PAGE 1
Coverage of Laser Technology by Health Insurers August 1995 OTA-BP-H-159
PAGE 2
Recommended Citation: U.S. Congress, Office of Technology Assessment, Coverage of Laser Technology by Health Insurers, OTA-BP-H-159 (Washington, DC: U.S. Government Printing Office, August 1995).
PAGE 3
iiiroject Staff Clyde J. BehneyAssistant Director, OTASean R. TunisHealth Program DirectorADMINISTRATIVE STAFFLouise StaleyOffice AdministratorCarolyn SwannPC SpecialistMonica FinchWord Processing SpecialistCharlotte Y. BrownWord Processing SpecialistPRINCIPAL STAFFDenise DoughertySenior Associate and Project Director, Technology, Insurance, and the Health Care System1Hellen GelbandSenior AssociateHelga RippenAnalystSara FreyAnalystJill EdenSenior AnalystCONTRACTORSClaudia Steiner, Neil Powe, and Gerard AndersonDepartments of Medicine and Health Policy and Management Johns Hopkins Medical InstitutionsPUBLISHING STAFFMary Lou HiggsManagerArna LaneProduction EditorSusan HoffmeyerGraphic DesignerCheryl DavisElectronic Publishing Specialist______________1 Now Program Director, Education and Human Resources.
PAGE 4
ivSummary 1 Coverage of Laser Technologies by Health Insurers 3Deciding to Pay for New Technologies 3 The Coverage Decisionmaking Process 4 The Survey 5 Conclusions 12Appendix A: Overview of OTA Assessment: Technology, Insurance, and the Health Care System 15 Appendix B: Survey on Medical Coverage Decisions for Lasers 19 REFERENCES 39ontents
PAGE 5
ummary1 ew medical technologies hold both the promise of significant health benefits and the prospect of additional health care spending. Private health insurance companiesthrough which most health care is paid forshoulder a considerable responsibility in deciding which new technologies will be covered by insurance, and when in the cycle of development the time arrives to approve coverage. In general, insurance coverage is denied for technologies that are considered unproved or experimental. Despite the obvious importance of these decisions, relatively little systematic information is available about the procedures that insurers go through and the criteria they use to weigh the evidence. This background paper presents some empirical information on how insurers consider payment for new medical devices. It describes the survey results of medical directors affiliated with private health insurers about their coverage decisions using, as examples, three applications of lasers: laser angioplasty for opening narrowed or blocked coronary arteries; laser discectomy for treating herniated intervertebral discs; and photodynamic therapy (using a lightsensitive dye) for bladder cancer. 1Though there is no set procedure that all insurers follow to evaluate new technologies for coverage under their policies, it appears that most companieswhether indemnity insurers or health maintenance organizations (HMOs)go about the process similarly. The company medical directors are nearly always involved in coverage decisions and, in most companies, are assisted by a committee. The factors weighed in coverage decisions appear to be relatively consistent across companies. Among the most important are medical acceptability, efficacy, safety, costeffectiveness, and regulatory considerations (in the case of lasers, Food and Drug Administration (FDA) approval of the device). One of the differences found between decisionmaking of indemnity insurers and HMOs was that HMOs appear to give more weight to costeffectivenessthey were less likely to cover a new technology if it had a higher cost for the same effectiveness. The largest barrier to decisionmaking, for all types of insurers, is the paucity of reliable information on the effectiveness, safety, and cost effectiveness of new technologies at the time coverage decisions have to be made. Insurer medical directors view the medical profession, health care institutions, manufacturers, and the federal government as having the greatest responsibility for assuring that technologies yield reasonable benefits at reasonable costs. 1This background paper is based on Technology Coverage Decisions: The Process and Considerations Used by Health Plans,, unpublished contractor report prepared by C.A. Steiner, N.R. Powe, and G.F. Anderson for the Office of Technology Assessment, U.S. Congress, Washington, DC, January 1995. |1
PAGE 6
overage of Laser Technologies by Health Insurers dvanced medical technologies are a hallmark of U.S. medicine: almost without exception, they come into use earlier and are used more widely than they are in other countries. From advanced imaging equipment to new surgical techniques, the United States leads all developed nations (31). These new technologies are often welcomed by the medical community and the public as the cutting edge in diagnosis and treatment and many important medical innovations are developed and used first in the United States. But advanced technology comes at a price, and may be responsible for as much as half the increase in health care spending over the last 20 years (18). Insurers have an important effect on the fate of new technologies by their decisions on which new technologies will be covered. This background paper reports the results of a survey of medical directors within private insurers concerning their decisionmaking process on covering new laser technologies in medicine.DECIDING TO PAY FOR NEW TECHNOLOGIESPhysicians are clearly key to the introduction of new technologies; but a vital and increasingly active role is played by insurers of various kinds who must pay for the use of these new items on behalf of their customers. At some point, insurers must decide whether each new technology warrants coverage, be it a drug, device, or procedure. Relatively little is known about the process insurers use to make these decisions (5,9,11,30,35). Private insurers have set up some formal technology assessment programs; but the number of evaluations they conduct is limited, and their conclusions are not always binding on the plans. For example, the Blue Cross and Blue Shield Association (BCBSA) (10) makes coverage recommendations based on a formalized process that includes a medical advisory panel. BCBSA considers a technology eligible for coverage if five criteria are met: 1.The technology must have final approval from a regulatory body (e.g., FDA); 2.There must be scientific evidence concerning the effect of the technology on health outcomes; 3.The technology must improve the net health outcome (e.g., survival, quality of life, ability to function); 4.The technology must be as beneficial as technologies currently existing; and 5.Net improvements must be attainable outside the research setting. |3
PAGE 7
4|Coverage of Laser Technology By Health Insurers The results of these assessments are provided to BCBSA member plans but plans are not required to follow recommendations and can perform their own assessments. Though public insurers (Medicare and Medicaid, in particular) have a role in assessing new technologies for coverage, in the end it falls mainly to private insurers to make coverage decisions, for the following reasons. First, private carriers insure almost three-quarters of the insured U.S. population. Second, while the Health Care Financing Administration (HCFA, part of the Department of Health and Human Services) is responsible for administering the Medicare program, it issues only about 10 national decisions each year affecting the coverage of new technologies or procedures (33). And third, Medicare's claims and payment policies are administered by private contractors across the country (e.g., BCBS, Travelers Insurance Company, etc.) who make day-to-day decisions about the appropriateness of paying for items of medical care on behalf of Medicare.z The Changing Private Insurance MarketTwo decades ago the insurance market consisted entirely of indemnity insurers (coverage that pays doctors, hospitals, and other providers for treatment given), but since that time managed care organizations, which combine health care delivery with the insurance function, have taken over a substantial and growing portion of the market. In 1992, an estimated 35 million members were enrolled in 558 HMOs, and 143 million people were covered by 1,200 or so private commercial insurers and 69 BCBS plans. Another 45 million are enrolled in preferred provider organizations (PPOs) and other forms of managed care organized by conventional indemnity insurers (14). Different types of insurers may have different incentives for evaluating and deciding about covering new technologies, but almost nothing is known about how they differ. A better understanding of how this process occurs in different types of insurance organizations could be helpful in understanding the likely long-term impact of the growing managed care market on the way health care is delivered and how much it costs. The tightening financial climate in health care, with greater emphasis on price competition, is likely to make technology assessment and coverage an even more important function within the insurance industry.THE COVERAGE DECISIONMAKING PROCESSThough limited, some sources of information relating to the coverage decisionmaking process exist. A recent U.S. General Accounting Office (GAO) report on technology assessment and medical coverage decisions for Medicare (34) noted that only a few national coverage decisions for Medicare are made by HCFA while the remaining are regional decisions made by the 79 contractors that process claims under contract to HCFA. The Agency for Health Care Policy and Research assesses technologies at the request of HCFA and makes recommendations about coverage. The factors considered in coverage decisions include the potential expense to the Medicare program, the potential for widespread use in medical practice, the level of disagreement about the technology's safety and effectiveness, and the variation among contractor coverage decisions. The sources of information used to make these decisions include physicians, suppliers, manufacturing groups, and the contractors. HCFA coverage decisions are made by Technology Advisory Committee. This 26-member committee, which meets for one and one-half days every quarter, is made up of HCFA physicians and other officials (about half the committee), contractor medical directors (seven), and officials from the National Institutes of Health, the Civilian Health and Medical Program of the Uniformed Services, the BCBS Association, FDA, and the Office of Health Technology Assessment. Coverage decisions can take from two months to several years to develop, depending on the issue's complexity. Once a decision is made, it is published as a proposed rule in the Federal Register The resulting reviews and public comments are
PAGE 8
Coverage of Laser Technology By Health Insurers 15 incorporated into the final notice, which is published (34). Most Medicare coverage decisions are made not through the process described above, but by the contractors who administer claims under Medicare. Lacking a national coverage decision, the 32 contractors review technologies themselves and make their own coverage decisions. This means that contractors may use no formal criteria, may develop their own criteria, or may use criteria developed by national insurers. Some create internal committees to perform technology assessments, although others have a more informal process. The only requirements are that each contractor has the equivalent of a full-time medical director responsible for making these decisions, and that representatives from the local provider community review all proposed medical policies. It is not surprising that Medicare coverage varies widely (34). Less is known about the process of making coverage decisions in the private insurance community. A study of insurance coverage for patients in clinical trials of autologous bone marrow transplantation for breast cancer (19) concluded that, in that case, the decisionmaking process was arbitrary and capricious. Coverage for patients enrolled in these clinical research trials varied among third-party payers, appeared to bear little relation to available medical or scientific information, and varied from one request to another (similar patients and identical protocols). Some of the inconsistency in coverage may result from the influence of legal battles over coverage of this experimental intervention (1,13). THE SURVEY The aim of the survey, which was carried out under contract to OTA, was to find out how private insurance companies in the United States decide about the coverage of new medical technologies under their plans. Questions were asked to determine who is responsible for and involved in coverage decisions, the criteria used for deciding, the timing of decisions, and what information is used in the decisionmaking process. Three laser technologies were used as examples to illustrate specific considerations applied to making coverage decisions. z The Technologies Three quite different laser technologies were the focus of this survey: laser angioplasty, laser discectomy, and laser photodynamic therapy for bladder cancer (box A). The three technologies are used by different medical specialties and have very different characteristics in terms of what is known of their effectiveness and safety. They were chosen specifically because they are at different stages of development and use. Laser angioplasty has been relatively well studied and reported on in the published medical literature. The use of lasers for percutaneous discectomy, though FDA approved, has not been well studied. There are only limited data available regarding its safety or effectiveness relative to the standard percutaneous discectomy and open-back surgery. Finally, laser photodynamic therapy for bladder cancer had not yet been submitted for FDA approval at the time of the survey. 2 Though still in its investigative stage, the survey portrayed this technology as offering additional benefits over other available treatments. z The Questionnaire The questionnaire had three sections (see appendix B). The first section addressed coverage issues relating specifically to the three laser technologies. A short summary regarding the available data, FDA approval status, side effects, and how it compares with alternative therapies preceded 2 As of June 1995, laser photodynamic therapy had not yet been approved by the FDA (8). 4
PAGE 9
6 I Coverage of Laser Technology By Health Insurers Laser angioplasty When arteries of the heart become blocked or narrowed by the gradual accretion of plaque (a collection of abnormal fat, cells, and debris), not enough blood gets to the heart and angina (chest pains) or eventually, a heart attack may result. One treatment for this atherosclerosis is angioplasty an intervention to open blocked or narrowed arteries. To get to the target artery, a needle is inserted (after local anesthesia) into the appropriate blood vessel. A catheter is then introduced and advanced to the narrowed area using a visualization technique (fluoroscope). Once the device is in place, angioplasty can be performed. The first method reported used catheters of increasing size to open the obstruction (23). Now many different methods are available. With balloon angioplasty a catheter with a collapsed balloon is used. Once in place the balloon is opened and the plaque is compressed against the sides of the artery resulting in a larger passageway, or lumen. Instead of compressing the plaque, it can be removed by laser energy. In this case a special catheter tip is inserted and laser energy IS transmitted to the narrowed artery, destroying the plaque. The laser technique had been fairly well studied at the time of the survey, and the published literature provided relatively good information about its safety effectiveness, and cost. Laser angioplasty may have a higher complication rate, be somewhat less effective, and be more expensive than balloon angioplasty (6,7,1 6,24). Laser discectomy Lower back pain was first linked with herniated lumbar intervertebral discs in 1934. Now it is one of common conditions treated by neurosurgeons in the United States (23). The intervertebral disc is made up of a tough annulus fibrosis surrounding a gelatinous material, the nucleus pulposus, which becomes more fibrous with age. An injury to the back can weaken the surrounding annulus, and with this, the nucleus pulposus can protrude (herniate) outside the ring. The disc is immediately behind the spinal cord so herniation may compress the nerve roots, causing back pain, and tingling or weakness of the legs. The surgical options to relieve cord compression are open back surgery and percutaneous methods, both mechanical and laser. Open surgery requires general anesthesia and entails an incision and dissection of the area, then removal of the disc. Several days of hospitalization are required. With the percutaneous methods, local anesthesia can be used while a needle is inserted into the affected region and the disc removed by suction or laser energy. The patient can go home the same day. There is relatively little reformation on the safety or effectiveness of laser discectomy compared with the alternatives (15,21 ,25). The laser used for this technique does, however, have Food and Drug Administration (FDA) approval. Photodynamic therapy Photodynamic therapy for bladder cancer was in an investigational stage (not yet FDA approved) at the time of the survey (and still IS considered investigational in 1995). The treatment involves injecting the patient with a photosensitive substance that is taken up selectively by the cancer cells. The area of the tumor is then irradiated with a laser of the appropriate wavelength to excite the photosensitizing agent, releasing highly active singlet oxygen (i.e., single atoms of unbound oxygen), which destroys the malignant tissue around it. The description of this technology on the survey questionnaire portrayed it as being supported by ample evidence for its effectiveness in bladder tumors for which conventional treatment had failed. In addition, few complications had been reported (7,17,26,27,28). SOURCE: Office of Technology Assessment, 1995, based on reference 29
PAGE 10
Coverage of Laser Technology By Health Insurers 17 l l l l l l l l l l l l l l l l l l l l l l l l Medically acceptable, reasonable, or necessary Experimental or investigational technique Potential for increased cost of the procedure due to laser technique Potential for decreased cost of the procedure due to laser technique Potential for increased volume of this procedure due to new laser technique Potential for decreased volume of this procedure due to new laser technique Concern that coverage will prompt influx of new patients into insurance plan Benefits policy excludes procedure Denial of coverage maybe legally challenged in the court system Alternate technique available which is clinically proven effective Increased complication rate Decreased complication rate Increased efficacy of this technique Decreased efficacy of this technique Potential differences between clinical trials (efficacy) and community experience (effectiveness) FDA approval Increased cost-effectiveness Decreased cost-effectiveness Complications present a liability risk for the company Technique is outpatient rather than inpatient Technique is inpatient rather than outpatient Laser technique is potentially last resort What other carriers currently cover Other a The treatment is generally accepted by the professional medical community as an effective and proven therapy and IS appropriate for the treatment of sickness or injury. SOURCE: Office of Technology Assessment, 1995, based on reference 29. exploration of the factors that would be considered in a coverage decision. For each technology, the respondents were asked to choose from among a list of considerations (table 1) the five that would weigh most heavily in favor of covering the technology, and the five that would weigh most heavily against it. The first section ended by asking whether the insurer was providing coverage for each of 15 laser procedures (figure 1 ) to assess actual coverage of these technologies. The second section of the questionnaire queried the general medical coverage decisionmaking process. Questions were asked to find out who was usually involved in coverage decisions, what types of information would be used, the timing of the decisions, what circumstances tended to make decisionmaking more difficult, as well as questions soliciting the respondents opinions on various coverage matters. The third section asked standard questions about the characteristics of the company and about the person filling out the survey (in most cases, the companys medical director). z Companies Surveyed The intent was to survey virtually all private health insurers in the country. Questionnaires were sent to all members of three trade associationsthe Health Insurance Association of America, Group Health Association of America, and Blue Cross/Blue Shieldand to the four largest commercial plans in the country (Aetna, Cigna, Metropolitan Life, and Travelers), which were not members of a trade association. In total, 573 questionnaires were mailed. Between October 1993 and March 1994, three copies of the questionnaire were sent, as well as two postcard reminders, to try to assure a good response rate. Overall, 41 percent of the questionnaires were completed and returned (table 2). All four large commercial companies responded and, in general, the larger HMOs and other indemnity insurers also responded (figure 2), so the response represented approximately 70 percent of all people with private health insurance in the United States, though less than half the companies. The respondent companies (other than being larger than average) were generally representative of the insurance market in their basic characteristics. The characteristics of the responding plans are shown in table 3.
PAGE 11
m 8 I Coverage of Laser Technology By Health Insurers Laser therapy Diabetic retinopathy treatment Cervical ca-in-situ ablation Skin ca ablation Endometriosis ablation Upper GI bleeding Inoperable lung ca ablation CoIonic adenoma removal Hemorrhoid ablation Urethral stricture ablation Stapedotomy Tonsil removal Percutaneous discectomy PTCA Bladder ca photodynamic therapy Tattoo ablation o 10 20 30 40 50 60 70 80 90 100 Health plans Abbreviations: ca=carcinoma: Gl=gastrointestinal; PTCA=percutaneous transluminal coronary angioplasty SOURCE: Office of Technology Assessment, 1995; based on reference 29 z Survey Results On the question of who is involved with coverage decisionmaking, it is clear that medical directors play a central role. About 80 percent of the questionnaires were filled out by medical directors, and nearly all the respondents indicated that the medical director had major involvement in these decisions. Respondents believed that insurers should continue to play a role in assuring that new technologies yield reasonable benefits at a reasonable cost, but that physicians, health care institutions, manufacturers, and the federal government should shoulder more of that responsibility (figure 3). z Coverage of Laser Therapies There was considerable variation in coverage of laser technologies. Less than 40 percent of the responding companies were covering laser angioplasty or laser discectomy, and about 25 percent were covering photodynamic therapy for bladder cancer at the time they answered the survey. Among the list of 15 laser technologies, only tattoo ablation was covered less frequently than the three focused on in the survey. The only technology covered by all the companies was laser treatment for diabetic retinopathy (figure 1). z Decisionmaking About the Three Sample Technologies Overall, the factors chosen most often among the top five that would weigh in favor of coverage for any of the three technologies are: 1. Medically acceptable, reasonable, and necessary; 2. Increased efficacy of the technique; 3. Increased cost-effectiveness; 4. FDA approval; and 5. Decreased complication rate. There was more variation regarding the factors that would weigh against coverage among the three technologies. The factors most often noted included: 1. 2. 3. 4. Experimental nature of the technology, Increased complication rate, Alternate technique available which is effective, Decreased efficacy of the technique,
PAGE 12
Coverage of Laser Technology By Health Insurers 19 Types of plans Respondents (n) Total mailings (n) Response rate (o/o) HIAA member plans 39 104 37.5% BCBS member plans 73 140 52.1 GHAA member plans 115 315 36.5 Large indemnity plans a 4 4 100.0 All clans 231 563 41.0 a Aetna, Cigna, Metropolitan-Life, and Travelers. KEY: BCBS = Blue Cross and Blue Shield; GHAA = Group Health Association of America, Inc.; HIAA = Health Insurance Association of America SOURCE: Office of Technology Assessment, 1995 5. Decreased cost-effectiveness of the technique, and 6. Benefits policy excludes the technique. Laser photodynamic therapy was not FDA approved and this factor was ranked in the top five for recommendations against coverage. (Thirtyseven percent of respondents ranked this in the top five for photodynamic therapy, as opposed to 8 percent for both laser angioplasty and discectomy.) z Differences Among Plan Types Respondents from HMOs were more likely than those from indemnity plans to list the potential for decreased costs as a point in favor of covering laser angioplasty and laser discectomy. There were also differences between HMO and indemnity plans in what they considered important considerations against covering a technology. For laser angioplasty and discectomy, HMOs were more likely than indemnity plans to list increased complications rate as an important factor. For photodynamic therapy, indemnity plans were more likely than HMOs to list potential increased volume due to laser technique. For this technology, HMOs were more likely to list complications may present liability risk than were indemnity plans. z Awareness of Use of Laser Technology Insurers must be aware that they are being asked to pay for a new technology before they can decide to make a formal coverage decision about it. Insurance claims are generally made using billing codes that represent certain procedures. Until a new technology is given a specific code, physicians often use an existing code, so the insurer will not necessarily be aware that the new technology was used (e.g., laser angioplasty might be billed using the general code for angioplasty, single 3530 25percent 20of HMOs 15105 0 n HMO respondents <20,000 20,00050,000100,000>250,000 49,999 99,999 249,999 Number of enrollees Abbreviations: HMO=health maintenance organization a Total HMO respondents = 159. Twelve did not report size of plan b n = 552 for all HMOs SOURCE: Group Health Association of America, Inc., HMO Industry Profile, 1993 Edition (Washington, DC 1993), Off Ice of Technology Assessment, 1995, based on reference 29
PAGE 13
10 Coverage of Laser Technology By Health Insurers Company type l HM O 159 69% l indemnity 72 31 Size a n small 106 49.5 l large 108 50.5 Profit status b n for profit 121 54 n not-forprofit 103 46 a Size of company in terms of enrollees for HMOs and covered lives for indemnity carriers. Six size ranges taken from questionnaires and combined into two groups. Seventeen respondents did not report size. b Seven respondents did not report profit status KEY: HMO = health maintenance organization. SOURCE: Office of Technology Assessment, 1995; based on reference 29. vessel). None of the three laser technologies focused on had its own billing code at the time of the survey. A series of questions was asked on this issue. For each technology, 64 to 78 percent of respondents said they would not have known that the laser procedure had been used based on billing information. In all three cases, indemnity insurers were less likely to be aware of the new technology than were HMOs. Respondents were asked how they were likely to find out that a new procedure was being used. Most commonly, they were alerted by a query from a practitioner, by higher than average charges for treatment, or by utilization review. Internal discussion with medical or insurance colleagues was a more frequent source of awareness for HMOs than for indemnity insurers. Indemnity insurers were more likely to rely on manufacturers to alert them to a new laser technology. Once aware of the use of laser angioplasty in the plan, factors (cited more than 60 percent of the time) that would prompt a specific medical coverage policy decision for this technology are: 1) concern that this is an experimental procedure, 2) covering a technique with more potential complications, and 3) the technique is not considered a community standard. z Medical Director Characteristics and Role in Coverage Decisionmaking Ninety-three percent of all medical directors held a medical degree, with an additional 3 percent holding another medically-related degree. Most were from primary care disciplines (79 percent). The most frequent secondary degrees were Master of Business Administration (32 percent) and Master of Public Health (25 percent). The makeup of the committees that assisted medical directors varied. Half of the respondents noted the inclusion of their staff and of community physicians on the committee. About one-third of the committees included attorneys and representatives from utilization review, benefits, and claims departments. Ninety-two percent of the respondents noted that the medical director is involved with the review process for a medical coverage decision. The responsibility for making a medical policy coverage decision was either that of the medical director alone (27 percent) or the committee (68 percent). Three-quarters of the respondents indicated that, Physicians Health care institutions Manufacturers Federal government Insurers Patients State government courts O 10 20 30 40 50 60 70 Percent of respondents a Percent of respondents who indicated which party should have a great deal of responsibility SOURCE: Office of Technology Assessment, 1995: based on reference 29.
PAGE 14
Coverage of Laser Technology By Health Insurers 11 Medical journals Opinions of local experts FDA clearance documents Insurer association information Medical society statements/guidelines Opinions of national experts Medicare policies Government documents NIH consensus conferences Other larger insurers Other I 1 1 o Actual sources b n Optimal sources c I I I | 1 0 10 20 30 40 50 60 Percent of respondents Abbreviations: FDA=U.S. Food and Drug Administration; NIH=National Institutes of Health. a Medical directors were asked to rank actual and optimal sources of information used when making a medical coverage decision. b Four respondents did not report actual sources. Two respondents did not report optimal sources. SOURCE: Office of Technology Assessment, 1995, based on reference 29. ideally, a committee should make this decision. Indemnity insurers were more likely than HMOs to believe that ultimate responsibility for coverage decisions should lie with the medical director alone. The timing of the decision varied with the type of plan. Retrospective decisions are coverage decisions made after the medical service is rendered. This is in contrast to prospective decisions, when approval for medical services is made before it is provided. Retrospective decisionmaking was noted a quarter of the time for HMOs as compared to just over half the time for indemnity plans. Both types of plans reported that optimally, decisionmaking should be prospective (98 percent and 89 percent of HMO and indemnity respondents, respectively). z Sources and Types of Information Used for Coverage Decisions A variety of questions was asked about the sources and types of information used by insurers for making coverage decisions about new technologies. Medical journals, the opinions of local experts, and FDA clearance documents were the most frequently cited information sources. But they also indicated that they thought the opinions of local experts should be used less and that formal national committee statements, such as NIH consensus conferences, should be used more (figure 4). A variety of research types were considered useful for decisionmaking. The top three ranked types of evidence are: randomized controlled trials, meta-analyses, and review articles (figure 5). z Cost-Effectiveness as a Consideration in Coverage Decisions The survey asked whether plans would be likely to cover new technologies with varying ratios of cost to effectiveness. The responses indicated that higher cost technologies are less likely to be covered than alternative technologies, without some benefit in effectiveness (figure 6). However, indemnity insurers were more likely than HMOs to
PAGE 15
12 Coverage of Laser Technology By Health Insurers Non-randomized, controlled Observational study Case-control Study Case series Case reports Testimony or theory 1 I I o 20 40 60 80 100 Percent of respondents a Medical directors were asked to rank top three choices for types of evidence used when reviewing a laser therapy. b Type Iisted in any rank order. Six respondents did not rank types of evidence. SOURCE: Office of Technology Assessment, 1995; based on reference 29. cover a new technology that is equal in effectiveness to an existing one, even if it is more expensive. z Barriers to Making Coverage Decisions Respondents indicated that the most significant barriers for them in making coverage decisions concern lack of timely data: effectiveness data, cost-effectiveness data, and safety data. Administrative, regulatory, and legal barriers were secondW (figure 7). Indemnity plans also noted health care provider disagreement with insurer coverage decisions (provider contention) as a significant barrier. CONCLUSIONS Health insurers (both indemnity insurers and managed care organizations) play an important role in the introduction and dissemination of new medical technologies. Their decisions on covering new technologies affect both the cost and quality of health care for the country, yet little is known about the processes or the criteria used to make these decisions. This survey elucidated some aspects of the process, primarily focusing on applications of medical devices. This survey focused on only one level of the coverage decision process. It did not explore decisions handled at other levels, such as the claims department, or at what point a coverage issue is addressed by a formal decision. Once a decision regarding medical coverage is necessary, the insurance company medical directors are most often involved. Usually, a committee advises the medical director on specific coverage questions, but in some companies, the responsibility rests solely on that individual. All the readily available sources of information may be used in making coverage decisions, from the results of randomized controlled trials to the opinions of local experts. Even though there is no standardized procedure that all insurers follow in making coverage decisions, the factors that weighed most heavily in the decisions were quite similar across companies. The medical acceptability of and need for the new technique, whether devices involved had been approved by FDA, the cost-effectiveness of the new technology compared with existing treatments, the complication rate, and where the technology was along its path of development (e.g., still experimental versus accepted practice) were among Relative effectiveness (in percent) Greater Equal Less Relative cost effect effect effect Greater cost 90 24 3 Equal cost 99 95 4 Less cost 98 99 14 a Figure shows percentage of respondents who would cover a new technology given a cost and effectiveness profile relative to a standard technology. SOURCE: Office of Technology Assessment, 1995, based on reference 29.
PAGE 16
Coverage of Laser Technology By Health Insurers 13 the most important considerations. Many coverage determinations are made retrospectively i.e., when the company is billed after the procedure has been carried out, and this fact could also weigh in whether it will be paid for. (Retrospective evaluation is more often the case for indemnity insurers than for HMOs where a larger percentage of evaluations is carried out prospectively, before the service has been given.) Most insurers prefer a prospective decisionmaking process. Coverage decisions are often difficult for insurers because reliable information on effectiveness, cost-effectiveness, and safety often is not adequate when decisions have to be made. Cost-effectiveness is given considerable weight in these decisions, although indemnity insurers appear to be somewhat less concerned about it than are HMOs Private insurers recognize that they will continue to be gatekeepers for many new technologies, and in that role they can be most effective if armed with better information about the technologies at the earliest possible time. The decisionmakers in these companies also, however, would appear to welcome greater responsibility on the part of the No timely effectiveness data No timely cost-effectiveness data No timely safety data International administrative External regulatory Legal barriers Provider contention Other O 20 40 60 80 100 Percent of total a Respondents were asked to rank barriers in any order. b Seven respondents did not report barriers. SOURCE: Office of Technology Assessment, 1995, based on reference 29. medical profession, health care institutions, manufacturers, and the federal government in assuring that new medical technologies are effective, safe, and relatively cost-effective before they diffuse into widespread use.
PAGE 17
Appendix A: Overview of OTA Assessment: Technology, Insurance, and the Health Care System z BackgroundCongress has been concerned for many years with serious and growing problems of health care costs, access, and quality. In response to a request from the Senate Committee on Labor and Human Resources (Edward Kennedy, then Chairman) that was endorsed by the House Committee on Energy and Commerce (John Dingell, then Chairman), the House Committee on Ways and Means Subcommittee on Health (Bill Gradison, then Ranking Minority Member), and Senator Charles E. Grassley (Committees on Budget, Finance, Special Committee on Aging), the Office of Technology Assessment's (OTA) assessment, Technology, Insurance, and the Health Care System addresses these congressional concerns by focusing on the following issues: 1.What does the available literature say about the impact of health insurance on access to care and patient health outcomes? 2.Can a minimum benefit package for uninsured people be fashioned from the perspective of effectiveness and cost-effectiveness? In addition, Senator Ted Stevens (as a member of the Technology Assessment Board) asked OTA to examine an additional question under the auspices of this assessment: 3.What cost implications do the leading types of health care reform proposals have in seven areas: health care spending and savings; Federal, State, and local budgets; employers (large and small); employment; households (low-, middle-, and upper-income); other costs in the economy; and administrative costs? The assessment was approved by the Technology Assessment Board in April 1991, and began in July 1991. In June 1992, the letter was received from Senator Stevens. An advisory panel for the overall assessment was formed in November 1991. The advisory panel met in January 1992, December 1992, and in May 1993.z Documents Produced as Part of the AssessmentThe following documents have been or will be available as part of the assessment.z PUBLICATIONS AVAILABLE FROM THE U.S. GOVERNMENT PRINTING OFFICEDoes Health Insurance Make a Difference? September 1992. This interim report, requested by the U.S. Senate Labor and Human Resources Committee, summarizes the state of the literature on the rela|1
PAGE 18
2|Coverage of Laser Technology by Health Insurers tionships among insurance coverage, access, and patient health outcomes; provides a conceptual framework for evaluating access to health care and the health effects of such access; and provides an overview of insured and uninsured populations in the United States as of 1990. The background paper is available from the U.S. Superintendent of Documents (GPO stock number 052-003-01301-1, $5.00 per copy). An Inconsistent Picture: A Compilation of Analyses of the Economic Impacts of Competing Approaches to Health Care Reform by Experts and Stakeholders, June 1993 This report compiles and summarizes available analyses of the economic impacts of four major competing approaches to health care reform (popularly known as single payer, play or pay, individual tax credits or vouchers, and managed competition). The report was requested by Senator Ted Stevens, and was released in June 1993. The report is available from the U.S. Superintendent of Documents (GPO stock number 052-003-01327-4, $8.00 per copy). Benefit Design Series Publications from this series of reports explore issues involved in designing a benefit package based on effectiveness and cost effectiveness, in relation to other critical factors in benefit design. Two of the topics (clinical preventive services; mental health/substance abuse) were chosen in part because of Congressional interest in them as contentious, gray areas in benefit design and in part because of OTA's already-existing expertise in the topics. Patient cost-sharing was in some respects a new area for OTA, but was an issue of particular importance in the benefit design debates. The general issues report will pull together lessons learned about benefit design from the other reports in the Benefit Design Series and from other sources, including previous work by OTA. The reports in this series are: Benefit Design in Health Care Reform: Clinical Preventive Services, September 1993. This report addresses issues pertaining to insurance coverage of clinical preventive services. The report describes how information on effectiveness and cost-effectiveness can, and cannot, be used for purposes of insurance benefit design and for improving access to effective clinical preventive services. This report is available from the U.S. Superintendent of Documents (GPO stock number 052-003-01340-1, $7.50 per copy). Benefit Design in Health Care Reform: Background PaperPatient Cost-Sharing, September 1993. This background paper describes what is known, and not known, about the effects of patient cost-sharing on the use of health care services, expenditures, and health outcomes based on a review of the literature. This background paper is available from the U.S. Superintendent of Documents (GPO stock number 052-003-01339-8, $4.50 per copy).z BACKGROUND PAPERS AVAILABLE ONLY FROM OTAThese background papers are available from OTA. For congressional use call 202/224-9241, and for public use, call 202/228-6590. Health Insurance: The Hawaii Experience Background Paper, June 1993. This background paper provides a detailed look at the State that is often considered a model for what other States can do to help provide universal or near-universal health insurance coverage for their residents. Unfortunately, valid data were not available to demonstrate either the overall financial costs of Hawaii's approach or the health effects on residents.
PAGE 19
Appendix AOverview of OTA Assessment: Technology, Insurance, and the Health Care System|3 Coverage of Preventive Services: Provisions of Selected Current Health Care Reform Proposals, October 1992. This background paper summarizes the provisions of selected congressional (102d Congress) and private health care reform proposals with respect to the coverage of clinical preventive services.z Contractor Papers Available from National Technical Information Service, Congressional Research Service, or from the AuthorsPrimary Care for the Uninsured: A Review of the Literature, Congressional Research Service, May 1993. Paper prepared under contract to OTA by David Blumenthal, M.D., M.P.P., Elizabeth Mort, M.D., M.P.H., and Jennifer N. Edwards, M.H.S., Health Policy Research and Development Unit, General Internal Medicine, Massachusetts General Hospital. The Relationship Among Insurance Coverage, Access to Services and Health Outcomes: Case Study of Depression, July 1993. Paper prepared under contract to OTA by Thomas McGuire, Ph.D., Department of Economics, Boston University, Boston, MA. Universal Health Insurance and Uninsured People: Effects on Use and Cost, August 1994. Paper prepared under contract to OTA and CRS, by Steven Long and M. Susan Marquis, RAND Corporation, Washington, DC.
PAGE 20
Appendix B: Survey on Medical Coverage Decisions for Lasers B Note: Survey should not be used, cited, quoted, or reproduced without the permission of the Johns Hopkins Medical Institutions. I 19
PAGE 21
20 Coverage of Laser Technology By Health Insurers QUESTIONNAIRE ON MEDICAL POLICY SECTION 1: MEDICAL POLICY Three laser applications that are currently available in different fields of medicine are described on the following pages. Each application is followed by a series of identical questions. The data presented in these descriptions are as clinically accurate as possible. We would like you to read each description and answer the questions based on the information provided in each case. This section requires the most reflection; Sections II and III require less time. All responses will be kept strictly confidential. I have previously completed this survey. (Please return in pre-addressed envelope.) I am unable to complete the survey at this time. (Please provide reason, if possible, and return in pre-addressed envelope. ) Would you like to receive a summary of results of this survey? Ye s No FOR OFFICE USE ONLY
PAGE 22
Appendix B Survey on Medical Coverage Decisions for Lasers 21 2 Application I (Cardiovascular) Percutaneous transluminal coronary angioplasty is performed in selected patients (approximately 16/1 0,000 persons >=35 years of age per year). Laser angioplasty is a more recent non-invasive technique for treating coronary obstructions. According to the medical literature, a significant obstacle to laser angioplasty is the inadequate diameter of recanalization achieved, such that there continues to be a need for subsequent balloon angioplasty in at least 70% of cases. Major complications, such as death, myocardial infarction and need for coronary artery bypass grafting, may be similar to the more conventional balloon angioplasty. However, complications such as dissection of the vessel can be substantially higher (up to 17%), and perforation of the vessel wall moderately higher(2.5%) when compared to conventional angioplasty. In addition, restenosis rates using laser assisted-angioplasty are similar to conventional balloon angioplasty. Therefore, laser angioplasty appears to increase complications, to be less effective than balloon angioplasty alone, and to add an increased expense to PTCA. CurrentIy, this laser technique has no unique CPT code and would therefore be billed under the general code, 72982 Percutaneous transluminal coronary angioplasty; single vessel. QUESTIONS Q-1 Q-2 If the health care provider balls for this laser technique using the general CPT procedure code that is routinely paid, would you know that this laser application is being used? (Check one below) (1) Definitely not (2) Probably not (3) Probably yes (4) Definitely Yes 7 Which of the following would be most likely to alert you to use of this laser application on your insured population by a health care provider? (Please rank top three sources from the list provided below) 01 Higher than average charge submitted by 07 Internet technology coverage committee provider OS medical or trade publications 02 Provider queries about coverage policy 09 General public media 03 Patient queries about coverage policy 10 Manufacturers advertising 04 Manufacturers queries about coverage policy 11 lnformal discussions with your medical or 05 Internally aware because our type of HMO insurance colleagues initially approves the purchase of the laser 12 Other 06 Utilization review by medical record audit First likely source (enter number) Second likely source (enter number) Third likely source (enter number) .9,9 10,11 12.13 Q-3 Once you are aware that this laser is being used, which of the following factors would prompt YOU to make a specific medical coverage policy decision for this laser technique versus simply covering the routine procedure? (Please rank top three factors from the list provided below) 1 High potential number of insured population affected 2 High potential cost 3 Concern that this is an experimental procedure 4 Technique is not considered a commu nity standard 5 Concern over covering a technique with more potential complications 6 Concern that coverage may represent a liability risk 7 Other First important factor (enter numbed 14 Second important factor (enter number) 15 Third important factor (enter number) 16
PAGE 23
22 Coverage of Laser Technology By Health Insurers Q-4 For this laser technology as described, how strongly would each of the following considerations influence your companys decision to recommend coverage or deny coverage? (Please rank separately the top five considerations in favor of, and against, recommending coverage) 01 02 03 04 05 06 07 08 09 10 11 Medically acceptable, reasonable and necessary Experimental or investigational technique Potential for increased cost of the procedure due to laser technique Potential for decreased cost of the procedure due to laser technique Potential for increased volume of this procedure due to new laser technigue Potential for decreased volume of this procedure due to new laser technique Concern that coverage will prompt influx of new patients into insurance plan Benefits policy excludes procedure Denial of coverage may be legally challenged in the court system Alternate technique available which is clinically proven effective 12 13 14 Is 16 17 18 19 20 21 22 23 Decreased complication rate Increased efficacy of this technique Decreased efficacy of this technique potential differences between clinical (efficacy) and community experience (effectiveness) FDA l pproval Increased cost-effectivess Decreased cost-effectivess Complications present a liability risk the company trial s for Technique is outpatient rather than inpatient Technique is inpatient rather than outpatient Laser technique is potentially last resort What other carriers currently cover Increased comp lication rate The treatmnt is generally accepted by the professional therapy and is appropriate for the treatment of sickness or injury. 24 Other medical community as an effective and proven Most important consideration in favor of coverage (enter number) Second important consideration in favor of coverage (enter number) Third important consideration in favor of coverage (enter number) Fourth important consideration in favor of coverage (enter number) Fifth important consideration in favor of coverage (enter number)_______ Most important consideration against coverage (enter number) Second important consideration against coverage (enter number) Third important consideration against coverage (enter number) Fourth important consideration against coverage (enter number) Fifth important consideration against coverage (enter number) From the list provided above, please record the two considerations that would be of least importance in favor of and against recommending coverage. Least important considerations in favor of coverage (enter number) (enter number) Least important considerations against coverage (enter number) (enter number) 3 17,18 19,20 21.22 23,24 26.26 27.28 29,30 31.32 33,34 35,36 37.38 39.40 41,42 43,4 d
PAGE 24
Appendix B Survey on Medical Coverage Decisions for Lasers 23 4 Application II (Orthopedic and Neurosurgery) Mechanical low back pain is a common and substantial health problem, which is treated though a variety of conservative and surgical interventions. Excision or destruction of the intervertebral disk is a therapy for selected patients with a herniated disk, (approximately 17 cases/ 10,000 persons >= 18 years of age per year) typically involving an open procedure on the spine, general anesthesia and a hospital stay. Percutaneous diskectomy was introduced in 1975, with a success rate for the percutaneous approach itself reported at 60-70 %, compared to 8090% for the conventional surgery. The use of a Ho:Yag or Nd:Yag laser was more recently introduced as a technique for the ablation of the diseased disk. The procedure uses a fiber optic lens and laser, which are introduced percutaneously to a patient given local anesthesia, and sent home the same day. Although the laser is FDA approved, there is scarce clinical data on humans as to the lasers clinical safety, effectiveness and broad applicability for percutaneous diskectomy. Currently, this laser technique has no unique CPT code and would be billed under the general code, 62287 Aspiration Procedure Percutaneous, of nucleus pulposus of intervertebral disk, any method, single or multiple levels, lumbar. Q-1 If the health care provider bills for this laser technique using the general CPT procedure code that is routinely paid, would you know that this laser application is being used? (Check one below) (1) Definitely not (2) Probably not (3) Probably yes (4) Definitely Yes Q-2 For this laser technology as described, how strongly would each of the following considerations influence your companys decision to recommend coverage or deny coverage? (Please rank separately the top five considerations in favor of, and against, recommending coverage) 01 Medically acceptable, reasonable and necessary 12 Decreased complication rate 02 Experimental or investigational technique 13 lncreased efficacy of this technique 03 Potential for increased cost of the procedure 14 Decreased efficacy of this technique due to laser technique 15 Potential differences between clinical trials 04 Potential for decreased cost of the procedure (efficacy) and community experience due to laser technique (effectiveness) 05 Potential for increased volume of this 16 FDA approval procedure due to new laser technique 17 Increased cost-effectiveness 06 Potential for decreased volume of this procedure due to new laser technique 18 Decreased cost-effectiveness 07 Concern that coverage will prompt inflow of new 19 Complications present a liability risk fo r patients into insurance plan the company 08 Benefits policy excludes procedure 20 Technique is outpatient rather than inpatient 09 Denial of coverage may be legally challenged in 21 Technique is inpatient rather than outpatient the court system 22 Laser technique is potentialIy last resort 10 Alternate technique available which is clinically proven effective 23 What other carriers are covering 11 Increased complication rate 24 Other -----..-.. Most important consideration in favor of coverage (enter number) Second important consideration in favor of coverage (enter number) Third important consideration in favor of coverage (enter number) Fourth important consideration in favor of coverage (enter number) Fifth important consideration in favor of coverage (enter number) Most important consideration against coverage (enter number) Second important consideration against coverage (enter number) Third important consideration against coverage (enter number) Fourth important consideration against coverage (enter number) Fifth important consideration against coverage (enter number) From the list provided above, please record the two considerations that would be of least importance in favor of and against recommending coverage. Least important considerations in favor of coverage {enter number) (enter number) Least important considerations against coverage (enter number) (enter number) 45 46,47 48,49 50,51 52,53 54,55 56,57 58,59 60,61 62,63 64,65 66.67 68,69 70,71 72,73
PAGE 25
24 Coverage of Laser Technology By Health Insurers Application Ill (Oncology) 5 Photodynamic therapy is an experimental cancer therapy which is being studied for its effectiveness in transitional ceil carcinoma of the bladder. This therapy is currently undergoing evaluation for formal FDA approval for this cancer, but is not approved to date. For some stages of this tumor, no alternative, curative therapy exists. The therapy involves injecting a photosensitizing agent, usually a porphyrin-based compound into the patient, which IS selectively taken up by the malignant tissue. The tumor is then exposed to a non-thermal appropriate wavelength of laser light from a tunable-dye laser. The molecule of the photosensitizing agent is excited, releasing a cytotoxic singlet oxygen species, which destroys the malignant tissue. Current literature suggests that photodynamic therapy is an important therapeutic intervention for refractor carcinoma-in-situ and prophylaxis of recurrent superficial transitional-cell carcinoma of the bladder. The reported complete response rates for carcinoma-in-situ to photodynamic therapy have consistently been 80-100%. There is also data to support prophylaxis through a single photodynamic session for recurrent cancers which have failed previous interventions, providing 12 to 20 months of disease-free intervals. No deaths have been reported due to photodynamic therapy. Complications include permanent bladder contracture which was reported in 10% of earlier patients. Patients also experience temporary urinary frequency, urgency and nocturia of variable severity. The photosensitizing agent is relatively non-toxic, except the patient must avoid sunlight and bright indoor lighting for a period of time. Therefore, although not yet FDA approved, photodynamic laser therapy for bladder cancer appears to have no significant complications, has unclear cost implications, but has increased efficacy over more conventional therapies. Q-1 If the health care provider bills for this laser technique using the general CPT procedure code that is routinely paid, would you know that this laser application is being used? (Check one below) (1) Definitely not (2) Probably not (3) Probably yes (4) Definitely yes 74 Q-2 For this laser technology as described, how strongly would each of the following considerations influence your companys decision to recommend coverage or deny coverage? (Please rank separately the top five considerations in favor of, and against, recommending coverage) 01 Medically acceptable, reasonable and necessary 12 Decreased complication rate 02 Experimental or investigational technique 13 Increased efficacy of this technique 03 Potential for increased cost of the procedure 14 Decreased efficacy of this technique due to laser technique 15 Potential differences between clinical trials 04 Potential for decreased cost of the procedure (efficacy) and community experienc e due to laser technique (effectiveness) 05 Potential for increased volume of this 16 FDA approval procedure due to new laser technique 17 Increased cost-effectiveness 06 Potential for decreased volume of this procedure due to new laser technique 18 Decreased cost-effectiveness 07 Concern that coverage will prompt influx of new 19 Complications present a liability risk for patients into insurance plan the company 08 Benefits policy excludes procedure 20 Technique is outpatient rather than inpatient 09 Denial of coverage may be legally challenged in 21 Technique is inpatient rather than outpatient the court system 22 Laser technique is potentially last resort 10 Alternate technique available which is clinically proven effective 23 What other carriers are covering 11 increased c omplication rate 24 Other Most important consideration in favor of coverage Second important consideration in favor of coverage Third important consideration in favor of coverage Fourth important consideration in favor of coverage Fifth important consideration in favor of coverage l Most important consideration against coverage Second important consideration against coverage Third important consideration against coverage Fourth important consideration against coverage Fifth important consideration against coverage (enter number) (enter number) (enter number) (enter number) (enter number) (enter number) (enter number) (enter number) (enter number) (enter number) 76.76 77.78 79.80 81,82 83,84 86.86 87,88 99,90 91,92 93,94
PAGE 26
Appendix B Survey on Medical Coverage Decisions for Lasers 125 6 Q-2 Q-3 Please record the two considerations that would be of least importance in favor of or against recommending coverage. Least important considerations in favor of coverage (enter number) 95,96 (enter number) 97,98 Least important considerations against coverage (enter number) 99,100 (enter number) 101,102 Does your company currently cover the use of a lasar for the following conditions? (Check yes or no) Ablation of tatoos Ablation of basal cell carcinoma of the skin Diabetic retinopathy Removal of colonic adenomas Percutaneous coronary angioplasty Percutaneous diskectomy Photodynamic therapy for bladder carcinoma Ablation of inoperable endobronchial carcinoma Upper gastrointestinal hemorrhage Ablation of carcinoma-in-situ of the cervix Hemorrhoidectomy Endometriosis Stapedotomy Removal of tonsils and adenoids Ablation of urethral strictures (1 ) Yes (Covered) (2) No (Not covered) 103 104 105 106 107 108 109 110 111 112 113 114 116 118 117
PAGE 27
26 I Coverage of Laser Technology By Health Insurers 7 SECTION II: MEDICAL COVERAGE DECISION PROCESS The following section contains a selection of questions covering the process for making medical coverage decisions within your company. There are also questions about the sources of information you utilize when making coverage decisions. Please read and answer these questions.
PAGE 28
Appendix B Survey on Medical Coverage Decisions for Lasers 27 8 Q-1 Q-2 Q-3 Q-4 Q-5 What is your companys review process for making medical policy coverage decisions for a technology such as a laser? (1) Reviewed by medical director alone 118 (2) Initially reviewed by medical director, but then always referred to another individual (3) Initially reviewed by medical director, but then always referred to a Committee (4) lnitially reviewed by medical director, who then, at his/her discretion refers to another individual (5) Initially reviewed by medical director, who then, at his/her discretion refers to a committee (6) Othe r If referred to a committee, approximately how many members does it have? (enter number) 110,120 Who are the members? Chief executive officer or president Benefits director or designee Claims director or designee Medical director Medical director staff Attorney Medical Ethicist Community physicia n Utilization review representative(s) Marketing representative(s) Financial representative(s) Other 121 122 123 124 125 126 127 128 129 130 131 132 Who is responsible in your company for making medical policy coverage decisions for a technology such as a laser? 133 (1) MediCal director alone (2 ) A committe e (3) 0ther Who should optimally be responsible for making medical policy decisions relative to new technologies being used and reviewed for coverage? 134 (1) Medicai director alone (2) committe e 3) Othe r Are the majority of medical coverage policy decisions made in a: (choose one) (1) Retrospective fashion 136 (after claims submitted or paid for) (2) Prospective fashion (before claims submitted or paid for) What do you consider the optimal timing for making medical policy decisions relative to new technologies being used and reviewed for coverage? (1) Retrospective fashion 136 (after claims submitted or paid for) (2) Prospective fashion (before claims submitted or paid for)
PAGE 29
28 Coverage of Laser Technology By Health Insurers Q-6 Q-7 Q-8 What sources of information do you use when reviewing a new technology such as a laser for the purpose of making a medical coverage policy decision? (Please rank top three from list provided below) 01 Government documents, i.e. OHTA 07 Other larger insurers 02 FDA clearance document 08 Opinions of local expert physicians 03 Medicare policies I 09 Medical society statements or practice guidelines, i.e. AMA, ACS, ACP 04 Medical journals 10 NIH consensus conferences os Insurer association information, i.e. HIAA, TEC (BCBS) 11 Other 06 Opinions of national expert physicians I Most used source (enter number) Second used source (enter number) Third used source (enter number) What do you consider the optimal sources of information for making medical policy decisions for a new technology, such as a laser, being reviewed for coverage? (Please rank top three from list provided below] 01 Government documents, i.e., OHTA 07 Other larger insurers 02 FDA clearance document 08 Opinions of local expert physicians 03 Medicare policies 09 Medical society statements or practic e 04 Medical journals guidelines, i.e., AMA, ACS, ACP 05 Insurer association information, i.e., HIM, 10 NIH consensus conferences TEC (BCBS) 11 Other 06 Opinions of national expert physicians Most optimal source (enter number) Second optimal source (enter number) Third optimal source (enter number) 9 137,138 139,140 141,142 143, 144 146.146 147,148 When reviewing the current evidence for a laser therapy, what hierarchy would you assign the following types of evidence? (Please rank the top three types from the list below) | 1 Testimony or theory 6 Traditional review article I 2 Randomized, controlled trial 7 Formal meta-analysis 3 Non-randomized, control lad trial 8 Retrospective, case-control study 4 Case series 9 Observational cohort study of patients receiving different therapies 5 Case reports/anecdotes First type (enter number)_______ Second type (enter number)______ Third type (enter number)______ 149 160 161 d
PAGE 30
Appendix B Survey on Medical Coverage Decisions for Lasers 129 10 Q9 For each type of evidence listed below, do you consider it: a) adequate in combination with other sources, and/or b) sufficient alone, to use when making a medical policy decision? (Please check either or both) Adequate, used in Sufficient combination? alone? (1) YES (2) N O (1) YES (2) N 0 162 163 164 165 166 167 168 169 161 182 163 164 165 166 167 168 Testimony or theory Randomized, controlled trial Non-randomized, controlled trial Case series Case reports/anecdotes Traditional review article Formal meta-analysis Retrospective, case-control study Observational cohort study of patients receiving different therapies 169 160 Q-10 If cost-effectiveness data is available comparing the new laser therapy to the current standard of therapy, what do you consider necessary characteristics of the sources for the clinical safety and effectiveness data? Necessary? (1) YES (2) N 0 Primary data in a clinical trial ( VS secondary data analysis, e.g., decision analysis) 170 171 172 Multi-site study ( VS single site study) Published data (vs unpublished data) Published in a US journal ( VS published in a non-US journal) 173 Study conducted in the US ( VS study conducted outside of the US) of therapy, what do Q-1 1 If cost-effectiveness data is available comparing the new laser therapy to the current standard you consider necessary characteristics of the sources for the cost data? Necessary? (1) YES (2) N O Primary data in a clinical trial ( VS secondary data analysis, e.g., decision analysis) 175 176 177 Multi-site study ( VS single site study) Published data ( VS unpublished data) Published in a US journal ( VS published in a non-US journal) Study conducted in the US ( VS study conducted outside of the US) 179 d
PAGE 31
301 Coverage of Laser Technology By Health Insurers 11 Q-1 2 Assuming that a new therapy is equally safe compared to a standard therapy, IS your company Iikely to cover a new therapy which shows: (1) Yes (2) N o Equal effectiveness for equal cost? 180 Equal effectiveness for greater cost? 181 Equal effectiveness for lesser cost? 182 Less effectiveness for equal cost? 183 Less effectiveness for greater cost? 184 Less effectiveness for lesser cost? 185 Greater effectiveness for equal cost? 186 Greater effectiveness for greater cost? 187 Greater effectiveness for lesser cost? 188 Q-1 3 Which of the following considerations are the greatest barriers to establishing medical coverage policy in an optimal way? (Please rank the top three from list provided below) 1 Lack of timely effectiveness data 5 External regulatory barriers 2 Lack of timely cost-effectiveness data 6 Legal barriers 3 Lack of timely safety data 7 Provider contention/lack of support for 4 coverage policy lnternal administrative barriers 8 Other First barrier (enter number) Second barrier (enter number) Third barrier (enter number) 188 190 191 Q-1 4 To what degree should the following parties have responsibility for assuring that technology used in medical practice yields reasonable benefits at reasonable costs? No Little Some Moderate Great deal of Respo nsibility Resp onsibility Respo nsibility Respo nsibility Respo nsibility Federa l Government 1 2 3 4 5102 Stat e Government 1 2 3 4 5 19 3 Health Care Institutions 1 2 3 4 5 194 Insurers 1 2 3 4 5 195 Practicin g Physicians 1 2 3 4 5 196 Patients 1 2 3 4 5 197 Court System 1 2 3 4 5 198 Manufacturer 1 2 3 4 5 199
PAGE 32
Appendix B Survey on Medical Coverage Decisions for Lasers 131 12 COMMERCIAL INSURERS SECTION Ill: INSURER AND RESP ONDENT CHARACTERISTIC S The following section contains a selection of questions covering characteristics of your company and yourself. Please read and answer these questions only in reference to your health insurance business. For these questions, your company refers to your central corporate office, if, for instance, you are located at a subsidiary office.
PAGE 33
32 I Coverage of Laser Technology By Health Insurers Q-1 Q-2 Q-3 Q-4 What IS the approximate number of current covered lives and/or claims processed last year by your company? Approximately (1) 0-250,00 0 (2) >250,000 500,000 (3) >500,000 1 million (4) >1 million 2 million (5) >2 million 5 million (6) >5 millio n what percent of your covered 200 lives are: (Estimate Percent Children ( < 18 years) Young Adults (18-40 years) Middle-aged Adults(41-64 years) Older Adults (>65 years) 100 Data not available percentages, Claims (1) < 1 million (2) > 1 million 5 million (3) > 5 million 10 million (4) > 10 million 20 million (5) > 2O million 40 million (6) > 40 million (7) Data not available o-loo) What percent of the covered lives are in each type of health insurance listed below? (Estimate percentages, Type o f Insurance Percent Individual Indemnity, other than HM O Group Indemnity, other than HMO HMO 100 13 201 202-204 205-207 208-210 211-213 214 215-217 218-220 221-223 If you offer HMO coverage, what percent of the covered lives are the fallowing? (Estimate percentages, 0-100) Type of HMO Percent Staff model 224-226 Group model 227-229 IPA model 230-232 Network model 233-236 100 Does your company offer the following insurance products? (1) Yes (2) N o Preferred provider organization(PPO)* 236 Point-of-service plan(POS)** 237 An organized prepaid health care system that delivers health services through a salaried physician group that is empIoyed by the HMO. An organized prepaid health care system that contracts with one or more group practices, but primarily treats your HMOs enrollees. An organized prepaid health care system that contracts with one or more group practices, but the group provides care to patients who are not your HMO's enrollees. An organized prepaid health care system that contracts directly with physicians in independent practice, with one or more associations of physicians in independent practice and/or with one or more multi-speciality group practices to provide health services. A product whereby a third-party payer contracts with a group of medical care providers who furnish services at lower than usual fees in return for prompt payment and a certain volume of patients. ** A product that offers the consumer a choice of options at the time he or she seeks services, rather than at the time of enrollment.
PAGE 34
Appendix B Survey on Medical Coverage Decisions for Lasers 33 14 Q-5 Q-6 Q-7 Q-8 Q-9 For what percent of the covered lives does your company assume full or partial risk versus assuming no risk, as in the case of self-funded employers, for which your company provides administrative services only? (Estimate percentages. 0-100) On what basis Non-HMO Percent Full or partially insured 238-240 Administrative Services Only (ASO/CSO) 241-243 do the majority of your insurance policies have risk assessed? (Include ASO with non-HMO) HMO 244 (1) Community rated 246 (1) Full community rated (2) Community rated by class (2) Community rated by class (3) Full experience rated (3) Full experience rated For which plans and/or products offered do you decide on medical policy coverage decisions? Staff model 2413 Group model 247 IPA model 248 Network Model 249 PPO product 250 Open-ended product 251 Traditional indemnity product 252 Are medical coverage decisions made similarly across the types of insurance for which you decide on medical policy? (1) Yes 26: (2 ) N o If no: For which types of insurance do your responses in Section I and II apply? Staff model 254 Group model 255 IPA model 256 Network Model 257 PPO product 258 Open-ended product 259 Traditional indemnity product 260 In which state(s) does your company have its largest enrollment? (Please rank the 3 states with the largest enrollment. ) (15) I L (16) I N (17) K S (18) K Y (19) L A (20) M A (21) M D (22) M E (23) M I (24) M N (25) M O (26) M S (27) M T (28) N C (29) N D (30) N E (31) N H (32) N J (33) N M (34) N V (35) N Y (36) O H (37) O K (38) O R (39) P A (40) R I (41) S C (42) S D (43) T N (44) TX (45) U T (46) V A (47 ) V T (48) W A (49) W l 261-266 (50) W V (51) W Y
PAGE 35
34 I Coverage of Laser Technology By Health Insurers Q-10 How long has your company been (1) < 1 year (2) 1 -2 years (3) 3 -5 years (4) 6 9 years 15 in operation? 267 (5) 10 20 years (6) 20 50 years (7) 50 100 years (8) > 100 years Q-1 1 is your company: (1) for profit 268 (2) not for profit Q-1 2 What are your professional/post-graduate degrees? (1) M. D., D.O. (2) Ph.D. or doctorate in (3) Ph.D. or doctorate In (4) R.N. (5) M.P.H. (6) M.H.S. (7) M.B.A. (8) M. Sc. (9) J. D. (10) M.P.A. (11) R.N.P. 260-274 biological science social science (12) other Q-13 If you are an M.D. or D. O., what is your medical specialty and, if applicable, sub-specialty? 276 Q-14 How long have you served in your current or a similar position for an insurance company? (1) < 1 year 278 (2 ) 1 -5 years (3 ) 6 -10 years (4 ) 1 1 -15 years (5) 15 20 years (6) > 20 year s Q-1 5 What is your job title? 277 THANK YOU FOR COMPLETlNG THIS QUESTIONNAIRE. PLEASE ADD ANY ADDITIONAL COMMENTS ON THE BACK. PLEASE RETURN THE QUESTIONNAIRE IN THE ACCOMPANYING PRE-ADDRESSED POSTAGE PAID ENVELOPE TO: Neil R. Powe, M. D., M. P. H., M.B.A. Claudia A. Steiner, M. D., M.P.H. 1830 E. Monument St., 8th floor Baltimore, MD 21205
PAGE 36
Appendix B Survey on Medical Coverage Decisions for Lasers 135 12 HEALTH MAINTENANCE ORGANIZATIONS SEC TION Ill: INSURER AND RESPONDENT CHARACTERISTICS The following section contains a selection of questions covering characteristics of your company and yourself. Please read and answer these questions only in reference to your health insurance business.
PAGE 37
36 Coverage of Laser Technology By Health Insurers Q-1 Q-2 Q-3 Q-4 13 What is the approximate number of current enrollees and/or claims processed by your company? Enrollees (1) 0-19,999 200 (2) 20,000-49,99 9 (3) 50,000-99,99 9 (4) 100,000-249,99 9 (5) 250,000-499,99 9 (6) > 500,000 Approximately what percent of your enrollees are: (Estimate percentages, Percent Children ( <18 years) Young Adults (18-40 years) Middle-aged Adults(41-64 years) Older Adults (>65 years ) 100 (1) Data Not Available Claims (1) 0-19,99 9 201 (2) 20,000-49,99 9 (3) 50,000-99,99 9 (4) 100,000-249,99 9 (5) 250,000-999,99 9 (6) >1,000,00 0 (7) Data not available o-loo) 202-204 205-207 208.210 211-213 214 Which HMO plan(s) does your company represent? (Estimate percentages in terms of enrollees, 0-100) Type o f HMO Percent Staff model* 21s-217 Group model** 218-220 IPA model*** 221.223 Network model**** 224.228 Do you offer any of the following non-traditional products? (Estimate percentages in terms of enrollees 0-100) Open Ended Product# Preferred Provider Product## Traditional Indemnity Product### *An organized prepaid health care system that Percent 227-220 230-232 233.236 delivers health services through a salaried physician group that is empIoyed by the HMO. ** An organized prepaid health care system that contracts with one independent group practice to provide health services. *** An organized prepaid health care system that contracts with two or more independent group practices to provide health services. **** An organized prepaid health care system that contracts directly with physicians in independent practice, with one or more associations of physicians in independent practice and/or with one or more multi-speciality group practices to provide health services. # A product where individuals are enrolled in the HMO, but may self-refer to providers outside the network, typically with deductibles or extensive cost sharing required. ## A product whereby a third-party payer contracts with a group of medical care providers to furnish services at lower than usual fees in return for prompt payment and a certain volume of pet i rots. ### A product where benefits are paid in a predetermined amount in the event of a covered loss.
PAGE 38
Appendix B Survey on Medical Coverage Decisions for Lasers 137 14 Q-5 Q-6 Q-7 Q-8 Which payment method is used for the primary care and specialty care physicians in your HMO? (Estimate percentages. 0-100) Primary Ca re Physicians Spec ialty Ca re Physicians Percent Percent Salary 230-230 Salary 246-241 Capitated payment 230-241 Capitated payment 248-250 Payment-for-service 242-244 Payment-for-servic e 261-263 For which plans and/or products offered do you decide on medical policy coverage decisions? Staff model 254 Group model 255 IPA model 256 Network Model 257 PPO product 258 Open-ended product 259 Traditional indemnity product 260 Are medical coverage decisions made similarly across the types of insurance for which you decide on medical policy? (1) Yes 261 (2 ) N o If no: For which types of insurance do your responses in Section I and II apply? Staff model Group model IPA model Network Model PPO product Open-ended product Traditional indemnity product 262 263 264 265 266 267 268 In which state(s) does your company have its largest enrollment? (please rank the 3 states with the largest enrollment.) (01) A K (02) A L (03) A R (04) A Z (05) C A (06) C O (07) C T (08) D C (09) D E (10) F L (11) G A (12) H I (13 ) I A (14) I D (22) M E (23) M I (24) M N (25) M O (26) M S (27) M T (28) N C (29) N D (30) N E (31) N H (32) N J (33) N M (34) N V (35) N Y Q-9 How long has your company (1) 1 yea r (2) 2 3 years (3) 4 7 years (4) 8 -15 years (5) 16 -20 years (6) 21 -50 years (7) > 50 years (36) O H (37 ) O K (38) O R (39) P A (40) R I (41) S C (42) S D been in operation? 276
PAGE 39
38 I Coverage of Laser Technology By Health Insurers Q-1 o Q-1 1 Q-1 2 Q-l3 Q-1 4 15 Is your company: (1) for profit 276 (2) not for profit What are your professional/post-graduate degrees? (1) M.D.,D.O 277-282 (2) Ph.D. or doctorate in biological science (3) Ph.D. or doctorate in social science (4) R.N. (5) M.P.H. (6) M.H.S. (7) M.B.A. (8) M. Sc. (9) J.D. (10) M.P.A. (11) R.N.P. (12) other If you are an M.D. or D. O., what is your medical specialty and, if applicable, sub-specialty? 263 284 How long have you served in your current or a similar position for a carrier? (1) < 1 year 286 (2 ) 1 -5 years (3 ) 6 -10 years (4 ) 1 1 -15 years (5) 15 20 years (6) > 20 year s What is your job title? 286 THANK YOU FOR COMPLETING THIS QUESTIONNAIRE. PLEASE ADD ANY ADDITIONAL COMMENTS ON THE BACK. PLEASE RETURN THE QUESTIONNAIRE IN THE ACCOMPANYING PRE-ADDRESSED POSTAGE PAID ENVELOPE TO: Neil R. Powe, M. D., M. P. H., M.B.A. Claudia A. Steiner, M. D., M.P.H. 1830 E. Monument St., 8th floor Baltimore, MD 21205 (410) 955-4128
PAGE 40
R eferences 1. Anderson, G.F., Hall, M.A., and Steinberg, E.P., Medical Technology Assessment and Practice Guidelines: Their Day in Court, American Journal of Public Health 83:1635-1639, 1993. 2. Blue Cross and Blue Shield Association, Technology Evaluation Criteria, Blue Cross and Blue Shield Association, Chicago, IL, monograph, 1987. 3. Boren, S. D., I Had a Tough Day Today, Hillary, New England Journal of Medicine 330(7):500-502, 1994. 4. Brown, E., Practitioners Perspective II, Summary Report: New Medical Technology: Experimental or State-of-the-Art, M. Grady (cd.) (Rockville, MD: U.S. Department of Health and Human Services, AHCPR Pub. No. 92-0057, June 1992). 5. Bunker, J. P., Fowles, J., and Schaffarzick, R., Evaluation of Medical Technology Strategies, New England Journal of Medicine 306:620-624, 1982. 6. Cragg, A. H., Gardiner, G. A., and Smith, T. P., Vascular Applications of Laser, Radiology 172:925-935, 1989. 7. Dixon, J.A., Surgical Application of Lasers, Second Edition (Chicago, IL: Year Book Medical Publishers, Inc., 1987). 8. Felton, R., Department of Health and Human Services, Public Health Service, Food and Drug Administration, Rockville, MD, personal communication, June 1995. 9. Finkelstein, S.T., Isaacson, K.A., and Frishkopf, J.J., The Process of Evaluating Medical Technologies for Third-Party Coverage, Journal of Health Care Technology 2:89-101 1984. 10. Gleeson, S., Payers Perspective, Summary Report: New Medical Technology: Experimental or State-of-the-Art, M. Grady (cd.) (Rockville, MD: U.S. Department of Health and Human Services, AHCPR Pub. No. 92-0057, June 1992). 11. Greenberg, B., and Derzon, R. A., Determining Health Insurance Coverage of Technology: Problems and Options, Medical Care 10:967-978, 1981. 12. Group Health Association of America, Inc., HMO Industry Profile, 1993 Edition (Washington, DC: 1993). 13. Hall, M.A. and Anderson, G.F., Health Insurers Assessment of Medical Necessity, University of Pennsylvania Law Review 140(5):1637-1712, May 1992. 14. Health Insurance Association of America, Source Book of Health Insurance Data 1993 (Washington, DC: 1994). 15. Hijikata, S., Percutaneous Nucleotomy, Clinical Orthopedics and Related Research 238:9-23, 1989. 16. Holmes, D. R., The Excimer Laser Coronary Angioplasty Registry Experience, Mayo Clinic Proceedings 68:5-10, 1993. 17. Lamm, D.L. (cd.), The Urologic Clinics of North America, vol. 19, No. 3, (Philadelphia, PA: W.B. Saunders Co., 1992). 18. Newhouse, J. P., An Iconoclastic View of Health Cost Containment, Health Affairs 12(5) (suppl. ):152-171, 1993. 19. Peters, W.P., and Rogers, M. C., Variation in Approval by Insurance Companies of Cove age for Autologous Bone Marrow Trans139
PAGE 41
40 I Coverage of Laser Technology By Health Insurers plantation for Breast Cancer, New England Journal of Medicine 330(7):473-477, 1994. 20. Physician Payment Review Commission, Improving Medicare Coverage Decisions, Annual Report to Congress 1995 (Washington, DC: 1995). 21. Quigley, M.R., Shih, T., Elrifai, A., et al., Percutaneous Laser Discectomy with the Ho: YAG Laser, Lasers in Surgery and Medicine 12:621-624, 1992. 22. Rheinstein, P., Food and Drug Administration Perspective, Summary Report: New Medical Technology: Experimental or Stateof-the-Art, M. Grady (cd.) (Rockville, MD: U.S. Department of Health and Human Services, AHCPR Pub. No. 92-0057, June 1992). 23. Sabiston, D. C., Textbook of Surgery, 14th Edition (Philadelphia, PA: W.B. Saunders Co., 1991). 24. Schaldach, M., Cardiovascular Laser Application, Artificial Organs 14:28-40, 1990. 25. Schreiber, A., Suezawa, Y., and Leu, H., Does Percutaneous Nucleotomy with Discoscopy Replace Conventional Discectomy?, Clinical Orthopedics and Related Research 35-42, 1989. 26. Schlesinger, W.H., and Hunter, J.G. (eds.), Lasers in General Surgery, The Surgical Clinics of North America (Philadelphia, PA: W.B. Saunders Co., 1992). 27. Smith, J.A., The Urologic Clinics of North America, vol. 13, No. 3, (Philadelphia, PA: W.B. Saunders Co., 1986). 28. Smith, Jr., J.A., Lasers in Urologic Surgery (Chicago, IL: Year Book Medical Publishers, Inc., 1985). 29. Steiner, C. A., Powe, N. R., and Anderson, G.F., Johns Hopkins University, Baltimore, MD, Technology Coverage Decisions: The Process and Considerations Used by Health Plans, unpublished contractor report prepared for the Office of Technology Assessment, U.S. Congress, Washington, DC, January 1995. 30. Towery, O. B., and Perry, S., The Scientific Basis for Coverage Decision by Third-Party Payer, Journal of the American Medical Association 245:59-61, 1981. 31. U.S. Congress, Office of Technology Assessment, Health Care Technology and Its Assessment in Eight Countries, OTA-BPH-140 (Washington, DC: U.S. Government Printing Office, February 1995). 32. U.S. Department of Health and Human Services, Health Care Financing Administration,: Medicare Program; Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to Health Care Technology, proposed rule Federal Register 54 (18):4302-4318, Jan. 30, 1989. 33. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, Third-Party Reimbursement Policies for Clinical Trials; Survey Report, Bethesda, MD, February 1995. 34. U.S. General Accounting Office, Medicare. Technology Assessment and Medical Coverage Decisions, GAO/HEHS-94-195FS (Washington, DC: U.S. Government Printing Office, July 1994). 35. Williams, H. M., Cancer Therapy: Reimbursement of New Therapeutic Technologies, Yale Journal of Biology and Medicine 65:83-97, 1992.
xml version 1.0 encoding UTF-8
REPORT xmlns http:www.fcla.edudlsmddaitss xmlns:xsi http:www.w3.org2001XMLSchema-instance xsi:schemaLocation http:www.fcla.edudlsmddaitssdaitssReport.xsd
INGEST IEID EZ032FPW8_5RT82K INGEST_TIME 2017-05-24T20:54:59Z PACKAGE AA00055438_00001
AGREEMENT_INFO ACCOUNT UF PROJECT UFDC
FILES
|