Utah senator dramatically changed supplement regulation
This article first appeared January 3, 2018 on Medpage Today.
By Shannon Firth
With the announced retirement of Sen. Orrin Hatch (R-Utah), the supplement industry may have to look for a new champion.
Hatch, the longest serving Republican in the Senate, announced plans to retire in early 2019, according to The Salt Lake Tribune. He was one of the primary authors and "the moving force" behind the Dietary Supplement Health and Education Act (DSHEA) of 1994, according to Marc Ullman, JD, of counsel at Rivkin Radler on Long Island, New York.
"It is not possible to adequately state the magnitude of the impact Senator Hatch had on the supplement industry," Ullman told MedPage Today. Rivkin Radler's clients include members of the supplement industry, and the firm has been involved in cases related to the scope of the FDA's powers in relation to such products, according to its website.
Until DSHEA, the FDA held supplements to the standard of drugs, which Ullman described as "anything intended to treat, cure, or prevent disease in man or in animal or to affect the structure and function of the body."
But "DSHEA expressly said that the structure-function clause did not apply to dietary supplements," Ullman said.
Instead of being regulated as a drug, supplements were treated as food products, according to Michael Carome, MD, director of Public Citizen's Health Research Group.
The supplement sector grew from a $9-billion industry in 1994 when the bill passed to a $35-billion industry by 2013, reported the St. George News. In Hatch's home state of Utah, the supplement industry makes $7 billion annually, according to the same St. George News article.
DSHEA also included one very significant grandfather clause stating that any ingredient on the market at the time of the bill's passage would be legal and not subject to FDA review, Ullman explained. Hatch fiercely protected this clause, and pushed for "guidance and clarity and fair treatment" in the FDA's review of new ingredients, he added.
He also pressed the agency to take aggressive action against illegal ingredients, promoting the law's enforcement "in a manner that protects the legitimate, bona fide, mainstream supplement industry," Ullman said.
“Any FDA reforms in the past 35 years, Sen. Hatch’s fingerprints were on it,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association in a phone call.
“No one has passed as much legislation for the country or the FDA as Senator Hatch has,” he continued.
As for his understanding of healthcare, “I can’t think of another legislator who has the breadth and depth that he did. So, it’s a huge loss,” Fabricant said.
His ability to “reform and expand” industries extends beyond dietary supplements to drugs and biologics, Fabricant said, citing the Hatch Waxman Act of 1984, which opened the door to generic competition.
But one aspect of his career that’s often overlooked is the consumer protection aspect of his legacy, he continued.
His co-sponsors Sen. Dick Durbin (D- Ill.) and former vice president, then Sen. Joe Biden (D-Del.) were critics of FDA-regulated industry but Hatch, who was skilled at working across the aisle, managed to broker an agreement, he continued.
Hatch was also quick to give advice to his industry colleagues.
“Government can change your business quicker than anything, for good or bad. So, get involved,” Fabricant recalled Hatch saying.
The supplement industry showed their support for Hatch. The website OpenSecrets.orgreports that during the 1993-1994 election cycle, Hatch was the number one Senate recipient of contributions from members of the nutritional and dietary supplement industry, totalling $95,750. Former Sen. Tom Harkin (D-Iowa), DSHEA co-author, received $40,250.
In the 2015-2016 election cycle, Hatch ranked third in contributions from the supplement industry ($29,600), behind Sen. Marco Rubio (R-Fla.) who received $34,700, and Sen. Martin Heinrich (R-N.M.) who received $39,250.
Ullman noted that Heinrich "has shown very strong support for the trade."
Carome said he viewed DSHEA as weakening FDA regulation and oversight of dietary supplements.
"It took the agency in a direction it did not want to go," he told MedPage Today.
Before the law passed, the FDA was concerned about the potential links between supplements and serious health problems. For example, the use of L-tryptophan, advertised for treating insomnia, was tied to an outbreak of eosinophilia-myalgia syndrome, with more than 37 deaths were linked to the supplement, he added.
The passage of DSHEA "really resulted in deregulation of the industry," Carome concluded, noting that the industry has "exploded" since the bill passed.
He also noted that post-DSHEA, "hardly a week goes by now when the agency isn't putting out a warning about various dietary supplements that have been tainted in some way."
Products often don't contain the ingredients they say they do and consumers don't realize this, he added. For instance, an investigation by the New York Attorney General of four major supplement retailers found four in five products didn't contain the herbs listed on their labels, according to a 2015 New York Times report.
Carome said he did not think Hatch's departure would adversely impact the supplement industry. "[DSHEA] is so ingrained now, Hatch's departure is likely to have little impact on the regulatory landscape of dietary supplements. It's unlikely we'll be able to turn the clock back."
Hatch's departure also opens up a spot for a new chair of the Senate finance committee. It isn't yet clear who will fill that role, wrote Doug Holtz-Eakin, PhD, president of the conservative American Action Forum and a former Congressional Budget Office director, in an email to MedPage Today.
He suggested that Sen. Chuck Grassley (R-Iowa) would have the option, but he may choose to stay on the Judiciary Committee that he currently chairs. Another candidate could be Sen. Mike Crapo (R-Idaho), but he would have to give up the Banking Committee chair, he noted.
Regarding the priorities of the next finance committee chair, Holtz-Eakin said, "I think that the health agenda will be more driven by the needs for entitlement reform than by the policy preference of the chairman. Whoever is next would work on the same ACA, CHIP, Medicare, and Medicaid issues that Hatch would have faced."
Study finds decreased metabolites in early disease, regardless of caffeine consumption
This article first appeared January 3, 2018 on Medpage Today.
By Judy George
Blood levels of caffeine and its metabolites may be promising diagnostic biomarkers for early Parkinson's disease, Japanese researchers reported.
Unrelated to total caffeine consumption or disease severity, serum levels of caffeine and nine of its downstream metabolites were significantly lower in patients with early Parkinson's, Shinji Saiki, MD, PhD, of Juntendo University School of Medicine in Tokyo, and colleagues reported online inNeurology.
There were no significant genetic variations in the enzymes metabolizing caffeine between patients and controls.
Caffeine concentrations also were significantly decreased in Parkinson's patients with motor fluctuations than in those without motor complications. However, patients in more severe disease stages did not have lower levels of caffeine, "suggesting that the decrease in caffeine metabolites occurs from the earliest stages of Parkinson's," David G. Munoz, MD, of the University of Toronto, and Shinsuke Fujioka, MD, of Fukuoka University in Japan, wrote in an accompanying editorial.
Some previous reports have suggested an inverse association between daily caffeine consumption and reduced risk of developing Parkinson's, although a recent randomized controlled trial found no benefit to caffeine intake for Parkinson's symptoms.
Mechanistically, caffeine could improve motor symptoms by antagonizing adenosine 2A receptors (A2A-Rs), but changes in the entire caffeine metabolic pathway in Parkinson's patients are unclear.
In this study, researchers examined blood samples of 108 patients with idiopathic Parkinson's disease and 31 age-matched healthy controls, separating caffeine and 11 downstream metabolites by high-performance liquid chromatography. All Parkinson's patients had been treated at Juntendo University Hospital; on average, they had mild to moderate disease severity. Age, sex, and total caffeine intake were similar for both groups.
The researchers also recruited an additional 51 healthy controls and 67 Parkinson's patients for gene analysis, screening for mutations in caffeine-associated genes by direct sequencing.
Blood levels of caffeine and nine of its 11 metabolites were lower in Parkinson's patients than in controls (P<0.0001). The difference could be used to separate patients from controls reliably, with an area under the receiver operating characteristic curve of 0.98.
Analyses of caffeine-related genes showed no significant differences between patients and controls. The researchers saw no significant genetic variations in CYP1A2 or CYP2E1, the encoding cytochrome P450 enzymes primarily involved in metabolizing caffeine, between the groups. They found no associations between disease severity and single nucleotide variants of the ADORA2A gene, which encodes A2A-R.
They also detected no correlations between levodopa equivalent doses and absolute concentrations of caffeine and its metabolites.
One reason why early Parkinson's patients had decreased caffeine levels may be related to intestinal absorption, the authors suggested. Gastrointestinal problems like constipation can affect up to 80% of Parkinson's patients, sometimes preceding symptom onset by years, and a recent analysis showed that fecal microbial flora is altered in patients with Parkinson's.
"Although constipation and fecal bacterial change are predominantly attributed to large intestine function, caffeine absorption mainly occurs in the small intestine, where bacterial overgrowth in Parkinson's is associated with levodopa malabsorption leading to motor fluctuations," Saiki and colleagues observed.
Another explanation might be anti-parkinsonian agents.
"There is an elephant in the room: almost all patients with Parkinson's were receiving treatment," wrote Munoz and Fujioka. "The authors address this issue by finding no association between levels of caffeine metabolites and levodopa equivalent doses, but it is obvious that the validity of the study hangs on this point."
"If a future study were to demonstrate similar decreases in caffeine in untreated patients with Parkinson's, or persons with prodromal signs of Parkinson's including REM behavior disorder, many of whom would be expected to develop Parkinson's, the implications of the current study would take enormous importance," they continued. This could lead to an easy test for early diagnosis or point to a basic mechanism of Parkinson's pathogenesis.
One limitation of this study is that it did not include severe Parkinson's cases; its reduced power may have limited the researchers' ability to detect an association between disease severity and caffeine levels. Despite the lack of correlation between levodopa equivalent doses and caffeine concentration, Parkinson's medications still might have affected metabolism, the authors added.
"Similar to a recent study showing progressive decreases in caffeine metabolites with disease exacerbation, de novo Parkinson's studies including larger study populations and studies on differential diagnostic values among patients with Parkinson's and other parkinsonian patients should be performed," they wrote.
CHIP extension, more ACA reform among the possibilities
This article first appeared January 3, 2018 on Medpage Today.
By Joyce Frieden
WASHINGTON -- Capitol Hill is slowly coming back to life after the holiday recess -- the Senate is back this week and the House comes back next week -- and Congress has a full plate of healthcare items to deal with.
One big question is whether Republicans in the House and Senate will try again to repeal the entire Affordable Care Act (ACA), now that they have repealed the law's individual mandate as part of the newly passed tax reform bill.
"We don't have a clear picture there yet," Elizabeth Carpenter, senior vice president of Avalere, a consulting firm here, said in a phone interview. She noted that proposals to stabilize the ACA's health insurance markets "have less support now that the mandate has been repealed, and on the flip side, folks like Sen. [Lindsey] Graham (R-S.C.) are saying that now that the mandate has been repealed, Congress needs to take additional action."
Graham and Sen. Bill Cassidy, MD (R-La.), got pretty close to passing their bill to repeal and replace the ACA, "and they've been pretty clear they'd like to engage on that topic ... I suspect we'll get a better sense of that ... later this month," said Carpenter.
But Gail Wilensky, PhD, senior fellow at Project HOPE in Bethesda, Maryland, disagreed.
"There may be noise about repeal and replace ... but if it didn't happen [in the Senate] at 52 [Republicans] 48 [Democrats], it's hardly likely to happen at 51-49," she said, referring to the fact that the Senate is up by one Democrat now that Sen. Doug Jones (D-Ala.) has replaced Luther Strange, a Republican.
"It wasn't going to happen even if it stayed at 52-48 -- there was too much difference in the Senate to get something through that repeals the Medicaid expansion," Wilensky added.
Experts did agree, however, that Congress is likely to pass a more permanent extension of funding for the Children's Health Insurance Program (CHIP), whose funding expired at the end of September. As part of the tax reform bill, Congress passed an extension of CHIP funding designed to last for the first few months of 2018.
Michael Sparer, PhD, JD, chair of the department of health policy and management at Columbia University in New York, did admit to a little bit of hesitation: "I'm fairly confident CHIP funding will be extended, but my confidence is a bit shaken given the long delays and the ongoing partisan bickering over how to pay the bill," he said in an email.
CHIP funding "takes on special urgency with the announcement of Sen. [Orrin] Hatch's retirement," Kenneth Thorpe, PhD, chair of health policy and management at Emory University in Atlanta, said in an email. "As an original sponsor of the program, this would seem to be a key priority."
Getting the CHRONIC Care Act passed will also be on the agenda, he added. This bill, known as the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017, would increase access to telehealth for Medicare beneficiaries with chronic illnesses -- including those in Medicare Advantage plans -- as well as provide more incentives for enrollees to receive care through accountable care organizations. It also would extend the Independence at Home demonstration program to keep people in their homes rather than hospitals.
The CHRONIC Care Act "passed without opposition in the Senate but is taking a more fragmented direction in the House," said Thorpe. "There is lots of bipartisan Senate interest to get this passed."
Reforming the Medicare and Medicaid programs also has been mentioned by some Republican leaders. "There will be renewed efforts to cut Medicaid funding (via some sort of block grant) and also to cut Medicare spending," predicted Sparer. "My guess, however, is that both of those programs will survive these challenges; the political cost to cuts in these programs is increasingly high."
"Indeed," he continued, "as the Democrats develop their own healthcare agenda going into 2018 (and 2020), part of that agenda will be efforts to expand eligibility for both of those programs. I think it is also more likely than not that one (or more) states will enact a version of a Medicaid buy-in program."
Wilensky was more skeptical on the idea. "Don't hold your breath [on entitlement reform]," she said. "At some point we're going have to do it, but we don't have to do it in 2018 and we're not going to. Sometimes after the next presidential election, we will have to get serious because of the effects of the Baby Boomers, and especially because Medicare spending is going up again."
There is also a laundry list of other items, Robert Laszewski, president of Health Policy and Strategy Associates, a consulting firm in Alexandria, Virginia, said in an email. These include:
Permanent extension for community healthcare centers, whose funding -- like CHIP's -- ran out at the end of September.
Further extension of the health insurance tax and the medical device tax moratoria -- "they will reappear in 2018 if the Republicans don't keep their promise to extend the 2017 moratoria," he said.
Further extension of the "Cadillac" tax moratorium slated to restart in 2020. "Employers want to know now if they should plan for it."
The long list of Medicare extenders that have to be funded each year.
The big question will be whether Republicans and Democrats will be willing to work in a bipartisan fashion, Laszewski said.
"We are already hearing the White House is intent on seeing the Alexander-Murray and Collins-Nelson bills [to stabilize the ACA's health insurance markets] passed early in the new year," he said. "Conservative Republicans are dead set against these. And, it would take 60 votes to pass them in the Senate. I will suggest that these two bills jointly might well be one of the first tests for any willingness to put Democratic and Republican coalitions together to get things done."
Israeli researchers caution that 'the effect of confounding was notable'
This article first appeared January 3, 2018 on Medpage Today.
By Molly Walker
Folic acid and multivitamins both before and during pregnancy seemed to reduce the risk of autism spectrum disorder (ASD) in children, a large Israeli study found.
Compared with women with no exposure to folic acid and/or multivitamin supplementation, women who took folic acid and/or these vitamin supplements during pregnancy had a significantly reduced risk of offspring with ASD (adjusted RR 0.27, 95% CI 0.22-0.33, P<0.001), with similar results seen among women who took these supplements before pregnancy (adjusted RR 0.39, 95% CI 0.30-0.50, P<0.001), reported Stephen Z. Levine, PhD, of University of Haifa in Israel, and colleagues.
Similar results were found when the effects of folic acid and multivitamin supplements were examined individually, the authors wrote in JAMA Psychiatry.
But the authors outlined a number of limitations to their findings, namely that "the effect of confounding was notable," and expressed reservations about residual confounding. They also noted the small size of their study, and pointed out potential misclassification of exposure, or unrecorded use of supplements, such as a mother using over-the-counter supplements. Finally, they pointed out that there was no information about the mothers' whole-blood folate levels and that the registry could not distinguish between multivitamins with and without folic acid.
This case-cohort study examined data from certain healthcare registers in Israel on children born from January 2003 to December 2007. A diagnosis of ASD was performed by a physician after evaluation by a team of experts.
Overall, there were 572 children out of 43,500 in the study (1.3%) with a diagnosis of ASD. The study was comprised of 22,090 girls and 23,210 boys, with a mean age of 10 years at the end of follow-up.
In addition to the effects of folic acid and/or multivitamin supplements, Levine's group looked at the individual effects of maternal exposure to folic acid and multivitamin supplements compared to unexposed mothers and found similar results:
Folic acid during pregnancy: adjusted RR 0.32 (95% CI 0.26-0.41, P<0.001)
Folic acid before pregnancy: adjusted RR 0.56 (95% CI 0.42-0.74, P=0.001)
Multi-vitamin supplements during pregnancy: adjusted RR 0.35 (95% CI 0.28-0.44, P<0.001)
Multi-vitamin supplements before pregnancy: adjusted RR 0.36 (95% CI 0.24-0.52, P<0.001)
Sensitivity analyses that looked at different time periods of exposure or potential additional confounders generally did not lessen these associations, the authors said. They did note that for offspring whose parents had a psychiatric condition, folic acid supplementation did not significantly reduce the risk of ASD.
This article first appeared January 3, 2018 on Medpage Today.
By Ed Susman
ATLANTA – The combination of elotuzumab (Empliciti) with lenalidomide (Revlimid) plus dexamethasone led to objective response rates (ORR) in more than 80% of newly diagnosed multiple myeloma patients, researchers said here.
In a phase II, open-label trial of more than 80 patients, 89% treated with the three-drug combo achieve an ORR versus 73% treated with the lenalidomide/dexamethasone after a minimum of 6 months follow-up, reported Mitsuo Hori, MD, PhD, of Ibaraki Perfectual Central Hospital in Ibaraki, Japan, and colleagues.
In addition, increasing the infusion rate to 5 mL/minute from a standard of 2 mL/minute in the experimental arm of the trial did not increase injection site reactions among the 40 patients randomized to receive elotuzumab, they said in a presentation at the American Society of Hematology (ASH) annual meeting.
"In this first report of elotuzumab plus lenalidomide/dexamethasone treatment of patients with newly-diagnosed multiple myeloma, the primary endpoint of objective response rate was met," the authors wrote. "Elotuzumab in combination with lenalidomide and dexamethasone had an acceptable safety profile in this patient population. These data suggested that this combination with a faster infusion rate of 5 mL/minute was effective and well tolerated in Japanese patients with newly-diagnosed multiple myeloma."
The three-drug regimen has been approved in Japan for the treatment of relapsed/refractory multiple myeloma, the authors explained. Elotuzumab is a humanized IgG1 monoclonal antibody that binds to SLAMF7 expressed on myeloma and natural killer (NK) cells. It has a dual mode of action, by causing targeted myeloma cell death by directly activating NK cells and enhances NK cell-mediated antibody-dependent cellular cytotoxicity, they added.
The researchers enrolled patients newly diagnosed with multiple myeloma who were ineligible for high-dose chemotherapy plus hematopoietic cell transplantation.
They were randomized 1:1 to intravenous elotuzumab 10/mg/weekly for cycles 1 and 2, and then were treated every 2 weeks for the next 16 cycles. They were treated with a dose of 20 mg elotuzumab monthly after that, plus lenalidomide or were treated with lenalidomide alone in a 28-day cycle until disease progression or unacceptable toxicity.
All patients in the elotuzumab arm received premedication prior to elotuzumab to mitigate infusion reactions.
At baseline, median patient age was 72. Patients on elotuzumab were able to take a median of 13 cycles of treatment compared with 11.5 cycles as the median for the patients taking lenalidomide/dexamethasone.
The study's primary endpoint was to determine if treatment with the combination could achieve at least a 71% objective response rate based on investigator assessment. Hori's group reported that two stringent complete responses were achieved in the three-drug treatment arm and one stringent complete response was observed in doublet arm. One other person achieved an investigator-determined complete response with elotuzumab and two patients achieved a complete response with lenalidomide/dexamethasone.
Fifteen of the patients treated with elotuzumab achieved a very good partial response compared with nine patients receiving the comparator drugs. Objective partial response were reported in 17 patients on elotuzumab and 19 patients on lenalidomide/dexamethasone.
The researchers said the remaining five patients on elotuzumab maintained stable disease as did seven of the patients on lenalidomide/dexamethasone. Only one of the 82 patients in the trial had progressive disease, and that person was taking the doublet. Three patients on the doublet were not available for evaluation.
Adverse events were reported in all the patients on elotuzumab and in 41 of 42 patients on lenalidomide/dexamethasone alone. The most common adverse events was constipation in 43% of the elotuzumab patients and in 31% of the patients getting the doublet.
Diarrhea was experienced by 38% of the elotuzumab patients and in 21% of the doublet patients. Pyrexia was reported in 35% of the elotuzumab patients compared with 7% of the lenalidomide/dexamethasone. About 28% of elotuzumab patients complained of a rash compared with 36% of the patients taking lenalidomide/dexamethasone-treated patients.
Nasopharyngitis was reported by 25% of the patients using elotuzumab and 26% of those on lenalidomide dexamethasone. Dysgeusia (impaired taste) was reported by 23% of the elotuzumab cohort and by 19% of the comparator group. Malaise was reported by 23% of the elotuzumab patients and by 2% of the lenalidomide/dexamethasone patients.
The authors reported that a secondary primary malignancy was reported in one patient in the three-drug arm (rectum) and one patient in the two-drug arm (lung).
The combination regiment had a comparable safety profile when given at 10 mg/kg weekly, or every 2 weeks up to cycle 18, or at 20 mg/kg monthly from cycle 19 onwards, they noted, adding that profession-free survival data were not mature at the time of the ASH presentation.
MedPage Today asked 77 doctors about the value of the press.
This article first appeared December 15, 2017 on Medpage Today.
By Roger Sergel
Physicians, nurses, and physician assistants talk to the press for a variety of reasons -- sometimes they are reporting "good news" and sometimes the news is tragic as in the case of a natural or man made disaster. Other times they are joining the national debate on healthcare.
But aside from providing needed information the public and possibly burnishing either their reputations or that of their institutions, there may be an unintended, but beneficial side-effect: this public communication may improve their ability to communicate with patients.
MedPage Today raised that possibility with 77 physicians, all of whom previously agreed to be included in the MedPage Today source database that includes more than 4,000 practicing physicians, researchers, and academics.
Specifically, the 77 were sent this question: "Does speaking with reporters in any way help with speaking to patients?"
Fifty two of the 77 responded, and of the responders 28 agreed that talking to the press does make them better communicators with their patients.
Reviewing these positive responses four factors emerged as the main considerations for those who agreed with the premise:
Talking with reporters helped them simplify information;
Talking with reporters helped them learn how to summarize information;
Answering reporters' questions let them practice ways to answer questions;
Talking with reporters gave them the opportunity to develop messages.
Simplify, Simplify, Simplify
"Actually, speaking with the media is helpful in distilling otherwise complex medical information into a format that can be easily grasped by unsophisticated patients and family members who are trying to understand a given medical situation, " explained Robert Mayer, MD, an oncologist from the Dana Farber Cancer Institute.
The value of simplifying was echoed by Paul Pepe, MD an emergency medicine specialist from the University of Texas, Southwestern.
"Getting to (the) point, not getting too complex, yet still showing balanced thinking (in a sentence), is an important asset that years of speaking to reporters helped to hone." Pepe, who has written extensively about physicians and the media, added:
"Overall concept here -- know your audience -- never mention the technical stuff and why it's complicated -- they want to know the bottom line -- tell them more if they ask."
Summarize, Answer
This process of simplifying also helps when summarizing information, according to Ajay Kirtane, MD, a cardiologist from Columbia University Medical Center. "It sometimes feels like one is 'performing data-synthesis for the patient' the same way one might 'perform' for the camera/reporters."
"I have learned a lot not only having such people (the press) make me answer their questions over and over until I got it right but on their identifying what people really want to know rather than just what I think is important," said Larry Norton MD, oncologist from Sloan Kettering Cancer Center. Norton also noted that "Good communication is being able to hear things the way other people hear them even while you are speaking."
On Message?
Messaging was stated as another benefit by Jennifer Robinson, MD, a cardiovascular epidemiologist at the University of Iowa. "I do find that over time I develop essential messages into high impact 'sound bites' for patients."
Finally, the issue of doctors being a different kind of "bilingual" was mentioned. "We have to be bilingual, proficient in speaking two languages, medical and lay, while conveying complex medical issues," said Susan Manzi, MD, a rheumatologist at the Allegheny Health System. Manzi said contacts with the press provides practice in speaking the two languages. "The more practice we have the better we are at our second language, and speaking to reporters and doing media interviews is a great way to practice. It is so easy to slip into our first language comfort zone."
On the Flip Side
Although a majority of responders saw benefit in communicating with the press, 10 said the reverse was true.
Their conversations with patients, which are far more numerous, helped prepare them to speak with the press. The techniques of communication are different, in the view of Larry B.Goldstein, MD, a neurologist at the University of Kentucky. "Speaking with patients, I use a variety of techniques such as Ask-Tell-Ask to assure understanding, which is not appropriate in an interview setting."
Another difference mentioned was the issue of scientific breakthroughs. "When reporting scientific breakthroughs, patients and their families again want to know if the information is relevant to their condition whereas the general public is often just happy to know someone may be helped in the future," said Jerris Hedges, MD, an emergency medicine specialist from the University of Hawaii. "My point is that the conversations are different," he said.
And then one respondent suggested that the structure used for delivering information was different. Chris Cannon, MD, a cardiologist at Brigham and Women's Hospital said "You in journalism have the headline first, then key points, then some context, and at the very end, details on methods."
But Cannon said that isn't how medical communication works. "We do the opposite -- we give background, then methods, then slowly walk through results, and THEN we give the punchline of what is new and some context on why this is important."
A blunter view of the differences was put forth by Milton Packer, MD, a cardiologist from Baylor Scott and White Health, and MedPage Today blogger. "Actually, I think the two processes are very different. The goal in speaking to a patient is to make sure that they understand. The goal in speaking to a reporter is to make sure that they do not misunderstand. Do you see the difference?"
David Katz, MD, a preventive medicine specialist from Yale University said that in doctor-patient communication, listening is more important that talking. And he added, "At times, what matters most is simply, truly being there. Again, the clinical power of human touch does not translate well to morning shows!"
And one doctor's view was that the communication used with both patients and the reporters isn't different. "I think the principles of talking effectively with patients and reporters are the same and that the key is listening WHILE you talk so that you can ascertain whether the patient (or the reporter) is fully grasping the conversation," said Robert Schooley, MD, an infectious disease specialist from the University of California San Diego.
And Finally
What really matters, according to one respondent is not the differences but the similarities in communication to patients and the press. Clyde Yancy, MD, a cardiologist from Northwestern Medicine emphasized points that are important regardless if the conversation is with patients or the press.
What, then, is really important for any audience?
It is important to have an understanding of the subject matter and to develop the ability to distill complex information to easily digested and translatable key points. Likewise, Yancy said is a "willingness to learn how to communicate and the ability to make eye contact while communicating."
"Finally," Yancy said, "make certain that you are able to convey your points to a child; if you can't make a child understand your message, it's not the message, it's you."
A shared platform for medical records would make health history less of a mystery, writes Fred N. Pelsman, MD.
This article first appeared December 14, 2017 on Medpage Today.
by Fred N. Pelzman, MD
At this time of year, as the holidays approach, packages begin to arrive at our medical practice.
These often contain gifts, lovely gestures from patients or from other physicians or services we refer to, and include things like a bottle of wine, fresh fruit, and those towers with an assortment of treats in a basket.
We often open these gift baskets up and share them around the office, so there's plenty of caramel popcorn, Godiva chocolates, and other sweet and salty snacks for everyone to share in.
The other day I got a different kind of package, one which is often looked at with both joy and a little bit of trepidation by the recipient.
This offering comes in a large thick mailing pack, with the return address of a physician or hospital system, and contains a huge sheaf of Xeroxed papers.
The dreaded prior medical records.
Whenever a patient comes to us for an initial visit, transferring their care from a prior primary care doctor, or when the patient has been away from our care for a while possibly due to insurance issues, or they have been living out of state, we want to gather their records for the sake of completeness, and to inform us moving forward.
With new patients, one of the requests I make is that they make an effort to get their prior medical records so I can see a little more about their prior healthcare, and perhaps gain insight into the current state of their health.
If a patient was hospitalized elsewhere in an emergency, we want to know what was going on, how they were treated, anything we should know to follow up on or investigate.
Sometimes getting what we wish for is not always the best thing.
Occasionally the package that arrives is several inches thick, and contains badly photocopied old handwritten notes dating back many years, and despite our best investigative efforts, we learn little about the care the patient had, their prior symptoms and treatments, and sometimes we're better off not even looking.
When this package arrives, we are faced with the choice of whether to read it in its entirety, or do a quick skim through, hoping to get a general gestalt about what went on before they came to us, and hoping nothing bad is hidden inside this old chart.
By accepting these medical records, and copying them into our own, we are accepting responsibility for them, and the history contained therein is suddenly ours to reconcile and act upon if necessary.
Sometimes you can get a sense of what the patient's care was like, what their prior physician was like, what they expected, what they wanted done for their health, what was tried and failed.
Occasionally you discover something that explains a finding that you've uncovered, a medical mystery now answered in these crusty old pages.
Several cases that some of my partners have related to me proved the benefit of having access to prior medical records.
One told me about a worrisome liver lesion incidentally picked up on imaging done for another purpose on a patient of his, and later when digging through an old photocopied prior medical record he was able to discover that this lesion was essentially unchanged down to the finest details, the description of its size and morphology, from a CT scan done for another reason by a different provider 10 years earlier.
Another one of my partners has described getting back a lab value on a patient that she was seeing for the first time, suggestive of renal insufficiency. Unfortunately she had no way of knowing at the time whether this was acute or chronic.
However, when the patient brought in their old records, she was able to track back through the years of this patient's care with the different series of providers stretching back quite some time, that this had been in fact a slow and gradual process. The patient's creatinine had, while always remaining within the normal range, slowly been creeping up over years of medical care, right under the noses of multiple doctors. The creatinine had been 0.4, then 0.7, 0.9, 1.1, 1.3, all within the "normal" range, and no one had noticed the gradual rise over many years. It wasn't until suddenly it popped into the abnormal range that attention was paid, but by knowing this had been going on gradually for years she was able to eliminate several causes of acute kidney failure.
My hope is that as we move farther along in the 21st century, our healthcare system and the technology available will catch up with us, and that ultimately we will all be on one shared platform.
A complete blood count in one lab should be the same as a complete blood count in another lab, and a chest x-ray should look the same no matter whose computer you're viewing it on.
All our records should be instantly translatable and transferable, and all of our health history should travel with us.
We will leave it up to the technology gurus to decide what format this takes, what universal standards they adopt, although we know this needs guidance from clinicians actually out there doing the real clinical work.
How we translate all the old material buried in paper charts and previous electronic health records in other offices so that it is instantly accessible and valuable in the way it's presented to the provider sitting in front of the patient today will be informed by these processes.
Right now, when we get a package with old records in the mail, we need to put some time into it, some legwork, some elbow grease, to read through it to see what's in there, what nuggets of wisdom might lie within, what things that can help us take better care of our patients.
Often this is just a lot of the same stuff, the fluff of the electronic medical record and the patient chart, but we need to synthesize it and distill out the things we need to know to take care of our patients moving forward.
One project we are working on, still quite a ways from implementation, will be using several new technologies that will essentially allow us to "read" these prior medical records, no matter what form they come to us in, and find the real value that lies within.
As we continue to develop this, further updates will be available here.
For now, we'll just have to unwrap these like we do all the other gifts we receive in the mail over the holiday season, hoping that we got something good.
The lone holdout on ditching the program noted that eliminating MIPS and replacing it with the Voluntary Value Program (VVP) could cause more physicians to rush to become hospital employees.
This article first appeared December 08, 2017 on Medpage Today.
By Joyce Frieden
WASHINGTON -- Momentum appeared to be growing on Thursday for a proposal from the Medicare Payment Advisory Commission (MedPAC) to get rid of the Merit-Based Incentive Payment System (MIPS) for reimbursing physicians who see Medicare patients.
"We need to act on this now," MedPAC staff member Kate Bloniarz told the commissioners. She added that clinicians will start reporting their quality data this year for reimbursement in 2019. "The longer the payments go out, the more there will be an established [group] of clinicians receiving really high payment adjustments who will resist changes to the program."
MIPS, which was enacted as part of the Medicare Access and CHIP Reauthorization Act (MACRA), combines parts of the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier, and Meaningful Use into one single program based on quality, resource use, and clinical practice improvement. Under MIPS, doctors earn a payment adjustment based on evidence-based and practice-specific quality data that they report to the Centers for Medicare & Medicaid Services (CMS).
Bloniarz listed a number of concerns with MIPS, including:
It gives physicians a heavy reporting burden, which was estimated at more than $1 billion for the first year of the program
Much of the information reported isn't meaningful, partly due to small sample sizes and the fact that only a few quality measures assess meaningful outcomes, she said. In addition, each clinician is scored on different measures representing different levels of effort, "so it's not comparable across clinicians, but CMS will move substantial funds around each year based on these non-comparable scores"
CMS has exempted more clinicians from MIPS in 2018 than are required to participate, and has special rules for small and rural clinicians. As a result of these and other CMS actions, in years 3 and later, "small differences in [scores] will be blown up into potentially massive differences in payment adjustments. The system is inequitable ... It won't move clinicians and the Medicare program toward high-value care"
Commission staff members are recommending replacing MIPS with a new program called the Voluntary Value Program (VVP). Under the VVP proposal, all clinicians would see a portion of their fee schedule dollars withheld and lumped into a pool. Clinicians could then be measured with a group of other doctors -- based on population-based outcomes, patient experience, and cost -- to be eligible for value-based incentive payments from the pool.
Otherwise, they could decide to participate in an advanced alternative payment model (AAPM) program -- an option they have under the current reimbursement system, in which groups of physicians and hospitals can earn a bonus of up to 5%, based on patient outcomes, in exchange for taking on financial risk. If they chose neither of those options, they would lose all the money withheld.
Most commission members agreed with the staff's suggestions. "I strongly support the recommendation," said commissioner Bruce Pyenson, of the Milliman consulting firm, in New York City. "The virtue of this approach ... is that it's something the rest of the healthcare plans could use ... Here's a way where the Medicare program can actually make things easier for the rest of the healthcare system."
Pat Wang, JD, of the Healthfirst insurance plan in New York City, also liked the recommendation, but cautioned that "lots of important details" need to be worked out with the VVP, including attribution of patients and risk adjustment. "But I do support it because I think it's directionally better and has the potential to be a better system."
Commissioner Kathy Buto also supported the recommendation, "but I think the weak link is that there are not enough population-based measures," she said. "I don't think we have a good grasp of the complexity of what's going to be needed." She suggested eliminating MIPS but giving CMS time to come up with better population-based quality measures.
The lone holdout on ditching the program was commissioner Alice Coombs, MD, of South Shore Hospital in Weymouth, Massachusetts, who noted that eliminating MIPS and replacing it with VVP could cause more physicians to rush to become hospital employees. "If the withhold is higher ... I think people will go to the nearest hospital and say, 'I want to jump on your wagon'" so they don't have to worry about complying with the VVP and possibly threatening the viability of their practice, she said.
"I haven't heard large physician groups say it's a great idea. Initially, the physicians I talk to have a positive reaction to getting rid of MIPS, but when I tell them we're [thinking about] going to a VVP, then they say, 'Wow, I will be judged on something I have absolutely no control over.'"
Although some of the process measures required by MIPS may not be useful, "there are a lot of process measures you can check off that can cue you into something else [that's wrong]," she continued. "At least physicians are now coming to the table and saying, 'What can I do in the quality realm?' And I think patients are better for it."
In addition, some doctors don't have geographic access to AAPMs that they can readily join, "and many doctors caring for minority patients are faced with the fact that they have higher-risk patients who are not risk-adjusted well," she said.
Commission chair Francis Crosson, MD, of Palo Alto, California, emphasized that looking at a VVP "in no way should be read that we don't believe in the value of process measures. We certainly do ... We're just saying as a mechanism at a national level to move money" to individual physicians [it] isn't a good idea.
Nearly half pursuing value-based payment arrangements, small survey says
This article first appeared November 29, 2017 on Medpage Today.
By Joyce Frieden
WASHINGTON -- More family physicians are incorporating value-based payments into their practices, but they are still skeptical about whether it really works, a small survey found.
Nearly half of the 386 family physician respondents this year -- 47% -- said they were pursuing opportunities for value-based payment, which is generally defined as payment based on the quality and outcome of care, rather than on the volume of services provided. That percentage was up slightly from 44% in 2015, according to the survey, which was sponsored by health insurer Humana and conducted by the American Academy of Family Physicians (AAFP). However, 62% of respondents -- the same as in 2015 -- agreed that one barrier to implementing value-based payment was "a lack of evidence that using performance measures results in better patient care."
"Physicians are a skeptical bunch, and very skeptical of change," said Amy Mullins, MD, medical director for quality improvement at the AAFP, said at a briefing Wednesday morning. "It took 15 years for doctors to be convinced to give a patient an aspirin when they walked into the emergency room with chest pain ... To change the way someone's going to get paid, that's a bigger context than saying, 'Hey, take this aspirin.' But even though a lot of them are skeptical ... more of them are moving in that direction."
Other barriers to implementing value-based care contracts included a lack of uniform performance reports from payers, a lack of standardized performance measures, and the unpredictability of the revenue stream. That last item, although the percentage of physicians citing it dropped from 81% in 2015 to 76% today, is still seen as a "huge barrier," Mullins said.
In addition, "We need real-time data exchange," said Mullins. "The data we get is not actionable -- it's 6 months old, given to us in forms we can't interpret, and 10 payers send it in multiple ways we don't have time to sort through. So we need real-time data that is standardized in a consumable way for very busy physicians."
Lack of interoperability between electronic health records systems also continues to be a problem for physicians who are switching to more value-based payments, the panelists agreed. "I don't know if there's a light at the end of the tunnel on that, or not," said Mullins. "We have to have cooperation from a lot of different players to make that happen, but if we can get it to happen, it would be great."
The survey showed an increase in the percentage of physicians whose revenues from value-based contracts were shared directly with them based on quality measures rather than funneled through the practice's administration -- from 18% in 2015 to 37% in 2017.
"That's the biggest positive change -- the idea that value-based payments are trickling down to front-line doctors," said Jeff Micklos, JD, executive director of the Health Care Transformation Task Force, a coalition of patient, payer, provider, and purchaser organizations in support of the change to value-based reimbursement. "Without that financial incentive, it's hard to convince a medical professional to see a sustainable business model there."
Other survey results were also positive for VBP, Mullins said. For example, the percentage of respondents who said they were "not at all familiar" with value-based payment dropped from 12% to 7%, and those who said they were holding off on making changes to their payment models declined from 22% to 19%.
In addition, while the percentage of those updating or adding to their health information technology held steady at 54%, more respondents said their practices had hired or were hiring care management coordinators (43% in 2017 versus 33% in 2015), and those making no changes dropped from 26% to 14%. "So physicans are moving; they making the changes they need [make] to be successful in VBP," said Mullins.
One issue that had surfaced earlier in the transition to value-based payment -- the reluctance of physicians to take on sicker, more complex patients for fear that they would ruin the practice's outcomes -- doesn't really appear to be a concern any more, said Roy Beveridge, MD, senior vice president and chief medical officer at Humana. "Given that today we've got fairly sophisticated risk adjustments, there's no disincentive I've seen in terms of [physicians treating] complex patients, because the more complex the patient, the higher their risk score is and the more they get reimbursed. I don't see any issues with that."
And the recently released Medicare Access and CHIP Reauthorization Act (MACRA) rule also has a complex patient bonus built into it, noted Mullins. "That was just a 1-year provision; hopefully it will continue. People are starting to see that taking care of complex patients is hard. I wouldn't see people dumping their complex patients, but there are some plans that are building in bonus points for taking care of patients that are really complex."
The survey data came from a randomly selected sample of 5,000 active AAFP members in September; respondents could complete the survey either in print or online. The sample base for the survey underrepresented female physicians and newer physicians compared to the entire population of AAFP members, the academy noted.
Because veterans may not always go with the VA health system, everyone in healthcare should be sensitive to this population's medical circumstances and challenges.
This article first appeared November 16, 2017 on Medpage Today.
By Chiduzie Madubata, MD
When I walked into the hospital room with my team to meet him for the first time, what struck me was how young he looked. He was listed as 26-years-old, but he looked younger than that. He looked so young that it was hard to believe he had served a tour in Iraq a few years prior, or that he likely saw things there that no one would want to see. We didn't know much about what he did in Iraq, partly due to privacy rules, but also because he didn't want to tell us. With his lack of eye contact, I imagined he saw things in combat that still affected him at that moment.
He was back in the hospital dealing with an infection in his blood which required treatment with intravenous antibiotics. The problem was that, when hospitalized in the past with a similar infection, he had been known to leave the hospital prior to finishing his antibiotics. It got to the point where we were trying to figure out an effective oral antibiotic regimen in the event he left again -- and also to give him the understanding that oral treatment would not be as good as intravenous antibiotics. Our concern was that, without adequate therapy, the infection could quickly become life-threatening. Knowing his tendency to leave in the past, we did all we could to convince him to stay.
In the midst of all this, there was always the question of whether his prior military experience may have had something to do with his behavioral pattern, leading to him leave against medical advice. The challenge that presented itself, however, was whether to ask him more about his military history, particularly about any traumatic experiences he may have had. While asking him could give us a better glimpse into his history in Iraq, we were also aware of the potential discomfort it could cause and potentially impede our ability to care for him adequately. We didn't know how he would react, and we ultimately decided not to probe deeper into his past. As his admission continued, this question would play in our minds repeatedly, but ultimately our approach stayed the same.
This situation revealed to me that caring for our veterans, particularly for those who have recently come back from combat situations, can be a challenging task. A recent survey research from the Kaiser Family Foundation showed that veterans have unique medical and social challenges after returning from combat, which can impact how they use medical care and how they are treated by healthcare providers. In this particular survey of veterans who returned after serving in Iraq and Afghanistan, the majority of veterans felt that the average American did not understand their experience and that they felt disconnected from civilian life. Fifty-six percent of veterans who were involved in armed combat felt that their physical health was worse after the war, and 39 percent of veterans in the same group reported worse mental and emotional health after returning.
Other research demonstrates that veterans returning from war are vulnerable to medical conditions such as PTSD, depression, substance-use disorders, traumatic brain injury, and musculoskeletal injuries. Diagnosing and treating these conditions can be challenging if and when a veteran chooses to or is forced to delay medical care.
Recently, mental health providers have focused on the underlying mental health disorders caused by combat that potentially lead to behavioral changes, which in turn impact the care of other medical conditions and can lead to decreased continuity of care if veterans seek care in different facilities. In the midst of -- and despite -- this effort, there remains a stigma in mental health that could cause veterans to avoid mental health facilities and care altogether. Because veterans may not always go with the VA health system, everyone in healthcare should be sensitive to the medical circumstances and challenges surrounding this particular population.
Going back to the patient I was talking about earlier: while he was in the hospital, we continued to treat his bacteremia with IV antibiotics. Every day that we checked on him, he seemed to understand the importance of staying in the hospital for adequate treatment of the bacteria in his blood. Then, one day, we got word from a nurse that he was missing from his room. Despite an extended search, we were unable to find him. It was likely that he left the hospital again, against medical advice and without antibiotics. We could only hope that his infection would not progress while he was away from the hospital.
To this day, I wondered if he had an underlying mental health disorder caused by combat that went undiagnosed and may have affected his understanding of how sick he was or how important the medicine he received was to his recovery. Perhaps it is a lesson to us not to be afraid to truly ask veterans about their experience, even the uncomfortable parts, since a piece of information they provide may be vital for providing the best possible care. Veterans deserve our full respect for the sacrifices they made to ensure us a safe and brighter future. We should give them our full attention, too.