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Friday, December 6, 2019

MedPAC thinks hospice payments are too high

The Medicare Payment Advisory Commission is expected to vote against a pay increase for hospice in January.
Medicare hospice payments are probably too high, MedPAC’s staff said at a meeting on Friday. Their research found that access to care is trending upward, while quality seems to have improved slightly. Hospices also have steady access to capital and robust Medicare margins—12.6% overall—so there’s little reason to worry that beneficiaries’ access to care would be hurt by financial problems anytime soon.
“The hospice rates may be higher than needed to ensure appropriate access to care,” said Karen Neuman, a principal policy analyst for MedPAC.
The commission will likely recommend to Congress that they shouldn’t increase the conversion factor, or base payment amount, for hospices. Most MedPAC members also favor reducing the hospice aggregate cap by 20% and instituting a wage adjustment for 2021.
Their proposed recommendation was met with opposition from hospice providers.
“(The National Hospice and Palliative Care Organization) does not support today’s MedPAC recommendation to modify the hospice aggregate cap,” said Edo Banach, president and CEO of NHPCO. “NHPCO shares MedPAC’s goals, but this approach appears overly broad and likely to lead to a decrease in hospice access for patients and families. In the short term, we urge MedPAC to use a targeted approach that will have a higher likelihood of rewarding high quality, punishing low quality, and increasing access.”
Lowering the aggregate cap and wage adjustment would help level the playing field for hospice providers, generate cost savings and target the most profitable hospices with payment cuts.
These changes wouldn’t affect most providers because the hospices with the highest margins are mainly free-standing and for-profit providers. Those providers are disproportionately costly because their average lengths of stay are much higher.
“Hospice margins increase with the length of stay,” said Neuman.
Not-for-profit hospices have an average length of stay of 68 days, while for-profit hospices have an average length of stay of 110 days. Likewise, free-standing hospices have an average length of stay of 92 days compared to just 70 and 57 days for home health- and hospital-based hospices, respectively.
“For the same diagnosis, there tends to be a longer length of stay for the for-profits,” said Dr. Jaewon Ryu, president and CEO of Geisinger. “They also tend to enroll folks who (are more likely) to have a longer length of stay.”
For-profit hospices have different patient mixes than other hospices, but it’s not clear whether that’s driven by the types of referrals they receive—or solicit—or if they’re choosing to admit patients that are more likely to stay longer, he said.
Some commission members also wanted to know more about high live-discharge rates among hospices that have exceeded the annual cap on hospice payments—hospices that go over the cap must repay Medicare for the overages.
Most live discharges result from patients opting out of hospice or because they’re no longer terminally ill, according to MedPAC’s research. But there are questions about what’s driving patients to leave hospice care.
“Is the beneficiary choosing not to enroll? Is the beneficiary being encouraged to leave hospice?” said Neuman.
Some larger hospice organizations track how close they are to the aggregate cap and their average length of stay, said James Mathews, executive director of MedPAC. They even adjust their business practices to make sure they don’t exceed the limits.
“They are able to change their referral sources . . . if they start to see they’re having cap issues,” said Mathews. “They might seek referrals from hospitals who are more likely to have shorter lengths of stay.”
Several MedPAC members lamented that Medicare’s hospice benefit hadn’t changed much since it was created for cancer patients in the early 1980’s, even though the needs of Medicare beneficiaries and medical practice have transformed.
It’s time to rethink the design of the benefit in light of the “changing demography of end-stage disease, and an aging and increasingly disease-burdened society,” said Dr. Jonathan Perlin, president of clinical services and chief medical officer of HCA Healthcare.

Short-term radon test kits not effective in measuring radon gas exposure

As awareness increases about the health danger of radon gas, more people are making the decision to test their homes for the deadly gas. A University of Calgary led study finds the only reliable way to measure exposure to radon gas is with a long-term testing kit, which takes readings within the home for 90 or more days.
“Radon gas levels can fluctuate wildly day to day,” says Dr. Aaron Goodarzi, PhD, assistant professor in the departments of Biochemistry & Molecular Biology and Oncology and member of the Arnie Charbonneau Cancer Institute at the Cumming School of Medicine (CSM). “Short term tests can give a false sense of alarm, or worse, a false sense of security as they cannot precisely predict long term exposure.”
Researchers placed two test kits, a short term (five-day) and long term (90-day) in the same homes. Tests were conducted during summer and winter months. Findings showed the short-term kits were imprecise up to 99 percent of the time when compared to a long term test.
Radon is a known carcinogen. Health Canada lists radon as the number one cause of lung cancer in non-smokers. The gas is naturally occurring, colourless, and odorless. It can accumulate to unnaturally high and dangerous levels in homes. Health Canada has promoted the use of long-term testing kits for some time.
“Our recommendation was based on research from international authorities including the US and Europe,” says Kelley Bush, manager, radon education and awareness Health Canada. “This research is critical because it provides Canadian data that confirms the value of long term testing.”
Goodarzi has also been working with the Real Estate Council of Alberta (RECA) to educate realtors against using short term radon kits for real estate transactions.
“RECA is appreciative of the assistance provided by Dr. Goodarzi in the development of education enabling real estate professionals to advise buyers and sellers to take radon into consideration during the purchase and sale of a home, in the absence of reliable short-term testing,” says Joseph Fernandez, director of education programs at RECA. “All real estate professionals have completed radon related education and new professionals will be required to complete it before entering the real estate profession.”
The findings also show the Prairies are home to the second highest radon exposed population on Earth. The pan-Canadian scientist and physician led Evict Radon research initiative is now recruiting participation from all Canadians.
The research is aimed at gathering as much data as possible to understand and ultimately defeat Canadian’s exposure to radon problem.
“We need to know exactly what factors influence high and low radon in Canadian homes. It’s not just in the Prairies, we know of high concentrations in areas throughout the country,” says Goodarzi. “This is easily one of the most preventable forms of environmentally-caused cancer. We have already learned so much from the work we’ve done in Alberta and Saskatchewan to test for and mitigate radon. We plan to build on that.”
In addition to the data gathered on short-term testing kits, Goodarzi’s team was also able to get a better understanding of how the size, design and age of home are related to radon gas exposure.

Story Source:
Materials provided by University of Calgary. Original written by Kelly Johnston. Note: Content may be edited for style and length.

Journal Reference:
  1. Fintan K. T. Stanley, Jesse L. Irvine, Weston R. Jacques, Shilpa R. Salgia, Daniel G. Innes, Brandy D. Winquist, David Torr, Darren R. Brenner, Aaron A. Goodarzi. Radon exposure is rising steadily within the modern North American residential environment, and is increasingly uniform across seasonsScientific Reports, 2019; 9 (1) DOI: 10.1038/s41598-019-54891-8

BPA levels in humans dramatically underestimated

Researchers have developed a more accurate method of measuring bispehnol A (BPA) levels in humans and found that exposure to the endocrine-disrupting chemical is far higher than previously assumed.
The study, published in the journal The Lancet Diabetes & Endocrinology on Dec. 5, provides the first evidence that the measurements relied upon by regulatory agencies, including the U.S. Food and Drug Administration, are flawed, underestimating exposure levels by as much as 44 times.
“This study raises serious concerns about whether we’ve been careful enough about the safety of this chemical,” said Patricia Hunt, Washington State University professor and corresponding author on the paper. “What it comes down to is that the conclusions federal agencies have come to about how to regulate BPA may have been based on inaccurate measurements.”
BPA can be found in a wide range of plastics, including food and drink containers, and animal studies have shown that it can interfere with the body’s hormones. In particular, fetal exposure to BPA has been linked to problems with growth, metabolism, behavior, fertility and even greater cancer risk.
Despite this experimental evidence, the FDA has evaluated data from studies measuring BPA in human urine and determined that human exposure to the chemical is at very low, and therefore, safe levels. This paper challenges that assumption and raises questions about other chemicals, including BPA replacements, that are also assessed using indirect methods.
Hunt’s colleague, Roy Gerona, assistant professor at University of California, San Francisco, developed a direct way of measuring BPA that more accurately accounts for BPA metabolites, the compounds that are created as the chemical passes through the human body.
Previously, most studies had to rely on an indirect process to measure BPA metabolites, using an enzyme solution made from a snail to transform the metabolites back into whole BPA, which could then be measured.
Gerona’s new method is able to directly measure the BPA metabolites themselves without using the enzyme solution.
In this study, a research team comprised of Gerona, Hunt and Fredrick vom Saal of University of Missouri compared the two methods, first with synthetic urine spiked with BPA and then with 39 human samples. They found much higher levels of BPA using the direct method, as much as 44 times the mean reported by the National Health and Nutrition Examination Survey (NHANES). The disparity between the two methods increased with more BPA exposure: the greater the exposure the more the previous method missed.
Gerona, the first author on the paper, said more replication is needed.
“I hope this study will bring attention to the methodology used to measure BPA, and that other experts and labs will take a closer look at and assess independently what is happening,” he said.
The research team is conducting further experiments into BPA measurement as well as other chemicals that may also have been measured in this manner, a category that includes environmental phenols such as parabens, benzophenone, triclosan found in some cosmetics and soaps, and phthalates found in many consumer products including toys, food packaging and personal care products.
“BPA is still being measured indirectly through NHANES, and it’s not the only endocrine-disrupting chemical being measured this way,” Gerona said. “Our hypothesis now is that if this is true for BPA, it could be true for all the other chemicals that are measured indirectly.”
This study was supported by grants from the National Institutes of Health.
make a difference: sponsored opportunity

Story Source:
Materials provided by Washington State University. Original written by Sara Zaske. Note: Content may be edited for style and length.

Journal Reference:
  1. Roy Gerona, Frederick S vom Saal, Patricia A Hunt. BPA: have flawed analytical techniques compromised risk assessments? The Lancet Diabetes & Endocrinology, 2019; DOI: 10.1016/S2213-8587(19)30381-X

BeiGene agrees to allow Amgen to accumulate additional shares

Citing an increase in the number of outstanding shares due to option exercises and vesting of restricted share units, BeiGene (NASDAQ:BGNE) and cancer collaboration partner Amgen (NASDAQ:AMGN) have agreed to increase the number of shares allowable to the latter in order for it to maintain its 20.5% stake.

J&J CAR T nabs accelerated review status in U.S. for multiple myeloma

The FDA designates Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals’ CAR T candidate JNJ-682284528 (JNJ-4528) a Breakthrough Therapy for the treatment of relapsed/refractory multiple myeloma.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

Bristol-Myers and bluebird bio’s CAR T successful in mid-stage myeloma study

Bluebird bio (NASDAQ:BLUE) and licensee Bristol-Myers Squibb (NYSE:BMYannounce positive topline results from a Phase 2 clinical trial, KarMMa, evaluating CAR T therapy idecabtagene vicleucel (ide-cel) (bb2121) in treatment-resistant multiple myeloma (MM) patients.
The study met the primary and key secondary endpoints. Specifically, the overall response rate (ORR) was 73.4% (n=94/128) across three doses (primary endpoint). The response rate was dose-dependent, 50.0% (n=2/4) in the lowest, 68.6% (n=48/70) in the middle and 81.5% (n=44/54) in the highest. The complete response rates were 25%, 28.6% and 35.2%, respectively.
Median duration of response was 10.6 months and median progression-free survival was 8.6 months.
The safety profile was consistent with the Phase 1 CRB-401 trial. The rate of serious/life-threatening/fatal cytokine release syndrome (CRS) was 5.5% (n=7/128) including one death. CRS of any grade occurred in 83.6% of subjects (n=107/128). The rate of serious neurotoxicity events was 3.1% (n=4/128).
More detailed data will be submitted for presentation at a future medical conference.
BMY and BLUE are both up 1% after hours.

Why people buy, trade, donate medications on the black market

Altruism and a lack of access and affordability are three reasons why people with chronic illnesses are turning to the “black market” for medicines and supplies, new research shows. Scientists at University of Utah Health and University of Colorado ran surveys to understand why individuals are looking beyond pharmacies and medical equipment companies to meet essential needs. The reasons listed were many but centered on a single theme: traditional healthcare is failing them.
Instead, people with chronic conditions, like diabetes, are turning to online resources that are more typically associated with gift shopping. They are scrolling through craigslist, browsing for second-hand goods on eBay and searching social media message boards. Rather than toys and sweaters, they are looking for leads to medications and supplies like glucose strips for measuring blood sugar, and insulin, a drug they must take regularly to keep their blood sugar in control.
“People have to make a decision. Do they want to maintain their health? And if so, what are the medications and tools that they need in order to stay healthy?” explains Michelle Litchman, Ph.D., FNP-BC, lead author of the study and a nurse practitioner and researcher at the College of Nursing at U of U Health. “In some cases, people have had to go to extreme measures and find a network that can supply their healthcare needs.”
Results from the study were published online in the Journal of Diabetes Science and Technology.
An online survey of 159 people with diabetes and their caregivers showed the group had participated in different types of underground exchange activities, from donating (56%) to receiving donated goods (34%) to trading (24%), borrowing (22%) and purchasing (15%). Many had taken part in more than one kind of transaction.
When asked why they turned to underground exchange, lack of affordability and accessibility were frequently mentioned. These comments supported statistics showing that over half of participants in the study engaged in underground exchange activities out of financial necessity. People donated and traded with family, friends and strangers who could not get supplies themselves, despite most having health insurance.
In other instances, it was bureaucracy that got in the way. Delays in approval, filling a prescription or shipping prevented some individuals from getting supplies by the time they were medically needed. As a result, some resorted to making trades or accepting donations in order to meet their needs quickly and avoid hospitalization.
“I most likely would have ended up with ketoacidosis but I was lucky enough to get insulin from another person,” wrote one survey participant.
Listen to an interview with Litchman about how people with diabetes are foregoing basic needs and taking part in underground trading just to stay healthy.
“People with diabetes resort to underground exchange of diabetes supplies and medications not because they want to, not to turn a quick profit, but because their needs aren’t being met,” says the study’s senior author Sean Oser, M.D., University of Colorado, Denver. “Some turn to others to get what they need to feel safe.”
Many weren’t engaging in underground trading for themselves, but rather had excess items they knew others could use. “I… donate supplies to people who need them because it’s not fair for me to have excess while they struggle to survive, or even die, because our healthcare system is broken,” wrote another participant. In fact, altruism was a prevailing motivation behind underground exchange. Some reported feeling a strong desire to help others within the diabetes community but at the same time were aware that circumstances are volatile. Someone who is in a position to donate supplies on one day could become a person in need on the next.
A downside to acquiring medications and supplies outside the traditional health care system is lack of safety oversight, the study’s authors say. However, fewer than 1% of study participants who made transactions through underground markets reported safety concerns. Those that occurred included receiving faulty equipment and unrefrigerated insulin, although recipients did not experience ill effects. Still, the authors indicate there is plenty of room for additional error. Poor shipping conditions could spoil medications without the recipient knowing. Another risk could be someone taking the wrong medication if it were inadvertently provided to them. Despite these risks, people continue to use underground exchanges because at this stage there are few alternatives, says Litchman.
Participants of the survey were mostly Caucasian women with a college education. Next steps will be to carry out larger studies that sample individuals across the country, including participants with varied income levels and of different ethnicities to provide a more comprehensive picture of underground exchange and its impacts on the public. In any case, Litchman says that the black market for medications doesn’t appear to be going away soon.
“Underground trading of medications and supplies isn’t ideal. But what other real solutions exist so that people can actually get what they need without increasing bureaucratic delays and burden?” Litchman says. “Our study points to an urgent need to improve access to medications that are essential for life.”
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In addition to Litchman, co-authors are Sarah E. Wawrzynski, and Heather R. Walker from U of U Health and Tamara K. Oser and Sean Oser from University of Colorado, Denver.
The research published as “The Underground Exchange of Diabetes Medications and Supplies: Donating, Trading, and Borrowing, Oh My!” and was funded by the U of U Health College of Nursing and the Health Equity Resilience and Education Research Equity Team.