Medicare Coverage Policies Research Articles

The Voice of the Clinical Practice Committee: More Than a Single Story.

On a glorious Fourth of July on the coast of Maine, I began to wonder what the year would bring for the Clinical Practice Committee (CPC) and for oncology practice. Thanks to some great weather, most of the east coast was beginning to heat up, and folks were enjoying those lazy, crazy days of summer. Amid the sails that dotted Saco Bay, the soft breezes through the marsh grasses, and the ocean's loss of its frigid surprise for those who crowed onto the beaches, the work of the CPC has begun in earnest. Having been energized during the ASCO Annual Meeting, where there were many voices of change, debate, challenge, and opportunity, the CPC has set an ambitious work agenda. My first task as the newly installed chair of the CPC was to present our work to the ASCO Committee Chairs, whose efforts, time, talent, passion, and ambition form the focus of commitment for the mission of ASCO. At the Annual Meeting, I heard reports about new technologies; improved and efficient communication; and new tools for education, leadership, partnership, scientific discoveries, treatment breakthroughs, advocacy, marketing, and stewardship. It is clear to me that we who care for patients must not only succeed in practice, but must also integrate practice into the entirety of the ASCO community. During the month after the meeting in Chicago, the CPC leadership and staff prepared proposed topics for educational sessions for the 2011 Annual Meeting. We proposed topics that are of interest to those who practice, regardless of setting. These include “A Forum on Policy, Business, and Reimbursement Trends in 2011”; “Increasing Awareness and Participation in Clinical Trials”; “Assessing the Financial Health of Oncology Practices”; “QOPI Use in Various Practice Settings”; and “The Oncology Pharmacy-Office, Infusions Center, Practice Dispensary, Hospital Clinics.” The CPC leadership seeks best practices, successful processes, experienced pathways, and spirited participants whose presentations will encourage excellence and inspiration. Although the selection process for these sessions is competitive, the effort creates high standards and a valuable agenda for the CPC to work with over the year. As the Carrier Advisory Committee (CAC) transitioned into the Medicare Administrative Contractors Advisory Group, the CPC and ASCO State Societies cohosted another Annual Network Meeting with the American Society of Hematology. Hematology and oncology CAC members from all 15 Medicare Administrative Contractors jurisdictions gathered with contractor medical directors to discuss the beginnings of the implementation of health care reform, review local and national Medicare coverage policies, review the challenges of documentation in the era of the electronic medical record, and understand the role of compendia in validating off-label use of chemotherapy drugs in cancer care. Each of these tasks is taken up by CAC representatives regularly as they represent you and your ASCO State Society; they are intensely involved in these efforts and are truly unsung heroes. They carry the CPC presence into the policy debates, pilots and trials, and coverage decisions that allow better cancer care to be provided to patients. For without coverage policy that determines reimbursement, a practitioner is hard pressed to deliver care. The CPC Steering Subcommittee set the agenda for the fall meeting of the CPC and continues to drive a number of initiatives, including strategically driven government relations advocacy in an era of turbulent partisan politics; a Private Payer Initiative conference, which will bring payers and providers into a dialogue that should create improved collaboration, if not the seeds for partnership; a task force to help ASCO understand the forces and challenges that shape the practice of oncology; and the transformation of the Practice Management Curriculum into an educational effort to provide a standard of excellence for practice administrators and staffs. So what will the CPC work on as the fall brings a new term? We certainly will be doing all that we can to promote and provide the best care possible for patients with cancer. All of ASCO is behind us, and the CPC appreciates all the help you will give.

Medicare formulary coverage for top-selling biologics

Medicare formulary coverage for top-selling biologics

The interface of Medicare coverage decision-making and emerging molecular-based laboratory testing

The process of obtaining Medicare coverage for clinical services (both at the national and local levels) can be complex and often leads to considerable confusion among external stakeholders. The entry of molecular diagnostic testing into the clinical arena of laboratory medicine has posed some special challenges, both for those providing the testing, and those paying for such technology. This commentary will seek to clarify Medicare's pursuit of defining medical necessity by describing both the local and national Medicare coverage policy processes. However, it should be understood that the Medicare reimbursement for such esoteric testing is a work-in-progress, without an established step-by-step process for obtaining a positive coverage decision. Yet, this evolving process provides all stakeholders (payers, laboratories, industry, clinicians, etc.) with an opportunity to fully understand the health policy implications of complex molecular diagnostic testing. In addition, brief case study vignettes are incorporated into our discussion, to show how laboratorians, in conjunction with their clinical colleagues, can effectively engage the payer community in developing more medically sound and fiscally responsible coverage policies.

Optimal Parameters for the Destruction of Prostate Cancer Using Irreversible Electroporation

Irreversible electroporation is a new tissue ablation technique that consists of applying musecond pulses of direct current to create permanent defects in the cell membrane. Irreversible electroporation spares connective tissue in blood vessels and other tissue structures. When applied properly, it does not produce thermal damage. We determined the irreversible electroporation parameters that would reliably destroy prostate cancer cells. Irreversible electroporation pulses were applied to prostate adenocarcinoma cells in vitro. Three sets of studies were performed to determine the number, length and field strength of irreversible electroporation pulses required to produce complete cancer cell ablation without inducing thermal effects. The outcome of a treatment protocol was simulated. We found the upper and lower limit bounds of pulse length and number in a field range of 2,000 to 250 V/cm. A total of 90 pulses at 250 V/cm for 100 museconds separated by 100 milliseconds could completely ablate prostate cancer cells without inducing thermal damage. Irreversible electroporation represents a new nonthermal ablation modality. This study has produced values for prostate cancer treatment with irreversible electroporation.

The Impact of Medicare Coverage Policies on Health Care Utilization

To determine whether Medicare coverage policies affect utilization of services in Medicare. We constructed an analysis data set for eight different procedures using secondary data obtained from Medicare claims (1999-2002) and Medicare coverage policies posted on Center for Medicare and Medicaid Services website. We analyzed the impact of coverage policies using difference-in-difference approach in a regression framework. We found that in only one case (transesophageal echocardiography) out of eight did utilization change (reduced by 13.6 percent) after the effective date of the local policies. There is no systematic pattern that policies affect utilization, and the type of coverage policy does not seem to play an important role in its impact. Coverage policies have the potential but do not consistently impact utilization as policy makers intend and expect them to do. These findings raise significant policy questions about the effectiveness of Medicare coverage policies, which deserve further study.

Commentary: The Impact of Medicare Coverage Policies on Health Care Utilization

Traditional fee-for-service Medicare, by far the most popular choice of Medicare beneficiaries, lacks many of the tools that commercial health insurance and Medicare Advantage plans can use to control health care utilization. Prior authorization, selective contracting, utilization review, and capitation are generally absent from traditional Medicare. Furthermore, most beneficiaries are covered by supplemental health insurance. Supplemental plans cover many out-of-pocket payments, depriving Medicare of the ability to use cost-sharing to discourage overuse of medical services. Reimbursement can be an effective tool to control both utilization and expenditures. With Medicare's enormous market power, providers usually must accept the reimbursements it offers. As important as the ability to set reimbursement levels would seem to be, however, it is not a tool that the officials of the Centers for Medicare and Medicaid Services (CMS) can apply at will. CMS sets inpatient and outpatient reimbursement levels by formulas that it cannot easily modify or abandon (Medicare Payment Advisory Commission 2007). Congress, not CMS, sets basic parameters for provider reimbursement levels, and in recent years has chosen not to implement scheduled cuts in reimbursement. This experience has led to skepticism about the ability of reimbursement policy to control expenditures in the Medicare program.

Implementing Evidence-Based Medicine Through Medicare Coverage Decisions

Management of technology diffusion to improve quality and constrain spending in health care remains an elusive goal. Along with efforts to improve the quality of evidence, providers and payers must ensure that evidence actually effects changes in practice. Medicare coverage policies grant, limit, and condition payment based on evidentiary standards. This paper identifies the sizable barriers to implementation of evidence-based medicine in Medicare and proposes policy solutions to address them.

The New Medicare Coverage Policy −12 Months and Counting

The New Medicare Coverage Policy −12 Months and Counting

ASH Weighs in on Review of Medicare Coverage Policy for Erythropoietin-Stimulating Agents

ASH Weighs in on Review of Medicare Coverage Policy for Erythropoietin-Stimulating Agents

Improving Medicare coverage of psychological services for older Americans.

Professional psychology's ability to meet older Americans' psychological needs and to simultaneously thrive as a profession will be closely tied to the federal Medicare program over the coming decades. Despite legislative changes in the 1980s providing professional autonomy to psychologists and expanding coverage for mental health services, Medicare coverage policies, reimbursement mechanisms, and organizational traditions continue to limit older Americans' access to psychological services. This article describes how psychologists can influence Medicare coverage policy. Specifically, the authors examine widely unrecognized policy processes and recent political developments and analyze the recent creation of a new Medicare counseling benefit, applying J. W. Kingdon's (1995) well-known model of policy change. These recent developments offer new opportunities for expanding Medicare coverage of psychological services, particularly in the areas of prevention, screening, and early intervention. The article provides an analysis to guide psychologists in engaging in strategic advocacy and incorporating psychological prevention and early intervention services into Medicare. As Medicare policy entrepreneurs, psychologists can improve the well-being of millions of Americans who rely on the national health insurance program and, in so doing, can help shape the future practice of psychology.

Biotechnology And Medicare’s New Technology Policy: Lessons From Three Case Studies

Biotechnology has figured prominently in recent Medicare coverage and payment policies. Biotech treatments push policy boundaries for several reasons: They attract strong patient demand; they often treat rare or life-threatening diseases; they may have uncertain evidence of health benefits; and they are often costly. This paper considers case studies of Medicare coverage for off-label uses of biotech cancer drugs and payments for anemia biopharmaceuticals. The cases suggest Medicare's ongoing challenge to balance access considerations, the role and strength of evidence, and cost consequences of new treatments.

Racial disparities and trends in use of colorectal procedures among Tennessee elderly (1996-2000).

Blacks are more likely to be diagnosed at a later stage of colorectal cancer (CRC), and have poorer survival than Whites. Colorectal cancer (CRC) is usually curable when diagnosed at an early stage. We compare the use of CRC tests for screening between Whites and Blacks and compare the use of CRC tests for either screening or diagnosis and further check the test results for a diagnosis of CRC. The data we use are from physician claims files provided by the Centers for Medicare and Medicaid Services (CMS) (1996-2000) for a closed cohort of all Tennesseans eligible for Medicare in 1996, age > or = 6. Half as many Blacks as Whites were screened with fecal occult blood testing (FOBT), sigmoidoscopy, and colonoscopy. Significantly fewer Blacks had any colorectal procedures, sigmoidoscopy, colonoscopy, and/ or barium enema, for screening or diagnosis; however, the test results show that more Blacks were diagnosed with CRC than Whites. The use of CRC tests is low regardless of race. Only 24% of beneficiaries used at least one of the four procedures during the five years. During the five years, FOBT and barium enema use decreased significantly for both Blacks and Whites, while colonoscopy use increased significantly. Sigmoidoscopy use was highest in 1998, which corresponds to the change of Medicare coverage policy in 1998. Removal of financial barriers to screening alone has failed to substantially improve the use of colorectal procedures. Lack of vigilance and lack of access to good quality of care contribute to the fact that Blacks are more likely to be diagnosed at a late stage of CRC than Whites.

Forcing Isolation: Medicare’s “In the Home” Coverage Standard for Wheelchairs

Older adults and people with physical disabilities can get Medicare coverage for mobility devices, like wheelchairs, walkers, and scooters, which are necessary for use in their homes. However they cannot get coverage for mobility devices that are solely for functioning outside their home. Since the institution of Medicare's coverage standards for mobility devices, and other kinds of durable medical equipment, nearly four decades ago, advances have been made in three critical areas: improvements in design of mobility devices that allow people to participate more fully in their communities; widespread societal recognition that with appropriate accommodations many limitations on functioning can and should be lifted; and recent court decisions requiring that individuals with disabilities be provided with the necessary supports to live as independently as possible in their communities. The current interpretation of Medicare's coverage standards for mobility devices does not reflect these advances. The Centers for Medicare and Medicaid Services' (CMS) interpretation of Medicare's coverage standard prevents people from getting needed medical equipment to function within their communities. By contemporary medical and legal standards, the [CMS's] interpretation is unreasonable and quite likely unlawful. The Medicare statute neither specifies that durable medical equipment is exclusively for use in the patient's home nor bars consideration of an equipment's use outside the home. There is no indication of Congressional intent to support this limitation of coverage. CMS has both the authority and the responsibility to interpret the Medicare statute so as to be consistent with historical developments in law, technology and social mores. United States Supreme Court precedent holds that agencies are "charged with the administration of [a] statute in light of everyday realities." Everyday realities have changed since Medicare was launched in 1965. Laws such as the Rehabilitation Act of 1973, the Americans with Disabilities Act of 1990 and the Ticket to Work and Work Improvements Incentives Act of 1999 reflect a broad, bipartisan commitment to increasing community integration of people with disabilities. This commitment is evident in judicial decisions, including Olmstead v. L.C. ex rel. Zimring, and executive orders, such as President George W. Bush's New Freedom Initiative, a set of proposals to promote opportunities for Americans with disabilities to learn and develop skills, engage in productive work, make choices about their daily lives, and participate fully in their communities. Developing political and legal standards are consistent with medical opinion: the costs of isolation for people with disabilities can include poorer health outcomes and higher systematic health costs. Also, scientific evidence indicates that people who get inappropriate mobility devices given their needs develop secondary medical conditions. In light of technological advances that today make appropriate equipment available and community integration possible, CMS has a responsibility to update its interpretation of the Medicare statute. While CMS must rightly be concerned with costs associated with a more modern interpretation of Medicare's coverage policy, other insurers have found that an appropriate standard has not led to an explosion in the provision of more expensive mobility devices. Specifically, the brief recommends that the Centers for Medicare and Medicaid Services: (1) correct its Medicare coverage policy to cover medically appropriate mobility devices that help maintain or improve functioning for people in the environments they are likely to encounter in their daily routines (both inside and outside of the home), and (2) guard against unnecessary expenses for Medicare by incorporating mandatory equipment evaluations to ensure that people receive equipment that matches their needs. While durable medical equipment encompasses a wide array of assistive devices, this brief will focus on wheeled mobility items, recognizing that this analysis will have varying applications to other durable medical equipment as well.

Financing of care for fatal chronic disease: opportunities for Medicare reform.

Could financing arrangements influence whether the “better course of care” could become commonplace? Some shortcomings in care for patients with eventually fatal chronic conditions arise from inadequate professional education and quality standards,1 but health care professionals and expert panels also claim that inappropriate Medicare coverage and payment policies perpetuate dysfunctional arrangements in the care system.2,3 In this article, we show how financing might contribute to the perpetuation of inadequate care and suggest remedies for such situations. Three fourths of Americans die past 65 years of age.1 Thus, Medicare policy structures the pattern of care received at the end of life. More than three quarters of those dying in Medicare have chronic heart or lung failure, cancer, stroke, or dementia.4 Not only are most people very sick just before death, they also will have been very sick for many months earlier. During that time, they often receive care that is unreliable, inadequate, inappropriate, unwanted, and costly.1,5,6 Medical care in the last year of life accounts for 11% of overall health care spending and 27% of Medicare spending.7,8

Medicare coverage policies: A macro and micro analysis.

Medicare coverage policies: A macro and micro analysis.

US Medicare coverage policy soon to be public

US Medicare coverage policy soon to be public

Reimbursement of tumor marker tests

The diffusion of new technology is significantly affected by coverage and reimbursement decisions. A variety of agencies (public and private) make decisions as to which technologies or treatments will be covered and what the levels of reimbursement will be. Recently, these agencies' coverage decisions have tended to be strongly affected by whether a technology is cost raising or cost reducing. Historically, a common effect of medical innovation has been improved quality of health care but with a corresponding increase in cost of delivery. The Medicare program has significant influence on the coverage policies of public and private third-party payers. This influence is especially visible in coverage and reimbursement decisions for cancer-related diagnostic procedures and systems. Coverage for these procedures and systems is not widespread because payers have not been convinced of the clinical usefulness of the assays. The industry must take the responsibility of working through the issues surrounding coverage and reimbursement of cancer-related diagnostic procedures with the payers. The ability to successfully negotiate payment for assays requires knowledge of Medicare coverage policies and a grasp of the reimbursement system.

Medicare coverage, Medicare costs, and medical technology.

One possible approach to containing Medicare costs involves explicit changes in Medicare's coverage policy with respect to medical technology. This paper first describes the development and diffusion of medical technology in general and then describes how technologies are identified, assessed, and approved for payment by Medicare. Currently, cost is neither a criterion nor an explicit issue in coverage decisions, although coverage policy is an integral part of payment policy. A combination of policies to reduce the rates of adoption and use of certain technologies is needed--including cost considerations in technology assessments for coverage decisions, limiting diffusion of technology to certain providers and sites, limiting utilization to certain indications, and tightening administrative processes. Finally, the interaction between coverage policy and DRG payment needs to be explored more thoroughly.