    
Final Comments Avail
Board Administrator
Username: Admin
Post Number: 75
Registered: 10-2002
| | Posted on Wednesday, April 08, 2009 - 09:51 am: | 
|
Comment:
When a member of the WPS Carrier Advisory Committee was asked about this LCD he replied that there may have been one or two papers but, while this treatment may be promising, to date there has been no clinical double blind random studies performed to support that it is an effective treatment. Therefore it should be considered investigational.
Response:
WPS Medicare will deny this service as not medically necessary for dates of service on and after February 1, 2009.
Comment:
WPS received multiple letters from beneficiaries asking that Medicare keep paying for PTNS treatments.
Response:
This policy was based on our analysis of peer reviewed literature, other Medicare contractors’ medical policies on this topic, opinions of multiple Carrier Advisory Committee members (especially urological and gynecological), attending an American Urological Association meeting, meetings with the manufacturer, contacting other independent consultants (including at the Mayo Clinic), and solicitation of information via open meetings and our website. Today, all WPS Medicare policies are developed on evidence based medicine. Evidence based medicine does not rely on personal opinions, but on well constructed medical studies and research. Once there are sufficient published peer-reviewed literature that shows that this works, then we will change our decision.
Comment:
Multiple physicians sent letters with similar stories:
Since starting PTNS, we have experienced dramatic improvement of symptoms in our patients with OAB. Men and women both benefit from this treatment modality. ALL the patients on PTNS therapy have experienced decreased symptoms of urgency, frequency, nocturnal and urge incontinence. Patients have previously failed multiple anticholinergics medications prior to starting PTNS treatment. All of these patients are happy with their PTNS treatment. We have seen nocturnal 15 times per night halved to 6-7 in just 4 treatments. There has been complete resolution of most symptoms in others. Our patients enjoy the fact that they no longer have to endure the side effects of an anticholinergic medication.
Response:
They all received the following response:
When developing a LCD, WPS is required to follow the regulations in the Medicare Program Integrity Manual; Chapter 13 – Local Coverage Determinations; 13.7.1 - Evidence Supporting LCDs. (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf)
"Contractor LCDs shall be based on the strongest evidence available. The extent and quality of supporting evidence is key to defending challenges to LCDs. The initial action in gathering evidence to support LCDs shall always be a search of published scientific literature for any available evidence pertaining to the item/service in question. In order of preference, LCDs should be based on:
Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and
General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:
1. Scientific data or research studies published in peer-reviewed medical journals;
2. Consensus of expert medical opinion (i.e., recognized authorities in the field); or
3. Medical opinion derived from consultations with medical associations or other health care experts.
Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence must be considered and its quality shall be evaluated before a conclusion is reached."
If you have information that has been published in a peer review medical journal that you would like to submit, you may send the information to me at my e-mail address below or to Stephen Boren, MD the Medical Director responsible for this policy at Stephen_Boren@wpsic.com. Narrative accounts of individual beneficiary treatment, while interesting will not assist in the final determination for this policy.
WPS received no "Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies" or " Scientific data or research studies published in peer-reviewed medical journals". In addition WPS consulted with experts in the field who did not feel that PTNS was standard treatment.
Comment:
I have been billing CPT code 64555 Percutaneous implantation of neurostimulator electrodes; peripheral nerve (Excludes sacral nerve) for PTNS why is this LCD going to stop coverage of this treatment?
Response:
CPT code 64555 Percutaneous implantation of neurostimulator electrodes; peripheral nerve (Excludes sacral nerve) is not the CPT code that describes Percutaneous Tibial Nerve Stimulation (PTNS) and may not be used to bill this procedure. CPT code 95971 also my not be used as it does not describe the service rendered.
CPT code 64555 is used for the implantation of a neurostimulator electrode. It does not properly describe the service provided by the URGENT® PC Neuromodulation System. |
