PTNS and CMS' Misvalued Code Initiative - impact on Uroplasty

[Anonymous]

well, Mr. Stockholder, perhaps you haven't read the voiding diary data from the OrBiT or SuMiT trials at 12 weeks. Approx a mean reduction in voiding frequency of 20%. Barely a noticeable increase in voided volumes. Quite a bit different than the BS "80% response" crap this company espouses. So, when you say it works as well as anything else out there, you must be excluding Botox and Sacral Nerve stim who actually document much greater symptomatic improvement.

Here's a stock tip: Sell this dog, close your position NOW.

I get a feeling somebody took your stock tip to heart. I see huge trading volume and big drop in share price for this stock today.

 

[Anonymous]

well, Mr. Stockholder, perhaps you haven't read the voiding diary data from the OrBiT or SuMiT trials at 12 weeks. Approx a mean reduction in voiding frequency of 20%. Barely a noticeable increase in voided volumes. Quite a bit different than the BS "80% response" crap this company espouses. So, when you say it works as well as anything else out there, you must be excluding Botox and Sacral Nerve stim who actually document much greater symptomatic improvement.

Here's a stock tip: Sell this dog, close your position NOW.

Stock took a beating today, but not because of your error in reporting clinical data. The investment community finally got wind that NGS, NY Medicare, will not be covering PTNS. There were two huge blocks of stock traded today. 108K shares that took the price to $3.00, then a 122K block that beat it down to $2.83. NGS made an error in not covering PTNS, while other carriers have increased the time to cover out to three years based on good factual data. Just keep bashing the product, you sound foolish doing it.

 

[Anonymous]

Stock took a beating today, but not because of your error in reporting clinical data. The investment community finally got wind that NGS, NY Medicare, will not be covering PTNS. There were two huge blocks of stock traded today. 108K shares that took the price to $3.00, then a 122K block that beat it down to $2.83. NGS made an error in not covering PTNS, while other carriers have increased the time to cover out to three years based on good factual data. Just keep bashing the product, you sound foolish doing it.

There are two ways you can look at this: NGS made a mistake because they did not match the actions of the other Medicare Carriers, or that Management did a poor job of executing its dealing with NGS.

In your opinion you seem to put all the weight on the former. Some investors may tend to put greater weight on the later, because they may ask: Isn't it management's responsibility to successfully mange third parties who have such major implications on shareholder value? Stock dropped about 10 percent from previous day's close, assuming the drop is because of NGS' non coverage decision as you seem to suggest, for a loss of about $7 million to the shareholders in market cap.

It is also possible that another overhang on investors' mind may be the uncertain outcome of the issue of physician time involved with providing the TRx, and the potential downwards reevaluation of the reimbursement amount .

I agree with you that it is unfair to incorrectly bash the Company or the product as some may be doing on this message board, but I do not see why shareholders cannot have a legitimate discussion and ask tough questions, as should the Company's Board to its management.

 

[Anonymous]

There are two ways you can look at this: NGS made a mistake because they did not match the actions of the other Medicare Carriers, or that Management did a poor job of executing its dealing with NGS.

In your opinion you seem to put all the weight on the former. Some investors may tend to put greater weight on the later, because they may ask: Isn't it management's responsibility to successfully mange third parties who have such major implications on shareholder value? Stock dropped about 10 percent from previous day's close, assuming the drop is because of NGS' non coverage decision as you seem to suggest, for a loss of about $7 million to the shareholders in market cap.

It is also possible that another overhang on investors' mind may be the uncertain outcome of the issue of physician time involved with providing the TRx, and the potential downwards reevaluation of the reimbursement amount .

I agree with you that it is unfair to incorrectly bash the Company or the product as some may be doing on this message board, but I do not see why shareholders cannot have a legitimate discussion and ask tough questions, as should the Company's Board to its management.

I question if there are sufficient competencies in the company to mange proper execution of such complicated affairs with the Medicare carriers. The going will get even tougher when (not if) reimbursement amount for PTNS TRx is cut back.....just my opinion.

 

[Anonymous]

Well someone in the company must be doing something right with payors: In December 2013,the BCBS TEC reviewed PTNS and said it met the TEC criteria. That is a sizable win for PTNS and UPI. Now they can go after NGS again.

 

[Anonymous]

Please correct me if I am wrong: Can't you perform PTNS w/o the Uroplasty unit? You can use a acupuncture electro unit and set it up to the exact same parameters as the unit (well documented in the literature) at literally a fraction of the cost.
The unit is around four hundred dollars, lead wire around twenty (reusable) attached to alligator clip (reusable) attached to acupuncture needle (not reusable/six to eight cents a treatment) - you can reuse the lead wire and alligator clip on multiple patients since neither are touching the patient.
Why aren't more clinics using this method? Once the unit is paid for (very few treatments), you are making $64.02 more each session.
I really ask this out of curiosity. I have been thinking of adding this to my clinic, but exploring cheaper options. Is it illegal to do PTNS with a different unit? With the acupuncture electro unit you are doing the exact same treatment.

 

[Anonymous]

Please correct me if I am wrong: Can't you perform PTNS w/o the Uroplasty unit? You can use a acupuncture electro unit and set it up to the exact same parameters as the unit (well documented in the literature) at literally a fraction of the cost.
The unit is around four hundred dollars, lead wire around twenty (reusable) attached to alligator clip (reusable) attached to acupuncture needle (not reusable/six to eight cents a treatment) - you can reuse the lead wire and alligator clip on multiple patients since neither are touching the patient.
Why aren't more clinics using this method? Once the unit is paid for (very few treatments), you are making $64.02 more each session.
I really ask this out of curiosity. I have been thinking of adding this to my clinic, but exploring cheaper options. Is it illegal to do PTNS with a different unit? With the acupuncture electro unit you are doing the exact same treatment.

There are several IMRs doing "mobile PTNS" using this exact method. They own an older PTNS unit with the reusable leads (the company sold reusable leads back in the day). The CPT code is not specific to Urgent PC BUT the unit you are using must be FDA approved if you want to be legal. A certain Mobile PTNS company use to be an IMR for UPI and has been doing Mobile PTNS for over 5 years. Physicians don't care because the liability isn't theirs because they assume the IMRs unit is FDA approved (which it isn't because it uses an E-stim reusable lead). The patient can get Urodynamics and PTNS from the Mobile PTNS IMR.

 

[Anonymous]

Wow...the BCBCA TEC announcement is pretty major, especially since TEC said PTNS didn't meet its criteria 3 years ago. PTNS should soon get reimbursed by the 40 or so BCBS states that don't cover it currently.

Good job RK...

 

[Anonymous]

Wow...the BCBCA TEC announcement is pretty major, especially since TEC said PTNS didn't meet its criteria 3 years ago. PTNS should soon get reimbursed by the 40 or so BCBS states that don't cover it currently.

Good job RK...

I am all for giving credit where and to whom it is due, and I am sure RK is deserving of credits in many areas, but not with the success of BCBS TEC assessment.

95+% of the work on this was completed during DK's era. It was then simply a matter of the bureaucratic wheels at BCBS to finish churning.

For those of you who are fawning over RK, please let us give credit where it is due!

 

[Anonymous]

I wonder if the BCBS folks realized that you base your 3 year data on 29 patients out of the original 110 from SuMiT?

For those scoring at home, that's 74% lost to follow-up. Your statistics are crap. What does the Intent to Treat numbers look like at 3 years?

Did they even look at the results from OrBiT, or just ignore the fact that PTNS was no better than one of the oldest drugs on the market?

 

[Anonymous]

I am wondering if anyone can point me toward a "sham/placebo" PTNS study. i would like to know if anyone has proven that PTNS helps and that an alternative current/placement of needle is any better than true PTNS.

I often wonder if the improvement from PTNS is due to making the patient more aware of their bladder habits/behavior education/urge suppression techniques/timed voids/decreased bladder irritants/teaching a patient how to properly void etc.

Thanks

 

[Anonymous]

PTNS and CMS' Misvalued Code Initiative - impact on Uroplasty

According to CMS' proposed rule for 2014, "We are proposing CPT 64566 (Posterior tibial neurostimulation,
percutaneous needle electrode, single treatment, includes programming) as a potentially misvalued code because we think that the procedure typically is furnished by support staff with supervision as opposed to
being furnished by the physician. We are concerned that the current valuation is based on the procedure being furnished by a physician."

What could this mean for UPI?

Well, according to the comment letter that followed the proposed rule from Dr. Scott MacDiarmid (who is the co-author of a number of PTNS studies, including the STEP study):

"Having lectured nationwide on PTNS I believe that its current reimbursement is a significant barrier to Urologists beginning the treatment in their practice. I am afraid that lower reimbursement could threaten this even further limiting its access to patients."

What does CMS' position mean for Urgent PC, and therefore for UPI?

http://finance.yahoo.com/mb/forumview/?&v=m&bn=4a83b984-ebaf-3ee4-9565-d67c46bb32ca

As of January 31, 2014, we had Medicare coverage for Urgent PC in 40 states covering approximately 40 million lives, and we estimate private payers insuring approximately 107 million lives provide coverage for Urgent PC.




Medicare reimbursement coverage for PTNS is determined by regional Medicare Administrative Contractors (MAC), each of which cover certain states. Currently, there are eight MACs with seven providing reimbursement coverage for PTNS. National Government Services (NGS) is the lone MAC that does not provide coverage. NGS had jurisdiction over two states at April 1, 2013, but due to consolidation of certain MACs, now has jurisdiction over ten states. In November 2013, NGS re-affirmed its non-coverage policy for PTNS. We plan to continue to educate NGS Medical Directors about the benefits and positive outcomes of PTNS therapy.




It is expected that the Centers for Medicare and Medicaid Services (CMS) will continue to consolidate the regional Medicare Administrative Contractors, and there is no guarantee that Medicare beneficiaries in a region with reimbursement coverage will continue to be reimbursed when consolidated into a regional Medicare carrier with a negative reimbursement policy, or, if reimbursed, that coverage will remain unchanged.





We have a comprehensive program to educate the medical directors of both Medicare and private payers regarding the clinical effectiveness, cost effectiveness and patient benefits of using our Urgent PC System. We continue to work with the medical directors to expand coverage of Urgent PC, and to ensure that coverage continues after the number of Medicare regions are consolidated and regional Medicare administrators are transitioned.




In November 2013, CMS released the final 2014 Physician Fee Schedule, and the Relative Value Units (RVUs) for PTNS reimbursement are substantially the same as the proposed reimbursement published in July. The RVUs are multiplied by a standard conversion factor to arrive at the dollar amount of reimbursement. The conversion factor for 2014 has temporarily been set at $35.82 by Congress, but this conversion factor is in effect only through March 31, 2014. At that time the final reimbursement amount for 2014 is subject to any potential Congressional action as it relates to the Medicare Sustainable Growth Rate (SGR) formula.




The code under which PTNS is reimbursed was one of several hundred codes that CMS noted as a potentially misvalued code earlier this year. In November 2013, CMS indicated further review of PTNS is warranted, and as a result, CMS will be gathering additional feedback before a final decision is made. The final decision could result in an increase, a decrease or no change in the reimbursement rate for PTNS. Any change to the reimbursement rate due to this review is not expected to be published until November 2014 and will become effective beginning in January 2015.




In December, the Blue Cross and Blue Shield Association Medical Advisory Panel concluded that use of PTNS for the treatment of voiding dysfunction meets their Technology Evaluation Center criteria. This panel is responsible for assessing medical technologies through a comprehensive review of clinical evidence. This positive assessment concluded that PTNS improves net health outcomes as much as, or more than, other established therapies and is strong validation of the acceptance of Urgent PC as an important treatment option for OAB. Currently, there are approximately 100 million lives covered by the 37 BCBS companies across the United States, with 21 million lives currently having access to PTNS through positive coverage from their local plan. This decision can now be used by the remaining BCBS companies as an important tool in assessing positive coverage for PTNS for the treatment of overactive bladder.

http://archive.fast-edgar.com//20140206/AQ2ZA22CZ222B2EK222W2232GDLRZC22ZW62/

 

[Anonymous]

I wonder if the BCBS folks realized that you base your 3 year data on 29 patients out of the original 110 from SuMiT?

For those scoring at home, that's 74% lost to follow-up. Your statistics are crap. What does the Intent to Treat numbers look like at 3 years?

Did they even look at the results from OrBiT, or just ignore the fact that PTNS was no better than one of the oldest drugs on the market?

This is a cute message from the Interstim rep. Let's be honest, your data is BS, too. For what you charge and the amount of patients you double implant and implant that actually fail tests you should be disgusted. And, for the number of pts that get canned, you should have much better, long term prospective double blind sham data than that which you promote with. That data should include explanted pts, and measure a cost per successful pt averaging in the expense to test the failed ones...

 

[Anonymous]

This is a cute message from the Interstim rep. Let's be honest, your data is BS, too. For what you charge and the amount of patients you double implant and implant that actually fail tests you should be disgusted. And, for the number of pts that get canned, you should have much better, long term prospective double blind sham data than that which you promote with. That data should include explanted pts, and measure a cost per successful pt averaging in the expense to test the failed ones...

...and this makes your crap data better? At least interstim was able to show superiority over one of the oldest medications on the market. The OrBiT trial didn't.