Physicians and their advocates say the government's new Medicare payment rule is too narrow and too complex to achieve its overarching goal of boosting value of care over volume.
This article first appeared October 13, 2016 onMedPage Today.
By Shannon Firth
In interviews with MedPage Today, physicians and their advocates said the government's new Medicare payment rule is too narrow and too complex to achieve its overarching goal of boosting value of care over volume.
Congress repealed the loathed Sustainable Growth Rate formulain April 2015, via the Medicare Access and Chip Reauthorization Act (MACRA), setting the stage for the first major overhaul of physician payment in a quarter-century.
Under one payment channel, called advanced alternative payment models (APMs), clinicians meeting specific requirements would earn incentive payments of approximately 5% for 5 years in a "lump-sum payment" every year from 2019 to 2024.
Those ineligible for the advanced APMs will be assigned to a default framework, the Merit-Based Incentive Payment System (MIPS). From 2019 to 2024, these providers would receive small bonuses or penalties based on their ability to meet a series of metrics across four categories: quality improvement, performance, resource use and appropriate use of electronic health records.
The final rule is expected next month.
'Limited Options'
Regarding the advanced alternative payment models, "right now it's a pretty limited number of options for at least the upcoming year," said Laura Wooster, MPH, of the American Osteopathic Association. In particular the AOA has lobbied for including patient centered medical homes (PCMH) in the advanced APM pathway.
Wooster argued that some PCMHs and accountable care organizations (ACOs) are more stringent and more advanced than the track 2 Medicare shared saving programs that have been included. Nevertheless, under the preliminary rule, they were locked out of the advanced APMs and therefore blocked from receiving that 5% bonus.
"That's one of the first things that we're intending to look at as soon as we get the final rule," she said.
Another more sweeping concern is that the draft MACRA rule did not offer an even playing field for small practices in the MIPS track.
Wooster said one of the questions she hears most often from members relates to how small providers are supposed to outperform larger practices in a MIPS environment.
"They don't have the resources or a broad risk pool even, they feel like they'll be at a competitive disadvantage," she said.
Losers Pay Winners
MACRA was designed to be budget neutral, which in this case means "the losers essentially pay the bonuses for the winners," said Rob Tennant, health information technology policy director for the Medical Group Management Association.
One of the major initial concerns of the rule dealt with timing. Initially the rule was expected to be released in November 2016 with reporting requirements slated to begin January 2017.
Acting CMS Administrator Andy Slavitt mitigated some of those worries by announcing a "pick your pace" format, offering graduated options for those who want to delay full participation in the program while still allowing those early adopters to jump in head-long to the program with its original reporting requirements in anticipation of bonuses.
"Assuming that blog post is accurate, we think that it's a good start in terms of really having all providers, all sizes all specialties at least having the chance at avoiding the penalty," Tennant said.
However, because of the budget-neutral aspect of the law, the more providers who avoid penalties, the smaller the potential bonus will be.
This raises the question of how much physicians should invest to get that small bonus, Tennant said. For example, if the bonus is 2%, a physician paid $20,000 through Medicare will earn just $400 for his efforts in the MIPS track, but he might have to invest $10,000 in the technology he needs to succeed in the MIPS.
"We want to make sure that there's not a disincentive for practices to participate," he said.
Bias Against Primary Care?
In addition to the potential challenges of small provider versus large employers, MACRA also could pit primary care against specialty providers.
"So far a lot of those [MIPS] measures apply just to primary care," said John Meigs, Jr. MD, president of the American Academy of Family Physicians who practices in Centerville, Ala.
"If you're going to hold primary care to certain metrics, then you need to have the same or similar metrics that the subspecialties have to comply with.... That's where a lot of the cost in the system is. They do not need a free ride," he said, noting that CMS said it is in the process of developing measures for specialty providers.
Others, like Katie Orrico, JD, director of the Washington office for the American Association of Neurological Surgeons (AANS), said topline issues for her members include provisions around the reporting burden, the low-volume threshold and participation in qualified clinical registries.
Orrico said that under the preliminary rule, most practices would be required to report data on 80-90% of their Medicare patients, AANS has recommended CMS limit that requirement to 50% of applicable patients.
Immediately after the final rule is released, she'll also be scrutinizing it for changes to the low-volume threshold exemption. Under the proposed rule, providers who care for fewer than 100 Medicare beneficiaries and bill less than $10,000 in allowable charges, would not have to participate in MIPS.
For surgeons, a single complex spinal surgery could push them over the $10,000 benchmark.
AANS and several other medical groups have recommended that CMS delink the two criteria -- both the number of patients and the dollar amount charged -- shifting from an "and" to an "or" statement and increase the allowable charge amounts, some groups say to $30,000.
According to a survey of the general public by Public Citizen, 86% of respondents were against eliminating the 16-hour shift limit for interns set by the Accreditation Council for Graduate Medical Education. From MedPage Today.
This article first appeared September 13, 2016 on MedPage Today
By Shannon Firth
WASHINGTON -- Nine in 10 respondents to a national survey said they opposed scrapping a rule that limits the number of continuous hours first-year medical residents can work.
According to the survey of the general public by Public Citizen, 86% of respondents were against eliminating the 16-hour shift limit for interns set by the Accreditation Council for Graduate Medical Education's (ACGME), while 80% also supported dropping the maximum shift limit for second-year residents and above from 28 hours to 16 hours.
"Our basic take-home message today is that now is not the time for the ACGME to backtrack and allow resident physicians to work longer hours,"said Michael Carome, MD, director of the health research group for Public Citizen, which released the poll results during a press briefing on Tuesday.
Public Citizen engaged Lake Research Partners, an independent polling company, with conducting the survey about the public's attitude towards current restrictions on residents' work hours in response to mounting pressure on ACGME from physician organizations to soften such restrictions, and allow residents to work 28 hours or more without sleep.
Approximately 500 individuals participated in the 10-minute phone survey, which was "stratified geographically to reflect the expected voter turnout of the 2016 general election," and whose demographics were designed to mirror that of the U.S. adult population, according to the report.
In addition to the findings around work-hour policy, Public Citizen noted that 77% of respondents said they believe patients should be told if the medical resident treating them has worked more than 16 hours without rest.
The Public Citizen report also highlighted the following adverse impacts of sleep deprivation on medical residents and their patients:
A 2006 prospective cohort study of self-reported percutaneous injuries among interns that found "lapses in concentration" and "fatigue" were more likely to occur on extended shifts and were primary contributors to such injuries
A 1993 study reported internal medicine residents working 32-hour shifts every fourth night demonstrated "significantly higher rates of depression symptoms"
The ACGME is in the process of doing its own data review. In September 2015, it created a task force to review current resident duty-hour restrictions and produce a report, slated for release in the coming months. To date, the task force has reviewed the scientific literature -- over 120 position papers and responses -- and heard testimony from over 40 organizations including residents, according to Thomas Nasca, MD, ACGME CEO.
The task force will collect feedback on any proposed modifications during a 45-day public comment period, and the implementation of any revised requirements will target the 2017-2018 academic year.
Background
In 2003, the ACGME instituted standards for resident hours that included an 80-hour weekly limit, averaged over 4 weeks, and a 24-hour limit on continuous duty.
Roughly 5 years later, the Institutes of Medicine issued a report cataloguing the risks incurred by residents, and by patients, when residents worked for extended shifts, and recommended that no resident be allowed work for more than 16 hours at a time without sleep.
In 2011, the ACGME responded to this guidance by tightening its duty hour rules for interns to no more than 16 hours.
However, in the last few years, the council has issued waivers to medical institutions involved in two broad cluster-randomized trials that aim to study the impact of residents' shift length on patient safety and cost, and medical education: the Flexibility In Duty Hour Requirements for Surgical Trainees Trial (FIRST), and the ongoing Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
The FIRST trial, a prospective cluster-randomized noninferiority study was completed in June 2015 and the results, published 2016, showed that flexible, less-restrictive duty-hour policies for surgical residents were associated with noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality," according to the study authors.
The ACGME granted waivers in the two trials in order to evaluate the impact of the 2011 duty-hour requirements on patient safety and the welfare and education of residents, according to Nasca.
But the council stopped short of waiving the 2003 duty-hour requirements for all specialties, and for internal medicine since the early 1990s, specifically working 80 hours per week, averaged over 4 weeks, and having 1 day off every 7. Also, 24-hour in-house call duty cannot occur more frequently than every third night.
In 2015, Public Citizen and the American Medical Student Association demanded that the Office for Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services, investigate the two trials.
While Carome said the OHRP acknowledged receiving Public Citizen's complaint letters, "it appears that they've taken no action."
One of Public Citizen's core criticisms of both trials is that neither patients nor residents were given informed consent before participating. Their current survey found that 86% of respondents would want to know if they had been admitted to a hospital in the experimental arm of such trials.
"There are probably tens of thousands of patients who have unwittingly participated in these two trials over the past 2 years; who have no idea that they were being treated by first-year residents who were allowed to work up to 28 hours or longer without sleep," said Sammy Almashat, MD, MPH, of Public Citizen's Health Research Group.
Moreover, the FIRST trial inadequate design left it "underpowered" to detect certain changes because it did not measure "intern-specific performance measures," according to Charles Czeisler, PhD, MD, of Brigham and Women's Hospital in Boston. He told MedPage Today that the study's main outcomes -- morbidity and mortality -- were unrelated to the performance of interns whose schedules were modified as they are unable to operate at that point in their career.
"And so to subject the interns to this kind of a health risk would be like randomizing people to be in a group that is exposed to smoking or second-hand smoke without their consent to do an evaluation that does not even measure any of the health outcomes. No motor vehicle crash data were collected, no health data, blood pressure, illnesses. Nothing was monitored. No suicides, depression. etc.," Czeisler, who was not involved in FIRST or in the current survey, told MedPage Today.
No Complaints
"We had something on the order of a 99% response rate for 4,000 some residents, and were able to examine a lot of characteristics about their well-being about their views on patient safety; about their views around needle sticks and car accidents," countered Karl Bilimoria, MD, principal investigator of the FIRST trial, to MedPage Today.
Much of those findings were included in the initial report and additional data will be released in other papers within the next few months, added Bilimoria, who is at Northwestern University in Chicago.
"Between all the hospitals and program directors, we probably had 500 or 700 people who actually had to sign off on the study conduct. Not only that, but there were multiple institutional review boards that looked at this," he said.
Bilimoria stressed that no residents or oversight organizations have filed complaints with the FIRST trialists. "Really the only group that's really complained about this is Public Citizen."
Bilimoria also argued that the reports cited by Public Citizen in defense of restricting duty hours due to motor vehicle accidents, accidental exposures and depression, involved studies from individual institutions or anecdotal evidence. While additional findings from FIRST are currently under embargo, "[Public Citizen's] concerns will not be supported by the data."
Republicans on the House Budget Committee used a hearing about how the Congressional Budget Office scores Medicare demonstration projects to offer some harsh critiques of the projects themselves, as well as the Medicare division that runs them. From MedPage Today.
This article first appeared September 7, 2016 on MedPage Today
WASHINGTON -- Republicans on the House Budget Committee used a hearing about how the Congressional Budget Office (CBO) scores Medicare demonstration projects to offer some harsh critiques of the projects themselves, as well as the Medicare division that runs them.
"There have been legitimate questions about the Center for Medicare and Medicaid Innovation's (CMMI) new Medicare and Medicaid payment models," committee chair Tom Price, MD (R-Ga.), an orthopedic surgeon, said at Wednesday's hearing. "Concerns with the adverse impact these experiments might have on the practice of medicine and patient access to critical healthcare treatments; questions about the agency's decision to require mandatory -- rather than the usual voluntary -- participation of healthcare providers in the models; and generally whether the new models exceed CMMI's legal authority."
Mandatory participation is particularly concerning because it "shifts decision-making away from elected officials into the hands of unelected officials" at CMMI, he continued. "No matter which political party controls which branch of government at any given time, such a precedent is unhealthy for our democracy."
Because of these issues, oversight of CMMI is especially important, and yet, "in its own long-term budget outlook, CBO has admitted that it does not know which, if any, of the current demonstration projects CMMI has embarked upon will result in savings," said Price. "It's important that we have the opportunity to question and understand the underlying assumptions and methodology that inform the basis of its analysis."
Rep. John Yarmuth (D-Ky.), one of the committee's more senior Democratic members, disputed Price's contentions. "CMMI is a vital tool for improving quality and containing costs in healthcare," he said. "Healthcare is an evolving, dynamic, and highly technical arena; there has long been widespread agreement on the broad goal of providing higher quality and reducing unnecessary spending. But [doing that] requires giving real flexibility to Medicare and Medicaid ... That's why Congress created the innovation center."
Republicans are contending that CMMI is overstepping its authority, he continued. "If that's what they're contending, I would suggest we have a hearing [on that] ... But this is separate issue from the other stated topic for today: scoring." Noting that some Republicans have proposed defunding CMMI, Yarmuth added, "CBO's estimates are certainly inconvenient for members who want to undermine CMMI ... but it's CBO's job [to make them]. Let's be honest: Republican leadership ignores CBO's scoring when it suits their purposes."
After the opening statements, two-thirds of the 3-hour hearing featured a single witness: CBO deputy director Mark Hadley. Hadley remained unruffled as committee members asked many questions about the specific methodologies used by the agency to come up with its savings estimates for CBO demonstration projects.
"You said that the [durable medical equipment] demonstration project is a notable success [for CMMI]," Price said to Hadley. "But it also led to disruptions in care for seniors, and was associated with increased mortality and an increase in inpatient admissions. Does your model include those parameters?"
"Yes, the overall model looks at overall framework; a requirement is that the center can only expand projects that ... would improve quality without increasing spending, or would decrease spending without harming quality. When we look at specific cases, we would take that [increased hospitalizations] into account."
Republican committee members also expressed concerns about whether CMMI actually generates any savings. "We're now 6 years into [CMMI] 's work," said Rep. Tom McClintock (R-Calif.) "We've appropriated $10 billion; they've spent half of that money and we're not seeing any savings."
Hadley responded that it will take more time for the savings from some demonstration projects to become apparent. "The current estimate from savings we expect to generate from CMMI is $34 billion from 2017 to 2026," he said.
The last hour of the hearing focused on specific demonstration projects, such as the Bundled Payments for Care Improvement project, which pays physicians a single "bundled" rate for care given during a particular surgical episode. Mark Madden, MD, an orthopedic surgeon from Fairfax, Va., explained how his practice was seeing great benefits from participating in the project, including reductions in adverse outcomes and patient satisfaction rates of more than 95%.
However, there are problems with the way CMMI awards bonuses to providers who keep their cost of care below a certain target amount. "Despite achieving CMMI's goals on cost and quality, physician practices are being penalized financially, actually losing money on each episode" because of the way the bonuses are calculated, said Madden. "If doctors and hospitals can't participate, CMMI cannot generate savings."
Joe Antos, PhD, a healthcare policy scholar at the right-leaning American Enterprise Institute who formerly worked at both CBO and the agency that became CMS, told the panel that he was surprised at the CBO's statement in 2015 that it would "account for savings [from projects] CMMI is undertaking or expected to undertake" (his emphasis).
"This remarkable decision to score savings not yet announced is a sharp break from past practice," he said.
Another witness, Topher Spiro, vice president for health policy at the Center for American Progress, a left-leaning think tank here, praised CMMI's work, pointing to the bundled payment program for joint replacement surgery. "I can relay to you a result from one major healthcare system [in New York] -- it boosted the share of patients discharged to home rather than an expensive facility from 30% to about 50%."
Yarmuth urged his committee colleagues to work together to solve any perceived problems with CMMI's activities. "Let's talk together ... and see whether there are reforms in CMMI that are justified."
The Obama administration announced $53 million in grants to help states fight the opioid abuse epidemic while also calling on Congress to allocate another $1. 1 billion toward the effort. From MedPage Today.
This article first appeared August 31, 2016 on MedPage Today
WASHINGTON -- The Obama administration announced $53 million in grants to help states fight the opioid abuse epidemic while also calling on Congress to allocate another $1. 1 billion toward the effort.
"These grants we're announcing today are an important step forward, and we hope Congress will take the next step," Health and Human Services (HHS) Secretary Sylvia Burwell said Tuesday on a conference call with reporters.
Michael Botticelli, director of the Office of National Drug Control Policy, agreed. "We can't end this crisis on our own," he said. "We need Congress to act on the president's $1.1 billion funding request so we can expand access to treatment and move our country from crisis to recovery. Every day that passes without Congressional action ... is a missed opportunity to save lives."
Much of the HHS grant money is aimed at each part of the agency's three-part strategy to fight the epidemic, Burwell explained. They included:
Reducing overprescribing. HHS is giving $11.5 million to 14 states to help them "ensure that healthcare professionals have the tools and information they need to make informed prescribing decisions and in the process help reduce overprescribing," she said. "States can use it to enhance prescription drug monitoring programs [PDMPs], to further prevention efforts like educating providers and patients about the risk of prescription drug overdosing, and to help health systems make informed decisions about prescribing pain medications."
Increasing access to treatment. The agency is providing $11 million to 11 states to expand access to medication-assisted treatment such as buprenorphine, Burwell said.
Ensuring access to naloxone. HHS is granting up to $11 million to 12 states to help more first responders obtain the overdose-reversal drug naloxone and to make sure they're trained in how to use it.
"By focusing on these three pillars .... we can help states, communities, and families push back even harder against the opioid epidemic in a way we know will lead to the best outcomes," Burwell said.
In addition to those funds, 21 states as well as four tribes will receive $9 million through the Substance Abuse and Mental Health Services Administration to strengthen drug abuse prevention efforts. Another $10 million will be awarded to help states better track and collect data on the epidemic as well as to develop more abuse prevention programs, HHS said in a press release.
Access to treatment is one area where more help is sorely needed, according to Steve Williams, mayor of Huntington, W.Va., who also participated in the conference call. Huntington is at the center of the epidemic, with 70 overdose deaths last year, although that number has dropped to 35 so far this year. "We only have 28 detox beds in the entire state of West Virginia," he said, including eight in Cabell County where Huntington is located.
On one particular evening a few weeks ago, there were 26 overdoses in Huntington; two of those patients died. "That evening ... we didn't have enough beds in the entire state if every person [overdosing] had said, 'I want help,'" said Williams. "Most times we find it's a 6-month waiting period before someone can get into treatment. When someone is begging for help, we don't have 6 months to give, or 6 weeks, or 6 days; we should have no less than 6 hours available to place somebody immediately into a treatment facility."
That's why the administration's $1.1 billion proposal -- of which around $920 million is to pay for access to treatment -- is so important, he continued. "This isn't a Democratic issue; it isn't a Republican issue; this is an issue of saving lives. ... This appropriation needs to be acted on by Congress immediately -- not waiting for a presidential election."
Changing the prescribing culture among providers is also critical to stopping the epidemic, according to Anne Schuchat, MD, principal deputy director of the CDC. "States that are funded through these grants will be able to do a number of things to help reinforce appropriate prescribing. One is strengthening PDMPs," she said. "Clinicians who are prescribing opiates should be able to easily access PDMPs and understand whether the patients they're caring for have recently filled prescriptions with another prescriber."
Even with an FDA advisory and more careful patient selection by surgeons, some women who underwent morcellation still developed cancer, researcher tells MedPage Today.
Use of power morcellators in gynecologic procedures decreased significantly following an FDA warning but the cancer risk thought to be associated with the devices' use did not, a review of a national database showed.
Among women undergoing minimally invasive hysterectomy, use of power morcellators declined from a peak of almost 14% in late 2013, before the FDA warning, to less than 3% by early 2015. However, the rate of uterine cancer in women treated with morcellators actually increased from 0.28% before the FDA advisory to 0.53% afterward, although the difference did not reach statistical significance.
The rate of abdominal hysterectomy increased over the same time period, whereas the rate of minimally invasive procedures decreased. Nonetheless, the overall complication rate associated with hysterectomy did not change, Jason Wright, MD, of Columbia University in New York City, and coauthors reported in the Aug. 23/30 issue of the Journal of the American Medical Association.
"The striking thing about this study is that even with all the media attention and the uptake of guidance and the scrutiny -- and certainly, physicians are being more careful about who they choose to perform this procedure in -- some women who underwent morcellation still developed" cancer, Wright toldMedPage Today.
"I don't think there is any patient that you can say with certainty that there is no cancer risk," he added. "However, prior studies have shown us that younger women generally have a lower risk of cancer, and that's probably the group of women that is safest to consider morcellation in."
Without discounting the cancer risk, gynecologic oncologist Barbara Goff, MD, of the University of Washington in Seattle, called for a more balanced discussion of the potential harms and benefits of morcellation.
"From my perspective, I think it's always been a one-sided equation," said Goff, who was president of the Society of Gynecologic Oncology (SGO) when the morcellation controversy emerged during 2013 and 2014. "All we've done is talk about cancer. We're not talking about all of the other things that can happen. I think people have been very short-sighted in what they're looking at and not looking at the whole global picture for these patients."
Noting the increased rate of more invasive abdominal hysterectomies during the study period, she added, "Informed consent means that we not only talk about the cancer risk but that we also talk about risk of surgical site infection, the higher risk of wound complications, the higher risk of deep-vein thrombosis and pulmonary embolism. You can die from some of those things too."
The findings by Wright and colleagues reopened a discussion that has made headlines, off and on, since late 2013. In December of that year, the SGO published a position statement advising caution in the use of morcellation to treat uterine fibroids. Several case reports had documented that the procedure unleashed cells from unrecognized leiomyosarcoma, which evolved into advanced uterine cancer. An editorial published inThe Lancet Oncology in early 2014 noted that the cancer risk associated with morcellation had been recognized for at least two decades.
The FDA subsequently issued an advisory, discouraging use of power morcellators in association with hysterectomy or myomectomy procedures. An FDA advisory committee reviewed the evidence linking morcellation and cancer but came to no conclusions. Then, in July 2014, Wright and colleagues published the first comprehensive data on the issue, which showed a cancer risk of 1 in 368, derived from a review of 200,000 cases.
In November 2014, the FDA issued an updated advisory, specifically "warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids." A black box warning followed.
A decision-tree analysis published in early 2015 lent support to Goff's view that more balance is needed in the discussion. The data showed that laparoscopic hysterectomy with morcellation was associated with fewer overall deaths, fewer surgical complications, and increased quality of life as compared with abdominal hysterectomy.
The updated review by Wright and colleagues examined morcellation use, associated uterine cancer rate, and other factors before and after the FDA warnings. Using the Perspective database, investigators identified 203,520 women who underwent hysterectomy from 2013 to the first quarter of 2015.
The results showed that:
The proportion of minimally invasive procedures decreased from 59.7% to 56.2% (P<0.001)
The proportion of abdominal procedures increased from 27.1% to 31.8% (P=0.004)
Power morcellator use decreased from 13.7% of minimally invasive procedures to 2.8% (P<0.001)
The total complication rate did not change (8.3% versus 8.4%)
Complications associated with abdominal hysterectomy declined slightly but significantly (18.4% versus 17.6%, P<0.001)
The prevalence of uterine and other gynecologic cancers did not change significantly among women undergoing morcellation
Unswayed by the slight decrease in complications with abdominal procedures, Goff offered a straightforward interpretation of the new data.
"If you know there's cancer, don't morcellate the uterus," she said. "If you think there's cancer, don't morcellate the uterus. If you think that it's benign, go the extra mile to make sure it's not cancer. Once you're pretty sure there is no cancer there, I think it is a patient's right to choose between a higher complication rate versus a very, very low rate of morcellating cancer."
Patients with atherosclerotic disease did better the more they adhered to their medication regimens within a year-long period, researchers find. From Medpage Today.
Adhering to guideline-recommended secondary prevention therapies was linked to better outcomes and lower costs in the long run, investigators found.
After a myocardial infarction (MI), those who fully adhered to their medication for 6 months had an 18.9% rate of major adverse cardiovascular events (MACE) at the 2-year mark, significantly less compared to their peers that were non-adherent (26.3%, HR 0.73, 95% CI 0.61 to 0.87) or partially adherent (24.7%, HR 0.81, 95% CI 0.69 to 0.96).
Similarly, patients with atherosclerotic disease did better the more they adhered to their medication regimens within a year-long period, Valentin Fuster, MD, PhD, of The Mount Sinai Hospital in New York, and colleagues reported in the Journal of the American College of Cardiology.
In atherosclerotic disease patients, an 8.42% incidence of MACE was reported for the fully adherent; 17.17% for the non-adherent (HR 0.56, 95% CI 0.51 to 0.62); and 12.18% for the partially adherent (HR 0.76, 95% CI 0.69 to 0.84).
Fully adherent patients also saved hundreds in U.S. dollars in annual medical costs: the MI cohort saved $369 and $400 compared to the partially adherent and non-adherent, respectively; and the difference in atherosclerosis was $371 and $907, respectively.
"At least a 40% level of long-term adherence needs to be maintained to continue to accrue benefit," the authors noted, suggesting that "novel approaches to improve adherence may significantly reduce cardiovascular events."
"The fundamental message is that the more adherent patients were, the better they fared," they wrote in an accompanying editorial.
"To make definitive statements about how much of a therapy needs to be taken to achieve a clinical effect, more refined data on actual medication consumption and pathophysiological surrogate markers, such as blood pressure or cholesterol levels, are needed."
But like Fuster's group, they also expressed interest in strategies to improve patient adherence, because "despite scores of studies drawing attention to this topic for >40 years, patient adherence with cardiovascular agents remains suboptimal."
"The most promising approaches for improving patient adherence seem to be strategies to reduce dosing frequency or multidimensional, labor-intensive educational interventions revolving around monitoring and feedback. An often-neglected factor, which appears to be positively correlated with better patient adherence, is the frequency of physician follow-up and provider continuity," wrote Armstrong and McAlister. "As a bare minimum, our first step as clinicians must be to routinely ask about adherence with all of our patients at every visit and to encourage them to take their medications as instructed."
"We must learn from other disciplines, and make better use of information technology and behavior modification techniques, if we are to make progress. Our patients deserve it," the editorialists urged.
Fuster and colleagues analyzed the claims records from Aetna Commercial and Medicare Advantage databases, culling data for patients who were hospitalized from 2010 to 2013 for MI (n=4,015) or atherosclerotic disease (n=12,976).
Patients were stratified according to their adherence to medication after investigators analyzed fill dates for their prescriptions for statins and ACE inhibitors. They were organized into tiers of the fully adherent (80% prescriptions refilled), the partially adherent (40%-79% filled), and the non-adherent (less than 40% filled).
But this made the study vulnerable to underestimation if patients were paying out-of-pocket and overestimation if patients did not actually take their medication as prescribed, the authors acknowledged.
"In addition, the consistent association between nonadherence and MACE hospitalizations may be the result of a healthy adherer effect, whereby adherent patients are probably less likely to engage in risky behaviors and more likely to follow medical recommendations," they wrote.
Armstrong and McAlister listed yet other potential confounders in the Fuster's investigation, such as temporary breaks in medication, pill splitting, free samples, and adequacy of dosing.
Duration and extent of overweight and obesity in adulthood have been linked with a significantly increased risk of all obesity-related cancers, according to an analysis of Women's Health Initiative (WHI) data.
An AIDS-free generation is a slogan, not a reality. Statistically, the good news is that some 17 million people worldwide are getting treatment, something that has caused the death rate from HIV to fall dramatically. But another 20 million who need therapy can't get it.
In lower-risk patients, the CoreValve transcatheter aortic valve replacement (TAVR) device beat surgery when it came to patient survival, found a subanalysis of the pivotal trial that led to approval for high-risk patients.
Getting beta-blockers after percutaneous coronary intervention (PCI) did not improve outcomes for older patients with stable angina, an observational study found.