation of the deadline. Several EMR vendors allow ICD-10 coding now, so patient problem lists are being populated with both ICD-9 and corresponding ICD-10 codes. This can help get a practice acquainted with doing the ICD-10 coding, and when the switch is flipped in October, several ICD-10 codes will already be associated with established patients. For a Microsoft Excel list of common ENT ICD-10 codes, visit the Academy website: www.entnet.org/content/icd-10-coding-resources. There are several factors to focus on when improving the specificity of your documentation. Some examples include (documentation elements will vary by different codes): Anatomy (e.g., attic, tympanum, mastoid, diffuse cholesteatosis) Anatomical Location (maxillary, frontal, ethmoidal, sphenoidal, pansinusitis) Disease Acuity (e.g., acute, subacute, chronic, recurrent) Localization/Laterality (e.g., right, left, bilateral) Infectious Agent (e.g., scarlet fever, influenza, measles) Type (e.g., open, closed) Episode (e.g., initial encounter, subsequent encounter, sequela) Manifestations (e.g., serous, mucoid, suppurative, non-suppurative, with/without spontaneous rupture of tympanic membranes) Circumstances (e.g., exposure to environmental tobacco smoke, history of tobacco use, occupational exposure to environmental tobacco smoke, tobacco dependence) Below is a sample of incorrect versus correct documentation under ICD-10 requirements: INCORRECT DOCUMENTATION UNDER ICD-10 CORRECT DOCUMENTATION UNDER ICD-10 A 3-year-old female presents with unilateral otitis media with a ruptured tympanic membrane. A 3-year-old female presents with acute serous otitis media (L) ear with spontaneous 60% central ruptured tympanic membrane. Patient presents with adenotonsillitis, dyphagia, laryngitis, obesity. Patient presents with chronic adenotonsillitis with adenotonsillar hypertrophy, oropharyngeal dysphagia, acute obstructive laryngitis, morbid obesity with alveolar hypoventilation. Patient presents with hearing loss with history of high doses of IV antibiotics. Patient presents with bilateral hearing loss with a history of high doses of IV gentamicin. Hearing loss secondary to gentamicin.   Assess your claims for mapping risk Knowing your most frequent patient diagnoses and the optional ICD-10 codes will translate to help you assess which claims may be at risk for errors and their potential impact on revenues. See charts below for a few examples of risk levels. Low-risk claim with 1:1 translation ICD-9 Code Diagnosis ICD-10-CM Code Diagnosis 786.50 Chest pain unspecified R07.9 Chest pain, unspecified   Moderate-risk claim with 1:4 to translation ICD-9 Code Diagnosis ICD-10-CM Code Diagnosis 380.23 Chronic otitis externa NEC H60.60 Unspecified chronic otitis externa, unspecified ear H60.61 Unspecified chronic otitis externa, right ear H60.62 Unspecified chronic otitis externa, left ear H60.63 Unspecified chronic otitis externa, bilateral   Higher risk claim with 1: several translation ICD-9 Code Diagnosis ICD-10-CM Code Diagnosis 380.50 Other acute otitis externa H60.501 Unspecified acute noninfective otitis externa, right ear H60.502 Acquired stenosis of left external ear canal, unspecified H60.503 Acquired stenosis of external ear canal, unspecified, bilateral H60.509 Acquired stenosis of external ear canal, unspecified ear H60.511 Other acquired stenosis of right external ear canal H60.512 Other acquired stenosis of left external ear canal H60.513 Other acquired stenosis of external ear canal, bilateral H60.519 Other acquired stenosis of external ear canal H60.521 Acute chemical otitis externa, right ear H60.522 Acute chemical otitis externa, left ear H60.523 Acute chemical otitis externa, bilateral H60.529 Acute chemical otitis externa, unspecified ear H60.531 Acute contact otitis externa, right ear H60.532 Acute contact otitis externa, left ear H60.533 Acute contact otitis externa, bilateral H60.539 Acute contact otitis externa, unspecified ear H60.541 Acute eczematoid otitis externa, right ear H60.542 Acute eczematoid otitis externa, left ear H60.543 Acute eczematoid otitis externa, bilateral H60.549 Acute eczematoid otitis externa, unspecified ear H60.551 Acute reactive otitis externa, right ear H60.552 Acute reactive otitis externa, left ear H60.553 Acute reactive otitis externa, bilateral H60.559 Acute reactive otitis externa, unspecified ear H60.591 Other noninfective acute otitis externa, right ear H60.592 Other noninfective acute otitis externa, left ear H60.593 Other noninfective acute otitis externa, bilateral H60.599 Other noninfective acute otitis externa, unspecified ear   A longer list of common ENT ICD-9 codes and their relevant ICD-10 crosswalks can be downloaded online at www.entnet.org/ICD-10-Top-200-ENT-Diagnosis-Codes. Testing If you have not already, you should be testing claims with payers and/or Medicare Administrative Contractors (MACs). The Workgroup for Electronic Data Interchange (WEDI) has published a comprehensive guide on how to test your claims with ICD-10 at www.wedi.org/docs/resources/testing-for-small-providers-white-paper.pdf?sfvrsn=0. Your MAC should already have tested several claims by now. Request that your MAC share any testing results with you and check the CMS website for other published end-to-end testing results. Also remember, the closer you get to the deadline, the higher the likelihood that payer or MAC resources will be occupied by other physicians also trying to test. Test as soon as possible to beat the last-minute rush. Don’t get denied! The Academy’s ICD-10 website page has several resources, including a sample ENT ICD-10 Superbill that will assist your planning and preparation efforts. Visit the ICD-10 website for more at www.entnet.org/node/740.
hammer
Gauging new payment models for the future
Ad Hoc Payment Model Workgroup looks to the future with Alternative Payment Models (APMs) NUTS AND BOLTS Endocrine surgery bundled payment modelBy Drew M. Locandro, MD, excerpt from ENTConnect Report Our practice is an eight-physician, single-specialty independent practice with six offices in a major metropolitan area. Several years ago, one of our surgeons developed a busy endocrine (thyroid/parathyroid) surgical practice. Patients came from greater and greater distances—even from other countries—and some were willing to pay cash for surgery. Pricing from local hospitals and multispecialty centers required negotiation on a per-case basis that was inconsistent and often did not include anesthesia, pathology, and other fees. Similar to all practices, some patients defer surgery due to cost, especially if they have high-deductible insurance coverage, catastrophic coverage only, or no insurance. In 2011, our practice opened a single-specialty ambulatory surgery center. Want to find out how Dr. Locandro’s cash pricing system works? Interested in other alternative payment model experiences or have one of your own to share? Read more and engage in the conversation at today! Available on ENTConnect: http://entconnect.entnet.org. The Academy strongly supported the repeal of the SGR formula and the movement toward development of new payment models in the landmark legislation that became law in April 2015. We believe this effort will add to the momentum in the shift from the traditional fee-for-service (FFS) system to value-based care. As part of the Academy’s efforts over the past few years to prepare for this transition, the Ad Hoc Payment Model workgroup was created. Led by co-chairs Robert Lorenz, MD, MBA, and Jane T. Dillon, MD, MBA, and managed by Health Policy staff, this group is comprised of physician leaders from research, quality improvement, 3P, and the Board of Governors. The main goals of this workgroup include reviewing potential opportunities to improve quality of care and decrease cost for otolaryngology-related services and dissemination of information about alternative payment models. To that end, the Ad Hoc Payment Model Workgroup created a new Member awareness campaign to identify and leverage Member alternative payment model (APM) knowledge. Member awareness campaign To assess Member knowledge and participation, the Ad Hoc Payment Model Workgroup partnered with the Board of Governors (BOG) to conduct a survey regarding Members’ experiences in states already involved in a new payment model. The survey revealed an eagerness to learn more about alternative payment models, as well as several Members with leadership roles in these new schemas. These leaders were asked to tell their personal stories to help the membership become more familiar with how APMs are affecting the specialty. In addition, these leaders helped to provide Academy members with an introduction to the risks and benefits of the various payment model structures. These personal experience reports were distributed to the membership at-large via periodic ENTConnect posts detailing otolaryngology APM involvement. (See “Endocrine Surgery Bundled Payment Model” at far right.) Looking toward the future of the healthcare system, the Academy will be well-poised to work with private and public payers with the establishment of an Academy-owned registry. An Academy-owned registry will help to inform alternative payment models, help demonstrate clinical effectiveness, and will allow our Members to report quality measures directly to CMS—all crucial elements in value-based care. Medicare moves to value NUTS AND BOLTS Meeting of the minds for ongoing dialogueOn May 21, 2015, AAO—HNS/F leaders met with top CMS/CMMI officials who spearheaded the recent launch of the Health Care Payment Learning and Action Network. Academy participants in this critical meeting included Robert Lorenz, MD, MBA, coordinator for Practice Affairs and co-chair of the Ad Hoc Payment Model workgroup; Jane T. Dillon, MD, MBA, coordinator for Socioeconomic Affairs and co-chair of the Ad Hoc Payment Model Workgroup; Lisa E. Ishii, MD, MHS, coordinator for Research and Quality Improvement and Chair for the Registry Task Force, James C. Denneny III, MD, EVP and CEO; Jean Brereton, MBA, senior director, Research, Quality and Health Policy; Jenna Kappel, MPH, MA, director of Health Policy. During the meeting, Academy leaders discussed possible opportunities to partner with CMS in APM development by describing ways that we could improve value, decrease costs, and increase quality. CMS/CMMI was very receptive to several of the ideas and the Academy’s leadership will move forward with collaborative efforts. Stay tuned to the website, HP Update, and upcoming Bulletin articles for updates:   www.entnet.org/content/payment-reform. The Academy applauds the Department of Health and Human Services (HHS) recent efforts to promote the collaboration of partners in the private, public, and non-profit sectors to transform the nation’s health system by emphasizing value over volume. Following the announcement of an aggressive goal to have 30 percent of Medicare payments in alternative payment models by the end of 2016 and 50 percent by the end of 2018, HHS launched the Health Care Payment Learning and Action Network (Network). The Network, overseen by a third party contractor so that CMS is a participant in this effort, but not the main driver, will primarily work to enhance value by analyzing data for current APMs, then use that data to create common core issue approaches and implementation guides. The Academy was extremely pleased to participate in the first working session of the Network and looks forward to learning more about best practices and how best to analyze data and report on new payment models. As part of recent Academy efforts related to informing Members about alternative payment models, the HHS announcement, and the Network, Academy physician payment and quality leaders met with CMS/Centers for Medicare & Medicaid Innovation (CMMI) to continue dialogue with them about the Academy’s ongoing efforts to improve quality and reduce costs, and increasing otolaryngologist-head and neck surgeons opportunities to participate in alternative payment models. Academy leaders have developed a good relationship with Patrick Conway, MD, MSc, Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, that has led to ongoing open dialogue with him and his CMS team members regarding important quality-related issues impacting our physician members and the patients they treat. The open door policy with Dr. Conway and his team members has allowed for several policies to move forward that benefit otolaryngologist-head and neck surgeons and their patients, including CMS’ adoption of the new Sinusitis and Acute Otitis Externa (AOE) measures groups and CMS’ decision to include coverage  of  auditory osseointegrated implants (AOIs) as prosthetics. As many specialty societies including otolaryngology are trying to determine how to be included in the healthcare system transformation, this latest meeting was crucial for the Academy to receive feedback from CMS/CMMI about how societies fit in with the HHS goals. Thank you The Ad Hoc Payment Model Workgroup leaders and your AAO-HNS Health Policy staff greatly appreciate the support of our Members, committee volunteers, and other leaders in helping us shape policy in an ever-changing market. As key information, policy changes, and other issues related to alternative payment models that impact the specialty emerge; we will continue to keep Members informed via the Bulletin, HP Update, and the weekly news.
measuringtape
Measuring success: strong relationships with payers
The Academy’s Physician Payment Policy (3P) workgroup, in conjunction with health policy staff, has placed a high level of importance on developing and fostering relationships with national Medical Directors within both the private and public payer sectors.
cochairs
Key tools for a thriving practice
The Academy’s Physician Payment Policy (3P) Workgroup is the senior advisory body to Academy leadership and Health Policy staff on issues related to socioeconomic advocacy, regulatory activity, coding and reimbursement, and practice management.
Otolaryngologists of Indian heritage invited
The President, Satish Govindaraj, MD, and the Governing Board of American Association of Otolaryngologists of Indian Heritage invite you to attend the 38th annual dinner meeting Sunday September 27, 2015, at 7:30 pm at the Hyatt Regency Hotel in Dallas, TX.
stopsmoking
FROM THE DIVERSITY COMMITTEE Targeted smoking cessation programs in high-risk populationsExpanded from the print edition
In 2014, it was estimated that there would be 55,070 new cancer cases of the oral cavity, pharynx, and larynx. Additionally, it was estimated that 12,000 of those diagnosed with this cancer would die, thus representing 2.0 percent of all cancer deaths.
doc_computer
AAPC selected to provide coding and practice management resources to AAO-HNS Members
As a result of healthcare delivery system reform, otolaryngologist-head and neck surgeons are faced with a rapid transition in the way they will be paid for professional services.
peru1
Letting the life and light shine through her new eyes
As surgeons, we spend what feels like a lifetime training to become who we want to be in our professional careers. Through all of this hard work and study, we sometimes neglect to realize the huge impact we have on the lives of others, not only patients, but also their families and those around them.
FROM ACADEMY ADVANTAGE PREMIER PARTNER: HEALTHeCAREERSCheck your references: résumé advice from HR professionals
Employers are using social media and technology to assess your references. Consider your social media choices carefully when looking for a new job. Employers are now looking at social media accounts to get more information about potential employees. Is the content appropriate and does it reflect you in a positive way?
abramson
The Board of Governors fall meeting: Plan to be there
We are all excited about the fall Academy BOG meeting. The official start of the AAO-HNSF 2015 Annual Meeting & OTO EXPOSM is on Sunday, September 27.
An era of uncertainty in healthcare
No doubt about it. We are living in an era of uncertainty in healthcare. In medicine in the United States, we have been accustomed for decades to a system that has rewarded volume and intensity of services delivered.
The long (and winding) road to repealing the SGR
The physician community has reason to celebrate. On April 16, President Obama signed into law H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). In one swoop, H.R. 2—perhaps the most critical piece of health-related legislation since the Affordable Care Act—delivered to the physician community not one, but several legislative victories. Most notably, of course, are the provisions to permanently repeal the flawed Sustainable Growth Rate (SGR) formula used to determine payments to physicians under the Medicare program. Repealing the SGR has long been a top legislative priority for the AAO-HNS and others in the physician community. In fact, it took more than 14 years and laboring through 17 short-term payment “patches” to arrive at the policy agreements that coalesced in H.R. 2. So, what does the bill do? In regard to Medicare physician payments, H.R. 2 stipulates: Immediate repeal of the SGR formula. A “period of stability” with a .5 percent increase in physician payments for five years. A 5 percent added incentive payment for physicians in new Alternative Payment Models (APMs). Increased funding for technical assistance to practices of 15 or fewer professionals. Creation of a technical advisory committee to review and recommend physician-developed APMs via an open comment process. Other “victories” included in H.R. 2 are: Consolidation of three existing incentive programs (Physician Quality Reporting System, Value-Based Modifier, and Meaningful Use Electronic Health Records). Combining these programs via a new Merit-Based Incentive Payment System (MIPS) program will help to set performance thresholds and offer flexibility for specialties in achieving the necessary reporting requirements for bonus payments. Rescission of the new CMS policy to transition all 10- and 90-day global payment codes to 0-day codes by 2018. Also noteworthy about H.R. 2 is the manner in which it was passed. In total, 484 lawmakers in both chambers voted in favor of the bill. Given that legislative gridlock and partisan bickering have become the norm on Capitol Hill, the bipartisanship achieved on H.R. 2 was surprising and refreshing. For so long, the SGR issue has operated as a “vacuum” on Capitol Hill, often inhibiting work on other critical initiatives. In fact, it was frustration relating to the cyclical “doc fix” that led Congressional leaders, namely Speaker John Boehner and Minority Leader Nancy Pelosi, to—finally—begin private negotiations to permanently address the SGR issue. In reality, the burst of activity to resolve the SGR issue this spring has been two years in the making (see timeline). Throughout the 113th Congress, leaders from the committees with jurisdiction over health issues in both the House and Senate worked in earnest (with the physician community) to craft the Medicare physician payment replacement policies that were ultimately included in H.R. 2. In addition to hearings, briefings, hill meetings, stakeholder sessions, and mark-ups, a key component to the evolution of the SGR replacement policies were myriad comment letters submitted by organizations across the healthcare spectrum. For example, in 2013, at the height of the policy development phase, the AAO-HNS alone submitted seven SGR-related comment letters. With the SGR replacement policies in place by early 2014, efforts to advance the bill were thwarted by the question of how to pay for the measure. What changed? The answer is that Congressional leaders and rank-and-file lawmakers agreed to view the SGR formula as the budget gimmick it was. The track record for SGR patches was proof that Congress never intended to allow sweeping cuts to take place. So, why not finally fix the problem—even if it meant not funding the whole package. In the end, after substantial negotiations by party leaders, only the add-on provisions included in H.R. 2 (e.g., extension of the CHIP program) were paid for. Next steps Is the SGR replacement policy perfect? No. It is, however, a starting point. Now the AAO-HNS will work toward improving upon the foundation set forth in H.R. 2. For more information regarding H.R. 2, and/or additional AAO-HNS federal legislative priorities, contact legfederal@entnet.org or visit www.entnet.org/advocacy. TIMELINE OF SGR REPEAL ACTIVITIES   113th Congress   February 2013 • House Energy & Commerce (E&C) Committee holds hearing on SGR issue. • House Ways & Means (W&M) Committee staff briefs physician community on development of SGR legislation. • Congressional Budget Office (CBO) reduces cost estimate for SGR repeal.   May 2013 • House W&M holds hearing to collect information on potential reform proposals. • Senate Finance Committee solicits feedback from physician community regarding future of fee-for-service system. • House E&C briefs physician community on “framework” for SGR repeal legislation.   June 2013 • House E&C releases revised SGR framework.   July 2013 • House E&C holds mark-up of SGR bill and unanimously votes to advance the proposal.   October 2013 • Senate Finance and House W&M release legislative framework to repeal the SGR formula.   November 2013 • Staff for Senate Finance and House W&M brief physician community on legislative framework.   December 2013 • Senate Finance holds mark-up of SGR framework; approved by Committee. • House W&M holds mark-up of SGR legislation; approved by Committee. • Two-year budget deal signed into law; includes three-month SGR “patch.”   February 2014 • Bipartisan, bicameral legislation (H.R. 4015/S. 2000) to repeal the SGR formula and reform the Medicare physician payment system introduced in Congress.   March 2014 • H.R. 4015 passed by U.S. House of Representatives with partisan offset. • U.S. House passes 12-month SGR “patch” via voice vote. • U.S. Senate passes (64-35) 12-month SGR “patch.”   April 2014 • President signs 12-month SGR “patch.”   November-December 2014 • Members of GOP “Doc Caucus” urge leaders to address SGR repeal before adjourning the 113th Congress. • Congress passes “Cromnibus” bill without inclusion of SGR repeal provisions.   114th Congress   January 2015 • House E&C Committee’s Subcommittee on Health holds two-day hearing to discuss possible offsets for permanent SGR repeal.   February 2015 • CBO increases its estimate of SGR repeal to $177B. • Senate Finance Committee Chairman Orrin Hatch (R-UT) announces that no SGR-related hearings will be held before the March 31 “patch” expires.   March 2015 • March 10: Rumors of a possible deal on SGR repeal bill become more plausible. • March 13: Key House Committee (W&M and E&C) Chairmen confirm emerging SGR/CHIP reauthorization deal. • March 19: Rep. Mike Burgess, MD, (R-TX) introduces H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015. H.R. 1470 mirrors the bipartisan, bicameral policy agreement from the 113th Congress—H.R. 4015. • Additional Medicare reform provisions beyond SGR repeal are finalized by Speaker John Boehner and Minority Leader Nancy Pelosi. • March 24: Rep. Burgess is given the honor of introducing H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). • March 24: The GOP “Doc Caucus” sends H.R. 2 support letter to leadership. • March 25: The AAO-HNS sends H.R. 2 support letter to members of the House. • March 25: The White House signals its support of H.R. 2. • March 26: The AAO-HNS sends H.R. 2 support letter to members of the Senate. • March 26: The House passes H.R. 2 in an overwhelming bipartisan vote of 392-37. • March 27: Unable to “fast-track” its consideration of H.R. 2, the Senate delays voting on H.R. 2 until after its two-week spring recess. • March 27: CMS instructs its carriers to “hold” for 10 business days any Medicare claims for services submitted on or after April 1, when the current “patch” expires. The hold means April claims will be held through Tuesday, April 14.   April 2015 • April 9: Sen. Ron Wyden, top Democrat on the Senate Finance Committee, announces his support for H.R. 2. • April 14: Senate leaders reach deal to vote on H.R. 2, including consideration of six amendments. • April 14: All six Senate amendments to H.R. 2 fail, and the Senate passes the bill in a bipartisan vote of 92-8. • April 16: President Barack Obama signs H.R. 2 into law.
data
FROM ACADEMY ADVANTAGE PREMIER PARTNER: THE DOCTORS COMPANY Safeguard your practice against data breachesExpanded from the print edition
The healthcare industry suffers more data breaches than any other business segment—a total of 51 percent of all breaches. Cybercriminals target healthcare organizations because personal patient information is more valuable to exploit than credit card numbers.
budget
Proposed 2015-2016 (FY16) combined budget
Budgeting for FY16 represents the collaborative work of both the staff leadership and the members of the Finance and Investment Subcommittee (FISC) to develop a proposed combined AAO-HNS/F budget for the next fiscal year, July 1, 2015, through June 30, 2016 (FY16).
denneny
AAO-HNSF’s first Qualified Clinical Data Registry
As the Registry Task Force, chaired by Lisa E. Ishii, MD, MHS, completes its work to define what will be otolaryngology’s initial Qualified Clinical Data Registry (QCDR), it is appropriate to go over some basics related to clinical registries.
Gayle E. Woodson, MD, AAO-HNS/F President
I’ll take mine with barbecue, please
I don’t know about you, but I am really looking forward to some good Texas barbecue when we get to Dallas for our Annual Meeting in September. When I was a surgery intern in Baltimore, one of the nurses brought some “barbecue” to a potluck.