*NEW* FDA's ENT Panel Reviews Safety and Effectiveness of Hybrid Cochlear Device (12/5/2013)
On November 8, 2013, the Food and Drug Administration (FDA’s) Ear Nose and Throat Devices Panel (ENT panel) met in Silver Spring, Maryland to discuss the safety and effectiveness of a new hybrid cochlear implant device, the Nucleus® Hybrid™ L24 Implant System (Hybrid L24), to make a recommendation about pre-market approval status. The Hybrid L24 is designed for the treatment of adults who are 18 years or older, have residual low-frequency hearing sensitivity and bilateral severe to profound high-frequency sensorineural hearing loss, and obtain limited benefit from hearing aids amongst other indications.
Several Academy leaders hold prominent roles at the FDA and many voting members of the FDA panel are also Academy members. Notably, Gayle Woodson, MD, AAO-HNS President-Elect, serves as chairperson of the FDA ENT panel and several Academy members participate during meetings. Anjum Khan, MD, MPH, also an Academy member and a Medical Officer with the FDA, presented on the safety and effectiveness of the Hybrid L24. In addition, Academy members J. Thomas Roland, MD, and Bruce J. Gantz, MD both attended and presented at the meeting as principal investigators of the device.
The following Academy members sat in on ENT panel discussions as voting members or temporary voting members including: Steven W. Cheung, MD, MBA, Roberto A. Cueva, MD , Barry E. Hirsch, MD, Michael E. Hoffer, MD, CAPT MC, USN, Akira Ishiyama, MD, Herman A. Jenkins, MD, Margaret A. Kenna, MD, MPH, Arnaldo L. Rivera, MD, CDR, MC, Jeffrey T. Vrabec, MD, Bevan Yueh, MD, MPH, and Ronald von Jako, MD, PhD.
After listening to several patient experiences and clinical research presentations, the FDA panel members deliberated, unanimously recommending that the Hybrid L24 device is safe, effective, and provides benefits that outweigh the risks for patients meeting the criteria specified in the proposed indications. The FDA is not bound by the recommendations of its advisory committees, but will consider the recommendations and guidance during the final review of the device.
For further details on research presented at the meeting and other relevant materials, please visit the FDA website and view the Committee meeting materials here.
Academy Reaffirms Proposed Revisions to ICD-10 Unilateral Hearing Loss Codes (11/21/2013)
In a November 13th comment letter to the National Center for Health Statistics (NCHS), the Academy reaffirmed its previously proposed revisions to several unilateral hearing loss codes in the new ICD-10 code set. Along with 4 other organizations, the Academy proposed editorial changes to improve accuracy and classification of the codes. To view the letter, click here
Academy Meets with CMS to Advocate for You (11/12/2013)
On November 7, 2013 the Academy met with top officials at CMS to discuss payment reform efforts, the need for development of additional clinical quality measures to ensure successful participation in the Physician Quality Reporting System (PQRS) and Value Based Modifier programs, and inquired as to why 5 of the 9 sinusitis measures were not accepted within the 2014 proposed fee schedule. Health Policy staff and physician leaders also outlined our continued concerns regarding CMS’ proposed OPPS cap policy which would reduce practice expense relative value units for 13 Otolaryngology services when performed in the office setting, if finalized in the final 2014 rule. The meeting was yet another effort by the Academy to ensure CMS understands the critical role otolaryngologists play in the health care system and the impact these programs and policies have on our specialty.
2012 PQRS Feedback and QRUR Reports Available(11/7/2013)
Access your 2012 PQRS Feedback Reports Today
If you participated in the PQRS program from January 1 and December 31, 2012, you may now access feedback on your 2012 performance. Additionally, provider Quality Resource Use Reports (QRURs) are available on the CMS website for providers to assess their resource use and cost performance for CY 2012. Visit the Academy's quality website for instructions on obtaining both reports.
Doc Caucus Sends Letter to CMS Urging Repeal of OPPS Cap Proposal in 2014 MPFS (10/17/2013)
On October 17, 16 members of the House of Representatives’ Doc Caucus sent a letter to CMS outlining their concerns with CMS’ proposal to use hospital outpatient and ambulatory surgical center payment rates to cap practice expense payments in the physician office setting for CY 2014. If finalized, 13 ENT services would see reductions from 6-60 percent in 2014. The Academy is pleased to see the Hill take action in support of our position on this issue, and we continue to push CMS to retract this flawed policy proposal in the final rule. View the Academy's summary of the 2014 MPFS here.
CMS Releases New Rules on Hospital Inpatient Admissions (10/10/2013)
Recently, CMS released the 2014 Inpatient Prospective Payment System final rule which clarifies that a beneficiary is an inpatient of a hospital if formally admitted via an order by a physician or other qualified practitioner. The new rules are aimed at reducing long beneficiary stays as outpatients, and clarify if the ordering practitioner expects a beneficiary to stay at least two midnights, they should be admitted as an inpatient. Click here to view the rules.
Senators Urge CMS to Delay Meaningful Use Stage 2 Requirements (9/24/2013)
Recently, 17 Members of the U.S. Senate joined together to send a letter to Secretary Sebelius and the Centers for Medicare & Medicaid Services, urging them to implement a one year delay (from 2014 to 2015) for Stage 2 Electronic Health Record (EHR) Meaningful Use requirements. Click here to access the letter.
Aetna Clarifies Allergy Immunotherapy Policy
Through the joint advocacy efforts of the Academy, AAOA and AOA, we have received clarification from Aetna Medical Directors regarding their new Allergy Immunotherapy Policy for CPT 95165. To view the joint letter sent to Aetna in July, click here. We are particularly pleased that Aetna has chosen to accept our request to allow 120 units during the first year of escalation, and 90 units for years thereafter, for maintenance. For more information, access the response from Aetna on August 8th.
FDA's Nonprescription Drug Advisory Committee Recommends OTC access to Nasacort AQ
(7/31/2013)The FDA's Nonprescription Drug Advisory Committee (NDAC) has recommended over the counter (OTC) access to Nasacort AQ. AAO-HNS CEO David R. Nielsen spoke in opposition to the application, as did AAAAI, ACAAI, and AAOA, at an NDAC meeting July 31. Dr. Nielsen shared information from a joint AAOA/Academy letter outlining our opposition due to safety concerns and lack of evidence to support the change. Although the original application was for adults only, the Advisory Committee extended it to include ages 2-18, so the label would reflect the dosing difference for children. The Consumer Health Product Association gave data and testimony on the benefits of OTC medications, relatively low incidence of adverse outcomes, and the overall reduced costs of health care associated with OTC medications. The panel voted 10 to 6 (with 2 abstentions) in favor of OTC use. While the FDA is not required to follow the NDAC recommendations, they typically do so. The Academy will report out to members the FDA’s final ruling. For additional background information from the FDA Advisory Committee meeting, click here.
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Academy Issues Summary for 2014 Proposed Rules for the Medicare Physician Fee Schedule. Hospital Outpatient/Ambulatory Surgical Centers Proposed Rule Released
The Center for Medicare / Medicaid Services (CMS) released the proposed 2014 Medicare Physician Fee Schedule (MPFS) and 2014 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Centers (ASCs) proposed rules. The Academy has summarized the MPFS, which can be found below. The OPPS Rule has been divided into two summaries, one for the OPPS section and one for the ASC section as listed below:
*NEW* Academy Summary of 2014 HOPPS Section of Proposed Rule*NEW* Academy Summary of 2014 ASC Section of Proposed Rule *NEW* Academy Summary 2014 Proposed Medicare Physician Fee Schedule
Links to each proposed rule are provided below:
CMS 2014 Proposed Medicare Physician Fee ScheduleCMS 2014 Proposed OPPS / ASC Proposed Rule
Academy Submits Comments to CMS on 2014 IPPS Proposed Rule
On June 20th, the Academy submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the 2014 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. Comments focused on clarifying the definitions for inpatients and outpatients in a hospital setting. See the letter here.
Academy Submits Comments to CDC Requesting New Pulsatile Tinnitus ICD-10 Code
Academy Reapplies for DME Oral Appliance LCD Revision
On June 18th, the Academy sent comments to the Centers for Disease Control and Prevention (CDC) regarding a change.org petition received by the CDC from over 1000 patients, supporting the creation of a new ICD-10 code to distinguish between Pulsatile Tinnitus (whooshing sound) and non Pulsatile Tinnitus (ringing of the ears). Without a diagnosis code, patients with pulsatile tinnitus are being improperly classified as part of the larger tinnitus community, with whom they share few medical similarities, resulting in inadequate medical attention, diagnoses, and treatments. See the letter here.
On May 16th, the Academy resubmitted an application for CMS to revise their DME Oral Appliance LCD, which prohibits ENTs from fitting and billing for oral appliances. In the letter, the Academy addressed concerns regarding Stark law prohibitions. Read the letter here.
Academy Expresses Concerns to AARP Regarding United Healthcare Direct to Consumer Hearing Aid Sales
On May 16th, the Academy sent a letter to American Association of Retired Persons (AARP) regarding our concerns about patient safety and quality of care related to United Healthcare's Hi Health Innovations direct-to-consumer hearing aid program. We also too the opportunity to highlight our ongoing quality initiatives in the letter. See the letter here.
Academy Sends Request for Disclosure of Milliman Care Guidelines
On May 14, the Academy sent a letter to leaders at Milliman Care Guidelines (MCG), operated by the Hearst Corporation, regarding their care guideline for Stapedectomy procedures which requires a CT scan prior to the procedure. This requirement is contrary to the Academy's current clinical indicator, which does not require a CT scan. Milliman has not responded to our request to date, but Academy staff will continue to monitor the issue as many private payers utilize the Milliman criteria as part of their claims review process. Read the letter here
Academy Comments on Application of Exclusivity Rules to ACOs
The Academy recently submitted comments to CMS outlining concerns with the manner in which the Agency was interpreting exclusivity requirements for providers participating in Accountable Care Organizations (ACOs). These comments were crafted in response to feedback from various practices and specialties that had experienced issues surrounding exclusivity when trying to participate in more than one ACO. See the letter here
Academy Advocates for Modification to CMS DME MAC policy on Tracheostomy Tube Policy
Recently, the Academy led an effort to request that CMS modify the new tracheostomy tube replacement policy implemented by their DME MACs in late 2012. Under the new policy, tracheostomy tubes can only be replaced every 90 days. Upon learning of this new policy, the Academy collaborated with 10 other medical specialty societies to craft a letter requesting modification of the policy to allow replacement of trach tubes every 30 days to maintain consistency with available clinical evidence, including the Academy's Tracheostomy Care Clinical Consensus Statement, and standard care practices. See the letter here.