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he Impact of Technology onealth Care Cost and Policy Development

aul E. Wallner, DO,* and Andre Konski, MD, MBA, MA†

As health care spending in the United States continues to increase at a pace significantlyfaster than that of other sectors of the economy, there seems to be greater interest andwillingness to consider the root causes of the rise and to explore options for reform. Someof the reasons for cost escalation are associated with a growing and aging population thatall too often makes inappropriate personal choices, but others are clearly attributable togrowth in the cost of drugs, hospital and nursing home care, provider reimbursement, anddurable medical equipment. Some health care economists have suggested that the rapidintroduction of new technologies has also played a major role. Vendors understandablydesire early market penetration of any new device or technology, but often this may beaccomplished before significant evidence of benefit is available. Our current system ofdevice approval unlinked to coverage and payment has produced further disruption in thesystem. The nature of the problem and consideration of various factors in the introduction,implementation, and evaluation of new technologies will be considered.Semin Radiat Oncol 18:194-200 © 2008 Elsevier Inc. All rights reserved.

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he growth in health care spending in the United States iswell documented with estimates of an average annual

xpenditure of 9.8% since 1970, approximately 2.5% fasterhan the general economy.1,2 In less than 4 decades, annualpending on health care has increased from $75 billion1970) to $2.0 trillion (2005), and estimates are that totalirect expenditure will surpass $4 trillion by 2015. As a per-ent of gross domestic product, health care spending in thateriod has climbed from 7.2% to over 16% and is projectedo consume 20% of the gross domestic product by 2015.espite enormous expenditures, the number of uninsuredontinues to rise and is currently estimated at 47 million.espite this outlay, outcomes for most disease and condi-

ions measured appear no better and in some instances worsehan countries where health care consumes less of their totaludgets. Economists and health care policy makers differignificantly on the potentially beneficial or adverse impact ofhese increases on public and private programs for healthare funding and the economy in general, and the reasons forhe increase in the various sectors of spending may not beuite so clear. There is little question that some of the growth

s related to a changing demographic as sophisticated and

21st Century Oncology, Inc, Fort Myers, FL.Department of Radiation Oncology, Fox Chase Cancer Center, Philadel-

phia, PA.ddress reprint requests to Paul E. Wallner, DO, 140 Fellswood Drive,

Moorestown, NJ 08057. E-mail: pwallner@rtsx.com

94 1053-4296/08/$-see front matter © 2008 Elsevier Inc. All rights reserved.doi:10.1016/j.semradonc.2008.01.007

ssertive consumers increase in numbers and become greaterecipients of health care resources, and some is certainlyased on the evolution of disease patterns and management.s a society, we continue to indirectly encourage and, in-eed, with inappropriate tax policy, actually reward self-de-tructive (and, in terms of health costs, expensive) behavior.roviders of health services ultimately have a limited abilityo alter these societal factors. Additional causes of increasedpending are attributable to the rapidly rising costs of hospi-al services. Drugs and technologies, many of which haveeen introduced into the marketplace after being subjected tonly the limited testing essential to establish the regulatorypproval criteria of safety and effectiveness for the statedndications, are also significant drivers of increasing costs.

ost researchers agree that advances in medical technologyave significantly contributed to the rise in US health carepending, and some investigators have attributed almost halff the increase in spending growth to the introduction of newedical technologies.3-8

Technology as a driver of increasing health care cost maye manifested in many ways.

1. New treatments may be developed for previously un-treatable terminal diseases such as AIDS.

2. Advances may be made in the management of previ-ously unsuccessfully treated acute conditions, such as

coronary artery bypass for coronary artery disease.

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The impact of technology 195

3. New procedures may be developed for the diagnosisand management of secondary diseases, such as themanagement of anemia in chronic renal disease.

4. Indications for treatment may expand over time.5. Incremental improvements in existing therapies may

increase the patient population treated.6. Clinical progress may extend the scope of medical care

to conditions once considered as beyond its bound-aries, such as substance abuse and mental illness.

These essentially clinical and scientifically-based drivers ofncreased spending do not include the equally important so-ietal drivers of utilization such as competitive market forcesnd vendor and provider incentives.

In this milieu, the precise determination of whether a newechnology actually increases or decreases health care costsay be difficult. Therapies that actually increase spending for

ndividual patients or brief time periods could conceivablyeduce the total amount of health care dollars expended inhe future if they improve outcome or reduce toxicity, and anncrease in penetration of one service might decrease utiliza-ion of another. A new vaccine for a prevalent disease may bexpensive to develop, distribute, and use initially but might,ver a period of time, save huge amounts by preventing thereviously required disease management. The calculation ofost impact becomes even more problematic when both di-ect and indirect costs are taken into consideration. Directosts to patients, families, and payers are always more easilybtained and calculated than indirect costs to individuals orociety, and payers are primarily focused on direct costs tohem of delivered care.

The scope of this article does not allow for the investigationf hospital, durable medical equipment, or drug-related is-ues, but radiation oncology is arguably the most technology-riven specialty in medicine, and some examination of theole of technology in the increasing cost of health care deliv-ry is appropriate. There is an increasing awareness thatealth care policymakers must be provided with additionalecision-making tools, and this awareness has spawned theevelopment of a more rigorous and scientific approach toealth technology assessment with the creation of interna-ional academic societies, journals, and curricula. Despite themportance and potential impact of these efforts and theommitments of many other nations, US policymakers haveemained somewhat ambivalent to the potential risk associ-ted with inaction.9 The US Congressional Office of Technol-gy Assessment was established by Congress in 1972 andunctioned with a low budget and small staff until 1995,hen its existence as government’s “best and smallest

gency” ended.In recognition of the important role it plays in develop-ent of health policy issues related to radiation oncology, theoard of Directors of the American Society for Therapeuticadiology and Oncology empanelled an Emerging Technol-gy Committee in 2005. The mission of the Committee is toerve as a resource for all stakeholders with regard to theyriad issuers related to the introduction and implementa-

ion of new technologies. e

he Introductionf New Technology

he current system of introducing new technology to thearketplace lacks coherence, especially as it relates to theichotomy between regulatory approval for sale and federalgency/commercial payer decisions regarding reimburse-ent. From the perspective of federal government paymentolicy, the system is further confused by a dichotomy be-ween facility (hospital-based) and nonfacility (freestanding)eimbursement systems. Facility payment for outpatient ser-ices is based on the ambulatory payment category designa-ions, whereas nonfacility payment is based on Current Pro-edural Terminology (CPT®) codes and the resource-basedelative value system practice expense methodology. Not un-ommonly, with radiation oncology devices, payment in theacility setting may not translate into payment in the nonfacilityetting, and, if payment is made in both, rates may vary widely.

The introduction of new technologies into the marketplaceay be influenced by a variety of factors, especially in a

ree-market, profit-driven system. Consumer demand is aignificant issue, fueled by expectations, marketing with in-reased awareness, and vendor/provider self-interest. Pay-ent systems that encourage early postintroduction payment

or emerging technologies may also be a factor. In the Unitedtates, increases in spending on research and developmentave improved end-results for many diseases but, alterna-ively, have increased costs. Developers and investigatorsay be driven by personal and professional goals. Commer-

ial interests are involved and medical technology enterprisespend considerably greater amounts on research and devel-pment as a percentage of sales than other non–health care–elated industries. The extraordinary pace of this “innova-ion” demands rapid introduction of new products to thearketplace.

he Food and Drugdministration Approval Process

he responsibility for the evaluation and clearance of medicalevices for sale and use in the United States resides with theepartment of Health and Human Services, the Food andrug Administration (FDA), Center for Devices and Radio-

ogical Health (CDRH). The nature of device clearance, basedolely on safety and efficacy determination for specific indi-ations requested by the vendor, does not equate with regu-atory approval of a new treatment regimen or dose schedule.eimbursement by federal, state, or commercial payers isetermined by other means but, in the absence of FDA reg-latory approval for sales, is rarely if ever forthcoming. TheDRH is specifically precluded from consideration as tohether devices are additive or replacement to existing tech-ologies, offer more or less expensive care with similar out-omes, or have adverse economic implications for the bud-ets of other federal agencies. The cost of technology researchnd development and market introduction are not consid-

red in the regulatory approval process.

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196 P.E. Wallner and A. Konski

The FDA’s regulatory authority stems from the 1906 en-ctment of the Food and Drugs Act. The original legislationas designed to prohibit interstate commerce in misbranded

nd adulterated foods, beverages, and drugs. In 1938, theederal Food, Drug, and Cosmetic Act required that drugs beroven safe before marketing. In 1976, Medical Devicemendments significantly expanded the FDA’s authority toegulate devices, and, in 1982, the FDA’s Bureau of Radio-ogical Health was merged with the Bureau of Medical De-ices to form the CDRH. The Center has statutory authorityo ensure both the safety and efficacy of medical devices.10 In990, the role of the CDRH was expanded with passage of theafe Medical Devices Act and further expanded in 1997 byhe Food and Drug Administration Modernization Act. The

edical Device User Fee Modernization Act of 2002 allowedhe CDRH to charge manufacturers for reviews, regulatedeprocessing of single-use devices, and authorized delegationf certain functions such as reviews and inspections to con-racted third parties.

The Federal Food, Drug and Cosmetic Act defines a med-cal device as “an instrument, apparatus, implement, ma-hine, contrivance, implant, in vitro reagent, or other similarr related article, including any component, part, or acces-ory, which is recognized in the official National Formulary,r the United States Pharmacopeia, or any supplement tohem, intended for use in the diagnosis of disease or otheronditions, or in the cure, mitigation, treatment, or preven-ion of disease, in man or other animals, or intended to affecthe structure or any function of the body of man or othernimals, and which does not achieve its primary intendedurposes through chemical action within or on the body ofan or other animals and which is not dependent on beingetabolized for the achievement of its primary intended pur-oses.”10

The initial step in approval consists of the basic decision aso whether a product is indeed a device (as opposed to a drug,s defined earlier) and whether it should be regulated as such.his decision is partially driven by the nature of the product

tself and partially by the claims or indications proposed byhe manufacturer. Currently, agents such as strontium 89nd samarium 153 are considered as drugs and as such arender the jurisdiction of the FDA Center for Drug Evaluationnd Research, whereas agents such as yttrium 90 impreg-ated microspheres are considered as devices and fall underhe purview of the CDRH. Based on the evaluation of specificlaims, certain products could be determined to be consumerroducts and would fall outside of the regulatory mandate ofDA, with regulatory oversight falling to the US Consumerroduct Safety Commission.Title 21 Code of Federal Regulations Parts 800 to

20011define baseline regulations pertaining to all medicalevices including registration and listing, proper labeling,nd submission of a 510(k) application. A 510(k) submissions formal notification to the FDA at least 90 days before a

anufacturer intends to introduce a new or modified deviceo the marketplace. On review of the submission, the FDAill determine whether or not the device can be marketed.

he approval of a 510(k) application indicates that a device is a

ither considered of low potential risk of harm or is substan-ially equivalent to legally marketed predicate devices mar-eted in interstate commerce before May 28, 1976, the en-ctment date of the Medical Devices Amendments. Then-Board Imager Device (FDA # K040192, 2004) manufac-

ured by Varian Medical Systems, Inc, Palo Alto, CA, waspproved based on its substantial equivalence to the Elektaynergy® System (FDA # K032996, 2003) manufactured bylekta Oncology Systems, Ltd, Norcross, GA. The Elektaroduct had received its 510(k) approval based on substan-ial equivalence to imaging devices marketed before the 1976

edical Devices Amendments enactment.Certain medical devices require more stringent evaluation

ased on a predetermined classification of risk.12 Class I de-ices, such as a stethoscope, have inherently low risk. Class IIevices require a greater level of control, and class III devicesarry higher risk and may contain new and/or less well-un-erstood technology. Radiation oncology–specific examples

nclude the following: (1) Class I: personnel protectivehields; (2) Class II: medical linear accelerators; and (3) ClassII: hyperthermia devices, including radio frequency (RF)nterstitial, microwave, and ultrasound systems.

Class I devices may be exempt from greater review anday not require specific marketing applications. Class II de-

ices typically will require a 510(k) application, indicatinghat the device shows substantial equivalence to an existing,pproved device. Safety and effectiveness are presumed to beell understood because of this equivalence.If a device is not found to be substantially equivalent to an

xisting marketed product, called a predicate device, theanufacturer or developer must submit a Premarket Ap-roval Application (PMA) before marketing. PMAs are re-uired for most Class III devices. Typically, in PMA evalua-ions, appropriate clinical trials reviewed and approved byhe CDRH will be necessary before market approval. Becausehe device to be tested is not approved for sale, trials must beerformed under an Investigational Device Exemptionranted by the CDRH so that clinical data can be acquired. Ineneral, data from trials performed within the United States,ith rigorous oversight, are preferred by the FDA, but, in

ertain circumstances and with adequate evaluation of theireneralizability of the patient populations and results, datarom trials performed outside the United States may be ac-eptable for review and consideration.

When approval for devices emitting radiation is sought,he manufacturers and developers are not required to vali-ate the merits of the radiation itself because these propertiesre well understood. The issues for FDA are whether theadiation can be delivered in an appropriate, predictable, andafe manner. Intrinsically, radioactive sources such asrachytherapy seeds require additional regulatory oversighty the US Nuclear Regulatory Commission, and, at this time,nsealed radiation sources fall under the regulatory mandatef the Nuclear Regulatory Commission and the FDA Centeror Drug Evaluation and Research rather than the CDRH.ctual treatment protocols (postapproval), doses, and meth-ds of delivery are not typically evaluated by the CDRH and

re at the discretion of the treating physician.

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The impact of technology 197

Actual device testing is rarely done by the FDA, with re-iew primarily performed from the data provided by manu-acturers, developers, clinical investigators, consultants, andndependent testing facilities. Study design must be ap-roved by the FDA, and decisions are based on the dataubmitted.

echnology Assessmentechnology evaluation or assessment can be defined as aumber of techniques that can be used to help patients, pay-rs, providers, and government agencies make decisions onhe appropriate use of new technologies or new applicationsf older technologies. The end users of the information are asaried as the methods used to evaluate the new technology.he technology assessment should attempt to inform policy-akers of the implication of the various technological op-

ions and look at multiple scenarios, cost/benefit analysis,orecasts, environmental impacts, and social impacts. Tech-ology assessments or evaluations are usually performed by aovernment agency, firms specializing in technology assess-ent, or companies deciding a future policy path. Finally,

echnology assessments usually use a multifaceted approachhat includes an analysis of policy options. Technology as-essments are obliged to analyze and evaluate both desirablend undesirable consequences (the chances and risks) ofechnologies, regardless of whether they are new or estab-ished.13 The new technology must be better, not only scien-ifically but also in the social (socioeconomic) and environ-ental dimensions, compared with the technology it would

e replacing.

he Selection of Endpointseveral questions should be addressed before the initiation oftechnology assessment.14 First, how critical is the need for

he information, and how soon is the information needed?echnology assessments can be expensive and time consum-

ng. It may not be cost-effective to perform a technologyssessment on a technology without broad appeal or only aery minimal increase in marginal cost. Second, will the tech-ology assessment uncover significant information that isurrently unavailable to decision makers? Third, are all of theesources (time and money) available for the technology as-essment, and, last, will the technology being assessed have areat impact as compared with other potential topics beingonsidered?

The identification of what is being assessed or the selectionf the endpoint of interest is the first step in performing aechnology assessment. The endpoint of interest will directlyelate to the technology being assessed. Overall or disease-ree survival is a potential endpoint of interest. An evaluationf an image-guidance technology may consider whether theechnology allows for smaller margins around a tumor andherefore would allow the delivery of higher doses of radia-ion improving the therapeutic ratio between normal andancerous tissue and thereby improve overall or disease-free

urvival. A technology being evaluated may also allow for the p

isplacement of an organ at risk and therefore reduce toxicitynd improve quality-adjusted survival.

Once the topic and endpoint for the assessment are se-ected, the technology assessment should be bounded.15

ounding identifies the limitations and assumptions of thepecific technology assessment. In considering a technologyssessment for proton-beam radiation therapy, the universef sites treated could be considered, or, alternatively, aroject could have “bounds” limited to specific disease enti-ies such as acoustic neuroma or somewhat more generalategories such as pediatric cancers. The focus of the evalu-tion should be narrow enough to allow for a thorough eval-ation of the technology but not too narrow to limit thesefulness or generalizability of the analysis. The tasks of aypical technology evaluation include gathering, analyzing,nd synthesizing of the data; determining the impact of “do-ng nothing” or keeping the status quo; and developing alter-ative policy choices. The typical components of a technol-gy assessment according to The Institute for Technologyssessment include problem definition; description of the

echnology; prediction of future technology development;escription of society and persons affected; prediction of so-ial developments; identification, analysis, and evaluation ofonsequences; analysis of political options; and communica-ion of the results in generally accessible form.16

Armstrong and Harmon17 have characterized technologyvaluation in terms of 3 functional elements. The first ele-ent is technology description and alternative projections

ncluding data acquisition, bounding the assessment do-ain, and projection of technological alternatives. The sec-

nd functional element is impact assessment and includesmpact criteria selection, prediction and assessment of im-acts, and impact comparisons and presentation. The finallement is policy analysis and cross-cutting concerns. Tech-ology description and alternative projections are composedf data acquisition, bounding the assessment domain, androjection of technological alternatives. Impact criteria selec-ion, predicting and assessing impacts, and impact compari-ons and presentation comprise impact assessment with themplementation of technological alternative and search forermeating issues; concerns and uncertainties makes up pol-

cy analysis.The techniques used to perform a technology assessment

re too numerous to list and describe in this brief review. Theechniques for technology assessments include risk analysis,rainstorming, interpretive structural modeling, and cost-enefit analysis to name a few. More than 1 technique can besed in a single technology assessment. We would refer theeaders to a text such as A Guidebook for Technology Assessmentnd Impact Analysis by Porter et al18 for a more in-depthescription of technology assessment techniques.

he Role of thearious Stakeholders

he dissemination of the technology assessment is the last

art of the technology assessment, but potential stakeholders

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198 P.E. Wallner and A. Konski

n the process will need to be considered early in the design ofhe assessment. The target population for the assessmenteeds to be clearly defined at the outset. A narrowly boundedssessment may not be appropriate for a general audience,nd a very broad assessment would not be appropriate for anssessment targeting a board of directors of a small startupompany. Stakeholders for technology assessments includend users of the product being assessed, including patientsnd their families, physicians, patient advocacy groups, tech-ology creators, government agencies, and payers.

echnology End Users (Patients and Families)atients should be the primary concern in any technologyssessment. The goal of a new technology is to improve over-ll, disease-free, or quality-adjusted survival. Recently, “pa-ient-based health technology assessments,” a techniquehereby patients have been included in technology assess-ent, have been introduced.19,20 Ideally, a patient-based as-

essment would promote patient knowledge by providingccess to information and promoting a dialog between pa-ients and physicians19 Patient-based health technology as-essments are successful when they ask patient-orienteduestions and involve patients throughout the entire process,romoting patient empowerment and thereby making pa-ients more capable to play a more active role in health careecision making.

hysicianshysicians help generate the data used in technology assess-ents and are the end users of the technology being evalu-

ted. As with patient-based health technology assessments,ata are emerging on the role of user involvement in healthare technology development and assessment.21 Physiciansave special expertise in the use and implementation of newechnology but also have potential biases for rapid accep-ance of the new technology. This was evident in the rapidncorporation of bone marrow transplantation for breast can-er in the late 1980s and 1990s before published randomizedrials showing no benefit and potential harm to women un-ergoing the procedure.

echnology Creatorsompanies involved in the discovery, development, manu-

acturing, and marketing of any new technology have tre-endous pressure to exhibit a return on investment for in-

estors. Companies would prefer as little time as possible tolapse between the inception of their product and reimburse-ent for the new technology. Technology assessments are

ital for this process, and most new products will not bepproved for reimbursement without it.

atient Advocacy Groupsatient advocacy groups have as much interest in seeing thedaptation of new technology as individual patients. The in-uence of patient advocacy groups on the provision of healthare has been steadily increasing. The groups want their con-tituency to have access to the latest and most advancedealth care treatment options. Unfortunately, this advocacyan be a dual-edged sword as evidenced by the breast cancer

dvocacy groups’ pressure and litigation to have bone mar- a

ow transplant services covered by insurance companies.nce again, this treatment option was believed by the advo-

acy group to be the only option available but was not beingovered by payers. Ultimately, randomized studies showedhis treatment to be no better than other therapies available athe time.

overnment Agenciesovernment agencies are natural end users for technologyssessments because most technologies require approvalrom the FDA for use and require a CPT® code for reimburse-ent. Until September 29, 1995, the Office of Technologyssessment provided Congressional members and commit-

ees with objective analysis of new technologies. Since thatime, Congress and other government agencies have had toely on other sources of technology assessment from compa-ies such as Hayes Inc., Lansdale, Pa 19446.22

ayersnsurance companies and agencies that fund health care arenother group of end users for new technology assessment.nfortunately, but understandably, little data exist at the

ime of new technology introduction for payers to make cov-rage decisions with the available data that often consist ofingle-institution or small multi-institution studies withmall patient numbers and limited follow-up. Because of thencreased cost and relative lack of efficacy with some newechnologies, payers are hesitant at times to provide coverageor new technology; they rely on technology assessment fromompanies such as Hayes as noted previously.

Radiation oncology has evolved into a field highly depen-ent on technology whether it be in the form of new and

mproved immobilization devices or multimillion dollar pro-on-beam facility. It is incumbent on radiation oncologists toake an active role in the confirmation of the beneficial effectsefore the wide adoption of each new technology. Healthechnology assessments are only 1 piece of that evidence-ased evaluation process, and evidence-based decision mak-

ng will ultimately involve the synthesis of data and judg-ent.

overage and Paymenthere is some agreement that the current system for intro-uction, coverage determination, and payment of new tech-ologies is flawed and that improved methods of evaluatingisks, benefits, and costs are necessary.23-25 Many suggestionsor reductions in the growth of technology costs focus onost-effectiveness analyses. Although these analyses provide“scientific” approach to policymakers, taken out of context,

hey offer limited solutions in a market-driven system that isolitically attuned to provide significant provider and con-umer-driven decision making. Other countries have at-empted solutions that remain politically unpalatable in thenited States, such as regulation, rationing, and budget-riven constraints.26 Other “experiments” such as managedare and certificate-of-need approvals have had limited suc-ess and, in the case of certificate of need, have been largely

bandoned for most services. Arguments proposing greater

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The impact of technology 199

enetration of consumer-driven health care, pay for perfor-ance, and introduction of more use of information technol-

gies belie the presence of conflicting evidence of benefit.27,28

Decisions regarding coverage for specific services and/orechnologies are often frustratingly convoluted and are mostrequently made at the local level by individual commercialarriers or Medicare fiscal intermediaries. The rationale forhese local carrier determinations may be based on no morehan personal relationships but may also involve a judgments to cost versus benefit or medical necessity. In these situa-ions, carrier medical directors and providers are often atdds regarding the strength (and interpretation) of availableiterature. Local carrier determinations may be made for aariety of reasons and may be patient specific or based onore generalized corporate coverage policy development.he Centers for Medicare and Medicaid Services (CMS) hasoutinely avoided publication of national coverage determi-ations because of time and personnel constraints and a de-ire to “field test” coverage policy at the local level.29 Thisoverage development schema, varying between federaledicare regions and individual carrier venues, is a constant

ource of confusion and frustration within the vendor androvider communities.

aymentcommon benchmark for any payment decision is the need

or FDA approval of any new device or technology. Absenthat approval, carriers will routinely deny payment becausef a lack of a formal federal determination as to safety andfficacy. After FDA approval for marketing, vendors may seekither a new technology payment determination under theedicare Outpatient Prospective Payment System (OPPS)

Medicare Part A), through the Medicare Physicians Feechedule (MPFS) (Medicare Part B), or both. OPPS paymentsre for hospital technical services only and do not impacthysicians payment. The MPFS includes payments for phy-ician work, professional liability insurance, and practice ex-ense (technical charges) where appropriate. OPPS payment

s determined through the Ambulatory Payment CategoryAPC) structure managed entirely by the CMS, with physi-ians, other providers, and the insurance industry providingirect input through the Medicare APC Advisory Panel.The lengthy process of payment under the MPFS is initi-

ted by application to the CPT® Editorial Panel for definitionf a new or altered service, assignment of a 5-digit identifyingode, and referral of the code to the American Medical Asso-iation/Specialty Society Relative Value Scale Update Com-ittee (RUC). The application for a code definition may be

equested by a vendor, investigator, specialty society, orther interested party, but, as a function of the Americanedical Association, code development will be significantly

ampered without the support of an interested specialty so-iety. The CPT® Editorial Panel members will require FDApproval, evidence that a device or technique is used by aumber of physicians in a variety of venues, and a body ofupporting peer-reviewed clinical literature.

The RUC will require specialty societies to provide surveys

f users (generally a minimum of 30 individual users) for

etermination of the appropriate time and resources ex-ended and for assignment of work and expense values. RUCecommendations for payment values are then sent to theMS for consideration. Other payers, although not required

o follow RUC/CMS decisions, often tie their levels of pay-ent to the processes of those organizations.30

The lack of coherence in coverage and payment policy maye a factor in the continued use of existing albeit less effectiveechnologies, introduction of costly yet insufficiently testedechnologies, and lack of data to adequately support paymentor potentially expensive new technologies. To expedite andationalize the process, the CMS has introduced the conceptf coverage during evidence development (CED), and thetrategy is being actively considered by a number of commer-ial payers. Concerns have been raised that the policy may beoercive, unethical, and potentially unfair because underED patients might be required to participate in a specificlinical trial to gain access to the technology being investiga-ed.31 The consideration of CED as a method of technologyssessment and coverage/payment determination does raiseoncerns from all stakeholders but may ultimately be thenly manner in which these decisions can be made.32

ummarydvances in health care technology have been a significantriver of certain outcome improvements over the past severalecades but have also added to the steep growth in healthare spending, especially in the United States. In the absencef a unified rationale, acceptable method of determination ofppropriate introduction, utilization, and payment for theseechnologies and in the face of increasing constraints onealth care spending at every level, a new paradigm must beonsidered. Various stakeholders must recognize that newpproaches and relationships may be the only way researchnd development can progress.

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