Month: October 2012

CMS New WCMSA Decision Memo: TENS Units: Not Appropriate for Chronic Low Back Pain

October 5, 2012

Tens units not appropriate for low back pain
Tens units not appropriate for low back pain
The Centers for Medicare and Medicaid (CMS) issued a new memorandum that will affect pricing determinations for TENS (Transcutaneous Electrical Nerve Stimulation) units for the treatment of Chronic Low Back Pain (CLBP) included within the Workers’ Compensation Medicare Set-Aside (WCMSA) that have been submitted to CMS for approval.

On June 8, 2012, CMS issued a new Decision Memo that defined CLBP as “an episode of low back pain that has persisted for three months or longer; and is not a manifestation of a clearly defined and generally recognizable primary disease entity.” CMS further stated that a TENS unit was not “reasonable and necessary for the treatment of CLBP under section 1862(a)(1)(A) of the Social Security Act.”

TENS is the use of stimulating pulses across the surface of the skin produced by a device to stimulate the nerves for therapeutic purposes. TENS help stimulate your body to produce higher levels of Endorphins. The TENS units are small, battery operated devices that deliver these stimulating pulses across the surface of the skin. It has been an ongoing dispute over the years as to whether TENS units do more than act like placebo’s, and whether they actually treat and cure CLBP.

CMSs New Pricing Determination will affect the WCMSA’s proposal as follows:

  1. Workers’ Compensation cases settled prior to June 8, 2012:

    “For those Workers’ Compensation cases settled prior to June 8, 2012, and where the settlement included pricing for TENS for CLBP, CMS will consider funds spent for TENS for CLBP by beneficiaries and claimants as being an appropriate expenditure of funds as part of the WCMSA.”

  2. Workers’ Compensation Cases Settled After June 8, 2012:

    “For those Workers’ Compensation cases that were not settled prior to June 8, 2012, and where the WCMSAs proposal includes funding for TENS for CLBP as part of the WCMSA, CMS will re-review the cases and remove pricing for TENS for CLBP. (Regional Offices shall obtain from Submitters requests for a case re-review, along with a signed statement indicating a settlement had not occurred prior to June 8, 2012.)”

It is important to note that in the event CMS does re-review a WCMSA for removal of a TENS unit for CLBP, the claimant may NOT use the funds from their WCMSA to pay for the TENS for CLBP. If a claimant uses the funds for the TENS, this would result in an inappropriate expenditure of funds.

For additional questions on the use of TENS units as treatment for chronic low back pain, and its implications on future medical treatment and the WCMSA, please contact Tower MSA Partners at 888-331-4941 or email us at info@towermsa.com. For the full text of the CMS Decision Memo, see Decision Memo for Transcutaneous Electrical Nerve Stimulation (TENS).

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