Skip to main content

Specialists Say 'Slow Down' on Dual-Eligible Pilots


May 29, 2012 — A coalition of medical societies representing some 100,000 specialists says a well-intentioned federal effort to improve the care of some of the nation's sickest and neediest patients could backfire, in part by cutting provider compensation.
The patients in question are roughly 9 million "dual-eligibles" who are enrolled in both Medicare and Medicaid. They represent a disproportionately large share of Medicare and Medicaid spending, in part because they are generally sicker, and also because the 2 programs — each with its own benefits, billing systems, and provider networks — sometimes work at cross-purposes.
Under the auspices of the Affordable Care Act, the Center for Medicare and Medicaid Services (CMS) is hatching demonstration projects that would turn over the care of dual-eligibles to state-operated managed care programs. The goal is to improve the lives of these patients, expand their access to care, eliminate duplicated services, and lower costs.
However, in a letter last week to the CMS, the Alliance of Specialty Medicine (ASM) warned that the demonstration projects could inadvertently disrupt the care of dual-eligibles and restrict their access to specialty care. The ASM, which consists of 12 medical societies, asked the CMS to hold off rolling out the dual-eligible demonstration projects for at least 1 year while the kinks get worked out.
The ASM consists of the American Association of Neurological Surgeons, the American Association of Orthopaedic Surgeons, the American Gastroenterological Association, the American Society of Cataract and Refractive Surgery, the American Urological Association, the Coalition of State Rheumatology Organizations, the Congress of Neurological Surgeons, the Heart Rhythm Society, the National Association of Spine Specialists, and the Society for Cardiovascular Angiography and Interventions.
The letter is the latest example of organized medicine attempting to erect speed bumps in the path of healthcare reform. Medical societies have successfully lobbied the CMS to postpone the implementation of a new set of diagnostic codes called the ICD-10, which stands for the International Statistical Classification of Diseases and Related Health Problems, 10th Revisionnew standards for electronic claims called Version 5010; and requirements for drug and medical device makers to report payments made to physicians.
Will Cash-Strapped States Pinch Provider Rates?
For a federal government keen on curbing budget-breaking costs in Medicare and Medicaid, dual-eligibles represent an obvious target for economizing.
Roughly 40% of dual-eligibles are individuals with disabilities who are younger than 65 years, and 60% are low-income individuals aged 65 years and older. Fifty-seven percent have a cognitive or mental impairment compared with 25% of other Medicare beneficiaries. Dual-eligibles are also 8 times as likely to be in a long-term care facility. Six in 10 have multiple chronic conditions.
More morbidity means more spending. In 2007, dual-eligibles made up 15% of Medicaid enrollees, yet accounted for 39% of Medicaid spending, according to the CMS. Likewise, dual-eligibles amounted to 15% of Medicare enrollees and 27% of that program's cost in 2006.
In its letter to the CMS, the ASM applauded the government's attempt to integrate the 2 entitlement programs for the sake of dual-eligibles and providers alike. However, the organization expressed misgivings about the ability of state-run plans to achieve the goals of the demonstration projects. For one thing, the ASM said, most Medicaid managed care plans focus on children and families, "and have little or no experience with the more complex needs of the frail elderly or patients who are mentally ill, developmentally disabled, or institutionalized." The CMS must ensure that it has the "necessary infrastructure and processes in place" to oversee the state dual-eligible plans before the demonstration projects begin.
The specialists also worry that state dual-eligible plans will reduce their reimbursement, which in turn could drive away physicians and reduce patient access to care. Cash-strapped state Medicaid programs already are notorious for stingy reimbursement, and the ASM fears more of the same with the dual-eligible plans, particularly if a state fields only 1 or 2 plans. The ASM reasons that a wider field of plans would compete harder for providers by offering higher payment rates.
Yet another concern is how patients will be enrolled in state dual-eligible plans. Some of the states seeking to participate in a demonstration project have proposed passive enrollment; that is, a patient is automatically signed up for a plan unless he or she opts out. The ASM says this approach is "offensive" because it runs contrary to the notion of patient-centeredness and shared decision-making. Patients who fail to opt out, perhaps because they are uninformed, may end up in a plan that does not include their established providers, and may experience "harmful disruptions in care" as a result.
The ASM is asking the CMS to delay the implementation of the dual-eligible demonstration projects for at least 1 year, just as they are approaching their launch dates. In May 2011, the CMS announced that it had awarded up to $1 million apiece to 15 states to design dual-eligible programs. The states were given 12 months to develop a model that could go live sometime in 2012. For some states, the design period began in April 2011; for the rest it began in May 2011. The CMS said it would work with states to implement the most promising submissions and held out the possibility of additional funds (if available).
The 15 states that received the design grants are California, Colorado, Connecticut, Massachusetts, Michigan, Minnesota, New York, North Carolina, Oklahoma, Oregon, South Carolina, Tennessee, Vermont, Washington, and Wisconsin.

Comments

Popular posts from this blog

Missing Data Lead FDA Panel to Vote Against Rivaroxaban for ACS May 23, 2012 (Updated May 24, 2012) (Silver Spring, Maryland) — The missing data issues plaguing the ATLAS ACS 2 TIMI 51 trial of the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the FDA Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting, the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus clopidogrel, or ticlopidine. Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the ATLAS ACS TIMI 46 phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the risk of bleeding and intracranial hemorrhage, but the studies were hindered by early patient withdrawals and missing data. We Don't Know What We're Missing Based on the ATLAS ACS 2 results, FDA reviewer Dr Karen Hicks recommended approval of rivaroxaban for the requested indications except all-cause mortality. However, another FDA reviewer, Dr Thomas Marciniak, was adamant that the trial results are not interpretable because about 12% of the patients had incomplete follow-up, far higher than the 1% to 1.5% differences in the end-point rates between rivaroxaban and placebo. A total of 1294 subjects discontinued the trial prematurely, and the company was only able to contact 183, of which 177 were confirmed to be alive. Because of the patient dropouts, the company adopted a "modified intention-to-treat analysis," whereby patients were observed for 30 days after randomization or the global end date for the trial, instead of observing all the patients until the end of the trial as the FDA originally suggested. Marciniak criticized the sponsor's efforts to follow the patients and said that three patient deaths not counted in the modified intention-to-treat analysis may just be the "tip of the iceberg." Because the percentage of patients whose ultimate vital status remains unknown is much greater than the reported differences in mortality rates, the claimed mortality benefits are not reliable. The majority of the panel sided with Marciniak. For example, Dr Sanjay Kaul (University of California, Los Angeles) voted "no" because "there was enough uncertainty in the quality and robustness of the data that dissuaded me from voting yes. . . . The 'missingness' of the data doesn't invalidate it, but it certainly makes it hard to infer [the conclusion]." Dr Steven Nissen (Cleveland Clinic, OH) said that the decision to use the modified intention-to-treat analysis had a "profound impact" on the interpretability of the data. "It's saying we don't care what happens after 30 days, [and] that colored the trial in ways we couldn't recover from." Given the risk of major bleeding, "I want to see better evidence that this strategy of adding an Xa inhibitor or a direct thrombin inhibitor or something else to a good antiplatelet agent is robustly better for the patient," Nissen said. He recommends that the companies run a new trial of the 2.5 twice-daily dose of rivaroxaban using a strict intention-to-treat approach, but, he said, "I don't expect the death benefit to be too robust." Several panelists said they were concerned that the patients who dropped out of the trial were disproportionately likely to have a bleeding event, which led them to quit the trial, or a "protopathic" event, as statistician Dr Scott Emerson (University of Washington, Seattle) put it. "We're worried that an impending event is what is changing their behavior. We see that all the time in clinical trials--that regularly measured end points do not pick up [all of] the events," he said. He said that since the company was only able to contact 183 of the over 1200 patients who dropped out, it is possible that the dropouts skew the outcomes comparison of the trial. "Differential event rates after dropout are the number-one thing we're afraid of, so you have to explore it" in a statistical sensitivity analysis of the potential impact of these unknown outcomes. "It would not surprise me if, at the end of the day, these data did not hold up under a proper sensitivity analysis," he said. "What I want to know is, among the people who had events, how differential was the follow-up, but I can tell you by just looking at it, there was a very slightly different amount of follow-up of the people in the treatment arm. But I don't know whether everyone in the treatment arm was cured and they were trekking in the Himalayas and everyone in the placebo arm went home to die. I don't know that that's not the case." Dr Maury Krantz (University of Colorado, Denver) voted in favor of approval but said he does not know how rivaroxaban would perform in general clinical practice, especially when used with aspirin and clopidogrel. "I felt very much torn by this. This isn't a simple paradigm shift. It means going to triple therapy, which is really a three-headed monster in many ways. I think that what you're going to see in practice, if this is not done carefully with the proper labeling and secondary studies, is really dramatic magnification of bleeding and perhaps minimization of the efficacy benefit."

May 23, 2012   (Updated May 24, 2012)  (Silver Spring, Maryland)  —  The missing data issues plaguing the  ATLAS ACS 2 TIMI 51   trial of the factor Xa inhibitor  rivaroxaban  (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the  FDA  Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting , the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus  clopidogrel , or  ticlopidine . Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the  ATLAS ACS TIMI 46   phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the ri...

Antidepressants Linked to Higher Diabetes Risk in Kids

Pediatric patients who use antidepressants may have an elevated risk for type 2 diabetes, the authors of a new study report. In a retrospective cohort study of more than 119,000 youths 5 to 20 years of age, the risk for incident type 2 diabetes was nearly twice as high among current users of certain types of antidepressants as among former users, Mehmet Burcu, PhD, and colleagues report in an article  published online October 16 in  JAMA Pediatrics . The risk intensified with increasing duration of use, greater cumulative doses, and higher daily doses of these antidepressants. The findings point to a growing need for closer monitoring of these products, including greater balancing of risks and benefits, in the pediatric population, the authors caution. They undertook the study because, despite growing evidence of an association between antidepressant use and an increased risk for type 2 diabetes in adults, similar research in pediatric patients was scarce. "To our know...

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...