Medicare Modernization Act Research Articles

Politics and health care spending in the United States: A case study from the passage of the 2003 Medicare Modernization Act

This paper analyzes the interplay between congressional politics, the actions of the executive branch, and hospitals’ regulated Medicare payments. We focus on the 2003 Medicare Modernization Act (MMA) and analyze a provision in the law – Section 508 – that raised certain hospitals’ regulated payments. We show, via our analysis of the Section 508 program, that Medicare payments are malleable and can be influenced by political dynamics. In the cross-section, hospitals represented by members of Congress who voted “yea” on the MMA were more likely to receive Section 508 payment increases. We interviewed the Secretary of Health and Human Services who oversaw the MMA, and he described how these payment increases were designed to win support for the law. The Section 508 payment increases raised hospitals’ activity and spending. Members of Congress representing recipient hospitals received increased campaign contributions after the Section 508 payment increases were extended. Ultimately, our analysis highlights how Medicare payment increases can serve as an appealing tool for legislative leaders working to win votes for wider pieces of legislation.

Comparative Effectiveness of Medication Therapy Management Eligibility Criteria Across Racial/Ethnic Groups.

Previous research indicates that eligibility criteria for medication therapy management (MTM) services in Medicare prescription drug (Part D) plans, defined under the Medicare Modernization Act (MMA), are associated with racial/ethnic disparities and ineffective in identifying individuals with medication utilization issues. Our study's objective was to determine the comparative effectiveness of MTM eligibility criteria under MMA and in the Affordable Care Act (ACA) in identifying patients with medication utilization issues across racial/ethnic groups. ACA and MMA MTM eligibility criteria were compared on proportions of eligible individuals among patients with medication utilization issues. Multinomial logistic regression was conducted to control for patient/community characteristics. Need-based and demand-based analyses were used to determine disparities due to need and demand for healthcare. Main/sensitivity analyses were conducted for the range of eligibility thresholds. Medicare data (2012-2013) linked to Area Health Resources Files. A total of 964 610 patients 65 years or older. Medication safety/adherence measures, developed primarily by the Pharmacy Quality Alliance, were used to determine medication utilization issues. Higher proportions of patients were eligible based on ACA than MMA MTM eligibility criteria. For example, in 2013, proportions based on ACA and MMA MTM eligibility criteria would be 99.7% and 26.2%, respectively, in the main analysis (p < .001); in the demand-based main analysis, ACA criteria were associated with 13.6% and 9.8%, respectively, higher effectiveness than MMA criteria among non-Hispanic blacks and Hispanics than non-Hispanic whites. ACA MTM eligibility criteria are more effective than MMA criteria in identifying older patients needing MTM, particularly among minorities. J Am Geriatr Soc 67:581-587, 2019.

Race and Time to Receipt of Androgen Deprivation Therapy Among Men With Metastatic Prostate Cancer

BackgroundThe Medicare Modernization Act (MMA) drastically reduced reimbursement for androgen deprivation therapy (ADT) in 2005. One unintended consequence of the MMA may be an increase in the racial disparities in receipt of ADT. Given these policy changes, it becomes increasingly important to assess racial disparities in timely receipt of ADT. MethodsThe purpose of this study is to evaluate the associations between race and median time to receipt of ADT among men with metastatic prostate cancer before and after the passage of the MMA. A population-based retrospective cohort was created from the Surveillance, Epidemiology, and End Results-Medicare. ResultsA total of 1,846 African-American and 9,462 Caucasian men diagnosed with metastatic prostate cancer from 2000 through 2011 were included. An accelerated failure time regression model was used to examine factors associated with racial differences in median time to receipt of ADT. Results indicate that African-American men had a longer median time to receipt of ADT both before the MMA (Time Ratio (TR): 1.15; 95% Confidence Interval (CI) [1.05, 1.27]) and after the MMA (TR: 1.29; 95% CI [1.10, 1.53]) as compared to Caucasian men. In addition to race, men residing in South had longer median time to receipt of ADT (TR: 1.26, 1.52; 95% CI [1.01, 1.52; 1.24, 1.87] before and after MMA, respectively) compared to the Northeast region. ConclusionConsidering the palliative benefits of ADT, it is important to develop effective strategies to address racial differences in receipt of treatment for metastatic prostate cancer.

Predictive Value Positive of MTM Eligibility Criteria under MMA and ACA in Identifying Individuals with Medication Utilization Issues.

To compare the predictive value positives (PVP) of medication therapy management eligibility criteria under the Medicare Modernization Act (MMA) and Affordable Care Act (ACA) in identifying individuals with medication utilization issues (MUI). This is a retrospective analysis of Medicare database (2012-2013). MUI were determined based on medication utilization measures related to Medicare Part D Star Ratings. PVP or proportions of individuals with MUI were compared between individuals eligible for MTM under MMA and ACA. Need-based and demand-based logistic regression was used to adjust for patient characteristics. MTM eligibility thresholds in 2009 and 2013 and proposed 2015 MTM eligibility thresholds under MMA were examined. Main/sensitivity/disease-specific analyses were conducted to cover the range of eligibility thresholds and combinations. MMA has higher PVP in identifying patients with MUI than ACA. Proportions of individuals with MUI were higher based on MMA than ACA (e.g., 74.96% for 2009 MMA, 73.51% for 2013 MMA, and 62.46% for proposed 2015 MMA vs. 52.17% for ACA in main analysis; P<0.05). Adjusted findings were similar. For example, based on the demand-based model in the main analysis, the odds ratios were 2.474 (95% CI: 2.454-2.494) for 2013 MMA in comparison to ACA. These numbers indicate that the MMA MTM eligibility criteria for 2013 had 147.4% higher PVP in identifying patients with MUI than ACA. Similar patterns were found in most sensitivity and disease-specific analyses. MMA has higher PVP than ACA in identifying patients with MUI. This study may inform the government on future MTM policy.

PHS83 - Comparative Effectiveness of Mtm Eligibility Criteria Under ACA and Mma Across Racial and Ethnic Groups in Medicare

To examine the comparative effectiveness of the Medicare medication therapy management (MTM) eligibility criteria under Patient Protection and Affordable Care Act (ACA) and Medicare Modernization Act (MMA) in identifying patients with medication utilization issues (MUI) across racial/ethnic groups in Medicare. This study analyzed Medicare data (2012-2013) linked to Area Health Resource Files. MUI were defined based on medication utilization measures used in Medicare Part D Star Ratings. MTM eligibility criteria under ACA, and MTM eligibility thresholds in 2009, 2013, and proposed 2015 MTM eligibility criteria under MMA were analyzed. Multinomial logistic regression was used to analyze the comparative effectiveness of ACA and MMA MTM eligibility criteria across racial/ethnic groups. The study controlled for patient characteristics at both individual and community/county levels. Main/sensitivity analyses were conducted to cover the ranges of eligibility thresholds and combinations. Higher likelihood of and lower racial/ethnic disparities in MTM eligibility were found under ACA than MMA. For example, in the main analysis for 2013, 74.50% more patients met MTM eligibility criteria under ACA than MMA (P<0.0001). Disparities between non-Hispanic Blacks (Blacks) and Hispanics versus non-Hispanic Whites (Whites) were 2.47% and 1.79%, respectively, lower under ACA than MMA (P<0.05 for both). Adjusted relative risk ratio (RRR) for Blacks versus Whites was 0.69 (95% Confidence Interval (CI)=0.67-0.70), indicating that the ACA MTM eligibility criteria were 31% more effective compared to those under MMA among Blacks vs. Whites. The same RRR was 0.79 (95% CI=0.76-0.81) for Hispanics/Whites. Similar patterns were found in all unadjusted/adjusted sensitivity analyses. The ACA MTM eligibility criteria were more effective than those under MMA and were also more comparatively effective among racial/ethnic minorities than Whites. Although the future of ACA is uncertain, ACA-based MTM eligibility criteria provide an alternative to MMA-based MTM eligibility criteria in improving effectiveness of MTM eligibility.

Higher Predictive Value Positive for MMA Than ACA MTM Eligibility Criteria Among Racial and Ethnic Minorities: An Observational Study.

The objective of this study was to examine positive predictive value (PPV) of medication therapy management (MTM) eligibility criteria under Medicare Modernization Act (MMA) and Affordable Care Act (ACA) in identifying patients with medication utilization issues across racial and ethnic groups. The study analyzed Medicare data (2012-2013) for 2 213 594 beneficiaries. Medication utilization issues were determined based on medication utilization measures mostly developed by Pharmacy Quality Alliance. MMA was associated with higher PPV than ACA in identifying individuals with medication utilization issues among non-Hispanic blacks (blacks) and Hispanics than non-Hispanic whites (whites). For example, odds ratio for having medication utilization issues to whites when examining MMA in 2013 and ACA were 1.09 (95% confidence interval [CI] = 1.04-1.15) among blacks, and 1.17 (95% CI = 1.10-1.24) among Hispanics, in the main analysis. Therefore, MMA was associated with 9% and 17% higher PPV than ACA in identifying patients with medication utilization issues among blacks and Hispanics, respectively, than whites.

A Critical Analysis of Obamacare: Affordable Care or Insurance for Many and Coverage for Few?

The Affordable Care Act (ACA), of 2010, or Obamacare, was the most monumental change in US health care policy since the passage of Medicaid and Medicare in 1965. Since its enactment, numerous claims have been made on both sides of the aisle regarding the ACA’s success or failure; these views often colored by political persuasion. The ACA had 3 primary goals: increasing the number of the insured, improving the quality of care, and reducing the costs of health care. One point often lost in the discussion is the distinction between affordability and access. Health insurance is a financial mechanism for paying for health care, while access refers to the process of actually obtaining that health care. The ACA has widened the gap between providing patients the mechanism of paying for healthcare and actually receiving it. The ACA is applauded for increasing the number of insured, quite appropriately as that has occurred for over 20 million people. Less frequently mentioned are the 6 million who have lost their insurance. Further, in terms of how health insurance is been provided, the majority the expansion was based on Medicaid expansion, with an increase of 13 million. Consequently, the ACA hasn’t worked well for the working and middle class who receive much less support, particularly those who earn more than 400% of the federal poverty level, who constitute 40% of the population and don’t receive any help. As a result, exchange enrollment has been a disappointment and the percentage of workers obtaining their health benefits from their employer has decreased steadily. Access to health care has been uneven, with those on Medicaid hampered by narrow networks, while those on the exchanges or getting employer benefits have faced high out-of-pocket costs. The second category relates to cost containment. President Obama claimed that the ACA provided significant cost containment, in that costs would have been even much higher if the ACA was not enacted. Further, he attributed cost reductions generally to the ACA, not taking into account factors such as the recession, increased out-of-pocket costs, increasing drug prices, and reduced coverage by insurers. The final goal was improvement in quality. The effort to improve quality has led to the creation of dozens of new agencies, boards, commissions, and other government entities. In turn, practice management and regulatory compliance costs have increased. Structurally, solo and independent practices, which lack the capability to manage these new regulatory demands, have declined. Hospital employment, with its associated increased costs, has been soaring. Despite a focus on preventive services in the management of chronic disease, only 3% of health care expenditures have been spent on preventive services while the costs of managing chronic disease continue to escalate. The ACA is the most consequential and comprehensive health care reform enacted since Medicare. The ACA has gained a net increase in the number of individuals with insurance, primarily through Medicaid expansion. The reduction in costs is an arguable achievement, while quality of care has seemingly not improved. Finally, access seems to have diminished.This review attempts to bring clarity to the discussion by reviewing the ACA’s impact on affordability, cost containment and quality of care. We will discuss these aspects of the ACA from the perspective of proponents, opponents, and a pragmatic point of view. Key words: Affordable Care Act (ACA), Obamacare, Medicare, Medicaid, Medicare Modernization Act (MMA), cost of health care, quality of health care, Merit-Based Incentive Payments System (MIPS)

Trends in antineoplastic receipt after medicare payment reform: Implications for future oncology payment design

BackgroundThe Medicare Modernization Act (MMA) reduced reimbursement for many antineoplastics delivered in outpatient settings, altering practice patterns for some cancers. To further evaluate the MMA’s effect, we focus on colon cancer, where longstanding fluorouracil-based regimens were augmented in 2004 with 3 newly-approved drugs (oxaliplatin, bevacizumab, and/or cetuximab). Staggered implementation of MMA reimbursement changes (physician offices implemented reimbursement changes in 2005 vs hospital outpatient departments(OPD) in 2006) provide a natural experiment to examine policy effects. MethodsUsing the 2000–2009 SEER-Medicare data, we examined antineoplastic use among 59,642 stage II–IV colon cancer patients. Using multivariate logistic regression models, we conducted difference-in-differences analyses to examine an interaction between time (pre-post MMA) and setting (physician offices versus OPDs) on antineoplastic receipt, adjusting for patient and cancer characteristics. A significant interaction indicates different practice patterns in physician offices versus OPD during the staggered implementation. ResultsAfter the reimbursement change in 2007–09 relative to 2000-03, use of fluorouracil-based therapy decreased slightly (Marginal Probability(MP): −0.07 stage II;−0.05 stage III;−0.05 stage IV; p<0.01), while use of new drugs increased substantially (MP: 0.48 stage II; 0.69 stage III, 0.79 stage IV; p<0.01). The interaction between MMA implementation and physician office setting was significant when examining use of new agents for Stage IV disease only. ConclusionsOur results indicate that providers responded to reimbursement changes after the MMA by increasing use of newly approved agents, but the magnitude of the response was small and limited to individuals diagnosed with Stage IV disease.

Favorable Risk Selection in Medicare Advantage: Trends in Mortality and Plan Exits Among Nursing Home Beneficiaries.

The 2003 Medicare Modernization Act (MMA) increased payments to Medicare Advantage plans and instituted a new risk-adjustment payment model to reduce plans' incentives to enroll healthier Medicare beneficiaries and avoid those with higher costs. Whether the MMA reduced risk selection remains debatable. This study uses mortality differences, nursing home utilization, and switch rates to assess whether the MMA successfully decreased risk selection from 2000 to 2012. We found no decrease in the mortality difference or adjusted difference in nursing home use between plan beneficiaries pre- and post the MMA. Among beneficiaries with nursing home use, disenrollment from Medicare Advantage plans declined from 20% to 12%, but it remained 6 times higher than the switch rate from traditional Medicare to Medicare Advantage. These findings suggest that the MMA was not associated with reductions in favorable risk selection, as measured by mortality, nursing home use, and switch rates.

Trends in antineoplastic receipt after Medicare payment reform: Implications for future oncology payment design.

6513 Background: The Medicare Modernization Act (MMA) changed antineoplastic reimbursement from average wholesale price to average sales price +6%, reducing many outpatient reimbursement rates and ...

Are Oncologists' Financial Incentives Aligned With Quality Care?

In the article that accompanies this editorial, Malin et al use data from the Cancer Outcomes Research and Surveillance study (CanCORS) to measure the association between medical oncologists’ compensation structure and their perception of whether their income will increase if they administer chemotherapy or growth factors. Compared with medical oncologists who were paid a fixed salary, those who were in fee-for-service (FFS) practices or who were paid a salary with a productivity incentive were more likely to anticipate greater income if they administered chemotherapy (odds ratio, 7.05 and 7.52, respectively; both P .001). Similar associations were found for growth factor administration. Several unanswered questions remain from this study. The study measures perception only; we cannot determine from these data if oncologists actually made more money by prescribing more chemotherapy or growth factors. We also do not know the structure of the oncologists’ productivity incentives, the magnitude of any increased income, and what drugs or disease settings may be responsible for the largest gains. In addition, the CanCORS study included patients treated for lung or colorectal cancer between 2003 and 2005 who were either living in one of five geographic regions or received care in one of five integratedhealthoroneof10Veterans’AdministrationHospitals. In addition, not all physicians responded to the survey. Therefore, it is possible that physician respondents may be not representative of contemporary practice patterns across the country. Despite these limitations, the findings of Malin et al are potentially significant because they suggest that perceived incentives might matter. If oncologists think that they will make more money by prescribing more, perhaps they will write more prescriptions. The rational choice theory of economics assumes that individuals will act in their own interest. Oncologists are no different; the current system is set up to reward prescribing more. To place this study in context, it is important to understand the current reimbursement policy. Before the Medicare Modernization Act (MMA) of 2003, Medicare reimbursed outpatient chemotherapy drugs at the lesser of the charge billed for the drugs or 95% of the average wholesale price. However, the acquisition cost was often much lower than the published average wholesale price, resulting in large margins for the prescribing physician. Reimbursements for paclitaxel were reported as being as high as six times the acquisition cost. Under the MMA, chemotherapy is now reimbursed at 1.06 times the average sales price of the previous two quarters, leading to a reduction in margins. To make up for some of this loss in revenue, additional payments are now included to reimburse for the cost of administering drugs. The work by Malin et al complements other empirical data that suggest that oncologists respond to financial incentives. A study of luteinizing hormone–releasing hormone agonist used for prostate cancer treatment found that use decreased after the MMA, particularly among patients for whom the benefit of these agents was uncertain, such as those with low-risk disease. This finding suggests that removing financial incentives may reduce unnecessary use, which should improve outcomes while controlling costs. However, in a situation in which treatment is indicated, prescribing patterns may shift in response to incentives toward equally effective but more expensive treatments. An analysis of Medicare payments for non–small-cell lung cancer found that after the MMA, older drugs such as carboplatin and paclitaxel that experienced significant cuts in reimbursement were used less frequently. However, docetaxel, which retained a relatively high margin given its higher baseline cost, was prescribed more often. Despite the limitations of the FFS system, modern oncology care requires coordination among physicians, payors, specialty pharmacies, and home care agencies. Oncologists should be reimbursed for the cognitive services they provide, unrelated to the amount of officeadministered chemotherapy they prescribe. One major change in oncology that is not reflected in the current FFS buy-and-bill system is the introduction of oral cancer therapies. For example, there are new hormonal therapies for prostate cancer, immunomodulatory agents for myeloma, and small molecules for breast, renal cell, and lung cancers. Oral therapies are much more convenient for patients but can be much more expensive for oncologists to use. Oncologists are responsible for managing toxicities, which can be significant, such as hypertension, diarrhea, or hand-foot syndrome, but do not receive any additional reimbursement for these efforts because the treatments do not involve office-administered drugs. For many indications, intravenous alternatives to oral drugs exist for which an oncologist could recoup margin incentives, as well as additional reimbursement for drug administration. These intravenous treatments are dually less convenient for patients and more costly for our health care system. The Affordable Care Act includes support for programs that will study alternatives to the FFS system. Two proposed models of payment reform include so-called global and bundled episode payments that provide different incentives. JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 31 NUMBER 5 FEBRUARY 1

Medicare Part D Benzodiazepine Exclusion and Use of Psychotropic Medication by Patients With New Anxiety Disorders

The Medicare Modernization Act (MMA) specifically excluded benzodiazepines from Medicare Part D coverage starting in 2006; however, benzodiazepines are an effective, low-cost treatment for anxiety. This study evaluated the effect of the Medicare Part D benzodiazepine coverage exclusion among patients with new anxiety disorders. The authors used a quasi-experimental cohort design to study patients with new anxiety diagnoses from a large national health plan during the first six months of 2005, 2006, and 2007. Logistic and zero-truncated negative-binomial regression models using covered claims for behavioral, medical, and pharmaceutical care linked with eligibility files were used to estimate utilization and costs of psychotropic medication and health care utilization among elderly Medicare Advantage enrollees (N=8,397) subject to the MMA benzodiazepine exclusion and a comparison group of near-elderly (ages 60–64) enrollees (N=1,657) of a managed care plan. Medicare Advantage enrollees diagnosed in 2005 had significantly (p<.05) higher rates of covered claims for benzodiazepines and all psychotropic drugs, lower rates of covered claims for nonbenzodiazepines, and lower expenditures for psychotropic drugs than enrollees diagnosed in 2006 and 2007. There were no significant differences over time in utilization or expenditures related to psychotropic medication among the comparison group. There also were no significant changes over time in outpatient visits for behavioral care by either cohort. Among elderly patients with new anxiety diagnoses, the MMA benzodiazepine exclusion increased use of nonbenzodiazepine psychotropic drugs without substitution of increased behavioral care. Overall, the exclusion was associated with a modest increase in covered claims for psychotropic medication.

The Impact of Comparative Effectiveness Research on Interventional Pain Management: Evolution from Medicare Modernization Act to Patient Protection and Affordable Care Act and the Patient-Centered Outcomes Research Institute

The Patient-Centered Outcomes Research Institute (PCORI) was established by the Affordable Care Act of 2010 to promote comparative effectiveness research (CER) to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis. The development of PCORI is vested in the Medicare Modernization Act (MMA) and the American Recovery and Reinvestment Act (ARRA). The framework of CER and PCORI describes multiple elements which are vested in all 3 regulations including stakeholder involvement, public participation, and open transparent decision-making process. Overall, PCORI is much more elaborate with significant involvement of stakeholders, transparency, public participation, and open decision-making. However, there are multiple issues concerning the operation of such agencies in the United States including the predecessor of Agency for Healthcare Research and Quality (AHRQ), the Agency for Healthcare Policy and Research (AHCPR), AHRQ Effectiveness Health Care programs, and others. The CER in the United States may be described at cross-roads or at the beginnings of a scientific era of CER and evidence-based medicine (EBM). However the United States suffers as other countries, including the United Kingdom with its National Health Services (NHS) and National Institute for Health and Clinical Excellence (NICE), with major misunderstandings of methodology, an inordinate focus on methodological assessment, lack of understanding of the study design (placebo versus active control), lack of involvement of clinicians, and misinterpretation of the evidence which continues to be disseminated. Consequently, PCORI and CER have been described as government-driven solutions without following the principles of EBM with an extensive focus on costs rather than quality. It also has been stated that the central planning which has been described for PCORI and CER, a term devised to be acceptable, will be used by third party payors to override the physician’s best medical judgement and patient’s best interest. Further, stakeholders in PCORI are not scientists, are not balanced, and will set an agenda with an ultimate problem of comparative effectiveness and PCORI that it is not based on medical science, but rather on political science and not even under congressional authority, leading to unprecedented negative changes to health care. Thus, PCORI is operating in an ad hoc manner that is incompatible with the principles of evidence-based practice. This manuscript describes the framework of PCORI, and the role of CER and its impact on interventional pain management. Key words: Patient-Centered Outcomes Research Institute (PCORI), comparative effectiveness research (CER), National Institute for Health and Clinical Excellence (NICE), Patient Protection and Affordable Care Act (ACA), Medicare Modernization Act (MMA), American Recovery and Reinvestment Act (ARRA), interventional pain management, interventional techniques, evidencebased medicine, systematic reviews.

Impact of the medicare modernization act of 2003 on utilization and spending for medicare part B–covered biologics in rheumatoid arthritis

To examine changes in utilization and expenditures for infliximab in rheumatoid arthritis (RA) patients associated with the 2 changes implemented by the Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003, specifically 1) reductions in physician reimbursement for Part B drugs between 2003 and 2005 and 2) availability of alternative RA biologics in 2006. Using 2002-2006 5% Medicare files, nationally representative estimates of infliximab use and expenditures were estimated in annual cross-sectional samples of RA beneficiaries. Infliximab initiation and continuation rates were estimated in 2-year longitudinal cohorts (2005-2006 versus 2002-2003, 2003-2004, and 2004-2005). Total payments (in 2006 dollars) for infliximab increased from $357 million in 2002 to $492 million in 2006. The largest annual increase in infliximab payments occurred in the pre-MMA period from 2002 to 2003, wherein payments per RA patient increased by 31%. From 2003 to 2004, despite the reduction in payments brought by the MMA, there was a 4% increase in total expenditures for infliximab per RA patient driven by an increase in utilization factors. Total payments for infliximab per RA patient actually decreased from 2004 to 2005, when reimbursement was further reduced. Continuation and initiation rates for infliximab use remained unchanged in 2006, as compared with previous years. Infliximab expenditures increased from 2002 to 2006, yet the passage of the MMA was associated with a remarkable slowdown in the rate of increase in expenditures. There was no evidence of significant substitution of infliximab with other biologics made available in 2006.

Facts, Fallacies, and Politics of Comparative Effectiveness Research: Part I. Basic Considerations

While the United States leads the world in many measures of health care innovation, it has been suggested that it lags behind many developed nations in a variety of health outcomes. It has also been stated that the United States continues to outspend all other Organisation for Economic Co-operation and Development (OECD) countries by a wide margin. Spending on health goods and services per person in the United States, in 2007, increased to $7,290 – almost 2½ times the average of all OECD countries. Rising health care costs in the United States have been estimated to increase to 19.1% of gross domestic product (GDP) or $4.4 trillion by 2018. The increases are illustrated in both public and private sectors. Higher health care costs in the United States are implied from the variations in the medical care from area to area around the country, with almost 50% of medical care being not evidence-based, and finally as much as 30% of spending reflecting medical care of uncertain or questionable value. Thus, comparative effectiveness research (CER) has been touted by supporters with high expectations to resolve most ill effects of health care in the United States and provide high quality, less expensive, universal health care. CER is defined as the generation and synthesis of evidence that compares the benefits and harms of alternate methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The efforts of CER in the United States date back to the late 1970’s even though it was officially born with the Medicare Modernization Act (MMA) and has been rejuvenated with the American Recovery and Reinvestment Act (ARRA) of 2009 with an allocation of $1.1 billion. CER has been the basis for health care decision-making in many other countries. According to the International Network of Agencies for Health Technology Assessments (INAHTA), many industrialized countries have bodies that are charged with health technology assessments (HTAs) or comparative effectiveness studies. Of all the available agencies, the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom is the most advanced, stable, and has provided significant evidence, though based on rigid and proscriptive economic and clinical formulas. While CER is making a rapid surge in the United States, supporters and opponents are expressing their views. Part I of this comprehensive review will describe facts, fallacies, and politics of CER with discussions to understand basic concepts of CER. Key words: Comparative effectiveness research, evidence-based medicine, Institute of Medicine, National Institute for Health and Clinical Excellence, interventional pain management, interventional techniques, geographic variations, inappropriate care.

Facts, Fallacies, and Politics of Comparative Effectiveness Research: Part 2 - Implications for Interventional Pain Management

The United States leads the world in many measures of health care innovation. However, it has been criticized to lag behind many developed nations in important health outcomes including mortality rates and higher health care costs. The surveys have shown the United States to outspend all other Organisation for Economic Co-operation and Development (OECD) countries with spending on health goods and services per person of $7,290 – almost 2½ times the average of all OECD countries in 2007. Rising health care costs in the United States have been estimated to increase to 19.1% of gross domestic product (GDP) or $4.4 trillion by 2018. CER is defined as the generation and synthesis of evidence that compares the benefits and harms of alternate methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The, comparative effectiveness research (CER) has been touted by supporters with high expectations to resolve most ill effects of health care in the United States providing high quality, less expensive, universal health care. The efforts of CER in the United States date back to the late 1970s and it was officially inaugurated with the enactment of the Medicare Modernization Act (MMA). It has been rejuvenated with the American Recovery and Reinvestment Act (ARRA) of 2009 with an allocation of $1.1 billion. CER has been the basis of decision for health care in many other countries. Of all the available agencies, the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom is the most advanced, stable, and has provided significant evidence, though based on rigid and proscriptive economic and clinical formulas. While CER is taking a rapid surge in the United States, supporters and opponents are emerging expressing their views. Since interventional pain management is a new and evolving specialty, with ownership claimed by numerous organizations, at times it is felt as if it has many fathers and other times it becomes an orphan. Part 2 of this comprehensive review will provide facts, fallacies, and politics of CER along with discussion of potential outcomes, impact of CER on health care delivery, and implications for interventional pain management in the United States. Key words: Comparative effectiveness research, evidence-based medicine, Institute of Medicine, National Institute for Health and Clinical Excellence, interventional pain management, interventional techniques, geographic variations, inappropriate care.

2008 oncology trends: Views from payors, specialty pharmacy, and oncology providers

e20750 Background: Kikaku International Research was engaged by Genentech USA to conduct survey research among four key stakeholder groups involved in the financing, management and delivery of cancer care and drugs. Methods: Surveys were distributed and collected from January to June 2008. Survey questions addressed issues on volume of services, utilization of specialty pharmacy, management methodologies and degrees of involvement, volume and staffing levels in oncology practice, oncology physician staffing and retirement, payor evaluations, cost and impact of public and private payor reimbursement policies, Average Selling Price (ASP) and Medicare Modernization Act (MMA) issues and use of guidelines/pathways. Results: Managed Care Organizations: Ninety (90) managed care professionals responded. Key findings addressed: anticipated shifts in cancer spending from the medical benefit to the pharmaceutical benefit, adoption of ASP-based reimbursement and revaluation of professional fees. Specialty Pharmacy Providers: Forty-two (42) specialty pharmacy professionals responded. Key findings: total revenues and volume from cancer drugs and supportive care, distribution of drugs to patients and physician offices, Injectable drugs and oral drugs precription volume, patient education and disease management. Oncologists - Surveys were returned by 139 oncologists. Key findings: workloads and patient loads, income declines, drug margins declines, buy and bill volume. Oncology Practice Managers: Sixty (60) oncology practice managers responded to surveys about practice management, billing and reimbursement. Key findings: payer coverage and reimbursement policies, ASP rates, health plan contracts, negotiation of fee schedules. Conclusions: The conclusions of each section of the survey, when combined in aggregate, paint a picture of a very complex topic with wide variation in both approach and recommendations for how each segment addresses the specialty. Disconnects, challenges and opportunities observed in evaluating the responses include perspectives on ASP, Medical vs pharmaceutical benefit, contract negotiations, disease management, pharmaceutical management. [Table: see text]

Are changes in US practices for androgen deprivation therapy financially motivated?

This commentary discusses the retrospective study by Weight and colleagues, which evaluated the practice patterns of US physicians using androgen deprivation therapy (either medical castration with luteinizing hormone-releasing hormone [LHRH] agonists or surgical castration by orchiectomy) for the treatment of Medicare patients with prostate cancer during 2001–2005. In 2003, the enactment of the Medicare Modernization Act (MMA), which lowered reimbursement for LHRH analog administration, was introduced. The authors found that LHRH agonist use increased in 2001–2003, and decreased in 2004 and 2005, while surgical castration rates increased. The authors speculated that the treatment decisions for androgen deprivation therapy were financially influenced. Although this study highlights the possible influence that reimbursement levels might have in the decision to prescribe androgen deprivation therapy, the study has several limitations, and the conclusion that financial incentives were solely responsible for the observed decrease in LHRH agonist use can not be made.

Androgen deprivation falls as orchiectomy rates rise after changes in reimbursement in the U.S. Medicare population

Expenditures related to the use of medical androgen deprivation led in part to the Medicare Modernization Act (MMA) in 2003. This mandated a decline in reimbursement to 80% to 85% of the average wholesale price starting in 2004 followed by a more significant reduction in 2005 to 106% of the average sales price, which effectively reduced the reimbursement by approximately 50% of 2003 values. The authors hypothesized that these changes in reimbursement may affect the way practitioners administer these treatments. The publicly available dataset Medicare Part B Extract Summary System was examined from 2001 to 2005 for trends in the number of allowed services and dollar amounts of allowed charges and payments. The reimbursable Medicare codes of J9217 (leuprolide acetate), J9202 (goserelin acetate), J9219 (leuprolide acetate implant), and J3315 (triptorelin pamoate) were examined for medical castration. The code for simple orchiectomy, 54520, was used for surgical castration. The use of medical castration increased from 2001 to 2003, whereas, over the same period, surgical castration decreased. Total allowed charges for medical castration peaked in 2003 at $1.23 billion. After the enactment of the MMA, surgical castration rates increased, and medical castration decreased. Total allowed charges for medical castration in 2005 dropped 65% from the 2003 peak. The use of medical androgen ablation decreased significantly with the decrease in reimbursement. The administration of either surgical or medical castration in the U.S. Medicare population appears to be tied closely to reimbursement in trend, but not always in magnitude.

Part D Plans Impose Strategies to Reduce Medication Costs

Part D Plans Impose Strategies to Reduce Medication Costs