A study appearing in the journal Pain attempted to quantify the rate of transition from one-time to chronic opioid use. MedPage Today clinical reviewer F. Perry Wilson, MD, examines the crucial missing data.
This article first appeared January 11, 2017 onMedPage Today.
When I see a patient in clinic, I'm given a sheet with their vital signs like this.
Blood pressure: 142/65. Heart rate 74. Pain: 5 out of 10. I'm a nephrologist. I specialize in chronic kidney disease – a completely painless condition. But there has been a coordinated and I think well-intentioned campaign to increase physicians' awareness of patient pain. Some have argued that the adoption of pain as the "fifth vital sign" has led to an increased rate of opioid prescription, addiction, and overdose.
It is quite clear that overdose deaths are increasing.
In the face of data like this, we are forced to examine our own responsibility as physicians. Do these numbers reflect some deeper societal issues, or is our prescribing behavior to blame?
The hypothesis is that a patient gets an initial opioid prescription, and, due to the well-documented addictive properties of opioids, turns into a chronic abuser of the drugs.
This article appearing in the journal Pain attempts to quantify just how frequently this pathway is followed.
The researchers used MarketScan data – this is a huge database of mostly employer-insured individuals – and identified a bit over 10 million individuals with a new opioid prescription between 2003 and 2013. These were matched with controls who never got an opioid prescription.
Those who got opioids were more likely to have an antecedent history of opioid use disorder, substance use disorder, and a host of other psychiatric problems. They were also significantly more likely to have received psychotropic medications.
So opioid prescriptions are going to some high-risk individuals. But how many of those would turn into chronic users?
The study concludes – not that many. After 18 months, only 1.3% of individuals had transitioned from one-time to chronic use ... at least based on prescription records.
How do we think about that 1.3%? It may seem like a small percentage that isn't worth worrying about, but multiply that by the number of prescriptions we're handing out per year: about one for every person in the country.
And also realize that that 1.3% is an underestimate.
MarketScan largely captures people who are productively employed, and it's only capturing chronic prescription opioids. Most opioid abuse comes from sources other than the individual's doctor:
This chart shows that most non-medical users of prescription opioids get them from friends or family, not their doctor.
And this study, appearing in JAMA in 2008, found that diverted drugs were the major source of opioid overdoses:
We need to update our conceptual model to look like this:
The major unknown here is the rate of transition from licit to illicit opioid use. And that data is harder to find than, well, street fentanyl nowadays. We also need to know the reason for that initial opioid prescription. It is a very different thing to receive oxycodone after you have your wisdom teeth removed and to receive it for chronic low back pain, and the risk of transition to opioid use disorder is much higher in the latter.
In 2016, the CDC came down hard on opioid prescriptions for chronic conditions. This is the correct framework. Are docs responsible for the rise in opioid abuse and deaths in this country? Not exclusively. But we can't deny that somewhere in the chain of events that leads to opioid abuse lies a prescription pad.
Although some physicians want to use MIPS, which would allow them to stay in the fee-for-service system, others seem willing to try participating in one of the new alternative payment models. Lawmakers will be watching. From MedPage Today.
This article first appeared December 15, 2016 onMedPage Today.
WASHINGTON -- Members of the next Congress -- from both sides of the aisle -- will be watching to see whether the Medicare Access and CHIP Reauthorization Act (MACRA) is being properly implemented over the next few years, congressional staff members said here Thursday.
"Making sure MACRA is a success [is important]; we all held hands and jumped on that one," a Republican congressional aide said at the event, which was sponsored by the Alliance for Health Reform and the Jayne Koskinas Ted Giovanis Foundation for Health and Policy. "We all own it, and it needs to be a success, because this was our effort to take ideas from both sides and say 'This is how we want to slowly start reforming the Medicare program.'" Staff members at the briefing agreed to be quoted only if they were not identified by name.
"There are plenty of places within MACRA that the committees will have to be engaged in," he told MedPage Today. "One area we think has great potential is this idea of virtual groups, of allowing small providers to use technology to come together to ease reporting requirements ... I think that will be something we'll kind of check in and say, 'OK, to what extent are we capable of doing that? Are there things we may need to look at doing further?'"
As the Centers for Medicare & Medicaid Services explains it in a fact sheet, MACRA "provides that solo and small practices may join 'virtual groups' and combine their ... reporting" under Medicare's Merit-Based Incentive Payment System (MIPS). "CMS is seeking public comment on how virtual groups should be constructed, and anticipates being able to implement virtual groups in the second year of the program."
Although some physicians want to use MIPS, which would allow them to stay in the fee-for-service system, others seem willing to try participating in one of the new alternative payment models (APMs), noted a Senate Democratic staff member. However, "providers are nervous about taking on risk, and they want a model that provides incremental steps towards taking risk," she said. Therefore, it's important that under a Republican administration "they continue to put out models that provide providers with 'landing spots' to engage in APMs."
The Republican House staff member said he found it "amazing" how far providers have come on this issue in the past few years. "We went from a world of 'I don't know what an APM is; I'm scared of it; it's new; it's different; I don't want it' to now, when you have providers post-MACRA going, 'I want to be in an APM.' I don't want to talk about it too much because I don't want to spook anybody away, but that's a significant movement from where we've been."
He spoke in measured tones about CMS's Center for Medicare & Medicaid Innovation (CMMI), which has been criticized for being too heavy-handed with the demonstration projects it has launched in the physician payment area. "I do think there are legitimate concerns when it comes to CMMI [in terms of] the delegation of congressional authority ... I think you can find a balance between the legitimate concerns we have expressed ... and realizing there is a need to provide providers with the tools they need to be able to look at ways to transform their practice in a responsible way that does not have them scared away by the risk."
The Democrats, for their part, will be watching to see if the Republicans' numbers add up when it comes to repealing the Affordable Care Act (ACA), said a House Democratic staff member. "We will hold folks accountable to their own statements and their own commitments."
For example, "We've heard that the preexisting condition exclusion will be protected. Analyze that carefully, because not all preexisting exclusions or protections look alike ... Under what situations can you be charged more, and can you be denied?"
"We've also heard a lot about how whatever's coming will ensure that coverage doesn't decrease, and coverage may increase ... Look at the numbers," she continued. "How does the distribution change? Who's gaining coverage? Who's losing coverage?" One ACA alternative proposed in 2009 by then-House Speaker John Boehner (R-Ohio) covered 3 million new people, and "that's a big difference from where we are today," with an additional 20 million people covered under the ACA, she said.
Finally, she said, "How can the underlying subsidies and underlying revenues be repealed, and [the Republicans] still find a way to maintain the same level of support, coverage, and subsidy for the average working family? Part of the health insurance experience is being able to access a doctor, but the other part of it ... is financial security."
"IPAB is not a tool to improve the value of the Medicare program," says Mary Grealy, president of the Healthcare Leadership Council, the group that is spearheading the repeal push. From MedPage Today.
This article first appeared December 6, 2016 onMedPage Today.
The Affordable Care Act's Independent Payment Advisory Board (IPAB) is a bad idea and should be repealed, according to a coalition of more than 600 healthcare organizations.
"IPAB is not a tool to improve the value of the Medicare program," Mary Grealy, president of the Healthcare Leadership Council, the group that is spearheading the repeal push, said during a teleconference last week. "Rather, it's a blunt instrument intended to reduce what Medicare pays for treatment. IPAB was a fatally flawed concept from its inception, and now, as we're on the verge of its activation, it's a very real danger and needs to be prevented."
The IPAB was designed to be a 15-member independent body that would make recommendations on cuts to the Medicare budget; if Congress didn't agree with the IPAB's recommendations, it would have to devise its own plan to cut the Medicare budget by an equivalent amount.
That idea was so controversial that no members were ever appointed to the board and it has never met. But that could change next year, when -- according to Medicare's board of trustees-- projected per-capita Medicare spending is expected to exceed its target; such an occurrence would require the IPAB to meet and act, according to the law.
"When all groups agree on something, it really does send a signal about IPAB that this should be taken seriously," former senator Kay Hagan (D-N.C.) said on the call. "When I was a senator I heard these same concerns."
"In 2013 I co-sponsored legislation to repeal IPAB," continued Hagan, who is now a senior policy consultant with the Akin Gump law firm in Washington. "I believed then, and I believe now, that IPAB is the wrong way to try to hold down Medicare spending. It delegates way too much authority to the IPAB board and takes authority away from Congress, and puts it in the hands of the Health and Human Services Secretary without any judicial oversight." The House voted to repeal IPAB in 2012, but the Senate has never followed suit.
In addition, IPAB would operate with a total lack of transparency, said Andrew Sperling, director of federal affairs at the National Alliance on Mental Illness, a mental health advocacy group in Arlington, Va. He compared it to the Base Closure and Realignment Commission, a group charged with deciding which military bases would be closed.
"[The commission] was required to hold open meetings ... and had public meetings and open records," Sperling said. "They voted in public. IPAB would be bound by none of this; it would meet in secret." And IPAB members cannot hold another job while they're serving on IPAB, so policy experts in academia would be barred from serving on it. "So for lack of a better term, dumbing down the expertise would be part of this panel."
Finally, the IPAB requirements "bar administrative and judicial review, so if a beneficiary group or patient group were unhappy with IPAB's recommendations, it would not have the ability to go into federal court to block their implementation. I'm concerned this ... would not serve the interests of patients very well," said Sperling. "We need an open, transparent process where [hard decisions are made by elected officials] and patients can hold members accountable at the ballot box."
Alex Valadka, MD, president-elect of the American Association of Neurological Surgeons, expressed concerns about what would happen if the IPAB convened and recommended cuts to the budget for educating physicians. "The healthcare dollar is shrinking more and more; as IPAB [shrinks Medicare's budget], it's going to be harder and harder to train the next generation of physicians, much less sustain the system we have right now," he said.
The coalition has established a website entitled "Protect My Doctor and Me" to raise awareness about IPAB, Grealy said. "We're going to engage, to really educate members of Congress, and generate more bipartisan support to get this legislation passed in Congress," she said. "There is great bipartisan interest in the House, and they are working on it in the Senate as well."
Cherokee Indian Hospital CEO Casey Cooper, BSN, MBA, discusses the community's continuum of recovery services and their new hospital.
This article first appeared November 27, 2016 onMedPage Today.
By Taylor Sisk
Cherokee, N.C. – On Nov. 16 of last year, the Eastern Band of Cherokee Indians opened the doors of an $80 million, 155,000-square-foot hospital, located here on the Qualla Boundary, a community of roughly 10,000 people tucked into the Great Smoky Mountains of western North Carolina.
In 1988, Congress passed the Indian Gaming Regulatory Act, paving the way for gambling on the Qualla Boundary. Today, Harrah's Cherokee Casino Resort – situated on the edge of the Cherokee village, featuring 150,000 square feet of gambling floor space and a 21-story hotel – brings in some 3.5 million visitors a year who spend about a half-billion dollars on slots, cards, and dice.
Gambling revenues have been a tremendous boon to the Eastern Band, allowing the tribe to tackle some considerable health issues. The Cherokee have significantly higher rates than the general population in a number of chronic diseases, including alcoholism, depression, diabetes, heart disease, and obesity.
In recent years, the tribe has either opened or begun construction on an immediate care clinic, a dialysis center, a diabetes clinic, an eye clinic, recovery-support housing, and an outpatient counseling center. It's amped up programs and services for tribal members both on the reservation and beyond, and has expanded free services for many elders.
In July, the Eastern Band broke ground on a $14-million residential behavioral health treatment center on tribal land in nearby Graham County.
In a recent conversation, Cherokee Indian Hospital CEO Casey Cooper, BSN, MBA, discussed the community's efforts in general, its continuum of recovery services in particular and the crown jewel of their investment, the new hospital.
Cooper: I frequently tell people that it's a beautiful building, but it's just a strategic tool to help us achieve our vision, and that is to reduce health disparities and improve the health of the population.... It's a seven-generation strategy, and we really believe that the building is helping us executive that strategy.
Integrated with primary care in the hospital are behavioral, dietary, dentistry, optical, and other services. Patients are assigned a case manager, doctor, behavioral health specialist, nutritionist, and pharmacist, all working out of the same suite.
Cooper: We've completely redesigned the way we deliver primary care. We're doing it more on a team-based approach, which we refer to as being more reciprocal interdependent, rather than sequential – just more patient centered.
Everything about the building is about reducing stress and strengthening the relationship between the primary care team and patients and families.
A "River Walk" winds through the hospital, lined with depictions of Cherokee legend and infused with natural light, offering soothing views of the surrounding Smoky Mountains.
Hospital numbers are at record-breaking levels.
Cooper: Folks are coming home to get care. They're returning home, and that tells us that they have faith and confidence in their medical home. That's at the foundation of our strategy. First they have to trust us. Then we have to be in a relationship with them. Then they will have a good experience of care. And if they have a good experience of care, we think they'll be more engaged in their own health care journey. And then, and only then, will we get improvements in population health at a low cost per capita.
In October, tribal council passed legislation to appropriate $1.7 million to begin remodeling the former hospital, next door. The primary objectives are to create an inpatient crisis stabilization unit and colocate all hospital-based behavioral health and substance abuse services.
Cooper: We'll have a 12-bed inpatient crisis-stabilization unit with three additional high-acuity psychiatric beds so that we can unplug ourselves from the state system. We'll no longer be dependent on mobile crisis, we'll no longer be dependent on the state hospitals to take care of our patients who are involuntary committed and need really intense, safe psychiatric behavioral health services.
Those who then need longer-term care will go to the new center in Graham County, where they'll receive treatment that, Cooper said, is in critically short supply throughout North Carolina.
Cooper: It's just absolutely horrible that we have patients waiting in our ERs for 22 to 25 days... Big health systems that have the capital and the resources are building their own capacity and they're building their own facilities to move those patients to a more appropriate location so they can get the services they need. Small rural communities are still vulnerable....
Tribal leadership sees that when we simply alienate people and we incarcerate them, we don't stop that perpetual cycle of intergenerational stress and trauma that continues to weaken us over the next seven generations. We're trying to build in that intergenerational resiliency.
The hospital has grown from a budget of about $16 million in 2002 when management was turned over to the tribe from the federal Indian Health Service to what Cooper anticipates to be in excess of $60 million next year.
Obviously, this ramp-up in services is expensive.
Cooper: I don't mind telling you, our operating loss was $4 million this year. We knew it was going to happen, so over the last decade and a half we've been stockpiling cash like crazy. At one point, we had built up to about a high of over 330 days of cash, because we knew this period was going to come when we would really need to scale up our services and it would be awhile before we could get those services to be break-even or self-sustaining. Some of them will never be self-sustaining ... but the tribe has stepped up with a recurring appropriation.
The hospital operates under a set of Cherokee guiding principles, one of which is Ni hi tsa tse li: "It belongs to you." A great deal of pride is invested in a state-of-the-industry facility that, Cooper said, was "planned, constructed and paid for" by the Cherokee people.
As he told those gathered for its ribbon-cutting last autumn, "We are not here today because of the federal government's commitment to Indian health. Rather, we stand here today in spite of it."
The agency will wait until the new administration is place before releasing its final guidance for regulating laboratory developed tests.
This article first appeared November 21, 2016 onMedPage Today.
By Shannon Firth
WASHINGTON -- The FDA backed off from a plan to issue final guidance for the regulation of laboratory developed tests (LDTs).
"We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future," the agency said in a press statement.
The agency also emphasized the need for "accurate, reliable, and clinically valid tests to make good health care decisions -- inaccurate or false test results can harm individual patients."
Republicans in Congress, who believe such oversight unnecessary, applauded the decision. Patient advocates and research groups, concerned about the validity and accuracy of such tests, are hopeful a new administration will take up their cause.
LDTs are developed and used in a single laboratory, primarily to diagnose illness or to help determine the best treatment for individual patients. Historically, these tests have not been regulated by the FDA. Instead, the Centers for Medicare and Medicaid Services (CMS), under the Clinical Laboratory Improvements Amendment (CLIA), has conducted reviews and inspections of the labs to ensure that adequate equipment is in place, and personnel are properly trained, to perform the tests.
The FDA has had the ability to regulate LDTs since 1976, explained Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health at a congressional briefing last year.
Initially these tests were simple and scarce and the agency did not see a reason to intervene. But over the past decade, the tests have become more numerous, more complex, and heavily marketed, he explained, so the agency began taking steps towards regulation.
In 2014, the FDA published a draft rule outlining a framework through which the agency could expand its jurisdiction over molecular tests to also include LDTs.
In 2015, the agency issued a report citing 20 examples where LDTs may have caused patient harm. Half of the case studies related to cancer -- detecting the disease or the risk of disease or guiding treatment. Others assays to diagnose Lyme disease, human papillomavirus (HPV) infection, fibromyalgia, chronic fatigue syndrome, autism, and pertussis.
In one case, a defective non-invasive prenatal test, or "cell-free DNA test" used to detect fetal chromosomal abnormalities, was found to have contributed to decisions to abort healthy fetuses.
In late November, the FDA announced that it would wait for the new administration, and freeze the finalization of guidance that would have altered the regulation of LDTs, to the delight of some Republicans in the House and Senate.
"I am glad that the FDA has listened and will delay making final its current draft guidance that could have halted more than 60,000 lab-developed tests in their tracks, and will work with Congress and the new administration on next steps," said Sen. Lamar Alexander (R-Tenn.) in a press statement.
In a previous statement, Alexander has stressed that subjecting a single test to FDA approval could cost academic centers from $30-$75 million.
"It was the right call," said Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, in a press statement. His committee has debated the issue of LDT regulation for the last 3 years and has said that adopting non-binding guidance is "not the best approach. Working together, we are forging significant consensus among a number of patient groups, labs, and manufacturers around a 21st century approach uniquely designed with all diagnostic tests in mind from the outset," he said.
While critics of LDT regulation view it as duplicative, costly, and a barrier to innovation, others are not convinced.
"Current oversight of LDTs falls short of ensuring these tests produce accurate and meaningful results, according to a press statement from the American Cancer Society Cancer Action Network (ACS CAN). Many tests now come to market without independent verification that their results were accurate or clinically valid, the group explained. Without final guidance, labs that perform tests to diagnose diseases where the test is critical to safety, health, or a treatment decision will not be required to validate a test's accuracy and clinical claims with FDA.
In addition, they will not have to report adverse events impacting patient health.
ACS CAN urged the new administration to "prioritize the safety of patients and continue to work with stakeholders to develop and implement a framework for LDT oversight."
Jeff Allen, PhD, president and CEO of Friends of Cancer Research, and an advocate for LDT regulation by the FDA, testified before a Senate Committee in October on the topic. He said he was not surprised by the decision to delay final guidance.
"It has been a challenging topic," he told MedPage Today in a phone call, during which a public affairs representative was present. Allen emphasized that the issue had become quite polarizing in Congress, and noted that it could be wise to pursue legislation, "to at least codify the fact that FDA has the authority to regulate these products if they choose to do so."
"These tests are are of growing importance, and of growing use in the future of personalized medicine. So I think we'll see this debate continue," he added.
An FDA representative said the agency could not speculate on "the potential, future policy or timing" of any new guidance.
Heart failure patients can pay as little as $30 for a 90-day supply of three mainstays of therapy or as much as $1,144 a month, depending on where they shop, researchers reported.
This article first appeared November 17, 2016 onMedPage Today.
By Ed Susman
NEW ORLEANS -- Heart failure patients who go to their local pharmacy for generic formulations of lisinopril, carvedilol, and digoxin can pay as little as $30 for a 90-day supply of all three mainstays of therapy or as much as $1,144 a month, depending on where one goes shopping, researchers reported here.
Hauptman and colleagues reported that they surveyed 175 pharmacies in the greater St. Louis area encompassing eastern Missouri and neighboring Illinois to assess how much they charged uninsured customers for the three generic medicines.
"The idea for the study originated with one of our patients, a 25-year-old man with heart failure, who called the office and said he could not afford to fill a prescription for digoxin," coauthor Zachary Goff, BS, a medical student at the university, told MedPage Today.
"When I found out that a month's supply was going to cost him $100," Hauptman said, "I couldn't believe it. Like me, I think a lot of doctors assume that if you're writing a prescription for a generic drug that it will be affordable -- and that's not necessarily the case."
Hauptman said that the price differential was not affected by where in the region the survey occurred – some of the prices were wide ranging even if the pharmacies were across the street. He said that price differences even occurred between pharmacies in the same pharmacy chain.
For example, the researchers said that the combination of the three low-dose medications ranged from $20.19 for 30-days to $256.77. The median cost would be $67.98.
The 90-day supply ranged from $50.89 to $703.97, with a median of $169.67.
Individual prices included a range of $10 for a 90-day supply of high-dose digoxin at one pharmacy to $910.99 at another pharmacy.
Hauptman added that it is common for patients with heart failure to take five or six medicines to treat the condition, making it even more difficult for patients to get the lowest combined price of the drugs they need.
"It's not reasonable to expect patients who are sick and of limited financial means to call or visit half a dozen pharmacies to get the best price," he said. "What is more likely to happen is that patients visit a pharmacy and find out that the drug is too expensive, so they don't fill the prescription and therefore do not garner benefit from guideline-directed medical therapy."
In commenting on the study, Frederick Masoudi, MD, of the University of Colorado Anschutz Medical Campus in Aurora, told MedPage Today, "The range of prices that an uninsured patient would have to pay depending on the pharmacy for these generic formulations of common medication for heart failure ranged from about $30 to more than $1,100. That's a 40-fold difference for generic drugs."
"This creates a challenge for physicians that many of us were unaware of," Masoudi said. "I presumed there was some differences in the pricing of drugs if they were generic but I was not aware at all that the price differentials were so high.
"I think it is important for clinicians to realize where their patients can get drug[s] inexpensively. For example, Walmart and other stores have discount formularies where you can get 90-day prescriptions of these medications for $10. But it is important for physicians to know what is in the formulary. For example, the current Walmart formulary does not include digoxin, so patients couldn't get digoxin for $10.
"We as physicians have to be cognizant that patients who are getting generics and don't have an insurance plan could be facing substantial costs for their medication be it for heart failure or anything else. For that reason we have to be aware what kind of barrier to adherence that might be for these patients."
Because a greater understanding of pricing practices at the retail pharmacy level is required, the researchers said their study should be replicated across other parts of the country and with different generic drugs to treat other medical conditions.
Hauptman said he would expect the results of such studies to be similar. "With heart failure, we have a chronic condition that affects millions of people and usually requires treatment with several drugs. Why would it be different for other conditions?"
He said that there is so little transparency in how the prices are set that his researchers could not determine if the high prices are set by the manufacturer, the distributor, or the local pharmacy.
Goff said that the researchers just called the pharmacies and asked for their prices as uninsured patients. He said asking for the insurance plan price could not be done because it would require having insurance plan numbers for myriad companies and plans.
A study of 32 ACOs found that 16 of them were working to address patients' non-medical needs. Housing instability, food security, and transportation were among the most common needs addressed, with various methods being used for each.
This article first appeared November 10, 2016 onMedPage Today.
WASHINGTON -- Accountable care organizations (ACOs) and other players in the healthcare system need to look after patients' non-medical needs if they want their health outcomes to improve, several speakers said Thursday at a briefing on the "Culture of Health" sponsored by Health Affairs.
"The culture of health is about meeting people's needs to attain health and well-being," Alan Weil, editor-in-chief of Health Affairs, explained at the start of the briefing. "And if there's one thing we heard this week [in the election], it's that there are a lot of people in the country who don't feel like their needs are currently being met to provide them with the well-being that they think is warranted given the work that they do and the efforts that they make, and pulling those things together in the context of culture is important for us as we think about health and healthcare going forward."
Taressa Fraze, PhD, research scientist at the Darmouth Institute in Lebanon, N.H., presented her group's study on what some ACOs are doing to help meet their members' non-medical needs. Fraze's study, like the others presented Thursday, appears in the November issue of Health Affairs.
Fraze's group interviewed leaders at 32 ACOs and found that 16 of them were working to address patients' non-medical needs. Housing instability, food security, and transportation were among the most common needs addressed, with various methods being used for each.
For example, an ACO might discover that a patient wasn't taking her diabetes medication because it needed to be refrigerated and she didn't own a refrigerator; the plan would then find the funds to buy her one.
In the transportation area, "ACOs in areas with high-quality public transit typically relied on existing infrastructure," Fraze and colleagues noted in their article. "For example, some ACOs gave transportation passes to patients before their appointments. One ACO provided monthly bus passes -- which could be used for any transportation need -- to all patients who had four or more medical visits per month."
ACOs in suburban or rural areas had more challenges with transportation. One rural ACO provided transportation services through an external for-profit transportation company. The ACO paid the company a per-member-per-month rate. Another ACO in an urban area with poor public transportation was considering developing a mobile device application that would allow patients to request transportation from local drivers, who would be paid by the ACO.
To address food insecurity, one ACO worked with a local food bank to provide food for patients, but noticed that the patients were making unhealthy selections, so the ACO arranged for the food bank to provide fresh, healthy meals each day.
"The first thing we noticed is that ACOs tended to segment their patient population," Fraze said at the briefing. "That makes perfect sense if, for instance, the ACO has several quality measures related to how it cares for diabetic patients. So it may develop a [housing] program just for them, but it's not just diabetics who have housing instability, so they are still missing out on a large part of their patient panel that has similar needs."
Sandra Newman, PhD, a professor of policy studies at Johns Hopkins University, in Baltimore, and colleagues looked a little more intensively at the housing issue. "The greatest, most prevalent housing problem faced by low-income families with children in the U.S. is housing affordability," she pointed out. "It far outruns physical problems in the home."
She noted that while it's widely believed that unaffordable housing -- housing that costs a family more than 30% of its income -- strains the family budget and forces cutbacks in other expenditures that benefit themselves and their children, some people also believe that spending too little on housing also is bad because it is not likely to result in a high-quality home or a high-quality neighborhood with lots of amenities.
If both of those theories are true, researchers would expect to find an "inverted U"-shaped relationship between the cost of housing and children's scores on cognitive tests -- one measure of children's health.
And, in fact, that is exactly what Newman and her colleagues found in their study of 688 children whose family incomes were no more than 200% of the federal poverty level -- a group of families in which excessive housing cost burdens are common. "This is ... the first hard empirical evidence" showing that families shouldn't spend more -- or much less -- than 30% of their income on housing, she noted.
In another study, Elizabeth Rigby, PhD, assistant professor of public policy and public administration at George Washington University here, and colleagues found that three economic policies -- tax credits for the poor, a higher statewide minimum wage, and not having a right-to-work law -- were associated with better health outcomes. "These policies seemed to be associated with a range of measures of population health -- for example, improving the earned income tax credit shifts mothers' behavior in a way that impacts low birthweights," Rigby said.
"We know that income and wealth are key determinants of health, so policies that redistribute income and wealth would seem to be policies we should care about."
Community health infrastructure is another social good that seems to benefit communities, according to Glen Mays, PhD, MPH, professor of health services and systems research at the University of Kentucky, in Lexington, and colleagues. They studied data from the National Longitudinal Survey of Public Health Systems, which tracks 360 communities across the U.S. with at least 100,000 residents. The survey follows the communities over a 16-year period and measures the availability of 20 recommended community health activities, including developing a community-wide health improvement plan and linking people to health and social services.
"Communities that have comprehensive health systems see a large reduction in their overall mortality rate," Mays said. "Large health gains accrue to a comprehensive system."
Incorporating drug costs into bundled payments, and allowing Medicare to negotiate drug costs, would lower costs and enhance care, says one expert. From MedPage Today.
This article first appeared November 1, 2016 onMedPage Today.
By Shannon Firth
WASHINGTON -- While health policy experts can agree that something needs to be done about increasing Medicare drug costs, they differ on how to go about managing those costs.
Medicare pays for 29% of all retail drug spending, explained Shawn Bishop, MPP, vice president of controlling healthcare costs and advancing Medicare at the Commonwealth Fund. Bishop co-moderated a recent congressional briefing on curbing Medicare drug costs.
Even though the average annual rate of spending growth across key sectors in Medicare has declined in most sectors, such as inpatient services and post-acute care, Medicare Part D spending has increased 7% per year and Medicare Part B has grown 3% in most recent years, noted Laura Keohane, PhD, assistant professor in the department of health policy at Vanderbilt University in Nashville. Keohane spoke at a recent panel hosted by the Alliance for Health Reform and The Commonwealth Fund.
What solutions are health policy experts putting forth? Gerard Anderson, PhD, a professor at Johns Hopkins Bloomberg School of Public Health in Baltimore, suggested at the panel meeting that incorporating drug costs into bundled payments, and allowing Medicare to negotiate drug costs, would lower costs and enhance care.
For example, the Centers for Medicare and Medicaid Services (CMS) did not include drug costs in its Comprehensive Care for Joint Replacement (CJR) model, a bundled payment model for hip and knee replacements. But Anderson noted that "strong clinical evidence" suggests that including drugs in the bundle could have a significant impact on pain management. Drug costs are only a small portion of the expense in CJR models, but these "baby steps" could eventually lead to inclusion in models where drug costs are more significant, such as oncology care.
While he acknowledged difficulties, such as determining which drugs to include, and how much to pay in such a bundle, the ESRD model showed including pharmaceuticals in a bundle is "doable."
Anderson also touted Medicare price negotiation as a second vehicle for reining in the rising expense of catastrophic spending in Medicare Part D.
After meeting a certain catastrophic benchmark, Medicare currently pays 80% of Part D drug costs while private insurers pick up 15% and beneficiaries are responsible for 5%, Anderson explained. The Medicare Payment Advisory Commission (MedPAC) has suggested flipping these responsibilities: Holding Medicare responsible for 15%, and private insurers for 80% of drug costs. MedPAC argues with more on the line, private insurers would be incentivized to negotiate lower prices with manufacturers.
However, Anderson acknowledged that this approach could lead to access issues, as some Part D plans might exclude people with multiple chronic conditions, out of concern for the high costs they would incur.
But Medicare could negotiate the price of any drug over $7,500, because such high costs immediately place payments in Medicare's catastrophic threshold, where it pays 80% of costs, he said.
Anderson said he believes that by "means testing" the Part D program, instead of scrapping it, CMS could ensure that only the wealthiest beneficiaries would pay for drugs passed that threshold. This kind of value-based pricing is what's done in the U.K. through the National Institute for Health and Care Excellence for the last 30 years, he said.
But whether such cost-saving measures would pass muster with government accountants is another matter. The challenge with a lot of the government price negotiation proposals, is that they aren't likely to meet the Congressional Budget Office's criteria for saving money, noted Mark McClellan, MD, PhD, director of the Margolis Center for Health Policy at Duke University.
McClellan said one reason these plans fail is that they don't give CMS, or an entity within the agency, any real authority to tell a patient it won't cover a drug.
"Setting up an entirely new government entity that would have real authority to restrict access to drugs seems challenging," he added.
But Anderson stressed that he doesn't want to limit access to drugs. "What I want to do is say 'The value of this drug is X. This is how much we're willing to pay for it.' If pharma doesn't want to sell it for X, that's their choice," Anderson said, adding that value-based pricing would only apply to very high cost drugs.
McClellan expressed skepticism, and said the suggestion by MedPAC for making drug plans "more sensitive" to drug costs seemed a more practical first step.
But McClellan did agree with Anderson to some degree, that incorporating drug costs into new models, such as advanced alternative payment models (APMs) could help to lower such costs.
In the same way providers contract with post-acute care organizations, sharing risk and upside benefit in advanced APMs, McClellan argued that having manufacturers share risk with providers could improve care and lower costs.
Such models would require changes to anti-kickback rules and off-label communication, because sharing data between manufacturers and providers on factors such as medication adherence, would be important.
"I think it's a different way, without having to disrupt the whole Part D structure, to get at the same goal," McClellan stated.
While sepsis is rare, it's nearly 80% more likely after treatment with certain "high-risk" antibiotics, compared with no antibiotic therapy, according to the Centers for Disease Control and Prevention. From MedPage Today.
This article first appeared October 27, 2016 onMedPage Today.
NEW ORLEANS -- Exposure to antibiotics during a hospital stay can sharply increase the risk of sepsis or septic shock after discharge, a researcher said here.
While sepsis is rare, it's nearly 80% more likely after treatment with certain "high-risk" antibiotics, compared with no antibiotic therapy, according to James Baggs, PhD, of the Centers for Disease Control and Prevention (CDC).
The study is "interesting because it brings together a number of really hot topics -- antibiotic use, sepsis, and this whole concept of the good bacteria in our bodies, the microbiome," commented Arjun Srinivasan, MD, of the CDC, and the conference program chair for SHEA.
Srinivasan told reporters the study builds on intriguing data from animals that has suggested, "if you mess up their microbiome" with antibiotics, they are much more susceptible to serious infection and sepsis.
Baggs and colleagues, he said, have shown that in humans, the same is true: "There really is a tremendous disturbance in the healthy bacteria when we get an antibiotic that can have a significant downside."
It's "one more call to focus our efforts on using antibiotics only when we need them," he said.
Baggs said there has been "emerging evidence that environmental exposures, such as antibiotics, can lead to a shift in the microbiome with great pathogenic potential."
To investigate the issue, he and colleagues turned to the Truven Health MarketScan Hospital Drug Database, which includes demographic, treatment, and hospital admission and discharge data for millions of patients. The database also includes pharmacy data, making it possible to track antibiotic use.
For the years 2006 through 2010, Baggs said, the researchers obtained data on 12.7 million hospital stays in 516 facilities, including 18,307 that were associated with a sepsis admission within 90 days of discharge following a previous admission.
For the retrospective cohort study, the team defined a list of antibiotics with a high risk of disturbing the microbiome: third- or fourth-generation cephalosporins, fluoroquinolones, lincosamides, beta-lactam/beta-lactamase inhibitor combinations, oral vancomycin, and carbapenems.
Another set of drugs, including earlier cephalosporins, tetracycline, and sulfa drugs, was regarded as low-risk, while control antibiotics, such as penicillin, were thought to have limited potential to disrupt the microbiome.
The primary endpoint of the analysis was the risk of sepsis following use of those drugs compared with no antibiotic use, Baggs said, but they also looked at the risk associated with other antibiotics and the risk associated with longer versus shorter treatment lengths.
In 43% of the hospital stays, patients had not been given any antibiotics, Baggs reported, while patients got high-, low-, and no-risk drugs in 28%, 24%, and 5% of the stays, respectively.
A multivariate analysis showed that, compared with no antibiotics, the odds ratio for sepsis was:
1.78 (with a 95% confidence interval from 1.72 to 1.85) after high-risk drugs
1.10 (1.04 to 1.16) after low-risk drugs
1.22 (1.11-1.35) after no-risk drugs
Baggs added that duration of therapy also played a role: Regardless of drug type, patients treated for more than 14 days had twice the risk of later sepsis as those given shorter therapy, with an odds ratio of 2.4.
"The exact mechanisms remain under investigation," Baggs said, but the study "contributes to the growing body of observational evidence and animal data [that antibiotics can have] broad detrimental effects."
But he noted that physicians and health authorities have one preventive measure that's currently available: "improved antibiotic stewardship."
Baggs cautioned that, while the study had a large population and many years of data, it is based on an administrative database with a potential for misclassification. He noted that the study could not account for antibiotic exposures outside the hospital setting and captured only sepsis patients admitted to the same hospital they had recently left.
The candidates squared off on the issue of entitlements and abortion during a contentious third and final debate at the University of Nevada, Las Vegas on Wednesday night.
This article first appeared October 19, 2016 onMedPage Today.
By Shannon Firth
LAS VEGAS -- Hillary Clinton and Donald Trump squared off on the issue of entitlements and abortion during a contentious third and final debate at the University of Nevada, Las Vegas on Wednesday night.
In the context of a question about the federal debt, Fox News anchor Chris Wallace asked both candidates what they would do about entitlements, which Wallace said were the main drivers of the debt -- he then cited reports that Medicare would run out of funds in the 2020s and Social Security would be broke in the 2030s and asked each of them if they would be willing to raise taxes or cut benefits.
Trump said his plan for curbing the debt is to take back jobs from other countries, cut taxes and "repeal and replace Obamacare."
"You take a look at the kind of numbers that that [the Affordable Care Act] will cost us in the year seventeen [2017], if we don't repeal and replace [Obamacare] -- now it's probably going to die of its own weight... premiums are going up sixty, seventy, eighty percent. Next year, going to go up over one hundred percent," Trump said.
Clinton said she wouldn't cut benefits but would consider raising the cap on Medicare payroll taxes. "And I'll say something about the Affordable Care Act, which he wants to repeal: the Affordable Care Act extended the solvency of the Medicare trust fund. So if he repeals it, our Medicare problem gets worse," Clinton said.
She said she would improve the ACA by focusing on "long-term health care drivers," on lowering healthcare costs and increasing value, and emphasizing wellness.
A second important question Wallace posed was about the direction they see the Supreme Court taking with regard to the constitution.
"I feel that at this point in our country's history, it is important that we not reverse marriage equality, that we not reverse Roe v. Wade, that we stand up against Citizens United," Clinton said.
But Clinton went even further saying that even with Roe v. Wade in place women's reproductive rights have been curtailed.
"So many states are putting very stringent regulations on women that block them from exercising that choice to the extent that they are defunding Planned Parenthood, which of course, provides all kinds of cancer screenings and other benefits for women in our country. Donald has said he is in favor of defunding Planned Parenthood, he even supported shutting the government down to defund Planned Parenthood."
Clinton said she will defend Planned Parenthood and a women's right to choose and castigated Trump for saying "that there should be some form of punishment for women who obtain abortions."
Trump did not address Planned Parenthood funding, but he said he would nominate pro-life justices and those that would defend the second amendment.
Asked whether he would over-turn Roe v. Wade, he hedged, "Well if we put another two or perhaps three justices on that's really what's going to be -- that will happen. It'll happen automatically in my opinion because I am putting pro-life justices on the court. I will say this it will go back to the states and the states will then make a determination."
Asked specifically about her decision to vote against a ban on late-term partial-birth abortion, Clinton doubled down on her pro-choice stance.
Trump said, "I think it's terrible if you go with what Hillary is saying in the ninth month you can take the baby and rip the baby out of the womb of the mother just prior to the birth of the baby." (In a 1999 interview Trump said he opposed the ban partial birth abortion, according to NPR.)
Clinton called his use of "scare rhetoric" unfortunate.
"I've been to countries where governments either forced women to have abortions like they used to do in China or forced women to bear children like they used to do in Romania. And I can tell you the government has no business in the decisions that women make with their families in accordance with their faith and with medical advice, and I will stand up for that right," she said.