J Voigt

Jeffrey Voigt

LA Frey-Law

S Goyal

English

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COMMENTARYThe Case of Penny Wise but Access and Quality of Care FoolishJeffrey VoigtPublished online: 12 March 2015 The Author(s) 2015. This article is published with open access at Springerlink.comRecently, the Healthcare Common Procedure CodingSystem (HCPCS) coding committee for supplies [headedup by Center for Medicare and Medicaid Services (CMS),with private payer representatives] denied a request for aunique HCPCS level II code for use of a novel bonemarrow biopsy system in the physician office setting(POS). This code would in effect allow access/use of apowered bone marrow biopsy system (brand nameOnControl) in this setting, where a significant number ofbone marrow biopsy procedures are performed. Hema-tologists and oncologists perform the vast majority of thesetypes of procedures [1]. In randomized controlled trials thisnew system has demonstrated significant reductions inpatient pain as well as significantly improving upon thesample yield to more accurately assess a patient’s pathol-ogy [2]. It also demonstrated the potential ability for apatient to be able to better tolerate the pain of the biopsybased on the visual analog scale (VAS) pain reduction seenwith the powered system [3]. Interestingly, 3 years prior tothis, CMS granted a unique code for the use of OnControlin the hospital outpatient setting (HOPS), permitting thefull amount of this technology to be paid for. Why wouldCMS pay additionally in one care setting but deny access inanother less expensive care setting (i.e., POS)? Before thisquestion is answered, we need a history of how this de-termination was made.CMS has a decision tree that it uses in determiningwhether a product/service should be granted a uniqueHCPCS code [4]. According to CMS representatives, thisrequest for a new code answered every one of the decisiontree points (including strong support from lymphoma pa-tient advocacy groups for its use based on less pain andimproved outcomes) in the affirmative, save one: that thistechnology belongs in a different code set, namely Com-mon Procedure Terminology (CPT) level 1 coding [4]. Aunique CPT code had been applied for through theAmerican Medical Association (AMA) CPT back in 2011.As part of the application process, the AMA CPT editorialpanel provides feedback to the applicant. The feedbackprovided by medical specialties such as the American So-ciety of Hematology (ASH) and the American Society ofClinical Oncology (ASCO) stated that a CPT code alreadyexisted (CPT 38221—bone marrow biopsy, needle or tro-car) and that the AMA only established codes for services,not technologies.Currently CPT 38221 is paid by CMS at a national av-erage rate of US$170.19 in the POS. This payment includesthe cost of a manual biopsy needle at an amount ofUS$34.47—an inferior system to OnControl (based onoutcomes). Unfortunately, OnControl, has a list price ofUS$140. Thus, if a clinician were to use OnControl in thePOS, they would likely lose money considering the othercosts that are incurred in this setting include physicianlabor, other clinical labor, and other supplies associatedwith this procedure. Therefore, the CMS payment ofUS$170.19 effectively prohibits access of OnControl inthe POS. An alternative presented back in 2013 to ASCOand ASH was to ‘‘re-price’’ CPT 38221 to include the costsof OnControl. The problem with this option is that if CPT38221 were ‘‘re-priced’’, it would incentivize clinicians touse the manual needle system instead of OnControl and‘‘pocket’’ the difference. ASCO representatives suggestedthat a unique HCPCS level II code was a reasonable path tofollow. An application and presentation was made to CMSon 28 May 2014, with the hope of establishing a uniqueJ. Voigt (&)Medical Device Consultants of Ridgewood, 99 Glenwood Road,Ridgewood, NJ 07450, USAe-mail: meddevconsultant@aol.comAppl Health Econ Health Policy (2015) 13:121–123DOI 10.1007/s40258-015-0163-8HCPCS level II for the POS—to be used in conjunctionwith CPT 38221. Unfortunately, CMS came back with thedetermination that coding for this is the AMA’s responsi-bility and not theirs. This effectively restricted access(based on inadequate payment) to the use OnControl onlyin the HOPS. What is so bad about having adequate pay-ment for OnControl in the HOPS only?In addressing this question, here are the issues withhaving access to only one care setting (HOPS): first, it coststhe healthcare system significantly more to provide thesame procedure in the HOPS versus the POS. Even ifOnControl were to be paid additionally in the POS[HOPS pays US$910 vs. POS at US$276(US$170 ? US$106; assumes that OnControl would bepaid at the differential of its list price of US$140 less anexisting payment of US$34 for the manual biopsy system)],POS would be significantly less costly. Second, not everypatient has access to HOPS, some only have access to thePOS. Third, it denies access to better medicine, as notedabove.Why would CMS allow for access for this product(based on coding and payment) in one care setting and notanother? Perhaps it has to do with more clinicians usingOnControl in the POS and its cost. Current estimates arethat approximately 43 % of all bone marrow biopsies areperformed in the POS. For CMS, this amounts to 61,000bone marrow procedures performed in the POS for the2012 fiscal year [1]. If a unique HCPCS level II code wereestablished (and assuming all of these procedures were nowperformed using OnControl), it would amount to an ad-ditional US$6.5 million to CMS. Considering CMS’sbudget is US$525 billion, this amounts to a 0.001 % in-crease in their budget—in essence a rounding error. Per-haps it has to do with the HCPCS coding committee settinga precedent in establishing a unique HCPCS code. In thepresentation made to the committee on 28 May 2014, nu-merous examples were provided where CMS had estab-lished unique HCPCS codes that were the responsibility ofthe AMA CPT panel [5]. What is it then? The only con-clusion that this author can come up with is that CMS isbeing penny wise but access and quality of care foolish. Asit relates to the US’s triple aim [improving health out-comes, enhancing the patient experience (including ac-cess), and controlling/reducing per capita costs of healthcare] [6], the decision made by CMS has achieved a sin-gular aim in ensuring care is less costly. However, im-proving the experience and outcomes were apparently notconsidered in this decision. CMS’s mission is as follows:‘‘as an effective steward of public funds, CMS is com-mitted to strengthening and modernizing the nation’shealth care system to provide access to high quality careand improved health at lower cost’’. Again, the CMS ap-parently did not consider its mission in this decision.So whose responsibility should it be to ensure thatOnControl is accessible? It is this author’s contention thatthe responsibility for establishing a HCPCS code and inpricing it lies with the provider and payer communities,since they are using and paying for it. CMS’s abdicatingthis responsibility to others is avoiding a decision that theyshould be making (and for which they have done so in thepast) and goes against their mission. Providers abdicatingthis responsibility goes against ensuring their patients haveaccess to high-quality care. Thus, access to high-qualitycare is held in limbo, stuck between two entities (payersand providers) who are saying in effect, ‘‘This is your re-sponsibility, not mine’’.Is it also the author’s opinion that the Affordable CareAct has resulted in decision makers (i.e., CMS, privatepayers, hematology/oncology) becoming gun shy over anykind of novel medical technology that even hints at anincrease in costs to the system. As noted in the StrategicGoal #1 for strengthening healthcare located on theDepartment of Health and Human Services website [7],there is no mention anywhere in the objectives listed forincreasing costs, only in either keeping them the same (andimproving quality) or in lowering them and improvingquality. This is currently how value is being defined in theUSA. Based on the pressure that decision makers are underto decrease costs, it is not surprising that this technologywas not granted an HCPCS code. Decision makers are thusbeing encouraged to pay for value if it results in the sameor lower costs. This in itself is extremely concerning.Ultimately, how does this affect the medical community?This may just be the tip of the iceberg regarding CMSdeterminations that follow. CMS has effectively drawn aline in the sand stating it will not pay additionally for value.This may result in other more costly care that provides forbetter quality and access also being denied. Is this aharbinger for things to come, and is this what the medicalcommunity and patients want? Paying more for valueshould also be part of the purchase equation in healthcareas it commonly is in all other parts of commerce.What is needed are alternative methodologies that definevalue that is created. A way to do so is by examining thedownstream effects of a false negative finding with amanual biopsy (i.e., for lymphoma). Below is what thismight look like.For the cost differential:• CMS currently pays US$170.19 (national average) forCPT 38221 (bone marrow biopsy) when this procedureis performed in the POS. Embedded in this amount isUS$34.47 allocated for manual bone marrow biopsysupplies. As a side note, if the same procedure wereperformed in the HOPS (approximately 57 % areperformed in this setting), the CMS reimbursement is122 J. Voigtcurrently US$826.26 (hospital) ? US$84.37(physician) = US$910.63.• Assume that CMS were to pay for OnControl in thePOS at the differential in supply costs betweenOnControl and the manual biopsy needle costsembedded in CPT 38221, or US$140-US$34.47 = US$105.53. Thus, the total CMS reim-bursement for use of the powered biopsy procedurewould be US$105.53 ? US$170.19 = US$275.72.For outcomes:• A significantly longer trephine biopsy length (i.e.,biopsy sample) with OnControl [2]. In a recent study,this increased trephine length was shown to increase thepositivity for lymphoma diagnosis by 25 % [65.5 %positivity with a trephine length of 13–16 mm (OnCon-trol finding) vs. 40.7 % positivity with a trephinelength of 9–12 mm (manual biopsy finding)] [2, 8]. Inother words, the samples provided with OnControlreduced the number of false negative findings forlymphoma diagnosis (false negative = a negative di-agnostic finding when in fact lymphoma was present).• For the cost analysis, let’s assume based on above thatone in four lymphomas will be missed based on a 25 %differential in sensitivity between powered and manualbiopsy [8].Based on current National Comprehensive Cancer Net-work (NCCN) guidelines, a bone marrow biopsy may beconsidered adequate if it is diagnostic for lymphoma [9]. Ifthe manual biopsy result is not diagnostic and lymphoma issuspected, a patient will likely undergo follow-on contrast-enhanced computed tomography (CT) scans of the neck/chest/abdomen/pelvis (a total of three would be performed)[9]. At current CMS rates and with multiple procedurediscounts, this results in an additional cost of US$744.60.Using TreeAge Software, these costs were modeled out.In the case where a false negative occurs on biopsy and theclinician is smart enough to suspect lymphoma (and thusorder a CT scan), the costs of a false negative (which is aportion of all biopsy costs) equals US$356.34 (manualbiopsy at US$170.19 ? contrast-enhanced CT scans of theneck, chest, and abdomen/pelvis regions atUS$744.60 9 0.25) versus OnControl at US$275.72.Thus, in the case of a false negative finding on manualbiopsy for lymphoma, OnControl costs less. Again, sincetrephine sizes are smaller with a manual biopsy (andsmaller trephine sizes result in a higher proportion of falsenegatives), these types of situations likely occur morefrequently than realized [8].While new technologies that increase costs and improvevalue are likely to be denied by payers prima facie, addi-tional analysis such as the above may help. Until thishappens, newer, slightly more expensive technologies/ser-vices will likely be denied.Conflict of interest Jeff Voigt previously worked as a consultantfor the manufacturer of the OnControl system. No funding wasprovided for the analysis and writing of this manuscript.Open Access This article is distributed under the terms of theCreative Commons Attribution Noncommercial License which per-mits any noncommercial use, distribution, and reproduction in anymedium, provided the original author(s) and the source are credited.References1. Database query of 2012 Part B Physician Supplier ProcedureSummary data on 11/14/14. Public use files purchased at:cmsdata@gdit.com. Accessed 23 Feb 2015.2. Voigt J, Mosier M. A powered bone marrow biopsy system versusmanual methods: a systematic review and meta-analysis ofrandomized trials. J Clin Pathol. 2013;66:792–6.3. Frey-Law LA, Lee JE, Wittry AM, Melyon M. Pain rating schema:three distinct subgroups of individuals emerge when rating mild,moderate, and severe pain. J Pain Res. 2014;7:13–23.4. HCPCS decision tree & definitions. http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html. Accessed 20May 2014.5. May 28th, HCPCS public meeting (afternoon session). https://www.youtube.com/watch?v=GGoynEFnkic. Accessed 23 Feb2015.6. Institute for Healthcare Improvement. The triple aim: optimizinghealth, care and cost. http://www.ihi.org/Engage/Initiatives/TripleAim/Documents/BeasleyTripleAim_ACHEJan09.pdf. Ac-cessed 14 Feb 2015.7. US Department of Health & Human Services. Strategic goal 1:strengthening health care. Objective D: reduce the value of healthcare costs while promoting high-value, effective care. http://www.hhs.gov/strategic-plan/goal1.html#obj_d. Accessed 31 Dec 2014.8. Goyal S, Singh UR, Rusia U. Comparative evaluation of bonemarrow aspirate with trephine biopsy in hematological disordersand determination of optimum trephine length in lymphomainfiltration. Mediterr J Hematol Infect Dis. 2014;6(1):e2014022.doi:10.4084/MJHID.2014.002.9. Hodgkin Lymphoma. National comprehensive cancer networkclinical practice guidelines. Version 2.2014. https://www.nccn.org/store/login/login.aspx?ReturnURL=http://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf. Accessed 23 Feb 2014.The Case of Penny Wise but Access and Quality of Care Foolish 123

Applied Health Economics and Health Policy

The Case of Penny Wise but Access and Quality of Care Foolish

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The Case of Penny Wise but Access and Quality of Care Foolish

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