Request to FDA to Change Opioid Labels

October 1, 2012

FDA Opioid Labeling Petition
FDA Opioid Labeling Petition
To those who may not know, PROP (Physicians for Responsible Opioid Prescribing) http://www.supportprop.org/ is an organization comprised of practicing physicians whose mission is “to reduce morbidity and mortality resulting from prescribing of opioids, and to promote cautious, safe and responsible opioid prescribing practices.”   I follow PROP regularly and use many of their resources to educate my staff on opioid use as it relates to long term prescribing and the MSA.

As a PROP follower, I recently received the email below asking for my support.  I responded immediately and am forwarding to each of you in the hope that you will do the same.

 


Dear Friends and Colleagues,

As you may know, PROP filed a request to FDA for changes to opioid labels. Specifically, we asked them to add a suggested duration of use, a suggested upper dose and to limit (on-label) use to severe pain. You can read about this here:  http://supportprop.org/advocacy/index.html.

If FDA implements our request, opioid manufacturers will be prohibited from advertising long-term use of opioids for chronic non-cancer pain and the medical community will be informed that this practice has not been proven safe and effective. (However, clinicians will still be permitted to prescribe long-term opioids). We believe that this will help reduce overprescribing of opioids. And since it’s overprescribing that’s harming pain patients and fueling the opioid addiction epidemic, the label change could help bring this unprecedented public health crisis under control.

FDA is seeking public comment about the Petition. Thus far, they have received about 200 comments supporting the petition and 130 opposed to the petition. Not surprisingly, industry-funded pain groups (and pain patients misled to believe that this is an effort to ban opioids) have weighed in against the Petition.

Submitting comments to FDA is easy… just click here: http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001.

A couple of sentences is all you need. Please make sure to state clearly in the first or second sentence that you support the petition.

For example, you can write:

I support this petition. Drug companies should not be permitted to advertise long-term and high dose opioids for moderate chronic pain because this treatment has not been proven safe and effective. The medical community should be informed by a revised label that risks may outweigh benefits when opioids are prescribed long-term.

Please try to do this ASAP. As soon as FDA takes an action on the Petition (which could be very soon), they will close the comment period.

If you are interested in reading comments that have already been posted, you can do this here:
http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=fda-2012-p-0818.

Thank you for your support!

Andrew

Andrew Kolodny, MD
President, Physicians for Responsible Opioid Prescribing
www.supportPROP.org

Chair, Department of Psychiatry
Maimonides Medical Center
920 48th St., Brooklyn, NY 11219
Tel: 718 283-7557; Fax: 718 283-6540
akolodny@maimonidesmed.org

Medicare Secondary Payer and Workers’ Compensation Settlement Agreement Act: 30 Days and Counting…. Can it Succeed?

June 18, 2012

Introduced into the US House of Representatives on April 27, 2012, the Medicare Secondary Payer and Workers’ Compensation Settlement Agreements Act of 2012 (HR 5284) aims to streamline the settlement of workers’ compensation agreements by creating an exception to Medicare secondary payer requirements. The bill also provides language that could ease the path toward satisfying these requirements by using qualified Medicare set-aside arrangement (MSA) under these agreements.

Designed to apply to certain workers’ compensation settlements agreements, the bill proposes changes if any of the following criteria is present:

  1. The total settlement is $25,000 or under;
  2. The claimant is not eligible for Medicare at settlement date and is not expected to be eligible within 30 months;
  3. The settlement agreement does not limit or eliminate the claimant’s right to payment of future medical bills;
  4. The claimant is not eligible for future medical bill payments under the settlement.

US representative David Reichert (WA-8) introduced the bill in an attempt to improve the set-aside process for workers’ compensation claims. Current settlements that overlap with Medicare coverage create a lengthy review period on what constitutes the set-aside coverage amounts.

Currently, HR 5284 has been referred to the Subcommittee on Health for review. The bill has gained heavy support from industry organizations, including American Insurance Association (AIA), American Association for Justice (AAJ), American Bar Association (ABA), National Council of Self Insurers (NCSI), Property Casualty Insurers Association of America (PCI), UWC – Strategic Services on Unemployment & Workers’ Compensation (UWC), Washington Self-Insurers Association (WSIA), and Workers Injury Law and Advocacy Group (WILG).

Part of the problem may be that the legislation tries fixing what isn’t governed. There is a lack of any real definition of MSA from a regulatory sense. Would wrapping laws around an undefined practice work?

Also, industry buzz suggests that legislators are treating workers’ compensation issues much like they would group health issues. Also, detractors of the bill believe there is little to address the calculation of allocation amounts and too little consistency in understanding and applying CMS policies.

The success of H.R. 5284 will depend largely on how well the legislation understands the MSA environment. While the idea may be a good one, the actual practice may fall short of its intended goal.

Town Hall Teleconference Events – February through June, 2012

February 17, 2012

Mandatory Reporting for Liability Insurance (including Self-Insurance), No-Fault Insurance and Worker’s Compensation

Implementation of Medicare Secondary Payer Mandatory Reporting Provisions in Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007
(See 42 U.S.C. 1395y(b)(8))

The CMS will be hosting combined NGHP Policy and Technical Support related teleconference events. For these calls the format is opening remarks and a presentation by CMS, followed by a question and answer session with the audience. Following is the call schedule for the first half of 2012.

NGHP Policy and Technical Support Questions and Answers: These calls will address both policy and technical questions you have regarding Section 111 reporting. Policy discussions will focus on CMS policy supporting the Section 111 NGHP reporting requirements, and how policy is being and has been translated into procedures. Technical support questions will focus on EDI connectivity and data transmission, use of the COB Secure Website, disposition and error codes, and other aspects of the data exchange process. Both CMS staff and representatives of the CMS COBC EDI Department will be available throughout each call.

DATES:

  •  February 23 (Thursday), 2012
  •  March 22 (Thursday), 2012
  • April 24 (Tuesday), 2012
  • May 24, (Thursday), 2012
  • June 19 (Tuesday), 2012

Call-in time for all calls: 1:00 PM – 3:00 PM Eastern time. Participation is by telephone only.

Call-in line for all calls: (800) 603-1774

Pass Code: Section 111

Questions for the call: Please submit questions to PL110-173SEC111-comments@cms.hhs.gov.

Please begin dialing in approximately 20 minutes before the call start time, due to the large number of participants.

Tower MSA Partners Seeks Experienced Salespeople

January 4, 2012

Tower MSA Partners is aggressively seeking experienced salespeople in both workers’ compensation and liability markets. Interested parties should forward their resumes to info@towermsa.com.  To speak with someone directly, please call 888-331-4941 and reference this post.
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Top 10 Drugs Prescribed For Workers’ Compensation Claims

November 21, 2011

A recent study by NCCI Holdings, Inc. reports the top 10 most popular drugs prescribed for workers’ compensation claims.

1. OXYCONTIN®
2. LIDODERM®
3. HYDROCODONE-ACETAMINOPHEN
4. LYRICA®
5. CELEBREX®
6. GABAPENTIN
7. SKELAXIN®
8. CYMBALTA®
9. MELOXICAM
10. CYCLOBENZAPRINE HCL

Workers compensation medical costs per claim average more than $6,000 and soar to nearly $25,000 for lost-time claims. The report examined workers compensation prescription drug (Rx) use, a medical expense that makes up 19% of all workers compensation (WC) medical costs.

Other key findings of the report on drugs prescribed for workers’ compensation were:

• The indicated Rx share of total medical is 19%; this is slightly higher than the estimate given in the 2010 update
• OxyContin® climbs from the number 3 WC drug in Service Year 2008 to number 1 in Service Year 2009
• Hydrocodone-Acetaminophen drops from the top WC drug in Service Year 2008 to number 3 in Service Year 2009
• Recent overall cost increases are driven more by utilization increases than by price increases
• Physician dispensing continues to increase in Service Year 2009 in almost every state
• Increased physician dispensing is associated with increased drug costs per claim
• Per-claim Rx costs vary significantly by state