News and noteworthy information for September:


New FDA Commissioner Nominated

On September 15, President Obama nominated Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA). Margaret Hamburg resigned as FDA Commissioner in March of this year; since that time, Stephen Ostroff, previously the FDA’s chief scientist, has served as Interim Commissioner. Dr. Califf currently serves as the FDA’s Deputy Commissioner for Medical Products and Tobacco, a position he’s held since March 2015. Dr. Califf is a Cardiologist and received a B.S. and an M.D. from Duke University. He has held multiple positions at Duke University School of Medicine and the Duke University Medical Center between 1982 and 2015. The White House news release can be found at the following link: utm_source=WhatCountsEmail&utm_medium=Physician’s%20First%20Watch+PFW%20with%20VALID%20Emails+PFW%20with%20VALID%20Emails&utm_campaign=PFW%20150917%20LIVE


FDA Establishes Patient Engagement Advisory Committee on Medical Devices

On September 18, the Food and Drug Administration (FDA) announced the establishment of the Patient Engagement Advisory Committee to provide advice to the Commissioner of Food and Drugs on complex issues relating to medical devices, regulation of devices and their use by patients. The Committee is intended to integrate patients’ perspectives into FDA deliberations and will consist of nine voting members who are knowledgeable in areas such as clinical research, primary care patient experience and health care needs of patient groups in the United States. The FDA is asking for public comment on potential topics for the Committee to discuss and advise the Agency. Comments must be submitted by November 20, 2015. More information can be found at the following link:


ICD-10 News

On August 31, ISASS staff participated on a National Provider Call hosted by the Centers for Medicare & Medicaid Services (CMS), “Countdown to ICD-10”, where CMS emphasized preparation, assistance and collaboration during the transition to ICD-10. As you already know, ICD-10 codes must be used for services provided on and after October 1, 2015. ISASS compiled relevant information and provided its members with an “ICD-10 Guide for Spine Practices” on August 21, 2015. Since that time, CMS named Dr. William Rogers as its ICD-10 Ombudsman. Dr. Rogers is an emergency room physician, a Clinical Assistant Professor of Emergency Medicine at Georgetown University Hospital, a State Air Surgeon in the US Air Force, and the Director of CMS’ Physician Regulatory Improvement Team. You and your staff can email questions to the Ombudsman and his staff at A Powerpoint presentation from the National Provider Call can be accessed at the following link:

Additionally, in response to questions from the health care community, CMS has released updated “Clarifying Questions and Answers Related to the July 6, 2015 CMS/AMA Joint Announcement and Guidance Regarding ICD-10 Flexibilities,” which provides answers to the most commonly asked questions.

Lastly, on September 14, ISASS partner, The Business of Spine issued an ICD-10 Coding Advisory related to Department of Labor, Veterans Administration and Workers Compensation claims.


Medicare Administrative Contractor News

On September 15, First Coast Service Options Inc., the Medicare Administrative Contractor covering Florida, Puerto Rico and the U.S. Virgin Islands, announced it is removing three spine procedure codes from its Non-Covered Services Local Coverage Determination (LCD) based on a reconsideration request:

– 22856 (total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and micro dissection); since interspace; cervical);

– 22861 (revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical); and

– 22864 (removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical).

Removing a service from the Non-Covered Services LCD should not be interpreted as a positive coverage statement/coverage by Medicare; however, these procedures are no longer covered by a blanket non-coverage determination in Florida, Puerto Rico and the U.S. Virgin Islands. If the procedures meet the medically reasonable and necessary threshold for coverage, surgeons in Florida, Puerto Rico and the U.S. Virgin Islands will now get reimbursed by Medicare for performing these procedures effective for services rendered on or after September 9, 2015. More information on this announcement can be found at the following link:


Physician Quality Reporting System Payment Adjustment and Informal Review Process

On September 11, the Centers for Medicare & Medicaid Services (CMS) began distributing letters to Physician Quality Reporting System (PQRS) individual Eligible Professionals (EPs) and group practices about the 2016 PQRS negative payment adjustment. The letter indicates that an individual or group did not satisfactorily report 2014 PQRS quality measures in order to avoid the 2.0% 2016 negative PQRS payment adjustment.

If you believe that you have been incorrectly assessed the 2016 PQRS negative payment adjustment, you can submit an informal review through November 9, 2015. All informal review requests must be submitted via a web-based tool, the Quality Reporting Communication Support Page, during the informal review period. For details regarding the 2016 PQRS payment adjustment, please see the Payment Adjustment Information page of the PQRS website and click on the payment adjustment toolkit.


Physician Compare Preview Period for Reported Quality Measures

The Centers for Medicare & Medicaid Services (CMS) will be publicly reporting a sub-set of the 2014 Physician Quality Reporting System (PQRS) measures on Physician Compare.

Starting October 5, 2015, CMS is facilitating a 30-day preview period for select quality measures through the PQRS portal-Provider Quality Information Portal. This preview period provides an opportunity for group practices and individual eligible professionals to review their measures before they are publicly reported on Physician Compare. To learn more about which measures will be publicly reported and how to preview measures, visit the  Physician Compare Initiative page.


AMA Develops Resources for Evaluating and Understanding New Payment Model Commercial Payer Contracts

Commercial payers are increasingly pursuing contracts with physicians based on new payment models, such as pay-for-performance and bundled or episode-based payment. These alternative payment models can rely on both cost and quality metrics to determine payment rates for physicians. Navigating the assortment of new payer contracts can be made easier by gaining an understanding of payer agreements and the portions of those agreements that should be prioritized and can be negotiated.

The American Medical Association has developed two new resources that explain key issues physicians should consider when evaluating bundled or episode-based and pay-for-performance agreements.

Each of these documents outlines important considerations, including:

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