American Society of Interventional Pain Physicians News | October 29, 2014
FDA Meeting on Epidural Steroid Use and How You Can Get Involved
Letters deadline November 7
On November 24-25, 2014 the FDA Anesthetic and Analgesic Drug Products Advisory Committee Meeting will hold a meeting to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. The outcome of this meeting will determine future regulatory options, including but not limited to changes to the product labeling. This FDA hearing could be the greatest threat to IPM than anything we have faced in the past.
You can get involved in two ways:
- The most critical is support from patients with letters by Nov. 7, 2014.
- Attend the FDA meeting on November 24
ASIPP is attempting to secure time to present our views; however, we will not know the time allocated to us until October 31st. If you would like to submit your own request to speak, you may do so by October 30th. Request may be submitted via e-mail to:
Stephanie L. Begansky, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
It is our understanding that several pain organizations and other societies such as ASA, PMR, etc., will also be presenting both pro and con views. In addition and most importantly, there are many patient groups such as the Arachnoiditis Association, which may be presenting in opposition to epidural injections.
Because of this, it is crucial to obtain as many patient letters and send them to the FDA via our Capwiz link.
Time is of the essence. The comments must be sent by November 7th so you should start today and continue sending through November 7.
How to Get Patients Letters Signed and Submitted
1. Print off the sample Patient Letter.
2. Ask the patients to sign the letter as they check in. You can also include the patients' drivers.
3. Assign staff to enter the patients' letters using the Capwiz letter link:
4. If the patient does not provide an email address, you can use your practice's email.
5. All letters should be entered daily and any letters signed on Nov. 7 must be entered by COB that day.
The following information has been published thus far on epidural injections, FDA warning of epidural injections and other developments:
ASIPP's FDA Citizen Petition requesting the Commissioner to withdraw the present Safety Warning.
Pain Physician Journal Health Policy Opinion: Epidural Steroid Injections Safety Recommendations by the Multi-Society Pain Workgroup (MPW): More Regulations Without Evidence or Clarification
Pain Physician Journal Health Policy Review: Epidural Steroid Warning Controversy Still Dogging FDA:
Pain Physician Journal Letter to the Editor: The Food and Drug Administration's Recent Action on April 23, 2014 Failed to Appropriately Address Safety Concerns about Epidural Steroid
Work group passes epidural steroid injection consensus in response to FDA warning. Healio Spine Surgery, August 1, 2014
Recommendations for safe use of epidural steroid injections presented at the ASA 2013 annual meeting as part of FDA's Safe Use Initiative
American Society of Anesthesiologists. ASA Formally responding to FDA warning on injection of corticosteroids into epidural space, July 14, 2014.
International Spine Intervention Society. Update on ISIS Response to FDA Statement on ESIs.Â
The open public portion of the meeting will take place on Monday, November 24 from 8:00 a.m. to 5:00 p.m. If you would like to attend you would need to arrive on Sunday and could leave Monday afternoon and there are numerous hotels available in the area. The meeting location is:
FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
It is crucial that we have good representation at the meeting. If you are planning to attend please let us know.
Take a Moment to Participate in Physician Survey on Epidural Steroid Injections
A survey is being conducted to support a study on the technical performance of epidural steroid injections.
The benefit of completing this survey will be a peer-reviewed publication of the group data that informs the clinical community of the current practices that relate to performance of epidural steroid injections.
Click on the following link to take the survey: https://www.surveymonkey.com/r/STATEOFESI
The survey takes about 5-10 minutes to complete.
The study has been approved by the Institutional Review Board of NYU School of Medicine.
ASIPP Resident/Fellow Governing Counseling Seeking Officer Nominations
Interested in pursuing a career in pain management? Want to advocate on behalf of your profession and patients? Trying to distinguish yourself from other fellowship applicants? Enjoy networking with prominent members of your profession? Want to learn about prominent issues in pain medicine?
If you answered "yes" to any of these, consider joining the American Society of Interventional Pain Physicians (ASIPP) and serving as a member of the Residents and Fellows (RFS) Governing Council. The Governing Council will be tasked with creating content recommendations for this year's annual conference and improving resident and fellow membership in ASIPP.
We are soliciting nominations for the following positions (one year term):
Chair- directs the section and implements the agenda as outlined by the board
Vice Chair- assists the chair and lead membership recruitment
Secretary - responsible for accurate record keeping of the section activities
Member At-large - responsible for arranging RFS activities at the annual meeting
Treasure - responsible for accurate financial management of funding designated to the section
Please submit your CV and a 250 word maximum statement of interest to firstname.lastname@example.org by October 31st. You can express interest in any and all positions.
Governing Council members must be members of ASIPP, members of an accredited residency and/or fellowship program but must commit to attending the ASIPP Annual Meeting April 9-11 in Orlando, FL. ASIPP offers drastically reduced registration fees for the meeting to residents, fellows, and medical students. Governing Council members receive complimentary registration.
Joining ASIPP as a resident and fellow is free and is easy, simply go to www.asipp.org and follow the links.
Register Today for ICD-10 Preparation Webinar Set for Nov. 4
- Background on ICD-10
- Technology readiness to make sure the products are ready
- The new 'Road to 10' tool to create a custojmized action plan for ICD-10
- Key steps to ensure a successful transition
- Resources to help with a smooth implementation
- Discover the top ICD-10 areas likely requiring documentation updates for pain management providers
- Technology readiness to make sure the products are ready
- What are the testing procedures needed with payers
- Practice determining the correct ICD-10 diagnosis codes in common pain management conditions
WEBINAR FEE: $175
WEBINAR DATE: November 4, 2014
TIME: 11:00am-12:30am CST
CREDIT HOURS: 1.5 CEUs
LENGTH: 90 Minutes
Marvel J Hammer, RN, BS, CPC, CCS-P, ACS-PM, CPCO
Click HERE to register:
How Medicare 'Self-Referral' Thrives on Loophole
In a letter to a friend, the manager of a Florida urology practice worried in 2010 that her company would attract federal scrutiny for its frequent use of an expensive bladder-cancer test.
The manager's concern involved a program at 21st Century Oncology Holdings Inc.-a national chain of cancer practices-that gives its urologists a financial incentive to order the test from a central in-house lab. A federal law since the 1990s has prohibited "self-referral," in which doctors can profit from Medicare-reimbursed procedures they order. But 21st Century Oncology and many physician groups around the country have found ways to do it anyway, exploiting an exception to the law in ways its writers didn't anticipate.
The manager attached an email from a 21st Century Oncology executive who touted an increase in the number of tests ordered through the central lab, and encouraged doctors in her office to direct business to the lab and share in the revenue. The surge in orders for the bladder-cancer test was so sharp, she wrote to her friend, that it would "surely bring the OIG to our door!"
Wall Street Journal
Access to this article may be limited.
Efficacy and Safety of Oral Oxycodone Comparable to Oral Morphine for Postoperative Pain
Oral oxycodone could be an important analgaesic agent for the management of postoperative pain in hospitalised patients with moderate to severe pain (≥ 40 mm on the visual analog scale [VAS]), according to results of a double-blind study presented at the 2014 Annual Meeting of the American Society of Anesthesiologists (ASA).
When oxycodone hydrochloride capsules and morphine sulfate tablets were compared at a dose ratio of 1:2, oxycodone was comparable to morphine in terms of efficacy and safety, stated lead author Xinmin Wu, MD, Peking University First Hospital, Beijing, China, speaking here on October 13.
Doctors Tell All-and It's Bad
For someone in her 30s, I've spent a lot of time in doctors' offices and hospitals, shivering on exam tables in my open-to-the-front gown, recording my medical history on multiple forms, having enough blood drawn in little glass tubes to satisfy a thirsty vampire. In my early 20s, I contracted a disease that doctors were unable to identify for years-in fact, for about a decade they thought nothing was wrong with me-but that nonetheless led to multiple complications, requiring a succession of surgeries, emergency-room visits, and ultimately (when tests finally showed something was wrong) trips to specialists for MRIs and lots more testing. During the time I was ill and undiagnosed, I was also in and out of the hospital with my mother, who was being treated for metastatic cancer and was admitted twice in her final weeks.
E-Patients: Passing Fad or Bona Fide Movement?
In July of this year, our healthcare system lost a leading advocate when Jessie Gruman -- known by some as the "mother of patient engagement" -- succumbed to cancer at the age of 60.
Gruman helped found -- and for more than 2 decades led -- the Center for Advancing Health, working at the forefront of research on patient decision-making processes and championing patient empowerment.
She also recognized that much of the progress in individualized medicine has come about, in large part, as a consequence of the Internet.
Wait Times for Spinal Cord Stimulation: Current Outlook
Patients with chronic pain often must wait a prolonged period before they can be authorized for treatment with spinal cord stimulation (SCS); months or even years can elapse before a suitable candidate is identified, informed about the benefits and authorized by health insurance providers for SCS. [Editor's note: Researchers presenting at the 2014 American Academy of Pain Medicine annual scientific meeting found that the average time from symptom onset to implantation was 5.12 years.]
Part of the problem is that many physicians are not sufficiently knowledgeable about SCS. These physicians often believe that every possible method of conservative, interventional and surgical management should be exhausted before SCS is considered. Several intrinsic factors further increase the overall wait times after a patient is consulted; for example, authorization by insurance companies is required for reimbursement, which results in longer wait times. Another factor that loses the patient more time is the scheduling of a permanent implant after a successful trial of SCS.
Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up
ISSUE: Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The affected products are: boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength.
Consumers who intentionally avoid using Ibuprofen due to allergy, or other medical conditions, are advised that they may have inadvertently purchased Ibuprofen 200mg softgels, believing it was Naproxen Sodium 220mg tablets. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. The firm has not received any reports of adverse events related to this recall.
White House working on new Ebola guidelines
Gov. Andrew Cuomo has outlined guidelines for the mandatory, 21-day quarantining of medical workers returning from West Africa that he and New Jersey Gov. Chris Christie ordered Friday. (Oct. 27) AP
The White House on Sunday said that it is working on new guidelines for health care workers returning from Ebola-stricken areas, according to a senior administration official.
The decision comes as governors in Illinois, New Jersey and New York announced over the weekend that they were instituting quarantines for aid workers returning from Ebola-stricken West Africa.
Want To Fix The "Doc Fix"? Experiment!
For health policy wonks, the end of the year isn't just the holiday season. With the falling temperatures will come a renewed "doc fix" debate, as Congress deliberates on ways to avoid a scheduled double-digit (24 percent last year) cut in Medicare's physician payments. And avoid it they will. As health economist Austin Frakt put bluntly: "Good luck getting physicians to keep Medicare patients if the payments are suddenly cut 24 percent."
The problem, as anyone who follows health policy will tell you, is Medicare's "Sustainable Growth Rate," or SGR. The SGR is a formula created under the 1997 Balanced Budget Act, with a noble goal: keep Medicare physician spending under control. Under the formula, when spending per beneficiary grows faster than GDP, a payment cut is required. Because policymakers haven't been thrilled about cutting physician payments as the SGR would have required over the past 11 years, the required cuts have accumulated over the years, resulting in the 24 percent cut that Congress worked to avoid last year.
Insider-Trading Probe Focuses on Medicare Agency
The day Medicare officials began discussing whether to set new coverage limits on a costly new prostate-cancer treatment, the official in charge emailed three colleagues to put a "close hold" on the process. That meant: Keep quiet until an announcement later that month.
Yet by the end of that same day, June 7, 2010, shares of the company that made the treatment, Dendreon Corp., had plunged 10%. Before long, federal investigators took...
Wall Street Journal
Access to this article may be limited.
Call for Abstracts! Make Plans Today to Participate in 17th Annual Meeting Abstract Session
Make your plans now to participate in the American Society of Interventional Pain Physicians abstract and poster presentation at the 17th Annual Meeting, April 9-11 in Orlando Florida.
This year's abstract session will be bigger and better. In response to your many suggestions, the top 20 posters will be on display through our new electronic poster presentations with Q & A time with poster presenters. They will also be published in Pain Physician journal.
In addition the Top 8 posters will be presented for judging during Friday's session. The top three abstracts will receive cash prizes.
Posters will be on display during the meeting on both Thursday and Friday in the exhibitor hall.
The abstract submission deadline will be February 6, 2015.
For a complete set of rules and to access the online submission application, please go to: http://www.asipp.org/0415-Abstract-registration.htm
|State Society News
Save the Date: NY/NJ Chapters Schedule Pain Medicine Symposium
The New York and New Jersey Societies of Interventional Pain Physicians' 2014 Pain Medicine Symposium will be held on November 6 - 9, 2014 at the Hyatt Regency Jersey City in New Jersey.
More information will be available soon.
* Please send your State Society meetings and news to:
Holly Long at email@example.com
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