ML20198K055
| ML20198K055 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/1996 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-079, AF70-1-79, NUDOCS 9801140306 | |
| Download: ML20198K055 (12) | |
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- Analysis of Costs and Banofits !
- for the Use of C-14 Urea Breath Test l l
J Tri-Med Specialties, Inc. -
Charlottesville, Virginia :
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- U.S. Nuclear R ulato ' Commission Offleeof Nuclear Material and uords Medioel, Academio, and Commerotel Use Sa Stench i
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ANALYSIS OF COSTS AND BENEFITS
- l. Background 3
The recent discovery of and the pathogenic implication of Helicobactor pylori (H. pylori) to antral
- gastritis and doodcaal tdoeration has caused a dramatic change in the underntanding and treatment of peptic ulcer disease duri C.c past decade. H. pylori!s a spiral or helical shaped gram negative
! bacterturn,with 4 to 6 uni sheathed flagella. This bacecr um normally inhables the gastric j mucouslayer spithallum human stomach and the gastric metaplastic epithclium in the duodenum i and esophagus. H. pylori is probably the most common cause of non autoimmune gastritis.
The propowd action is for the U.S. Nuclear itegulatory Commission (NRC) to grant Tri Med j S metalues,Inc. in Charlottesville, Virginia, its petition filed on August 23,1994 (Tri-Med,1994).
the generallicensing and/or J
Nis proposed exemption action from licensing woulddistribution for commercial be taken to allow, through th*='p,hamiaceutic by licensed capsules containing 1 pCi of pharmaceutical tdC uma to test for the presence of H. p lori.
This prwes is based upon the fact that H. lori produces the enzyme u* ease that is rare present in human cells and in capabic of down usea to ammonia and bicarbonate ( wiey, et al,1995).
Usease CO(NH 3): + 2 H2O +H+ = 2NH4 * + HCo r- ,
, Uma Ammonium Bicartenate 1ha HCOr enters the blood stream and can rapidly be exhaled through the lungs as CO2. Since '
the administered unca is manufactured with radioactive carbon (t4C ), detected 14CO: in the patient
, breath is indicative of ursane prenonce. Codey, et al. (1995), pointed out that t4CO2 is usually ,
detectable in the breath 5 minuten after administration with a peak excretion in 10 to 15 minutes (Peurs, et al. ,1996). The urea breath test (UBT) using 14C is only positive if H. pylori infection '
is prenent it is ideally suited to follow treatment to cont rm eradication of this specific bacterium.
Specifically, Tri Med Speciakles, lac, potilkn in to permit the distribution of the capsule contairdng 14CO2 either asperately or as part of a diagnostic kit which supplies to perform the test. The manufacturing process catis for one pCi of the 14C-ures to be placed in a gelatin capsule. Afler insertion of the idC into the capsule which is inupseted enteenally for any contamination. The ,
- . mck and then nealed. The sealed packap is then .
capsule is thencontainer placed into another placedwhichintoisaalso commeretal scalo blister ;d.1 hat packagepping is than placed lat contahar that is approximately 15.2 cm by 15.21 cm by 5.1 cm (6"x6"x2").
The petitioner states that this test is cussently being studied at four siten under an investigauon of New Drug (IND) application acce stod by the U.S. Food and Dru g Administration (FDA) and at other sitos under resecre h protocols.1he data obtained from these tests agarding the fate and biulogic ways pnwided the basis upon which to perform the dosimetric calculaticms and psovida to estimate (using a boundmg method approach) the possible exposure of memhara of the public, family, and others who are Ike}y to come into contact with the test .
materials or patients who have taken the capsule.
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h This proposed procedme is a nontavasive method and positive only if active H. pylori infwtion is .
pecacat . %is test . as appmved by the PDA (Tri M41994), is ideally suited to follow treatment to confitta credication of H. pylori and la to he used in lieu of the gastrointestinal endoscopy j procedet which is an invasive test, more costly, and involves nome risk to patient . !
Test Pmencol: !
Tri-Mod Specialties, Inc. (Tri.Med,1994) and Marnhall, et al (1991) described the UBT for the !
dignetis of H. pylori, ne preparation of the patient for this test includes fastina for 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> and !
assurance that no antibiotics or bismuth sahs have been taken at Icant 4 wocks pr or to the test. The !
capsule is then swallowed with 30 ml of warm water to help the capsule to dissolve and release of _i tdC-wea into the asomach . AAer 15 minutes, up to 2 liten of breath sample will be exhaled into a collection bag and promptly mailed by priority rr.J1 to a specialised laboratory to count 14C .;
redloactivity. Breath samples containing less than 30 disentegration's per minute (dpm) above i background would be considered llP . Activities above one hundred dpm mee considered HP*. 't has been mponed that the 14C-urva breath test has a high diagnostic accuracy, with a sensitivity and specificity of up to 9g% ( Marshali,1994 and pours, et al ,19%).
- 2. Need for the Proposed Action ,
The proposed rulemaking is to grant the Trl.Med Specialties, Inc. waition to allow for the general licensing anNor esemption for commercial di6tribution by licensed pharnaceutical manufactwcrs ;
I af the isc. urea capsule from licensing. Dis would provide greater ficxibility to lost for nad monitor the prenonce of H. pylori in ulcer patienta. Currently, these tests are limited to only few ,
facilities licensed to receM IdC. Licensing exemption for commercial distribution of 14C-urca capsule would allow most W.: tors tc, perform the UBT st a cost saving to patients. Geneni ,
licensing would Ihnit the distribution of thete capsules and kits to only licensed physicians. !
It is clearthat ensuri eradication of H. pylod infection and curing uleen can have a direct beneSta to the ly new 500,000 new ulcer patients socking health care each year, and more than a mi hospitalizations each year (Penneny, et al,1994). Ths new auninvasive test usic g C-ues capsules, as pmposed, by Tri Med Specialties, Inc., has a potential to eliminate the
. noct for many gastmendoscoiles performed to view the neomach and duodenal ulcers ud to obtain samples fot the detection of i+ Pylori in ulect patients. Gastrocadoscopies are expenalve and unoner.fortable to patients and the general public. Erudication of H. pylori infection is associated with a snarked decrease in the recurrence rate of ulcers. A quanthative relationship between the degree of H. pylori infection accrus to bc un===ry, since any detectable inicction will bc ,
treated. .
1.2 Alternatives Addressed NRC mvlew of the Tri-Mod petition will resuk in one of the following three actions:
N N thw Pulitaa. Tri Mod would be restricted to distributing the tcat only to those c inics or physicians curantly holding a specific license under NRC Part 35 regulation. Thiv ;
case is an==ise==t with current regulseory 13quirements. ,
na'taa 1 - k~ =* Paaltia= The test would be exempted from N1(C Pan 35 segulate'y contro!.
enabling Tri-Mod to distnbute the test to all physicians and clinics requesting it without ch
- - parties bearing the labor cost orcompleting regulatory paperwork or complying with l
2 h
ses also will show that this regulatory inspection option yields significant and audit regulatory requirements.
cost savings The benefits for following analyRC, since the NRC w the N not have to evaluate and pmcess initial applications and conduct annual reviews.
Ontion 2. k munM Mandon of Petitinn. A modified adoption of the Tri-Med petition would mean that N LC Part 35 would be amended to allow the test to be distributed to physicians and clinics under an NRC general license, requiring NRC registration only. This approach is similar to that taken under NRC 3.19.87, covering general licenses for in vivo usc. It differs imm Option 1 in placing a minor regulatory burden, that of registration, on the physician or clinic. However, the burden is not as great hs that placed on physicians under the Base Case.
- 2. BACKGROUND 2.1 Overview of Trt.Med Specialties Claim The Tri Med petition claims $500 million of benefits, based on the company's claim that their test for determining the presence to H. pylori bacteria provides a low cost option (appmximately $100 per test) relative to the alternative of performing an endoscopy at over $1,000,per procedure. NRC adoption of the petition (Opdon 1) would lift the regulatory burden from physicians wanting to use the test. Such action would promote wider distribudon of the test, resulting in hmad public benefits based on the low cost of the non invasive test relative to the invasive endot, copy Pmoodure.
2.2 Scope of NRC Review of Tri Med Specialties Claim The NRC review is not beoed on evaluation of the benefit of a lower cost test for the presence of H. pylori. Such an approach would involve medictJ decisions about the frequency with which a given patient would receive the test, based on the patient's condition. NRC regulatory review does not consider such medical lasues. Rather, the NRC review is based on the costs and benents to the NRC, patients, and medical facilities that result from the NRC's regulatory action. For the NRC, an exampic benefit is regulakry cost savin n. For patients, an example benent is the savings in travel arxl personal time taken to travel fart wr to a licensed physician recommended by the patient's general practice physician. For medical facilities, benefits are in the form of license filing and annual license maintenance cost savings. This review approach differs from that take by Tri-Med, which based its benefit calculation on the lower cost of the H. pylori test.
Furthermore, it is assuned that 600,000 tests will be administered r year regardless of NRC's action with respect to the Tri-Med petition. It is anticipated that ph sicians will use the test as deemed medically necessary. 'Ihe extent to which NRC repulateA intribution of the test.will only impact the costs borne by patients and medical fur!!ities. T1is position differs fmm that taker by Trt Med.
2.3 Major Consequences of Adopting the Tel Med Petition 2.3.1 E!! acta _nn Pubus Health and Safety The Safety Re prt submitted as a art of the NRC review of the Tri Med petition presents evidence that supports t w conclusion that t se health and safety risks from C 14 exposure because of administration of 600,000 tests per year is very (mull.
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. l Additionally, the Safety Report suppotts the contention that the bcalth and sdety efkcts cost, !
mancesed at $2,000 per person-rem, be set at 90 based on the following rationalc. It is assumed '
that 600,000 test administrations will necur te ens of whether the Tri Med petition is granted or denied. A 1to emcollective 000 annual test administrations has been calculatal.
De done calc incheded ex scenarios oc mily ap Wicable to all physicians, menikss of I
licensing manus, b dose le t of any tra ning a p aysician would neceive u6 o r.ondition of Part 35 licensing. Therefore, a is no additional exposum tiud might result if Part 35 is i arnended to allow the tost to be distributed to all physicians.
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- 3. ANALYSIS OF COSTS AND BENEFITS
'The following analysis anseues the incremental costs and benefits of Options 1 and 2 relative to the Base Case. Costs and benefits are evaluated fmm three perspectivos . the NRC, the patient, 4 and the medical facility. Costs and benefits me classified as either one time or annual. An example I of nas time benefit is the segulatory cost savings realized under Option I telative to the Bau Case by nut having to process new a ,
- savings realland under relativeOption 'ylicationt,.
to the Bau Case by not An exampic requiring of an annual efforts to annual benc0t maintain active licenne2. !
'!he analysis of costs and benefits is based on their present value, calculated based on a 7%
discount ruse and a 20 yere term. One-time custs are assumed to be incurred at A beginning of the :
20 year term and are not discounted, it is assumed that annual costs and benents are realized at yea'r end for the purposes of discounting. Since such costs and benents are assumed to be condant ,
froen year to year, the following Caphal Recovety Factor (CRF) fonnula will be used to detemtine .
. theirpresent value:
CRP 8 m (1-(1+i)*)/l = (1-(1+.07) **)/.07 = 10.59 .
Annual costs will be multiplied by 10.59 to determine their pment value.
.. Option I and Option 2 net preseat values are calculated based on their increnzatal berefit relative to the Base Case.
3.1 NRC Costa and Benents 3.1.1 Oualitative Overvlaw Costa Rulemaking costs are incremental to the Base Case, since the NRC incurs them if it chooses to do other then deny the Tri Med petition (Base Case).
Besofits Under the Base Case, the NRC would bear the cost of re t.lating distribution of the H. pylori test. ;
it would bear none of these segulatory costs if it adopted on 1, resulting in a large regulatoiy
' cost savings benent. De benent would be somewhat lower if Option 2 were adopted because physicians would be requhsd to register with the NRC. ,
- The magnitude of the benent is also affected by the number of physicians who cleoose to
, administer the test. De segulatory requiremenh of the Base Case make it most restrictive; it'A
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adoption would astract fswer physicians than either Opdon 1 or Option 2. Option 1, which -
imposes no regulatory burden, is least restrictive and woukt attract the most physicians, -
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Base Caos Doey Petitioas -
Ruhunaldag coat No rulemaking action is required.-
c Reeta w c~a The cost of NRC regulation is approximaar.d conservatively by the fees received j
by the MC for Part 3? >==
l One time regulatory cost = $1,400 NRC new liocnac feel *6000 Unlicensed physicians *C,10
" fractica of p nsicians seeking the testing priviley = $840,000 l f .
Annual regulatory cost = ($4,300 annual Part 171 fee 2)*6000 Unlicenwd physician **0.10 i fraction of physicians seeking the testing privilege = $2.58 million/ year ;
j Present Value of Base Case. One time regulatory cost + CRF 1* Annual regulatory cost = $0.84 ;
!- million + $27.32 million = $28.16 million l Option'I Accept Petition Rulemeldagfog 'Ihose costs are calculated bened on the following equation:
Rulemaldag cost = 1.5 FTE NRC cffort'$50&our*2000 heurvycar + 0.33 FTH contractor 1
, thne'$123/ hour f fully loaded rate)*2080 hourdyear = $240,427
- Regulatory Cast Savings (Banafit). The NRC expands its revertes to cover the time and a maserials expended to pmoons and maintain the license, la doing w, the NRC incurs resciatory .
costsi If a license were not required, NRC cost savings would result since it would not incur such costs. Por purposcs of this analysis, regulsory costs are estimated to be the NRC Part 35 license application fee and annuallicense maintenance fee. These regulatory cost pmxies am conservative because they include soras fixed costs thu would be unaffected by the NRCs decision about how to regulate tu Tri-Med test.
Note: Allowence is not made for license amendment, at a fee of $440, because it is assumed that a
. physician applyiry for a license will tend to be a single practitioner interested in performing the test. It la assumsc that the phytician would never face a license amendment situation, in cases
. whem the physician closed or otheiwise changed his4cr practice, they would choose to
- discontinue the test. Any now physician taking over the practice would file for a new license.
4 One time resulatory cost savings = $1,400 NRC new license fee *6000 Unlicensed physicians *0.80 fraction of physicians seeking the tenting privilege = $6.72 million E N .l - NRC i 17C 51 Item 7A.
H9> : NItC i 171.16 liem 7A. Th G enven annual NRC npeases includlag inspectioni, and license .
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._ physicians *0.80 fraction of p tysicians seeking the testing privilege = $20.64 million/ year.
Nat P== V=b= af Deutar.1. Onc Time Regulatory Cost Saving= +$6.72 million + $2 8.58CR Cost Savinga Rulemakmg Cost - Not Present Valric of Base Case =
nsillion - $240,427 $28.16 million = $196.9 million
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Opties 2 - INodined / deptlen of retidos Rulernking Comt. Anwnd Part 35 NRC regulation to allow distribution of the test under a general 4
license. The rulemaking needed to im ld izquhe the same level ofenort as
- that requirrd for Option 1. Therefore:plement this change wou Rulemaking cost savings = $240,427 e Rs-+=v co,x savian m norin. NRC uvings will be less Dian in Option 1 because the NRC
'would bear general livsine reklatration and processing costs that are sigmficantly lower than the NRC regulatory costs cited under Option 1.
One time regulatory cost uvings = $1,400 NRC new liccuse fec'6000 Unlicensed j physicians *0.25 fraction of physicians seeking the testing privilege = $2.1 million 1 Annual regulatosy cost . avinan = ($4,300 annual Part 171 fee)*6000 Unlicensed physicians *0.25 fraction of p iysiciana neeking the testing privilege = $6.45 milliorJyear Net Panaat Value of Option 2. One Time Regu!atory Cost Savings + CRF l* Annual Regulatory Co6t Savin - Rulemaking Cost - Net Present Value of Base Case = $2.1 million + $68.31 million - $ 427 - $28.16 million = $42.01 million 3.2 Patient Benefits 3.2.1 Qualitative Ovanlaw Costs There are no costs that are incremental to the Base Case.
Benefits ;
4 ~ If tt i NRC adopts either Option 1 or Option 2, patients will find that more physicians o#er the test and that they are likely to be more conveniently located. The patients will, therefore, realize travel I
cost and personal time savin s relative to the Base Cme, ladeed, Ow reduced regulatory compliance burden, especial if Option 1 is adopted, may result in genemi pract ce physicians y regws the test from Tri- on an *as needed" henin. Patients using their local general practice ysician would realize the full travel cost and personal time savings credit relauve to the Base Case.
Under the Base Case, general practice physicians will acommend patients to licensed physicians, .
. who will probably assesa a new patient administrative charge for activities such as taking the patient's health history prior to administering the ten. By making it easier for a general practice phyncian to admininter the test to his/her smating patient, NRC wioption of Option 1, and to a y 6
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l o ;) esser extent Option 2,' would result in a full adeninistrative cost credit relative to the Bane Cane.
L - 3.2.2 Calsadadan of Preaant Value of Banaftts Base Case Deny Petition Cassa of Travel and Parannal Time. A high percentage of patients, repre6ented by the Patient Praction, will pay travel costs and use personal time (e.g., valued as sick leave or vacation time) to tiraveltolicensed ician or clinic scavicco scoommended by their general practice physician.
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'!hees costs are ' uit to estimate because of factors such as the distribution of patients among rural localities and cities, which are less and more likely, respectively, to have licensed physicians.
Travel and personal time costs = (100 miles roundtrip*$0.25/ mile + 2.5 roundtrip hours spent traveling *$25/ hour)*600,000 administrations / year *0.8 Patient fraction = $42 million/ year Ad=Wa%dve (wa. 'Ihc same high p"ercentage ofpaderas who travel to a recna== dad licensed ationt administrative fcc Since the fec is assessed ph on once,siciantheor clinic total number willofbear a one time new p/ year is reduced by an " initial administrations ted fraction val has been set for this Aractic,a since it is assumed that patients will mceive the test once, at the
- end of treatment, to confirm absence of H. pylori bacteria. This fee has been valued at the incremental cost of an office visit to a acncral family practice physician by a new patient ($64.90 per visit) nelative to an established patient ($45.90 per visit), resulting in a $19 administradve fbe that would be assessed the first time the patient was tested.3 E
Mmint*stive costs = $19 edministrative fee / number initial test administrations 600,000 edndnistrations/ycar*0.8 Patient fraction *0.9 Initial test fraction = $8.21 million/ year Pmment Value of Base Case. CRF HTravel and Personal Time Coats + CRF-t
- Administrative Costs = $444.78 nullion + $86.94 million = $531.72 million Option 1, Accept Petitles-rna savi w nala-d an Travel and Persanal Tima. Referral to a licensed physician would also rates the cost to the ent by adding the following incremental costs over those s sent if die patient were able to use hi local physicles: (1) time spent by the padent traveling to i to referred ;
physician and (2) the cost of the travel, including food and lodging. This option is lowest cost i relative to the Base Case since it puts fewer restrictions on granting testing privileges to physicians ;
than doen Optian 2, resulting in physicians being closcr to patients because more physicians choose to provide the scat.
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l Travel and personal time cost = (20 miles soundtrip*SO.25/ mile + 0.5 roundtrip houts spent tweling*$25/ hour)*600,000 administrations / year *0.2 Patient fraction = $2.1 million/ycar
.Adaninistrative Coat . The patient would be able to receive the test from his/her family
, )hysician, or a sustio al specialist, without an NRC license. The patient would not have to A se referred by this ysician to a licensed specialist, who would probably charge an administrative
~ fcc forreviewing patient's health history and completing "new patient" paperwork prior to A 3' O am fMd American Medical Association, haicina Markat Place Stadsinca.1995 edihon, Tahic 40 and Table 39, mpactively. General Family Practice is denned as oscludins radiolosists.
payohiatrista, anesthcalologists, and gatholosless.
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adannistering de kat, This option is lowest cost relative to the Baw Cae.e since k puts fewer.
restrictions on testing privilogos to physicians than does Option 2, resuking in patients - l heing more to use a phyrcian with whom they already have a relationship,
~ Administrative ecma. = $19 adadnistrative feelhumber initial test wiministrations*600,000 adannistations/ year *0.2 Patient fraction *0.9 Initial test fraction = $2.95 million/ year AletPar.annt Valus qf Option 8. Prenant Value of Bane Case CRF l* Travel and Personal Time Coat Savings - CRP l* Administrative Cost Savings = $531.72 million - $22.24 million - $21.71 million = 54A7.77 million Option 2 - Modified Adoption of Petition !
Cast Enviana paintad to Travel and Permnal Time. These savings are less than those assessed for Option I because, relative to Option 1, fewer physicians are likely to apply. !
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ersonal time cost = (60 miles mundtrip*$0.25/ mile + 1.5 roundtrip hours spent Travel traveling and
- S p/.5/ hour)*600,000 administrations / year *0.7 Patient fraction = $22.05 m Administrative Cast Savinen: These savings am iens than thone assessed for Optiort I because, relative to Option 1, fewer physicians are likely to apply.
Administrative coat = $19 adminintrative fee / number initial ten miministrations*600.000 administrations /ysar*0.7 Patient fraction *0.9 Initial test fraction = $7.18 million/ year j Net Pr*=*as Value af Optign2. Present Value of Base Case - CRF I
- Travel and Personal Time
- Cost Savi n - CRP l'hdministrative Cost Savings = $531.72 million - $233.51 million - $76.04 adll'.on = 22.17 million 3.3 Medical Facility Benefits 3.3.1 Qualitative Overview j.. Costs There ase no costs that are incremental to the Baue Case.
- Benefita Under the Base Case, physicians spend time eting paperwork related to initially filing for, then maintaining, a license. If the NRC adopts ion 1, the physicians will realize a full credit relative to the Base Case for lic:nse filing costs, s occ Option I grants distribution of the test on an "as needed" basis without a licensing requirenwnt. If Option 2 were adopted, savings relative to the Base Case willdimialdi slij thti , the cost of time taken to register with the NRC for the
- right to administer thelost. If tw adopts either O ption 1 or Option 2, the physicians will realias a full credh relative to the Base Cane for annual licenne maintenance costs.
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L Base Case < Deny Pottelen 1u pm.,-d A ... a i um w. m.nce costs. The physician nmst complete paperwork i for either 14 cones app : cation or annual D conse maintenance. NRC estimaten indicate that 70 hours8.101852e-4 days <br />0.0194 hours <br />1.157407e-4 weeks <br />2.6635e-5 months <br /> 4
- are spent onlicense ication and 70 hours8.101852e-4 days <br />0.0194 hours <br />1.157407e-4 weeks <br />2.6635e-5 months <br /> por year am spent on annual liceum maintenmaco. It
- is assumed that phy perfonalag the test, regardless of NRC's dis msition of the petition, !
. will not wask in licensed nuclear medicine clinics and will not have staff ta complete paperwork.
, Licensed nuclear medicine clinics would have such stan, capable of working, at an hourly wage i Iste lower than a physician's, under the supervision of the licensed physician responsible for i establishing and administering policies and pmcedures for the safe use of the test. Therefore, hours spent on linanam filing and annual maintenance are valued at $111/ hour, the fully loaded rate of a physician. This value was calculated by uveraging 392/ hour and $13Whour. The low end of
, the range is an catimate of hourly rates based ou national avenge office visit rates charged by a scaeral family practice physician.4 The hourly raie of $ 130 per hour is baned on a telephone san:pling of some general practice physician visit rates for the Washington, DC area. ,
Given the cost burden imposed by this option, it resuks in the fewest number of physicians -
- choosing to adatinister the test, relative to Options't and 2.
One time license filin; cost = $111/ hour *70 hours to complete wpenwork*6000 Unlicensed physicians *0.10 fract on of physicians seeking the testing privi ege = $4.66 million ,
Annual license maintenance cost = $111/ hour *70 hours / year to complete paperwork *6000 Unlicensed physicians *0.10 fraction of physicians necking the testing privilege = $4.66 leg i .-
c f am c=e. One Time Liccasc Costs + CRF l' Annual License Costs = $4.66 g + . 5 mil.lon = $54.01 million Option I hecept Petitlen
- I 4 . Filin. und A ..mi 1 w. u=ineaaance Cost Savia= This ion eliminates the licensing '
requusmentt 'tbus, the physician would not have to complete pape foreitherlicense application or annual heenas maintenance, resulting in owlical Pacility cost savings. It is anumed that a physician choosing to administer the test will have a unell stan and will not have a clinician
,- who can cwp-t license filing and maintenance paperwork; therefare, the paperwoit would bc
- ea=W4 by the physician ultimately maponsible for establishing and adelai policies and procedures for the safe use of the test. The Aysician's time to complete is valued at the mesomental cost of the physician's fully lorc ed rate over the rate of the el inn established for the Base Case.
This option elianinetes'the cost burdon of Gling for and maintaining a licena; themfore, it results in the largent number of physicians interested in offering the test, relative to the Base C:'ae and Option 2,
2 One time license filing cost = $111/ hour *70 hours to complete paperwork *6000 Unlicensed l:
j 4 - Amer 6can Medical Association, Etamian Market Place Stathtics.1995 edillon. Toble 39..
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J physicians'0.80 fraction of physicians socking the testing privilege = $37.30 million Annuallicense maintenance cost = $111/bour*70 hoursfyear to complete paperwork *6000 Unlicensed physiciansN).80 fraction of physicians socking the testing privilege = $37.30 .
millios@sar Nat Prent Vab of onela= 1. One Time License Savings + CRP-l' Annual License Savings -
Present Value of Base Case = $37.30 million + $395.01 million - $54.01 million = $378.3 million Option 2. Meditled Adoption of Petition i kne pitin and Annuali hnse Malaten=nce Cost Savings. Since this option results in some regulatory burden, fewer physicians will choose to administer the test under this option than under Oxfon 1. 'Ihene physicians will bear sonx minor costs related to filin,t for a general license, witch will reduce this benefit slightly relative to Option 1 (a $5/ genera license filing value is assumed, to cover the NRC licenne processing cost).
One line license filin g cost = $111/ hour *70 hours to complete paperwork *6000 Unlicensed physicians *0.25 fract on of physicians seeking the testing privilege = $11.66 million Annual license maintenance cost = $111/ hour *70 hours' year to complete pape.rwork*6000 Unlicensed physicianr30.25 fraction of physicians seeking the testing privilege = 511.66 N .
Net Praent Vah of Ondonj. One Time License Savings + CRF 3* Annual License Savings -
Present Value of Base Case = $11.66 million + $123.48 million - $54.01 million = $81.13 million
- 4. CONCLUSION
'Ihc picccding analysis shows that the act bencnt derived by the NRC. patients, and medical facil. ties is in each case greater under Option 1. Table I summarizes the benefits and shows that the total net benefit it is recommended that the (NRC, NRC adopt Option 1.wient, and medical facility) is clea 10
TABLE 1 COST BENEFIT ANALYSIS
SUMMARY
Net Present Value Relative to Base Case (snillions of dallars) l Optios 1 Option 2 NRC Net Benent $196.9 $42.01 Patient Net Benent $487.77 S222.17 Medical Pacillry Net Benefit $378.3 $81.13
. Total Net Benefit $1063.0 $345.3 4
9 11
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