A handful of Obama-era payment models, including bundled payments for joint replacement and treatment of several other conditions, will be eliminated or dramatically rolled back if Medicare implements a draft rule that was proposed this week.
This article first appeared August 16, 2017 on Medpage Today.
By Shannon Firth
WASHINGTON -- A handful of Obama-era payment models -- including bundled payments for joint replacement and treatment of several other conditions -- will be eliminated or dramatically rolled back if the Centers for Medicare and Medicaid Services (CMS) implements a draft rule that was proposed on Tuesday.
"Changing the scope of these models allows CMS to test and evaluate improvements in care processes that will improve quality, reduce costs, and ease burdens on hospitals," said CMS Administrator Seema Verma in a press release.
"Stakeholders have asked for more input on the design of these models. These changes make this possible and give CMS maximum flexibility to test other episode-based models that will bring about innovation and provide better care for Medicare beneficiaries," she continued.
The proposed rule calls for eliminating the Episode Payment Models (EPS) and Cardiac Rehabilitation (CR) incentive payment model altogether and reducing the number of areas for which participation in the Comprehensive Care for Joint Replacement (CJR) model is mandatory. The latter bundles orthopedic services related to lower extremity joint replacements and is now in its second year.
For 33 out of 67 areas overall, and in low-volume and rural hospitals in all areas, participation in the CJR model will be voluntary.
Both the EPMs and CR models, which aimed to test the impact of bundling cardiac and orthopedic care and improving the quality of care were slated to begin next year. The EPMs cover three major conditions: myocardial infarction treatment, coronary artery bypass graft surgery, and surgical hip and femur fracture treatment.
"We are concerned that engaging in large mandatory episode payment model efforts at this time may impede our ability to engage providers, such as hospitals, in future voluntary efforts," CMS wrote in its draft rule.
"Similarly, we also believe that reducing the number of providers required to participate in the CJR model will allow us to continue to evaluate the effects of such a model while limiting the geographic reach of our current mandatory models."
Stakeholders Respond
These models were part of CMS's agenda to move healthcare from a volume to a value paradigm, said Richard Chazal, MD, immediate past president of the American College of Cardiology, in a phone call.
While the cardiac models were "far from perfect" they did include elements with the potential to improve patient care and lower costs, including removing limitations on rewarding physicians for helping patients through what was seen as "game-sharing."
The announcement will likely mitigate a lot of the anxiety due to the limited time physicians would have had to implement their models, he said.
Physicians are being challenged to "do a good job clinically" -- keeping up with medical information and new technology -- while changes in the "non-clinical environment" such as reimbursement add another layer of difficulty to their work, he said.
Yet Chazal also warned that if the problem of rising healthcare costs isn't settled in a thoughtful and timely way, physicians could witness "crisis management at a larger level" -- such as a return to across-the-board cuts in Medicare payments or a shift to single-payer healthcare.
And there's still a lot of concern over what happens next, he continued.
"Will [the models] be implemented a little bit later with more time to prepare or will something different be proposed?" Chazal wondered.
Anders Gilberg, senior vice president of Government Affairs for the Medical Group Management Association (MGMA) said he was neither surprised nor unhappy with the proposal.
Gilberg noted that when HHS Secretary Tom Price, MD, was a Georgia congressman, he was very critical of the mandatory nature of the proposals coming from the Center for Medicare and Medicaid Innovation (CMMI).
CMMI was envisioned as a lab to test new models, but by making hospitals "the guinea pigs" of an untested programs, it provoked a lot of negative responses.
"You can't create a program and force people to test it and then hold them accountable for things that they may or may not be able to control and then penalize them," he said.
Still, he didn't see the new draft rule as the death knell for bundled payment models.
For him, the announcement signals the agency will shift towards testing programs on a voluntary basis before fully rolling them out, Gilberg said.
How hospitals in the areas affected by the CJR rule change respond to the announcement in their comments will be something to watch, he added.
Docs, Hospital Groups Happy
The American Academy of Orthopaedic Surgeons cheered the decision.
"As we have said before, AAOS strongly supports the efforts of all stakeholders to develop payment models that incentivize care coordination and address rising healthcare costs," wrote AAOS President William Maloney, MD in a press release.
While "appropriate alternative payment models are a necessary component of the current Quality Payment Program," Maloney argued that "imposing mandatory models on surgeons and facilities that lack the familiarity, experience, or infrastructure required has serious unintended consequences. Reducing the geographic area for CJR while still leaving a voluntary option significantly remedies this issue."
Also applauding was the American Medical Association, which noted that the programs had left physicians and post-acute care providers largely on the sidelines.
"Bundled payment models should instead be constructed to give physicians leadership roles in designing the care delivery process and ensuring that it achieves good patient outcomes without unnecessary costs," an AMA statement noted.
The association also cautioned the agency to ensure adequate payments for higher-need patients, "so physicians, hospitals, and others are not placed at financial risk for factors they cannot control," the group noted.
"While we understand and support the agency's care improvement goals, we believe CMS made the right move to pull back the cardiac care episode payment models. Providers selected for the Comprehensive Care for Joint Replacement (CJR) demonstration are only just now adapting to these new payment and delivery approaches and need more time before facing another demonstration and the potential for mandatory participation in two models simultaneously," said Bruce Siegel, MD, MPH, president and CEO of America's Essential Hospitals, in a press release.
"This cancellation gives CMS an opportunity to evaluate current models and correct for unintended consequences before developing another voluntary or mandatory demonstration," continued Siegel.
CMS said it had contemplated a shift from mandatory to voluntary participation for EPMs and CR payment model, but ultimately chose to propose cutting the two models given the limited time for providers to implement changes before the anticipated Jan. 1, 2018, start date.
The agency also explained why it only modified and didn't cancel the CJR model, saying physicians have been implementing that program for more than 18 months, and have, in many situations, invested in redesigning their program.
In its draft rule, the agency also noted that it did not anticipate the cancellation of the EPMs and CR incentive payment models would cost providers anything.
However, changes to the CJR model would reduce the previously estimated savings from approximately $294 million to $204 million.
The "financial toxicity" of cancer can adversely affect patients mental and physical state, particularly if they decide against recommended treatment, according to a research letter published online in JAMA Oncology.
This article first appeared August 10, 2017 on Medpage Today.
By Charles Bankhead
Out-of-pocket costs for cancer care that came in higher than expected had a significant association with patient-reported financial distress and increased reluctance to pay for recommended care, a survey of 300 patients showed.
Patients who reported "high or overwhelming" financial distress were almost five times as likely to say that the personal financial burden for their care exceeded expectations. On average, the cancer-related care consumed 11% of the patients' household income. The bite out of income increased to more than 30% among the individuals who reported feeling most burdened by finances. Two-thirds of patients who felt the most stress had private health insurance.
The findings emphasize how the "financial toxicity" of cancer can adversely affect patients mental and physical state, particularly if they decide against recommended treatment, Fumiko Chino, MD, of Duke University Medical Center in Durham, N.C., and co-authors reported in a research letter published online in JAMA Oncology.
"I think these findings suggest that, more and more, patients are taking cost into consideration as they make decisions about their cancer care," senior author Yousuf Zafar, MD, also of Duke, told MedPage Today.
Noting that a majority of the patients in the study had private insurance, Zafar said the findings imply that healthcare providers "can't rely on a patient's insurance status to determine whether or not they can afford care."
The findings also reinforced the need for clinicians to be proactive in addressing the cost of care they recommend to patients. Acknowledging that he does not discuss financial aspects of cancer care as often as he should, Zafar continued, "One easy thing for a provider to do is to ask very simply, 'Are you able to afford this treatment?' For patients who say no, we can refer them to financial counselors, or social workers or pharmacists to get them resources in a timely fashion."
The study added to a growing body of literature on the financial toll of cancer. One recent study showed that an increasing number of patients with cancer spend 10% or more of household income on healthcare costs.
Studies to date have provided little insight into patient expectations regarding the cost of cancer care and how those expectations might influence decision making. With that in mind, Chino, Zafar, and colleagues conducted a cross-sectional survey of patients identified by electronic medical records. Investigators collected standard demographic information, as well as data related to cancer diagnosis, stage, and the type and duration of treatment the patients received.
Estimated out-of-pocket expenditures for healthcare were derived from patients' self-reported estimates of recent monthly costs. Each study participant was asked how actual costs for care compared with their expectations and about how much they were willing to spend out of pocket to pay for cancer treatment, not including the cost of insurance premiums.
Investigators used a validated survey instrument to determine the patients' perceived financial stress. They calculated the median relative cost of care and assessed the impact of unexpected costs and high financial distress, taking into account patients' expected financial burden, willingness to pay for care, and subjective financial distress.
The 300 patients had a median age of 60, and 68% were married, 75% were white, 56% had private insurance, and most of the rest were covered by Medicare or Medicaid. The most common cancer diagnoses were colorectal cancer (27.0%), breast and lung cancers (17% each), and pancreas/biliary (13%).
About 40% (118/300) of the patients said their cancer care posed an "unexpected financial burden," and 49 patients (16%) reported "high or overwhelming" financial distress (score >7). Patients who reported unexpected financial burden were younger (57 versus 61), less likely to be married (62% versus 74%), more likely to be unemployed (41% versus 17%), had higher monthly out-of-pocket costs ($703 versus $553), and spent more of their income on care (17% versus 10%).
The subgroup reporting high or overwhelming financial distress had a median age of 54. They were more likely to have private insurance as compared with those who reported average financial stress or less (67% versus 54%), and they had a lower annual income (60% earned <$40,000 versus 26% for others). On average, they paid $728 a month for healthcare and spent 31% of their income on their care (versus $565 and 10% for others). They had a median financial distress score of 8.1 compared with 3.3 for other patients reporting less financial stress.
By multivariable analysis, a higher-than-expected financial burden boosted the odds ratio for high or overwhelming distress to 4.78 (95% CI 2.02-11.32, P<0.01) and decreased patients' willingness to pay for care by more than 50% (OR 0.48, 95% CI 0.25-0.95, P=0.03).
"Those who spend more than 10% of their income on healthcare costs are considered underinsured," Chino said in a statement. "Learning about the cost-sharing burden on some insured patients is important right now, given the uncertainty in health insurance."
The bill—known as the Health Care Freedom Act—would have repealed the employer and individual mandates, but would have left other elements of the ACA in place.
This article first appeared July 28, 2017 on Medpage Today.
Joyce Frieden, News Editor, and Shannon Firth, Washington Correspondent
WASHINGTON -- In a session that lasted into the wee hours Friday morning, the Senate voted down a “skinny” bill to repeal the Affordable Care Act (ACA), dealing a big blow to the chamber’s Republican leadership.
The vote was 49-51 to defeat the bill — known as the Health Care Freedom Act — which would have repealed the employer and individual mandates, but would have left other elements of the ACA in place. It also would have defunded Planned Parenthood and repealed the medical device tax. Along with all of the Senate’s Democrats and its two Independents, three Republicans — John McCain of Arizona, Lisa Murkowski of Alaska, and Susan Collins of Maine — also voted against the bill.
“This is a disappointment, a disappointment indeed,” Senate Majority Leader Mitch McConnell (R-Ky.) said after the vote. “I regret that our efforts were simply not enough this time.”
“I imagine many colleagues on the other side are celebrating, but the American people are hurting and they need relief,” he continued. “Now I think it’s appropriate to say, ‘What are [Democrats’] ideas?’ It will be interesting to see what they suggest as the way forward.” He immediately knocked down one idea: “Bailing out insurance companies with no thought of any kind of reform — that’s not something I want to be part of, and I suspect there are not many folks over here that are interested in that.”
Senate Minority Leader Chuck Schumer (D-N.Y.) adopted a conciliatory tone. “I’d say to [McConnell] that we’re not celebrating; we’re relieved that the millions of people who would be so drastically hurt by the proposals put forward will be able to maintain their healthcare,” he said. “But as I have said over and over again, Obamacare is hardly perfect. It did a lot of good things but it needs improvement.”
“I would suggest we turn the page … And I hope one part of turning the page is we go back to regular order and work [together] to improve Obamacare,” he continued. “There are suggestions we’re interested in that come from the other side of the aisle. So let’s turn the page and work together to improve our healthcare system.”
Democrats Oppose the Measure
Senate Minority Leader Chuck Schumer (D-N.Y.) urged Republicans to vote against the bill. "Listen to what the CBO said; it said that skinny repeal would cause 16 million Americans to lose insurance and millions would pay 20% more for premiums starting next year -- not 3 years from now but in January," he said. "One of the promises Republicans made was to bring down premiums, but this would break that promise."
"You don't vote to advance terrible legislation and hope it gets better in conference," he added. "Let's not forget -- months ago the House voted to pass their bill because they hoped it would get better in the Senate. Well, it hasn't gotten better yet."
Sen. Sheldon Whitehouse (D-R.I.) pointed out that most medical organizations opposed the bill. "Who did the magicians who came up with this listen to? They obviously didn't listen to the doctors," he said. "The American Medical Association is opposed, the American Academy of Family Physicians is opposed to this bill ... the American Heart Association is opposed to this bill ... Rural hospitals are warning that this could end their very existence."
Single-Payer Shot Down
Before the skinny repeal bill was debated, the Senate voted on a single-payer bill introduced by Sen. Steve Daines (R-Mont.). "The amendment I'm putting forward here today is ... a carbon copy, down to every last comma and period, of Rep. [John] Conyers' [single-payer House] bill, which has 115 Democratic cosponsors as I speak."
"I believe Montanans and the American people deserve to debate different ideas," said Daines. "Earlier today Sen. [Bernie] Sanders suggested that my amendment was intended to embarrass Democrats. Sen. Sanders, my amendment shouldn't embarrass anyone; I'm trying to show the American people who is supportive of socialized medicine and who is not. Tell the American people what you think. I think we should vote No on this; what say you?"
Sanders decried Daines' m0ve as a "political trick" to force some Democratic senators into an uncomfortable political position. "I hope this is really a breakthrough on the part of my Republican colleagues," he said. "I hope they recognize that the U.S. should join every other major country on earth in recognizing that healthcare is a right, not a privilege."
"I hope that's what Mr. Daines will be saying, but I kinda think that's not what he'll be saying," said Sanders. "If Mr. Daines is serious, let us work together, but now is not a time for political games."
Daines' bill failed 57-0, with Sanders, an independent, and 42 Democrats voting "present". Besides all 52 Republicans, those voting No included Sen. Angus King (I-Maine) and Democrats Joe Manchin of West Virginia, Jon Tester of Montana, Heidi Heitkamp of North Dakota, and Joe Donnelly of Indiana.
The Daines bill "was an explicit ruse, intended to waste some of the 20 hours of debate time and an attempt to taunt and then 'embarrass' Democrats into formally admitting that they are all socialists," said Jay Wolfson, DrPH, JD, associate vice president of USF Health, in Tampa, Fla., in an email to MedPage Today. "It was an old state legislative trick in which a member introduces a bill and then votes against it. Single-payer is not achievable in the current Congress in any event."
"Cadillac Tax" Repeal Passes
The Senate also voted down an amendment by Sen. Luther Strange (R-Ala.) to make the premium tax credits offered through the Affordable Care Act subject to the Hyde Amendment, which bars federal funds from being spent on abortion. The amendment, which required 60 votes to pass, went down by a vote of 50-50.
They did pass one amendment, which was to repeal the "Cadillac tax" on high-cost health insurance plans. The amendment passed by a vote of 52-48.
As the day wore on, some Republican senators expressed their misgivings about the skinny repeal bill. "We've been asked by the leadership ... to vote for the 'least common denominator,'" Sen. Lindsey Graham (R-S.C.) said at a news conference at which he appeared with Sen. Ron Johnson (R-Wisc.) and McCain. "The pitch is if we go to conference, we can get my [alternative] bill scored, we can get Sen. [Ted] Cruz's bill scored .... That makes eminent sense to me, with one condition -- that we actually go to conference."
On the other hand, Graham added, "The skinny bill as policy is a disaster; it's not a replacement in and of itself." He particularly objected to the bill's elimination of the employer mandate, which he said would increase premiums while keeping most of the ACA in place. "And we politically own the collapse of healthcare. So we're not going to do that with our vote. What we'll do is move the process along."
House Speaker Paul Ryan issued a statement Thursday that appeared to be intended to reassure anxious senators -- but with some caveats. "If moving forward requires a conference committee, that is something the House is willing to do," he said.
"The reality, however, is that repealing and replacing Obamacare still ultimately requires the Senate to produce 51 votes for an actual plan. The House remains committed to finding a solution and working with our Senate colleagues, but the burden remains on the Senate to demonstrate that it is capable of passing something that keeps our promise, as the House has already done. Until the Senate can do that, we will never be able to develop a conference report that becomes law."
The defeat of the Senate bill capped a difficult few days for Senate Republicans. On Tuesday, things were looking up when senators narrowly voted to proceed with a debate on a repeal bill, although it was not yet clear which bill that would be. But on Wednesday, the Senate voted down two bills — first a bill to repeal the ACA without a replacement, and then a second bill — the Better Care Reconciliation Act — to repeal and replace the law.
Overall, there was a 12.7% relative reduction in the incidence of hospital admission for respiratory illness among fee-for-service Medicare beneficiaries in high-dose vaccination facilities, researchers found. From MedPage Today.
This article first appeared July 20, 2017 on Medpage Today.
By Molly Walker
Nursing homes whose residents received the high-dose influenza vaccine had fewer hospital admissions for respiratory illnesses compared to those who received standard-dose vaccine, a large randomized trial found.
Patients who were at least 65 years of age were randomized to receive high-dose vaccine had a significantly reduced risk of pulmonary and influenza-related hospital admissions (adjusted RR 0.87, 95% CI 0.78-0.98, P=0.02) compared to patients who only received the standard dose of the vaccine, reported Stefan Gravenstein, MD, of Brown University, and colleagues.
Significant differences were observed in all-cause hospital admissions (adjusted RR 0.92, 95% CI 0.87-0.97, P=0.003) and pneumonia-related hospital admissions (adjusted RR 0.79, 95% CI 0.27-0.95, P=0.01) among the high-dose vaccination group versus the standard dose group, the authors wrote in The Lancet Respiratory Medicine.
"If given to all approximately 1.5 million nursing home residents, a one percent drop in hospitalizations would translate to thousands fewer being hospitalized," Gravenstein said in a statement.
The authors noted that lower respiratory tract infection, such as pneumonia and bronchitis, is the leading cause of admission to the hospital from infectious diseases and mortality among older adults, with influenza as the most important viral infection clinically.
While a high-dose influenza vaccine (Fluzone High-Dose from Sanofi-Pasteur), with four times more antigen than the standard dose vaccine, was approved in 2009, they said that only a single study examined immunogenicity of high-dose influenza vaccine in nursing homes.
Researchers conducted a randomized trial in Medicare-certified nursing homes in the U.S. within 50 miles of a CDC influenza reporting city, which had more than 50 long-stay residents, less than 20% of the population under 65 years of age and that were not already planning on administering the high-dose influenza vaccine to their patients.
In total, 823 facilities were randomized -- 409 whose residents received the high-dose influenza vaccine and 414 whose residents received the standard dose vaccine. Eligible participants were at least 65 years of age and had been in the facility for 90 days or more prior to vaccination. Their Medicare hospital claims were then tracked.
There were 38,256 Medicare fee-for-service beneficiaries -- 19,127 in the high-dose group and 19,129 in the standard-dose group. Patients in both groups were a mean age of 84 years old and about three-quarters were women and white race. Vaccination rates for each group ranged from 76% to 77%.
Overall, there was a 12.7% relative reduction in the incidence of hospital admission for respiratory illness among fee-for-service Medicare beneficiaries in high-dose vaccination facilities, the authors said. Incidence of all-cause hospital admissions was 8% lower in the high-dose vaccination group.
"The fact that we observed a lower rate of hospitalization from all causes, too, suggests that vaccine offers protection beyond flu-related outcomes, perhaps including heart and other conditions," Gravenstein said.
However, no significant difference was observed in all-cause mortality rates or the proportion of residents with a significant cognitive decline (defined as a change in Activities of Daily Living score of at least four points) between the two groups.
An accompanying editorial by Marc-Alian Widdowson, MD, and Joseph S. Bresee, MD, both of the CDC, sounded a couple of notes of caution about the findings. While they pointed out that the authors estimated that vaccinating about 69 residents with the high-dose vaccine would prevent one hospital admission of any cause, they characterized the scale of reduction in this study as "unexpectedly large."
"Since the respiratory-coded hospitalizations represented only one in five all-cause hospitalizations in the study, the 8·5% reduction in seasonal all-cause hospitalizations would [have mainly been] averted non-respiratory hospitalizations," they reasoned.
And, they observed, "no more than 10% of all-cause seasonal mortality in elderly people has been attributed to influenza."
Other limitations noted by Gravenstein and colleagues are that laboratory data were not available to confirm influenza activity, and that the predominant influenza strain during the study period -- influenza A(H1N1)pdm09 -- affects hospital admissions and functional decline to a lesser degree among older adults. In addition, the study did not include a group that received no vaccine.
WASHINGTON -- Non-economic damages in medical malpractice cases would be limited to $250,000 nationwide under a bill passed Wednesday by the House.
H.R. 1215, known as the Protecting Access to Care Act, passed by a vote of 218-210. It would cap non-economic damages in medical liability cases at $250,000 in states that have not set a limit. (In those that already have their own caps, theirs would prevail.) The bill was originally scheduled for a vote nearly 2 weeks ago, but was later rescheduled.
The act, which would apply only to cases involving services covered wholly or partly by federal insurance programs such as Medicare, Medicaid, and the Federal Employee Health Benefits Program, would also:
Set a statute of limitations for filing malpractice suits at 3 years after the date of the injury, or 1 year after the plaintiff discovers -- or should have discovered -- the injury.
Repeal the "collateral source" rule, which says that damages a plaintiff receives cannot be reduced due to payments they are receiving for their injury from someone other than the defendant (such as worker's compensation).
Ban "joint and several liability" in successful suits, which makes each individual defendant fully responsible for paying the entire damage award if others can't pay.
Limit attorneys' contingency fees in malpractice cases.
Prohibit successful plaintiffs from receiving jury awards in a lump sum.
Ban hospitals and healthcare providers from being named in lawsuits involving allegedly unsafe drugs, regardless of whether the hospital or provider was negligent in prescribing or administering the drug.
Republicans argued that the measure would save the government money and bring needed reforms to the medical malpractice system.
"We have a federal interest in healthcare, that if there's federal money involved, the federal government has an interest in limiting these [awards]," said Rep. Steve King (R-Iowa). "The $250,000 cap is reasonable, it's sustained itself over 40 years in California," which has a similar law, he said. "If we don't change the law, we will see these healthcare costs going up."
Billions of dollars are currently spent each year on "defensive medicine" -- tests and procedures that aren't medically necessary but are performed to protect physicians in case of lawsuits, he added.
Rep. Phil Roe, MD (R-Tenn.), an ob/gyn, also spoke in favor of the measure. "My insurance premiums increased from $4,000 to $50,000 per year by time I left practice [after 31 years]," he said, noting that he accepted patients with all types of insurance, including patients with complex problems. "When you're taking care of patients with elevated risks, you get more negative outcomes, increasing the risk of lawsuits ... and this decreases access to care."
Roe also introduced an amendment to the bill that would mandate that expert witnesses be from the state in which the case was being heard or a contiguous state, and be in the same specialty as the physician defendant. His amendment was passed in a voice vote.
Democrats opposed the bill, arguing that it would hurt plaintiffs in malpractice cases. "This bill will severely limit when an injured person is allowed to bring a suit by shortening the time to seek relief," said Rep. David Cicilline (D-R.I.). The cap on pain and suffering would "benefit insurance companies and wrongdoers. This cap even applies to intentional acts of misconduct. The legal system should work for the benefit of hard-working Americans, not for the powerful special interests. ... Middle-class families need to see that we're on their side."
Rep. Ted Deutch (D-Fla.) noted that Republicans said the bill would not cap any damages that could be catalogued with receipts. "A young child goes in for a simple procedure and leaves the hospital paralyzed; a young adult requires amputation of the left leg, but the doctor amputates the right leg and the [patient] leaves the hospital with neither ... There are no receipts to cover the costs those individuals will suffer for the rest of their lives," he said. "Why do my colleagues believe they are in a better position to determine how those wronged individuals should be compensated for atrocities that happened to them, instead of allowing a jury of their peers to do the same?"
One Republican, Rep. John Duncan Jr. of Tennessee, also spoke in opposition to the bill. "The bill ... could lead to massive expansion of federal authority because it could make almost every medical malpractice case a federal case," he said. In addition, "$250,000 29 years ago [when these limits were first sought] is not $250,000 today ... Conservatives used to believe strongly in the jury system and still should believe in it today."
The House also approved several other amendments to the bill, including one that would prohibit the introduction of physicians' apologies as evidence of liability and require patients to obtain a certificate of merit from a medical professional before a case could go forward. Another amendment approved by the House would fix the time at which the statute of limitations begins at either the date the injury occurred, such as with a surgical procedure, or -- in the case of longer-running treatment -- on the date of the last treatment given. An amendment to allow physicians to use national practice guidelines as a defense against a lawsuit was defeated.
The bill now heads to the Senate, where its prospects are uncertain.
Attendees of the annual AMA House of Delegates meeting want more study on licensing for advanced practice registered nurses. From MedPage Today.
This article first appeared June 15, 2017 on Medpage Today.
By Ryan Basen, Contributing Writer, MedPage Today
CHICAGO -- The American Medical Association voted Wednesday to oppose physician assistants having their own regulatory boards, but stopped short of addressing the independence of a group of nurse practitioners -- for now.
Debating at the annual AMA House of Delegates meeting, delegates also supported keeping medical licensing and regulatory boards in charge of regulating "the practice of medicine through oversight of physicians, physician assistants and related medical personnel."
The provision addressing physician assistant boards specifically calls for AMA to "oppose legislative efforts to establish autonomous regulatory boards meant to license, regulate, and discipline physician assistants outside of the existing state medical licensing and regulatory bodies' authority and purview."
The move follows the American Academy of Physician Assistants' approving a policy in May seeking to remove state ordinances that "require a PA to have and/or report a supervisory, collaborating, or other specific relationship with a physician ... [and seeking to establish] autonomous state boards with a majority of PAs as voting members to license, regulate and discipline PAs, or for PAs to be full voting members of medical boards."
An AMA committee report labeled this an "anticipated legislation to move PAs into a more autonomous role" since state medical boards have authority over PAs at the moment, the committee reported.
AMA delegates also introduced a similar measure to place advanced practice registered nurses (APRNs) under state medical board and regulatory control, with AMA developing model state legislation.
But by a 254-204 vote that measure was referred back to an AMA council for additional study. "Every state places the authority to regulate APRNs under the state nursing board -- a structure that is unlikely to change," according to an AMA committee report.
That vote likely frustrated some delegates who had spoken up during discussion. "This is a timely matter," said a delegate from California. "It has been set up wrong for years and it needs to be changed."
"We can only interview physicians to find out what's going on right now," said John Goldman, MD, a Georgia rheumatologist. APRN's report to nursing boards and "we never get anything back."
Targeting Tobacco
Also Wednesday the House debated, but ultimately declined to rule on, a resolution asking AMA to be more aggressive countering tobacco and nicotine use.
Portions of the measure contradicted AMA policy that favors "FDA-approved smoking cessation tools and prohibits product claims of reduced risk or effectiveness as tobacco cessation tools, until credible evidence is available," according to an AMA committee report. Delegates supported that committee, calling for the the measure to be dropped.
Other delegates successfully lobbied to have the measure studied further instead, pushing for research into cessation strategies and prohibiting marketing of "electronic nicotine delivery system" and tobacco to children. "A lot of people think these harm-reduction techniques are as dangerous as smoking," said James Felsen, MD, of West Virginia. "We need to get that message out (that they are not)."
"There are other ways to talk to patients about this," said Alan Klitzke, MD, of the American College of Nuclear Medicine. "We need to study this."
The measure was referred to an AMA council for further study, by a 299-154 vote (with those opposed seeking to squash it).
"After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," the agency said in announcing the move. "This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse."
In Thursday's action, the FDA said it was asking Endo to voluntarily cease marketing Opana ER. But it added that if the company refuses, the agency will "take steps to formally require its removal by withdrawing approval."
The FDA said its data indicate that the abuse of the drug has shifted from snorting to injection following reformulation in 2012, which was intended to help the pills resist physical and chemical manipulation. However, the agency had declined to allow Endo to market the product as abuse-resistant.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement. "This action will protect the public from further potential for misuse and abuse of this product."
Analysis shows that cost, quality of care, and survival rates are better under bundled payment models.
This article first appeared June 01, 2017 on Medpage Today.
By Matt Wynn
The fee-for-service model of cancer care is a major driver of waste, "creating perverse incentives to provide high-cost, low-value care without sufficiently monitoring quality," Ethan Basch, MD, writes in the latest issue of JAMA Oncology. Basch is director of the Cancer Outcomes Research Program at the University of North Carolina-Chapel Hill School of Medicine.
One solution, he argues, might be to adopt a model like that explored in a study published in March, also in JAMA Oncology, by C. Jason Wang, MD, and colleagues. That study used data from Taiwan to examine how cancer patients fared for 5 years. Some patients were treated under the country's bundled payment program, which pays hospitals for each newly diagnosed breast cancer based on stage-specific, guideline-recommended treatment costs. Others were treated at non-participating hospitals, which used a traditional fee-for-service payment method.
The results give strong evidence to finding alternative funding models, Basch writes. Event-free survival for women with nonmetastatic disease was almost 5% better in the bundled payment group at 5 years. Care was also more likely to adhere to quality standards, and costs were lower. Whether looking at cost containment, outcomes, or quality care adherence, the bundled payment system represented an improvement.
While not quite an apples-to-apples comparison, the findings indicate that the CMS Innovations Center's new Oncology Care Model (OCM) should improve care in the U.S., too.
Basch said that he is hopeful that the OCM is the first step toward a more sane payment system for cancer care.
"The United States must do more to improve quality and slow the increasing cost of care," he wrote. "In the past, the field of oncology was slow to experiment with new approaches, but that can no longer be the case."
The national age-adjusted Alzheimer's disease death rate per 100,000 population increased from 16.5 to 25.4 between 1999 and 2014—nearly a 54% increase.
This article first appeared May 25, 2017 on Medpage Today.
by Alexandria Bachert
Death rates from Alzheimer's disease in the U.S. increased 55% over the past two decades, with a significant increase in the percentage of deaths occurring at home, reported researchers.
The national age-adjusted Alzheimer's disease death rate per 100,000 population increased from 16.5 (44,536 deaths) in 1999 to 25.4 (93,541 deaths) in 2014.
Over this 16-year period, the majority of deaths due Alzheimer's disease continued to occur in a nursing home or long-term care facility, but the percentage occurring in these institutional settings decreased from 68% to 54%, reported Christopher A. Taylor, PhD, of the CDC, and colleagues.
Conversely, the percentage of patients who died at home increased from 13.9% in 1999 to 24.9% in 2014, they wrote online in the CDC's Morbidity and Mortality Weekly Report.
"Our new study reveals an increase in the incidence of Alzheimer's disease-related deaths. As the number of older Americans with Alzheimer's disease rises, more family members are taking on the emotionally and physically challenging role of caregiver than ever before. These families need and deserve our support," CDC Acting Director Anne Schuchat, MD, stated in a press release.
Taylor and colleagues analyzed state- and county-level death certificate data from the National Vital Statistics System from 1999 to 2014 to identify deaths with Alzheimer's disease reported as the underlying cause.
Age-adjusted rates of Alzheimer's mortality significantly increased for 41 states and the District of Columbia -- with country-wide rates ranging from 7.0 to 29.8 per 100,000 in 1999 and from 10.7 to 43.6 per 100,000 in 2014.
Using average annual county-level data, the researchers found that from 1999 to 2014 the age-adjusted rates of Alzheimer's deaths ranged from 4.3 to 123.7 per 100,000. Counties with the highest age-adjusted rates were primarily in the Southeast, followed by some additional areas in the Midwest and West.
Age-wise, the sharpest increases in Alzheimer's disease mortality were seen in those younger than 65 and those 85 and older. For both age groups, mortality rates rose more than 60% during the study period.
Explanations for the findings could include increases in diagnosis of Alzheimer's disease at earlier stages, increased reporting of the cause of death, and fewer deaths from other causes such as heart disease and stroke, noted the researchers.
The CDC concluded that the increase in caregivers tending to dying patients at home calls for better interventions -- such as education, respite care, and home health assistance -- to help them provide care.
"As Alzheimer's disease progresses, caregiving becomes very important. Caregivers and patients can benefit from programs that include education about Alzheimer's disease, how to take care of themselves and their loved one, and case management to lessen the burden of care," stated Taylor.
"Supportive interventions can lessen the burden for caregivers and improve the quality of care for people with Alzheimer's disease," he added.
Limitations were that death certificates might have underestimated the actual number of Alzheimer's deaths in the U.S., as well as that complications from Alzheimer's, such as pneumonia, might have been reported without mentioning Alzheimer's disease. Additionally, for some individuals with Alzheimer's disease, death certificates may have merely listed "dementia" as the cause and these were not counted in the study.
The bill targets services for chronically ill Medicare beneficiaries.
This article first appeared May 11, 2017 on Medpage Today.
by Joyce Frieden
The Senate Finance Committee unanimously approved a bill Thursday aimed at improving care for Medicare beneficiaries with chronic conditions.
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 (ACOs). It also would extend the Independence at Home demonstration program to keep people in their homes rather than hospitals, allow reimbursement for more non-health and social services, and extend permanently MA Special Needs plans that target chronically ill beneficiaries.
"One thing we hear a lot from ACOs is they have trouble keeping beneficiaries in-house rather than going to a provider outside the ACO, and that makes it harder to coordinate their care," a committee aide said. "This bill says that if you go to a primary care doctor in the ACO, we'll reduce or eliminate your cost-sharing for that primary care service. That will make beneficiaries stick to the ACO, and bring down their costs."
Sen. Ron Wyden (D-Ore.), the committee's ranking member, told MedPage Today that the measure is "transformative." "This is a formal recognition that this package of services -- the focus on care at home, the focus on new technology, the expanded role for primary care and prevention, which inevitably leads to more non-physician providers -- is the beginning of our push to update the Medicare guarantee. That's why it's transformative."
"Medicare is a promise, a guarantee that you get these defined benefits -- but Medicare 2017 does not resemble Medicare 1965," when the program first began, he continued. Back then, "All we were doing is talking about Medicare Part A and Part B ... Now we've got Medicare Advantage, coordinated care, patient-centered programs, and fee-for-service. This bill will benefit seniors in each one of the major ways in which they get their Medicare."
As for having the bill move through the House, Wyden said he has been talking about the bill to House Speaker Paul Ryan (R-Wisc.) and House Ways & Means Committee Chairman Kevin Brady (R-Texas). "Obviously the fact we passed this 26-0 will send a powerful message. This is an extraordinary development."
Finance Committee chairman Orrin Hatch (R-Utah) praised the bipartisan teamwork involved in getting the bill through the committee. "Given the contentious nature of our nation's current healthcare debate, it's remarkable we're able to get to this point," he said. "This endeavor has been the very definition of a team effort."
Several committee members spoke about the amendments they wrote into the bill. "If we want to bend cost curve and improve healthcare around the nation, we must address the issue of non-adherence," said committee member Pat Roberts (R-Kan.). "Our amendment directs [the Department of Health and Human Services] to establish a process by which Medicare prescription drug plans can request Parts A and B claims data to promote appropriate use [of medications]."
Others spoke about amendments that weren't included in the bill, or measures that they wanted to work on separately. Sen. Rob Portman (R-Ohio) said he had wanted to make permanent the Medicare Independence at Home Program -- which provides services to keep beneficiaries with chronic illnesses at home rather than in nursing homes or other facilities "[but instead] we got a 2-year extension. We only got that because the [Congressional Budget Office] score is misleading."
However, "another 2 years will give us the data to convince CBO that we're right," he continued. "It's worked really well; in Ohio we got great results. On average, we saved $3,000 per beneficiary."
Sen. Ben Cardin (D-Md.) urged the committee to take up a permanent repeal of Medicare's cap on reimbursement for physical, occupational, and speech therapy services. "It makes no sense whatsoever, and it does impact where people can get their therapy services," said Cardin, who has introduced a bill on the issue. "It also discriminates against those who have the greatest need."
"We've taken steps to make sure the cap doesn't take effect," he added. "And we have the votes to pass a permanent repeal of the therapy cap; we just haven't [managed ] to get it done. I urge the chairman and ranking member to find a way to get this done."
If Congress wants to tackle the issue of chronic illness, it can't ignore obesity, said Sen. Bill Cassidy, MD (R-La.). "The fact is, if you look at what's driving chronic disease in our nation, it's obesity. You cannot address a program in chronic disease without first addressing this. That's why senators [Tom] Carper (D-Del.), [Chuck] Grassley (R-Iowa) and I have introduced the Treat and Reduce Obesity Act," which would expand the types of Medicare providers who could be reimbursed for intensive behavioral therapy for obesity, and would require Medicare to pay for obesity medications.
"I am hopeful we can move forward with this legislation in the future," Cassidy said, adding that a CBO cost estimate on the bill was still needed.
In an unusual marker of the bill's importance, after the committee meeting ended, Hatch and Wyden posed for a photo with members of their staff, who had worked on the bill for several years.