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Medifocus I •• • •• 
December 30, 2019 
Centers for Medicare and Medicaid Services 
Mail Stop: C4-01-26 
7500 Security Boulevard 
Baltimore, MD 21244 
RE: POTENTIALLY MISVALUED CODES 
Dear Sir/Madam: 
Please consider this letter my official petition of the misvalued CPT code 53850 Transurethral destruction of prostate tissue; by microwave thermotherapy. 
Background: 
As per , 42 CFR Parts 405, 410,411, 4141, 415, 425 and 495 (CMS-1693-F, CMS-1693-IFC, CMS-5522-F3, and CMS-1701-F, please find our comments to the final rule which addresses changes to the Medicare Physician Fee Schedule (PPS) reflecting updates in medical practices and relative value of services. This specifically relates to (24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 53852, and 53854) as reviewed as a family of codes related to the CPT Editorial Panel to create a new code (CPT Code 52854). 
Comment: 
For CPT code 53850, which we currently fall under due to the lack of a proper code for our specific Prolieve BPH treatment device, is strictly only microwave single modality. The Prolieve BPH is the only Transurethral Thermodilatation (TUTD) approved by the FDA which is a combinational thermotherapy with Microwave, plus a "Prostatic Urethral Dilation Balloon." As a result of this, the reviewers and commenters of the AMA /Specialty Society RVS Update Committee (RUC) were not able to address many of the procedural, time, cost, etc. factors when they recommended and proposed to CMS. CMS accepted a major reduction of the RYU to 5.42 for the CPT code 53850, which represents almost a 24% reduction of the fees collected. Although this may be reasonable for the I st and 2nd generation TUMT treatment devices, this does not capture the resources and cost involved to provide the benefits of our Prolieve TUTD device and is considered as the 3rd generation TUMT (Aleksic L Mouraviev V, Alba/a DM: Transurethral Microwave Therapy. In: Chughtai B, Te AE, Kaplan SA, editors. Treatment of Benign Prostatic Hyperplasia: Modern Alternative to Transurethral Resection of the Prostate, New York: Springer; 2015, p. 121-129. ISBN· 978-1-4939-1586-6). 
M d1fric._,c,, nc. 10240 0 d (1.,lumb, Ro ic., S1..1t0 G, Columb1d, J'v'ID 21046 Phone (410) 290 5734 Fax (410) 290 7255 
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nc :::: .. 
Medifocus I •• • 
As per the minutes of the January 10-13, 2018 meeting, the Facilitation Committee #1 did have the latest FDA approved information on our 5 year follow up post approval study (PAS) for our TUTD Prolieve device dated March 8, 2018 (Attachment A) and the final FDA approved labeling on November 21, 2018 (Attachment B). 
In addition, which is very important to the justification of our request and comments, in November 2018, which was after the review by the AMA RUC meeting and the final acceptance by CMS in Sept. 2018, the FDA approved our PMA Supplement for new labeling based on a recently FDA approved 5 year follow-up Post Approval Study (PAS). This demonstrated not only Prolieve was effective for immediate improvement to their LUTS caused by BPH, but now Prolieve has demonstrated durable and long-term benefits for up to 5 years of follow-up for the responder group. The durability of response of up to 5 years can have a major savings impact to the overall healthcare costs for the treatment and management of the many men with LUTS caused by BPH. The Prolieve treatment is truly an office-based treatment. It does need to be performed in a surgical center and/or hospital, which can involve major added expenses, such as: sterile treatment room, high cost facility fees, addition support staff, general anesthesia, etc. as required for some of the other minimal or invasive treatments or surgery for the treatment and relief ofLUTS. 
We believe our immediate and long-term benefits of our office-based treatment, as approved by the FDA, is attributed to the combinational thermotherapy, plus the Prostatic Urethral Dilation Balloon. As a result of the requirement of the dilation balloon modality, it adds significant cost to the treatment console. In addition, the incorporation of the dilation balloon to the disposable treatment kit increases the cost of the equipment and supplies by 50%. The complexity of the dilation balloon to optimize the pressure and placement requires increased pre and post service time of an additional 15 minutes from that of the 1st and 2nd generation TUMT. For the unique Prolieve treatment to enable immediate relief and formulate a biological stent, an additional 5-minute cool down period is also required. Unlike the 1st and 
2nd 
generation TUMT, which in order to be effective, these modalities have over time shortened the procedural time to 28.5 minutes and increased higher powers which causes increased pain and potentially increased adverse events, and the majority require post treatment catheters. The Procedural Protocol of the Prolieve which enables effective prostatic tissue ablation at lower powers, resulting in a more patient friendly treatment, does not require pain blockers or general anesthesia and, the majority of the patients will not require a post treatment catheter. This treatment requires a total procedural time of 45 minutes, plus 5 minutes cool down, increasing the treatment time by 50%. 
The FDA approved Indication for use of Prolieve is below: 
1/'ed••ocu , I, L 1J240 VIC Co u,nb1d Ruud, Suite G Co U'Tlbi.i, MD 2104b Pro"le :410) 290 5734 Fax (410) 290 7255 
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Indications for Use 
The Prolieve® Transurethral ThermoDilatation n., (TUTD) System: 
Prolieve® is a transurethral thermodilatation microwave therapy device that provides a non­surgical, minimally invasive procedure for the treatment of symptomatic BPH in men with a prostate size of 20 to 80 grams, a prostatic urethra length of 1.2 to 5.5 cm and in whom drug therapy (e.g. Proscar®) is typically indicated. 
Note: In addition to the fact we are the only TUTD device, we are the only category CPT 53850 with an indication for use of "and in whom drug Therapy (e.g. Proscar®) is typically indicated" as well as the only thermodilatation device. 
This means, this could be an additional heath care costs savings for the men who are on drug therapy and may eliminate the need and cost for drug therapy for up to 5 years. 
The Prolieve FDA PAS study is the very latest 5 year follow up of minimally invasive BPH treatments in this class of treatment options and has fully demonstrated the safety and effectiveness of both immediate and long-term benefits. The following are additional and unique comments for the Prolieve Device, which is why we believe our CPT code 53850 Prolieve is potentially misvalued. 
1. 
The cost of the treatment console is higher to be able to control and inflate the transurethral prostatic dilation balloon used in the treatment. 

2. 
The cost of incorporating the transurethral prostatic dilation Balloon which expands to 44 French adds to the manufacturing and material cost for the single use treatment kit. 

3. 
There is extra time and steps required to inflate/deflate and pretest the dilation balloon prior to inserting it into the patient. 

4. 
There is extra time requirement to insert, position and expand the dilation balloon readying for treatment. 

5. 
An additional 5-minute cool down period is required with the dilation balloon fully inflated after the microwave session is completed. 

6. 
After the cool down period, an additional step would be the dilation balloon must be fully deflated to remove. 


IV'l;'d focu Ir>, lOl'iO Old C.olurnb1a Road, Su te G ColurntJ1J, MD 2104b Phone (410) 290 5 734 Fax (410) 290 7255 
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Medifocus I •• • 

7. The Prolieve TUTD 3rd generation TUMT requires an increase of 50% treatment procedural time over the 1st and 2nd Generation TUMT to provide the proven safe and effective treatment of the recent FDA approved treatment protocol to deliver the added clinical and safety benefits of our TUTD treatment modality. 
Since this is a multi modality treatment, we believe the additional CPT code 74485 with an RVU of .083 could be added. Although, it still may not cover the full impact of RVS and cost associated for the Prolieve treatment. We recognize CPT 74485 is diagnostic and is for another indication however, it is similar in scope. 74485 is the Dilation of urether(s) or urethral, radiological supervision and interpretation which was also just reviewed by RUC and CMS recommended. This will revalue our Prolieve treatment to incorporate and justify the revaluation of the Prolieve treatment. 
Thus, in summary, we hope that for the upcoming CY 2020 CMS, PFS can be revised to incorporate the unique cost and time required to perform the Prolieve treatment. We understand the CY2019 is already fixed. However, for CY2019, would it be acceptable for the Prolieve users to bill with the extra CPT code 74485, even though it may not cover the entire cost. 
Approximately 200 Urologists over the past 3 years have provided the Prolieve treatment in the USA as a truly office based BPH treatment option. With the significant, reduction in the CPT (2019) reimbursement by CMS/RUC, economically, the clinicians cannot cover the costs of providing the Prolieve treatment in their office to the benefit of their BPH patients. We cannot cover the costs of manufacturing to provide the Prolieve disposable kits without going out of business. 
I have attached the original letter to CMS and AMA dated Dec. 13, 2018 (Attachment C). In addition, urologic colleagues in Asia have similar findings to the benefits of Prolieve treatment for BPH (see Attachment D). 
Finally, we are the only FDA approved dual modality treatment and as mentioned prior it requires more time and expertise due to the added steps of the urethral dilation balloon, higher material and manufacturing cost for both the disposable treatment kit and treatment console in order to deliver the treatment which we believe is safer, less adverse events, less painful, yielding immediate relief, as well as durable long term efficacy as demonstrated by the most recent FDA approve 5 year follow-up post approval study . The recent deductions may be justified for the other single modality treatment using this CPT, which is without the dilation balloon and their treatment was shortened to 28.5 minutes. Our treatment requires 45 minutes 
Med focu~, nc 10240 Old Lok mbIJ Ro,id, Suite G, Lolumbld MD 21046 Phone (410) 290 5734 Fax (410) 290 7255 
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Medifocus I nc .•• .... . 
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plus a 5-minute cool down period, for a total of 50 minutes treatment time, plus addition pre­treatment time for the urethral dilation balloon. As mentioned, we believe our treatment is misvalued and should be increased and/or allow us to bundle and add a urethral dilation CPT when using our treatment modality. 
Without the revaluation, it is not economically feasible for the physicians to provide the Prolieve treatment and it is not economically feasible for Medifocus to stay in business. Plus, this will reduce the few truly safe and effective office based BPH treatment options, which not only benefits patients and improves their quality of life but significantly reduces the overall healthcare cost of the management of symptoms caused by BPH. 
We hope that you can provide us with a revaluation for our Prolieve treatment modality. 
Sincerely, 
~1J-.. 
John Mon, General Manager Medifocus, Inc. 

IV'E d fotUS, n 10..'40 Old ( vi rnb1d Ro~d, <,u tf' c,, (olumb1d, VID ..' 1046 Phone (410) 290 5/34 F-ax (410) 290 1255 

u.:a .. ruuu & un.uu ADMINISTRATION  ATTACHMENT A  
DEP  RT:\lE. 'T OF HEALTH & HU:\IAi~ SERVICE Punlic lh:alth C.,~r-.1ce  

r o,,d and Drug ,\<lm101strat1, ,n 

March 8, 2018 10'101 Nl·v. H,11np,h11 t A •.!nue ll,1,ument (\,ntrul cntc1 \\'On<d,60'1 '-il\t·r Sr11nf! MD 20'1'1'-t)(Kl:! 
Medifocus, Inc. Mr. Jon Mon 
Chief Operating Officer 8320 Guildford Road, Suite A Columbia, MD 21046 

Re: P030006/R027 Prolieve Thennodilatation System Study Name: OSB Lead-Prolieve PAS Received: June 15, 2017 Amended: November 6, 2017 
Dear Mr. Mon: 

The Center for Devices and Radiological Health of the Food and Drug Administration (FDA) has completed the review of your final post-approval study report for the Prolieve Thennodilatation System. This post-approval study requirement was described in the approval order dated February 19, 2004 for premarket approval application (PMA) P030006. FDA is pleased to inform you that you have fulfilled your post-approval study requirement for the study name referenced above. 
Please submit a PMA supplement, within 30 days from the date of our letter, which modifies the labeling to reflect the findings of the study. This supplement should include a new section of the label that reflects long-term data from the Post-Approval Study. The labeling supplement should include a summary of the post-approval study design, results, and study strengths and limitations. 
The format below is recommended. There are no fees associated with labeling change supplements based on post-approval study results; thus, please clearly indicate that this is a 
"Post-Approval Study Labeling Update." 

Post-Approval Study 

Summary of the Post-Approval Study Methods 
Study Objective 
Study Design 

U.S. Food & Drug Administration 10903 New Hampshire Avenue Sliver Spring, MD 20993 
www,fda.gov 
Page 2 -Mr. Jon Mon 
Study Population 
Data Source 
Key Study Endpoints 

Total number of Enrolled Study Sites and Subjects, Follow-up Rate 
Study visits and length of follow-up 
Summary of the Post-Approval Study Results 
Final safety findings (key endpoints) 
Final effectiveness findings (key endpoints) 
Study Strength and Weaknesses 

Please be advised that once you have submitted this supplement, you should also submit an amendment to this post-approval study final report that notifies us of the date you submitted the labeling supplement and what number the supplement was assigned by FDA. Your post~ approval study report will remain open until we receive this amendment. 
Please be advised that your study status will be marked as "Progress Adequate" on the Post­Approval Studies webpage until we receive your amended report ( www. f da.rwv /dev1 ceposta 1,1 prova I). 
The required 3 copies of your PMA supplement should include the FDA reference number to facilitate processing, be identified as a "PMA Post-Approval Study Labeling Update" and should be submitted to the following address: 
U.S. Food and Drug Administration Center for Devices and Radiological Health PMA Document Control Center -WO66-G609 10903 New Hampshire A venue Silver Spring, MD 20993-0002 
Page 3 -Mr. Jon Mon If you have any questions concerning this letter, please contact Allison O'Neill, PhD, MA at 
(301) 796-4141 or Allison.oneill@fda.hhs.gov. 

Sincerely yours, 

Benjamin C. Eloff -S 
on behalf of 
Danica Marinac-Dabic, M.D., Ph.D. Director, Division of Epidemiology Office of Surveillance and Biometrics Center for Devices and Radiological Health 

ATTACHMENT B 
U.S. FOOD & DRUG 
A ,1 I . ' 

November 21, 2018 
John Mon General Manager Medi-focus, foe. 10240 Old Columbia Road, Suite G Columbia, MD 21046 


Re: P030006/S028 Trade/Device Name: Prolieve Thermodilation System: Product Code: MEQ Filed: March 30, 2018 
Dear John Mon: 
The Center for Devices and Radiological l-kalrh (CDRH) of the Food ,md Dn.\g Administn.1tit)l1 ffl)A) h~. 
completed its review of your premarket approval application (.PMA) 180-dny ~u:ppknw.m, whi1:h l'l~t\i;::sl -~ 
approval for a labeling l.tpclnte with the results of the Post-Approval Study (PAS), fiasoo \ll)'{•n tht, 
information submitted, the PMA supplement is approved. You 1nay begin \)~)t\1.nW\\~iitl dislrihUU\•'f• ~)f\h~ 
device as modified by your PMA supplement in accordance ~ith the conditions tfo~crih<0t.'l bol~w, .Ahh-:-. gh 
this letter refers to your product as a device, please be aware that some npprt• ,I)() pn.)d\K'tS in~y h~s.•~~d h.: 
combination products. The Premarket Approval Database Jocatod at 
I ti 11 • ·.. \.,, \\ i\ . , , , 1 , 1 1, idc-111 ,tks ':f)~nbinatiun pfl)x°IH~t 
submissions. 
The sale and distribution of this dovice are resrricted to prescription uso in (~cconinn.:-c Witll ?. l t "fR ~()), l 09 and under section 5 l 5(d)(1 )(B)(ii) of the Federal Food, Drug, and Costl\~l\t A 't tth¢ ~tt), fl)A h~.' detem1ined that these resttictions on sale and distribution are n~cssary to provide l'ct)son:lbh) ~-.~sUt'M\t~i.l r~r the safoty and effectiveness of the device. Your device is therefore a restricted ,fovi0t) s-ubjoot H.'l thi.' requirements in sections 502(q) and (r) of the act, in addition to th~ n,a.ny uthl:'f fl)A l~\ll)'<o:ff\ ":t)l~ g(\Vrcn'ling the manufacture. distribution, and marketing of devices. 
Continued approval of the PMA is contingent upon the submission of periodic i'0~11i:~, req\lll-'et.°l md~r :!l CFR 814.84, at intervals of one year (unless otherwise specified) &om th" date uf~:pprov~) t)fth~ migini\J P.MA. This report, identified a.s "An._nua] Report" and bearing the applicable PMA :rcfi..~-~n~c-~n~mhQl\ ~-,uld be submitted to the address below. The Annual Report should indicate the beginni••t ~nd '¢l'\.J-intt Jatu t'iftfo~ period covered by the report and should include the inf01mation required h),' 21 CfR ·•]-UU, 
In addition to the above, and to provide continued reasonable assurance u:f1he safety tmd ¢t'f~'h'\\~l)l¢',s.."l ()ftht PMA device, the Annnal Rep01i must include, separately for e.<t~h modcl m.onb·)l' tif .\ppli~abfot th~ ntlliib~ 
U.S. Food & D1·ug A<Jmh1lstr<1tlon !0903 New Hampshire Avenue Sliver ~prln91 MD zo993 
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P030006/S028 -Jolui Mon 

of devices sold and distributed during the repmt-ing period, including thos.e di~uihuh .. ,l \u Ji::i.tnbul(>,L\ nw distribution dat£L will serve as a denominator and provide necessary conte. t fol' fl)A to itS~0l'l~ in l " 
frequency and prevalence of adverse events, a.:; FDA evaluates the continued ~afoty ~md d 'e,:1iY"<.n .... ~.-; ftl1ht device. 
This is a reminder that as of September 24, 2014, class III devices arc subject to Ct)Jt~in 1,,1--ovi~lt"':in& (If th~ final UD1 rule. These provisions include the requirement w provide a UOI on tho d~vi0c-hhcl :.\nd p!,\c.kt)~ ~s (21 CFR 801 .20), format dates on the device label in accordance with 21 (:f'R 801, l ~t tmd ~1\h-roit d~h• l() 1hci Global Unique Device Identification Database (GUDID) (21 Cf R 830 Suhpurt E), Attditlon::-lly, '.!l C._'R 
814. 84 (b )( 4) requires P MA anntial reports submitted after Septembei· 24, 2014, tt) idl~itify t'~ )h de-'\"'1: identifier currently in use for the subject dc;::vicc, and the device idontifiers i't,r devi(iu~ that h~\'t:: b'(.,°'t'U discontinued since the previous periodic report. It is not necessary to identity any d¢\'iN idel'ltm1:-r discontinued prior to December 23, 2013. Combination Products may also be subjQd tu UO) \'t.'t)ui.:·~n-.~'lit.' (see 21 CFR 801.30). For more info1.mation on these requirements, please ~ee the l1Dl \V~b~lL\ hfll"I '\ \.\ \ f,!1 t .. •.' l !t. 
Before making any change affecting the safety or effectiveness :)f the PM.A d~vit1:\ yuu nnlS.l. ~..-obn)it ~ )_,) ·iA supplement or an alternate submission (30-day notice) in accordance with 11 C'FR SH,39, All )•MA supplements and alternate submissions (30-day notice) must cmuply with the applicable l\..,q_Uil'®:"'.t~uts hl 21 CFR 814 .3 9. For more info1mation, please refer to the FDA go.idtmce doe;ument enl.itled, 11lvfodifo.xrtil)l)s t1.., 
11 

Devices Subject to Premarket Approval (PMA)-lne PMA Supp)em.ent :O~isiun-Mt,bng l"\'tttiQ:'~

tH. l 


You are reminded that many FD A requirements govern the 1nanufooturo, di, tribufo:m, llnd m4\d:.ot,uij ~f devices. For example, in accordance with the Medical Device Reporting (MOR)~ &\dufa.:\l :n .... )<' ,'0'.l$0 and 21 CFR 803 .52 for devices or postma:rkding safety reporl.ing (2 l C:fR 4, Suhpilrt B) f1.·w l;l()Ulh\Ol:\l.i~:-.n products, you arc required to report adverse events for this device. Manufru::tUl'et'~ uflticdit:al dv.:'i!i )~S, including in vitro diagnostic devices, are required to report to FDA no latei1· thiu1 30 t)t).\end~l.' d~ys rd\t:r tb) day they receive or otherwise becomes aware of information, :from any ~m.tr~, 1-httl l'0~$o.n~bl,' ~w~ ),~-~ 1hd one of their marketed devices: 
1. May have caused or contributed. to a death or serious injury; or 
2, Has malfunctioned and such device or similar device market.od by the ll\~~tnd1.ct'tll~' '2 ·\mM h12 likcl to cause or contribute to i:1 death or scn,.)US injmy if the malfimctit,n wa'e h) rte 'lll\ 
Additional infortna.tion on MDR, 1ncluding how, when, and whore to report i~ ~vl\il:!\hk tlt hrt11· \IV\\ w Id 1, •· 1 v di~ 111, 1 1 1. . r 1 1 ,1~ , _ 
, 1 und t.):O ct,mbin1:llli>ti -pl-Othh:.:l postmarketing safety reporting is available at (see lt11p.,, ,v,\.\ .• d,., inh 11, • 11 •.• d'. ~•ul,1tur~nfo1urnt1)1t1 m,271~.~.ht111l 
In accordance with the recall requirements specified in 21 CFR 806. l O tlw devices or '\he: .P\\~ll'.l.'.\.1 d:.~fo::tg safety reporting requirements (2 l CFR 4, Subpart B) for combination pr0tlucts., yo\t tU'¢ rcqui1 }tl \~~ ~\ll:n:nit , written report to FDA of any correction or removal of this devic~ initi&ted by you t<l, { l) •~~o:.. ri~ tt) health posed by the device; or {2) remedy a violation of the act caused b)I tho devke, which nu ' l"'ll~Nnl ~ P030006/S028 -Job.rt Mun 
risk to health, with certain exe~ptioru; spca.:ific<l m 21 CFR 806.lO(it)(.2). Additibrml i~·d1:.,rmmit,n ~\n l'1;•1..~~n:::. i~ 
available at 
111111 ,~\_1,_.t,_~<1 •):\ ~:d ·t\ l'c,,-,tll lndl1 ,11\ l ,t d 11 ·:" 1 i! I· ,Ill. 
CDRH does not evaluate information related to contract liability wru1.tU1tie~. w~ r~..roiud yor,~ huWt.•\'~, ~foil 
device labeling must be trnthfol and not misleading. 
Failure to comply with any post~approval requirement constitutes a ground for w1thth--a\val t)f t\l•l)\'t\ '-~l t)f n 
PMA. The introduction or delivery for i.ntrodu.ction into intersta1e comme\-c-t:., o,f ~ dc\'1"0 th~t •~ r1r•l in 
compliance with its conditions of approval is a violation oflaw. 
You are reminded that, as soon as possible and before commercial distributl\)l"' of your duvil.:e, ),''1..•H n,u~t submit an amendment to this PMA submission with a copy of all final la.holing. fin1l fabclin.~ thal i~ identical to the labeling approved in draft form will not routindy be :review1:--d by f'DA staffWhl.:l) accompanied by a cover letter stating that the final labeling is :identical tu the labeling l\l)J)l't, ~-d in Jr~ft form. If the final labeling is not identical, any changes from the final drat'\ fobohug ~m,ld b~-h(~hli~h\~! ~\l explained in the amendment. 
All required documents should be submitted, unless otherwise $}~cificd, m the addr1...~s b~lu\\' tu':h1 ~l'..)\~M reference the above PMA number to facilitate processing. 
U.S. Food and Dru.g Administration Center fo1· Devices rmd Radioloitical Hoahh Document Contml Center -W O66-G609 10903 New Hampshire A venue Silver Sp1ing, MD 20993-0002 
If you have ao.y questions concerning this approval order, plea..:_~~ cont~et .lhn Sdle-r ~l t)Ol) '7l)('!~~:;5~ {)f J UH• . ,i-, k rt·/ I I' !ill 
Sincerely, 
Joyce M_ Whang -S 
for 

Benjamin R. Fisl•cr • .Ph.D. 
Director 

Division of Reproductive, Gastro-R,)n~t 
and Urological Dovices 
Office ofDeivice Evaluation 
Center for Devices and Radfoh)t?,ical Uicl,lth 


ATTACHMENT C 
December 13, 2018 

Centers For Medicare and Medicaid Services Department of Health and Human Services Attention CMS-1693-IFC, Marge Watchorn, Deputy Director, Practitioner Services P.O. Box 8010 Baltimore, MD 21244-8016 


RE: Comments to 59452 Federal RegisterNol. 83, No. 226 
To Whom It May Concern: 
Backgr0tmd: 

As per, 42 CFR Paiis 405, 410,41 l, 4141, 415, 425 and 495 (CMS-1693-F, CMS~J693­1FC, CMS-5522-F3, and CMS-1701-F please find our comments to the final rule which addresses changes to the Medicare Physician Fee Sc.;hedule (PFS) retlecting update~ in medical practices and relative value of services. This specifically relates to (24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 53852, and 53854) as reviewed as a family of codes related to the CPT Editorial Pan~l to create a now vodc (CPT Code 52854). 
Comments: 

For CPT code 53850, which we currently fall under due to the Jnck of a proper code for our specific Prolieve® BPH treatment device, CPT code 538$0 as des:~ribed above is strictly reimbursed for microwave only single modality. Unlike the I"' and 21"1ct generation Non-Dilating Transurethral Microwave Them10the1·apies (TUMT), our Prolieve® BPH treatment is the only FDA approved Transurethral Thcnnodilnt~tionTM (TUTD™) which is a unique combination them1otherapy with Microwave J•I\\~ a "Prostatic Urethral Dilatation Balloon". As a result, we beli~ve tha.t the revieWct'S and commenters of the AMA/Specialty Society RVS Update Committee (RUC) had overlooked such important differences and did not addres the many prooedural~ time, cost, etc. factors in their recommendations and proposals to CMS. ('MS accepted ~ major :reduction of the RYU to 5.42 for the CPT code 538$0 which represents an approximately 24% reduction of the fee schedule for CPT code 53850, Although such fee reduction may be reasonable for the 1 i.1 and 2nd generation TUMT txei\tment devices, this does not capture the resources and costs involved to produce and provide treatr.nent using our Prolieve® TUTD™ device equipped with a highly pressurizQ(l and built-in safety feedback system. 
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In addition, as another important consideration to the justification of our request ~nd comments, the FDA recently on November of 2018, which was after the review by the AMA R.UC meeting and the final acceptance by CMS in Sept 2018; approved the Prolieve•1Il device an FDA PMA Supplement approval for now labeling based on a recently FDA approved 5-year follow-up Post Approval Study (PAS). This dem.onstrated not only Prolieve® was effective for immediate improvement of lower urinary tract symptoms (LUTS) caused by BPH, but also durable and long-tenn clinical benefits for up to 5 years of follow-up for the responder group. The durability ot response of up to 5 years can have a major cost savings impact to the overall healthcare costs fur thQ treatment and management of the many men with LUTS caused by BPH. The Prolieve~ treatment is truly an office-based treatment performed under local anesthesia and docs not require to be performed in a surgical center and/or Hospital, which can involve xnajor added expenses such as sterile treatment room, high-cost facility fees, additional support staff, general anesthesia, etc. as needed for most other minim~ invasive or invf\sive treatments or surgery for the treatment and relief of LUTS. lt would also save the patients from unnecessary exposores to IV sedation or general anesthesia., and their associated risks. 
The FDA approved Indication for use of Prolievc is as follows: 
Indications for Use 

The Pro1ieve® Transurethral ThermoDilatationTM (TUTDTM) Systern; Prolieve® is a transuretlrral thermodilatation microwave therapy_@vic· that ro rides a non-sui·gical., giinimally invasive procedure_for the treatment of SYffilltOmatic BPILh~ men with a prostate size of 20 to 80 grams, a QfOStatic urethra length of l .2 Jo $.$ 9ln l)nd in whom drug therapy (e.g. Pro scar®) is typically indicated. 
Note: ln addition to the fact we are the only TUTD™ device, wo are the only categt)ry CPT 53850 with an indication for use '•in whom drug Therapy ~n.)s~ar:!__}j_s tY,Dical}.y indicated", as well as being the only thermodilatationTM device, 
This translates into additional Healthcare cost savings for thost) men who are on dmg therapy and who may eliminate the need and cost of drug therapy for up to 5 year~, and to avoid the potential long-term side effects of these BPH medications. 
The following are additional and unique comments for the Prolieve® De ~ce com.pared to other Non-Dilating 1st and 2nd generation Transurethral MiCJ.\')Wave Thennothcrapies (TUMT): 
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• 

1. 
The cost of the computerized treatment console is higher to be able to t'et.-dbaok control and inflate the high-pressure transurethral prostatit: dilatation balloon used in the treatment. 

2. 
The cost of incorporating the transurethra1 prostatic dilation balloon which expands to 46 French adds to the manufacturing and material costs for tho singlc-­'Use treatment kit. 

3. 
There are extra time and steps required to inflate/deflate and pretest the dilation balloon prior to inserting it into the patient. 

4. 
There is extra time requirement to insert, position and expand the dilation balloon readying for treatment. 

5. 
There is an additional 5-minute cool down period with the dilation balloon fully inflated after the 4S~minute microwave session is completed. The total trel\b:nent time is significantly longer than other TUMT and minimally invasive procedures. 

6. 
After the cool down period, additional steps are needed before the dilatation balloon can be fully deflated and removed. 


Since this is a multi-modality treatment, we believe the additional CPT code 74485 with an RYU of .083 could be added. Nevertheless, it still may not i;;<w~r the foll ini.J)f\~t C\f RVS and cost associated with providing the Prolieve® h'eatlnen.t. We rooognize CPT 74485 is diagnostic and is for another indication; however, it is similar in scope, C'P'l' 74485 is the Dilation of Urethra(s) or urethral, radiological supervision and interpretation which was also just reviewed by RUC and CMS recommended. 
In summary, we hope that for the upcoming CY 2020 CMS, PFS can. be revised to incorporate the unique costs and time required to provide the Prolieve® treaun.ent. We understand the CY2019 is already fixed. However, for CY2019, would it be accoptablo for the Prolieve® users to bill with the extra CPT code 7448S, even though it n1ay not cover the entire cost? 
Sincerely, \ ·l 
l ' ! I . 
,,,~, -C ,--..._ 
'--, 1­
Il 
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.. 
Johri Mon General Manager, Medifocus Inc. 
11 

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ATTACHMENT D 

Abstracts 
(11 -231, ow ho~p1tal, 11 --16, 0utwfo hospitals), t~u pul1c11~ died (malignant disease) with stcnts in-situ, three had long-standing stents plans in progress. and two were missing despite these reminders. Four patients were traced via postal letters. Mild stent-related symptoms were reported in l 86 patients, with the most common being frequency with urgency; however. 12 patients had sovere stent-related symptoms. In total, 87% of patients prefen-ed voice reminder system to cext-ba~ed reminders. and 91 % preferred reminders in their regional language. Co11c/11sion Th,: use of UroSTENTBOOK voice-based application resulted in increased on-time extraction of stents. which could greatly reduce the incidence of forgotten ureteric stent patients. 
Microwave thermodilatation therapy for symptomatic benign prostatic hyperplasia; the first Asian experience 
W. M. P. CHOW, 1·• W. JOW2 
1 UMP Medical Services, Hong Kong, HongKong SAR, z Department of Urology, Hckensack Meridian Healrh-Bayshore Medical Cenn-e. Jiolmdel. U.S.A. 
3-Minute Oral Presentation 20 I Technology, August 9. 2019, 4:30 PM -5:30 PM Backgro1111d Transurethral 111enn0Dilatation (TUTD) offers a unique treatment for symptomatic benign prostatic hyp,:rplasia (BPH) by simultaneously using focused microwave heating together with pressurized balloon dilation therapy. The treatment is a 45-mmute, in­office, outpatient procedure which is perfonned and well tolerated under local anaesthesia. About 90% of patient do not require a post­treatment foley catheter and the majority of patients experience significant and immediate relief of their lower urinaiy tracr symptoms (LUTS). The 5-year follow-up USFDA Post Approval Study of TUID confinns long-tenn safety. efficacy and durability with improved LUTS, urinary flow rate, quality of life. and no sexual side effocts when compared to an untreated age-matched male population. We perfom1ed TUTD treatments on 15 Asian patients and presents our initial experience and clinical data pertaining to the clinical safety and efficacy of this minimally-invasive treatment for symptomatic BPH. Melltods From August-December 2018, 15 pati,mts (Ag<l 54-79, mean 62) were each treated once for their LUTS with the TUTD device. PROLIEVE by Medifocus inc Their lPSS (]7-35. mean 24), QOL (4-6, mean 4.5), PSA (0.57--7.7, mean 3.5), prostatic volumes (35-84 cc. mean 54 cc), Qmax (1.7-10.5 mL/s, mean 7.5 mL/s) and PMRV (50--330 ml. mean 190 ml) were recorded pre-treatment. At 6 weeks and 3 months post-treatment, IPSS, QOL, Qmax, and PMRV were reassessed. Results IPSS: 2--23 (mean 12) at 6 weeks; 2-22 (mean 10) at 3 months. QOL: 1-3 (mean 2.5) at 6 weeks; 2-3 (mean 2.75) at 3 months. Qmax: 3.6-14.9 mUs (mean 10 mUs) at 6 weeks; 6.8--17.5 mL/s (mean 13.2 mUs) at 3 months. PMRV: 0--33 mL (mean 8 mL) at 6 weeks, and 0-45 mL (mean 20 mL) at 3 months. Urological complications such as clot retention and sepsis (as evidenced by symptoms and MSU culture) were not observed. One patient required temporary post-treatment Foley cathetcrization for 72 h. Treatment related incidence of retrograde ejaculation or ereetile dysfuction has not been reported. The procedure was weli tolerated under local anaesthesia. We also obseived that both the voiding and storage IPSS improved in all patients treated. Co11dusi1>n Our initial experience with TUTU in a cohort of 15 
Asian patients compares favorably to the clinical outcomes and efficacy of the Caucasian population treated in the recently completed USFDA 5-ycar follow-up post approval study. W c observe significant improvements in post-treatment !PSS, QOL, Qmax and PMRV with minimal side effects; therefore, we conclude that TUTD is clinically safe and efficacious in the Asian population. Long-tenn prospective data collection in a larger patient population is in progress. 
576 
PSMA Tc-99 m SPEC1' 1•s Ga-68 PET for the staging of prostate cancer: a pilot case series 
H. J. SOH.1·* J. KAM,1.:?,3 A. AL-SAMERAA.ll. 1 
H.F. 
CHAN. 1 D. GILBOURD,1 K. llART,1 M. KAHLOON,1 

S. 
MCCREDIE, 1 H. HAXHIMOLLA. tA I. DUNCAN5 


1 Department of Urology, The Ctmberra Ho5pital. A CT, Aus1ralia. ~University of Newca.wle, Australia. 3 U11iversil).• ql Svd11ey, Australia. 4A1istralian National Universin'. .1u.~tralta. 5Gar;an Medical .lmagi11g, Garrm1. A11strC1lia · 
3-Minute Oral Presentation :w I Technology, Augnst 9. 201 ll, 4:.~Q PM -5:30 PM Jntroduction und objt1eti11es Prostate Sp~ific M(>mhr\lllQ ,\11tiQQn (PSMA) scans are becoming increasing prevulcnt for primory staging of prostate cancer or following bio.~hemk~l rec1me1,ce. Thi; n,0,1 commonly u1ilized modality romains Gallium-68 PET which requiNS a PET scanner which are less readily 3.vailable, PSMA bound to Tc­99 m is a more recent developmem which requires a SPECT scanner which are more prevalent and cheaper. We aimed to compal'i> lhfl imaging findings in patioms undergoing PSl\1.A scans with both modalities Methods An:ilysis of a. prospccliw dalabnse of all patients undergoing a Tc-99 m PSl\1A, ~can was used 10 idtintify p1,tieu1s undergoing concllm!nt Ga-68 PSMA PET scans btltWDon Ju11L' 2017 and August 2018. Patients were inclt1ded if the 2 PSMA mo<lolities were perfom1ed within 3 months of each other. Demographic dara and imaging findings were collected for analysis. Data wa; Qnalysed using SPSS 24.0 Results Six patients undeiwent both PSMA Tc-99 m and Ga-t18 scans within 3 months of each at.her. Five \\ ere dono ibr prim11ry staging while one was perfonned for hiochcmic::al r-...>ctm,mcc. In 1he primary staging group, one case had lo.::iliud disea~e on G11--68 PSMA while Tc-99 m PSMA showed n single cxtemlll ilia\! lymph node metastask Histopathology showed the Tc-99 m scan to he correct with positive lymph node metastasis fmind at radleal prostatectomy and lymph node dissection. Two ooses showed loc11li1.!)d dise3se only on hath Ga-6!1 and Tc.99 m PSMA. Ono case Khowcd widespread bony and lymph nooe meU\slasis, though tho volutno of disease w1\S slightly higher cm Ga-68 compared to Tc99 m PSMA. One fwther cnsa showed the presllnce of s gncrnl lymph nodt' motMtMOS on both Ga-68 and Tc-99 m PSMA. For the patient with biochemical recurrence both the Tc99 I\\ and Ga­68 scan showed no evidence of recu1 rem or meta~taric di8c•asci. Couclusions Our study is tho first Australian study to diiwtly compare Gn-68 to Tc-99 n1 PSMA im:iging. It sh(lw, early ovidonce that Tc-99 m PSMA muy ho a suitabl~ &ltcma1ivo 10 (ia-6& with the additional benefits of lower cost 11nd more widespr~ad iwnilt\bilily uf the required SPECT scanner:... 
646 
Utility of MRI fusion~targeted transrectal prostat<1 biopsy and prostato health index in detection of clinically significant prostate cancer 
J. LEOW. 1·* Y. YEOW, 1 T. TAN1 
'Department of Urolog>-, Ton Tock Seng Hospital. Si11g11p<ll't'. Singapore 
3-Minute Oral Presentation 20 I Tc,chnology, August'), 201\l, 4:J,t) PM -5:30 PM Background MRI Fusion.Targeted Tt-ansrectal Prostate Biopsy is commonly otlbrod to patients with clinical suspicion of 1.m~tato 0f\11oor 
with a largetable lesion ~cco on MRI. In an updQto 10 N1r early experience (J Endourology 20J7; 31(11):llll-6), wt aimed to tvsr the hypothesis that targeted biopsy has a highor detection rat<! for chnically 
significant prosrate canc.:r ( osPCa) lhan sysicmaiic biopsy. 

OA 



