Representatives of the American Medical Association, Trinity Health, and Blue Cross Blue Shield are pressing for a postponement to the proposed Medicare Access and CHIP Reauthorization Act rule. From MedPage Today.
This article first appeared July 13, 2016 on the MedPage Today website.
by Shannon Firth
Physician and other major healthcare groups continue to lobby the Centers for Medicare and Medicaid Services (CMS) to delay the start of the new rule that overhauls physician payment.
Representatives of the American Medical Association (AMA), Trinity Health, and Blue Cross Blue Shield (BCBS) pressed for a postponement to the proposed Medicare Access and CHIP Reauthorization Act (MACRA) rule at a panel Monday hosted by the Alliance for Health Reform, and sponsored by the AMA and the BCBS Association.
The reporting period for the new rule is slated to begin in January 2017, with payments adjustments based on those metrics to begin in January 2019.
Eppes also said that the window for trying to understand and meet the requirements of the MACRA rule is too short. The AMA has recommended delaying the start of the performance period from January to July 2017.
"Do it right. Do it right the first time," he said.
MACRA consists of two payment channels: the Merit-based Incentive Payment System (MIPS) and a system of advanced alternative payment models (APMs) that beginning in 2020, will receive a 5% bonus delivered in a lump sum each year.
Most physicians will not be eligible for the advanced APMs and will be relegated to MIPS, which relies on a four-part scoring model based on metrics of quality, resource use, advanced care information, and clinical practice improvement activities.
In addition to delaying the rule, Eppes and the AMA urged CMS to:
Further simplify the reporting requirements for quality and clinical practice improvement
Increase the low-volume threshold to exempt more physicians from the default payment program (MIPS)
Preserve the "hardship exemption" offered under Meaningful Use for its replacement, Advance Care Information
"You make it too complicated, you're going to lose physicians," he said. "They'll either quit [or] they'll quit taking Medicare and Medicaid. They will opt out. ... They'll do concierge. That's not what you want."
Tonya Wells, vice president of public policy and federal advocacy for Trinity Health in Livonia, Mich., also pushed to reset the start date of the performance year to January 2018. She also recommended pushing the first MIPS and advanced APM payment year from 2019 to 2020.
BCBS has recommended a "soft launch" of the MIPS program, said Donald Fischer, MD, MBA, of DRFischer Consulting in Pittsburgh, who recently retired as chief medical officer for BCBS's western Pennsylvania affiliate. He said the insurer would prefer either delaying the start date for the performance period or "staggering start dates."
Panel member Lemeneh Tefera, MD, medical officer for the Center for Clinical Standards & Quality at CMS, stressed that the rule's start date of January 2017 was only "the beginning of a window to report" and that some metrics could be reported as late as March or July 2017.
Joel Brill, MD, chief medical officer at Predictive Health in Phoenix, and a representative of the American Gastroenterological Association, criticized CMS for favoring primary care over specialty groups.
Brill, who was not on the panel, said he wanted to know why CMS wasn't including more disease-specific models in their advanced alternative payment models. Among the six proposed models that currently qualify as advanced APMs, only one, the Oncology Care Model Two-sided Risk Arrangement, targets specialists.
One model in the Predictive Health system showed a 50% reduction in emergency department visits and inpatient hospitalizations, Brill said, and also shrunk overall annualized costs for children and adults with irritable bowel syndrome.
"If we are demonstrating what you're asking for -- upside and downside risk, decrease in unnecessary care, improvements in patient engagement, and overall decrease in cost -- what else do you want from us for an APM?" he said.
"A lot of the work we're doing is incremental," he stressed. "We have not reached as many corners in the house of medicine as we'd like to but we are working to do that."
However, not everyone was in favor of a delay. Mara McDermott, vice president of federal affairs at CAPG in Washington, told MedPage Today that most of the physicians CAPG represents have been preparing for theses changes since 2006, and many have already applied to be aNext Generation Accountable Careorganization. CAPG represents physician organizations that practice capitated, coordinated care.
"We're very concerned about delay, leading to more delay," said McDermott, who did not sit on the panel.
In theory, paying for performance makes logical sense, says Ashish Jha, MD, MPH, director of Harvard's Global Health Institute. But eliminating pay-for performance programs isn't the answer, he says. Instead, an overhaul is necessary. From MedPage Today.
This article first appeared July 7, 2016 on the MedPage Today website.
by Shannon Firth
Should new pay-for-performance programs be improved and expanded on, or are such models simply ill-advised? Health policy experts debated value-based payment models at a recent webinar.
Take two hospitals, one with a high death rate after heart attacks, and another with a lower death rate after heart attack, but only after the numbers have been risk adjusted. Without incentives or penalties, both are paid the same by Medicare, he said.
"There's been a sense for a very long time, that that's just not right," Jha stated.
One early attempt to enhance care by rewarding performance was the Premier Hospital Quality Incentive Demonstration program of 2003. The program placed 2% of Medicare hospital payments at risk, mainly by measuring clinicians adherence to process measures.
But after 6 years, researchers evaluating the program found "no impact whatsoever on mortality," Jha said.
Despite these weak results, new pay-for-performance models were rolled out as part of the Affordable Care Act.
Under the Hospital Readmissions Reduction Programs (HRRP), which began in 2011, Medicare penalizes hospitals as much as 3% of their Medicare payments for "higher than expected" readmission rates for a handful of conditions, including heart attacks, heart failure, and pneumonia. Chronic obstructive pulmonary disease (COPD) and hip replacement were added later.
About 80% to 90% of hospitals were penalized under the program, but there were some positive results as readmission rates for targeted conditions fell from 21.5% in 2007 to 17.8% in 2015 -- a drop of nearly 4 percentage points -- according to a study in the New England Journal of Medicine.
However, most of the hospitals with the highest readmission rates were safety net hospitals, or facilities with a higher proportion of black patients, Hispanic patients, poor patients, poorly educate patients, and Medicaid patients. This left many policy experts questioning the risk adjustment abilities of such programs.
The results of the Hospital Value-Based Purchasing program, which tied Medicare payment to a broad spectrum of quality measures -- some process measures as well as outcomes, efficiency, and patient experience metrics -- mirrored those of the Premier program.
"In the 3 years or so that [Hospital Value-Based Purchasing] has been up and running there, has been no impact on mortality," Jha said.
In January 2015, the Secretary of the Department of Health and Human Services (HHS) announced a goal of linking 85% of all traditional Medicare payment to quality or value by 2016, and then 90% via incentive programs such as the Hospital Value Based Purchasing and the HRRP.
"The fundamental question is: If the old stuff didn't work, is this going to work any better?," Jha said.
He said eliminating pay-for performance programs isn't the answer, but an overhaul is necessary. He suggested that pay-for-performance models might be more effective if incentives were greater.
"Maybe 1, 2, and 3% aren't the right numbers?" he said.
Jha also suggested targeting a smaller number of outcomes, aligning metrics with things doctors and nurses are intrinsically motivated to do, and developing a more "nuanced approach" to safety net hospitals.
In comparing his view of pay-for-performance with Jha, Robert Berenson, MD, a fellow at the left-leaning Urban Institute in Washington, cited the old joke, "the food's terrible and the portions are too small."
Berenson disagreed with Jha's suggestion to scale up incentives.
He said that the science of performance measurement is still very young, and that there should be more investment in its research. While there are things that should be measured -- blood pressure, for example -- there are few uniform quality standards for doing so.
He also argued that one danger of pay-for performance models is "testing to the test," where clinicians acquire a kind of tunnel vision for the targeted metrics. He added that creating such focus on targeted metrics will "crowd out" physicians' professional obligations.
Even if targeted performance metrics do improve, one could see see an overall performance decline, he said. "In other words, we measure much less than what we care about."
Berenson stressed that opposing pay-for-performance does not mean accepting the idea of zero accountability. He said he believes metrics can be useful as part of comprehensive major quality improvement, taking the readmissions program as one example. But "we need to figure out what we're doing here."
This means deciding which measures are valuable, determining how to assess statistical significance, and learning to avoid unintended consequences, such as surgeons "gaming" the system by declining to operate on more challenging patients in order to reduce their mortality rates.
"We can't put the genie of performance measurement back in the bottle, even though some of us would like to ... so we probably should do it better than the way we're doing it now," Berenson pointed out.
“MACRA is just a gigantic illusion," said a senior fellow at the American Enterprise Institute at a briefing on the Medicare Trustees report in Washington. But a visiting scholar at the Brookings Institute said, "the Affordable Care Act is working." From Medpage Today.
Physicians are likely to be hurt by the legislation passed to repeal Medicare's sustainable growth rate reimbursement formula, several experts said at a briefing here Thursday on the Medicare trustees' report sponsored by the Brookings Institution and the American Enterprise Institute (AEI).
"Doctors are going to be livid when they absorb the fact that they spent so much political capital to enact MACRA [the Medicare Access and CHIP Reauthorization Act] only to find out ... that under the current payment system, doctors are going to get paid less; that gap will grow over time," said Robert Moffit, PhD, senior fellow in the Center for Health Studies at the Heritage Foundation, a right-leaning think tank here. "When they absorb that fact, I think we're going to see more trouble on Capitol Hill over physician payment."
At the discussion, Paul Stipalnic, Medicare's chief actuary, explained how physician reimbursement will work under MACRA. "Depending on whether the provider will ultimately be in an alternative payment model (APM) or in the Merit-based Incentive Payment System (MIPS), they will be either getting a 0.75% or 0.25% payment rate update each and every year into the future," he said. "That's the payment rate update whether inflation is 1.5% or 3% or 4%. The Medicare Economic Index is expected to increase at 2.2% for physicians, [so] this payment rate will create a gap in how payment rates will be increasing relative to what their costs will be."
"I think MACRA is just a gigantic illusion," said James Capretta, a senior fellow at the Ethics and Public Policy Center at the AEI, another right-leaning think tank. "Basically it says the federal government is going to rank every physician on quality metrics beginning in 2019 and pay them accordingly based on their score. Call me a skeptic, but the idea that the federal government is going to do that in a way people can accept, I think there's zero chance that will happen .... I really think MACRA is headed toward massive revision at some point."
Alice Rivlin, PhD, a senior fellow at the Brookings Center for Health Policy, a left-leaning think tank, called for a two-sided approach to dealing with the MACRA reforms. "We need to give patients more skin in the game if we believe accountable care organizations (ACOs) or some other payment reform is promising -- patients need to know they're in [an ACO] and they have an incentive to participate in improving the cost-effectiveness of their care. And I believe we need to move more aggressively toward competition among plans, and move deliberately but not too fast toward premium support in Medicare. We could start with competitive bidding in Medicare Advantage."
However, she added, "We need to be sure we can make competitive bidding work, and solve the risk adjustment problem, so we don't end up ... with the sickest people in traditional Medicare."
Overall, the American public needs to understand that it is "sleepwalking" into big financial difficulties as evidenced by the trustees' report, Capretta said. "People often say, 'Who knows what it's gonna be like in 2030 and 2040?' Well, we do know what it's going to look like -- we're going to have a lot older population with a lot more demand for health services ... that's crucially important in planning ahead."
Moffit agreed. "I think we are sleepwalking into a fiscal crisis," he said, adding that although much of the trustees' report sounded "somewhat soporific ... in defense of the trustees, they actually state some really dramatic things."
As an example, Moffitt quoted the trustees as saying in the report that there is an urgent need for action to fix Medicare's financing problems. "They've been saying this for years. The problem is that members of Congress who authorized all this, are not reading this, or if they're reading it, they're ignoring it."
Other panelists seemed to take a calmer view. "The overall message I'd take away is that in the near term, the Affordable Care Act is working," said Keith Fontenot, a visiting scholar at Brookings. "In the long term, there are challenges -- providers [need] tools to sustain productivity, and there are other issues like the cost of prescription drugs."
Rivlin, a former Federal Reserve governor and White House budget director, also agreed that more still needs to be done. "Given the fact that Medicare is such a vital program ... and so essential to seniors and the disabled, solving its problems will take a bipartisan effort," she said. "And you might not think we're going to get that in this highly polarized political system, but surprisingly that's not true of Medicare .... Quite a lot of bipartisan activity is happening; there is an explosion of experiments in payment being tried and evaluated."
Panelists also were uniformly critical of the Independent Payment Advisory Board, an organization set up under the Affordable Care Act (ACA) that is supposed to make recommendations to Congress about cutting Medicare costs in the event that the projected Medicare budget is expected to exceed a given target in a particular year. "I'm a skeptic of the approach of tinkering with Medicare costs on year-by-year basis," said Rivlin.
Moffit agreed. "Remember this: IPAB is one crude thing, the ultimate blunt axe for controlling costs," he said. The only thing the board ... can do is basically to reduce provider payments. They can't do too much beyond that. This is a controversial [ACA] provision and I don't think it will survive."
In two phase III trials, Bezlotoxumab appeared to cut recurrence rates by almost half relative to placebo. In the FDA's technical review, however, agency staff expressed reservations about the trial design and results. From MedPage Today.
by Shannon Firth
A drug that has shown promise for preventing recurrent Clostridium difficile infection comes before an FDA advisory committee Thursday, but the agency's technical staff have raised questions about the quality of the sponsor's data.
Bezlotoxumab, a product of Merck Sharpe & Dohme, is a fully human monoclonal antibody that binds to one of two toxins produced by C. difficile toxin B, preventing its pathogenic effects. The FDA's Antimicrobial Drugs Advisory Committee will be asked to vote on the safety and efficacy of bezlotoxumab and offer suggestions regarding any labeling or future studies for the injectable biologic. At present there are no FDA-approved drugs for preventing C. diff recurrence.
In the FDA's technical review prepared for the meeting, however, agency staff expressed reservations about the trial design and results.
In both trials, Merck tested bezlotoxumab alongside a second biologic, actoxumab, which targets the C. diff A toxin. That agent appeared to be much less effective, showing no difference from placebo when used alone. MODIFY I tested each drug individually and in combination, along with a placebo control arm. MODIFY II omitted the actoxumab-alone arm, testing bezlotoxumab alone, the two-drug combination, and placebo.
In both studies, the recurrence rate with placebo was 26%-28%; it was 15%-17% in the bezlotoxumab arms, both alone and in combination with the other drug.
In 2012-2013, the FDA urged the sponsor to change the primary endpoint in MODIFY II from CDI recurrence rate to rate of global cure, but the firm declined. Instead it left global cure as a secondary endpoint. Merck also suggested it would measure this secondary marker using pooled data from both phase III trials. The agency warned that pooling data for the secondary endpoint was a bad idea and that it would need "confirmatory evidence from separate trials."
As the agency briefing documents noted, the FDA also voiced concern about "inappropriate" elements of the sponsor's study design. Specifically, for the primary endpoint, participants who failed treatment of their initial CDI episode were viewed as "successes" and inappropriately lumped with the "sustained response" participants.
"[S]ubjects who were clinical failures of the initial CDI episode cannot be evaluated for recurrence, since one has to be cured first in order to develop recurrence," staff noted, adding that such factors make the primary endpoint "difficult to interpret."
Lastly, technical staff raised concerns over the "discordant results" seen with bezlotoxumab across the two pivotal trials.
In MODIFY I, neither clinical nor global cure rates for bezlotoxumab monotherapy were better than in the placebo group, and there was actually a trend toward lower clinical cure rates for the drug. In MODIFY II, bezlotoxumab alone did show a significantly higher rate of global cure than placebo, but clinical cure rates did not differ.
"Overall these results suggest that bezlotoxumab may negatively affect cure rate of the initial CDI episode," agency staff argued.
The review also noted that bezlotoxumab had "an overall favorable safety profile" with the exception of a potential signal from "numerically higher numbers of [serious adverse events] and deaths in bezlotoxumab-treated subjects with baseline congestive heart failure as compared to placebo."
In 2011, the CDC reported roughly 500,000 C. difficile infections in the U.S. and 29,000 deaths. It noted that the individuals most vulnerable to infection are older adults receiving antibiotics and frequent medical care.
Final FDA decisions usually reflect advisory committee recommendations but not always.
With just over 8 months on the job left to go, the head of the Centers for Medicare and Medicaid Services said Tuesday he now has "an obsession with the plight of independent physicians." From MedPage Today.
With just over 8 months on the job left to go, the head of the Centers for Medicare and Medicaid Services said Tuesday he now has "an obsession with the plight of independent physicians."
Since January, acting administrator Andy Slavitt and other members of agency have been traveling around the country listening to thousands of doctors complain about their electronic health record (EHR) systems, poor payment for their time, burnout, and confusion over quality metric requirements.
And all of this without measureable improvements in care for their patients.
It's all put the healthcare workforce on a precarious edge, he said in so many words.
Especially the primary care workforce. And that's a major problem, he told those assembled at the seventh annual Health Datapalooza conference here.
Because "knowing as we all do that if we don't invest in primary care, we'll invest double or triple when people get unnecessarily sick.
"Through these conversations, one thing became very clear," he said. "What we call 'interoperability' at this point would not be considered an impressive achievement by the average physician," he said.
But Slavitt told those gathered to look at Healthcare.gov for hope.
He said that when it launched 2 and a half years ago, it failed millions of people trying to get health coverage as promised, and was equally discouraging. "Once again, technology was the problem -- until it wasn't."
Fast forward a few months: 20 million people had insurance through the online portal. "What you didn't hear," Slavitt said, "was that after we got the technology functioning, we were using technology to do things that had been never been done before."
Easy comparison of plans brought down prices and brought more service offerings. He said more than two-thirds of those signing up "saved an average of $500 a month," with many other benefits such as waived deductibles in some plans.
Yet, he acknowledged, "while technology now supports us in getting coverage, it is largely failing us in the care experience," he said.
Today, interoperability of EHRs is seen as a similar failure as Healthcare.gov was 30 months ago.
"Robots can perform your mom's surgery but reminding her to fill a prescription? No. Can't do that," he said.
Tell her doctor how her surgery went? "No. Seems too hard," he said, even though "we know that all those things that happen after surgery can be just as important as what happened during her surgery."
But it can and it will, Slavitt promised, in time.
"I have the same feeling we faced" in October 2013, he said.
"We have to rise above proprietary interests and make this a national priority. Having seen it happen, I know we can get it right."
Slavitt's talk was followed by an animated panel discussion moderated by Patrick Conway, MD, CMS's chief medical officer, with American Medical Association CEO James Madara, MD; Geisinger Health System president and CEO David Feinberg, MD; and Chet Burrell, president and CEO for CareFirst BlueCross BlueShield.
At one point during their 30-minute discussion, Feinberg brought down the house with applause. Asked by Conway to identify the biggest barrier to better care delivery, Feinstein pulled no punches to criticize the healthcare industry.
"I think the biggest barrier is that we're completely worried about our own turf," Feinberg said, calling it "a crisis in America, the type of healthcare we deliver, who gets it, the quality, who doesn't get it and the cost.
"Physicians are worried about what's happening to them, you know. The systems are worried about what's happening to them, the insurance guys ... the pharma people, and it's never really been the year of the patient, right?
"And if we're going to fix this, it's going to take a huge dose of selflessness, and I don't see this industry talking about that."
Conway nodded in agreement, noting his own difficult experience "navigating the health system with my own family, friends and colleagues."
To which Feinberg quickly added: "Yes, and think about someone who is health illiterate, (or) the single mom. You're an insider, you're as inside as it gets. Man, it's tough to be sick, and then you put on top our crazy system. Everyone needs to see a psychiatrist."
The Centers for Medicare & Medicaid Services (CMS) is open to revising its proposal to change the way physicians are paid for drugs administered under Medicare's Part B program, a CMS official said Wednesday. From MedPage Today.
The Centers for Medicare & Medicaid Services (CMS) is open to revising its proposal to change the way physicians are paid for drugs administered under Medicare's Part B program, a CMS official said Wednesday.
"The proposal was to remove financial considerations from the prescribing of medicine," CMS chief medical officer Patrick Conway, MD, told reporters at a briefing sponsored by the Alliance for Health Reform, Health Affairs, and the Jayne Koskinas Ted Giovanis Foundation for Health and Policy. "That being said, if the proposal doesn't hit that point and we need to adjust it, we'd be open to that."
The CMS plan would replace the current Medicare reimbursement -- the average sales price of the drug plus a 6% add-on fee to cover costs -- with a rate of the average sales price (ASP) plus 2.5%, plus a flat fee of $16.80 per drug per day. The flat fee would be adjusted at the beginning of each year.
At the briefing, Conway noted that "for some of these practices, the drug revenue is over half of their revenue. I think" -- he paused for a few seconds -- "one could call that interesting."
Although most physicians do prescribe medications based on what's best for their patients, Conway said, "at a recent meeting [I attended] one doctor said that the ASP plus whatever wouldn't cover the cost [of one drug], so he wouldn't give it to a patient. That concerns me as a doctor."
CMS has a "first principle" that prioritizes patients having access to medication, he continued. "There is nothing in this proposed rule that limits access to any medication that we are aware of. If [it does], we want that to be identified" so it can be taken care of.
For example, "For small rural oncology practices, will this cover the provision of drugs?" Conway said. "We proposed it; we thought it did, but if it turns out it doesn't in certain situations -- classes, types of practices, or across the board -- we would be open to adjustments."
Asked by MedPage Today why the proposed changes to the Part B drug payment system didn't mimic the system used for drug payment under Part D -- a system that some analysts say produces more price competition for drugs -- Conway replied that Part D "has a different statutory construct; it was set up in law through the private health plan market."
However, he added, "[our] proposals we think would align with some principles in Part D ... Part D plans focus on value and outcomes for beneficiaries; we think it aligns with that principle."
"In Part D, competition and paying based on outcomes is part of the construct; we think this [proposal] would instill some of those principles or test them in Part B," he added. "We are attempting to apply some of the principles from Part D and the private market generally into the Part B drug space."
Improving Part B drug reimbursement is challenging, Conway said. "I was named in a Change.org petition where I got email about every 20 seconds from patients saying their doctor said they wouldn't get their medicine" under this plan. As a practicing physician, "it bothered me personally; it was clear that was not what this proposal is intended to do. It was disappointing they were hearing that from people in the healthcare system."
One issue that has come up in the comments has been whether to include in the Part B proposal those practices that are participating in CMS's new oncology care model, which is "an episode-based model that also includes a payment per beneficiary per month for care coordination," he said. "We said in the proposed rule that you could include [those] practices in the model or exclude them ... We have received some public input suggesting that we consider excluding those practices because they're in a total-cost-of-care model, so we'll have to consider that."
CMS chief medical officer Patrick Conway, MD, said "The proposed system would reward clinical practice improvements such as activities focused on care coordination, patient engagement, and patient safety, and also reduce reporting requirements... by reducing the number of measures required, and eliminating redundant quality reporting. From MedPage Today.
The Obama Administration proposed two rules Wednesday that officials say will ease physicians' documentation requirements and give them new opportunities to earn bonuses for providing high-quality care.
One rule implements what is called the Quality Payment Program, which gives doctors two options for getting reimbursed under Medicare: they can participate either in the Merit-Based Incentive Payment System (MIPS) or Advanced Alternative Payment Models (APMs).
"There have been a myriad of programs [for physician payment] developed over the years," Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services (CMS), told reporters on a conference call. He gave alternative programs such as accountable care organizations and shared savings programs as examples. The Quality Payment Program "replaces all these programs with a single platform. Physicians will have the opportunity to get paid more for investments that support patients, and do so with minimal burden."
In addition, said CMS chief medical officer Patrick Conway, MD, "The proposed system would reward clinical practice improvements such as activities focused on care coordination, patient engagement and patient safety, and also reduce reporting requirements ... by reducing the number of measures required, and eliminating redundant quality reporting. If physicans do well in the program, they could earn more than a 4% bonus in incentive payments ... with additional bonuses for the highest performers."
Physicians choosing the MIPS program would get paid based on their reporting on a single set of quality measures; the set combines measures from earlier programs such as the Physician Quality Reporting System and the Value-Based Payment modifier. However, to increase flexibility, "The program allows physicians ... to select quality measures from a range of options to reflect differences among specialties, and report technology utilization based on customizable measures that reflect how clinicians use technology in their day-to-day practice," Conway explained.
Those choosing the Advanced APM program would be paid based on their participation in newer payment models such as the Comprehensive Primary Care Plus model and the Next Generation Accountable Care Organization model.
Both programs are slated to go into effect in January 2017, beginning with a reporting period that will affect physician pay in 2019.
The second proposed rule makes changes to the highly unpopular Meaningful Use program, which requires physicians to document making "meaningful use" of electronic health records (EHRs). "We are proposing to replace Meaningful Use with a new effort that moves the emphasis away from the use of information technology to one that supports patient care that is supported by better and more connected technology," Slavitt said on a second conference call. "The program, Advancing Care Information (ACI), is designed to be more flexible and less burdensome," and would also take effect in January 2017, he said.
The ACI program "will allow physicians and other clinicians to select measures to reflect how [information] technology best suits their day-to-day practice; the proposal eliminates a number of measurements and entirely focuses on patient care and connectivity goals," Slavitt said. "The proposal allows 'acknowledgement reporting' to comprise 50% of the program, and it removes the all-or-nothing grading system. It also aligns with other quality and reporting programs, so it's simpler."
The proposed rule, which will be available for 60 days for public comments, applies only to physician offices, not to hospitals, and only to Medicare payments, not to Medicaid, he noted. "Even after it's implemented, as the programs meet the real world and physicians and patients begin having actual experience with it, we will need to continue" to listen to clinician concerns.
The expectations included in the ACI program "support our work around the changing culture of data-sharing," said Karen DeSalvo, MD, MPH, national coordinator for Health Information Technology (IT). "It advances... expectations around transparency reporting for vendors and putting information out into the public domain so clinicians are better able to compare products and understand what they're actually purchasing. There is also an expectation upon providers themselves ... attestations they will not block data and that it's moving on behalf of consumers."
Asked if there were any provisions in the rule that would penalize vendors who tried to block data, DeSalvo replied that although the rule applies to providers rather than vendors, her agency is working to prevent data blocking "through every lever we can find, through voluntary certification and otherwise, working in concert with providers and health IT developers."
"The 'good news' story is that everybody has a shared goal that we begin to compete within standards, not between standards, and toward meeting expectations of everyone in the country that their health information will be available when and where it matters to them," she told MedPage Today. "Through creating the right business case, we're creating an environment where people will continue to work together ... we want to help make sure it makes business sense for everybody."
The rules got positive reviews from several physician groups. "Our initial review suggests that CMS has been listening to physicians' concerns," Steven Stack, MD, president of the American Medical Association, said in a statement. "In particular, it appears that CMS has made significant improvements by recasting the EHR Meaningful Use program and by reducing quality reporting burdens."
He also announced that the AMA was releasing "new online information and resources to help physicians navigate the changing landscape."
The American Academy of Family Physicians (AAFP) also applauded the proposed rules. "Today's proposed regulations move toward meeting Congressional intent, which is to place greater priority on primary care that is comprehensive, continuous, coordinated, connected and a patient's first contact with the healthcare system," AAFP president Wanda Filer, MD, MBA, said in a statement.
"The law's emphasis on these priorities ... is a direct expression of the Congressional desire to see our healthcare delivery system more aggressively promote, reward and emphasize primary care."
The False Claims Act case argued before the Supreme Court on Tuesday will have implications for physicians no matter which way it is decided, according to one legal expert.
This article first appeared on Medpage Today website.
Facts of the Case
The case, known as Universal Health Services v. United States ex rel. Escobar, involves a Massachusetts mental health clinic which treated Yarushka Rivera, the stepdaughter of Julio Escobar and daughter of Carmen Correa; Rivera adversely reacted to prescribed medication and eventually died in 2009 following a seizure.
An investigation found that social workers at the clinic were not properly supervised and licensed as required by state law. Escobar and Correa filed suit under the False Claims Act on the theory that even though the claims submitted to Medicaid for payment by the clinic accurately represented the services that were provided, the claims were false because the clinic had not complied with state laws.
The clinic, for its part, says the False Claims Act is not meant to punish those who submit claims for services actually provided but who may have violated some regulations.
The argument is "as fundamental as whether the government has almost unbounded ability to investigate claims for alleged violations of any sort, and either extract a settlement or litigate," Laurence Freedman, JD, of the law firm Mintz Levin here, said in a phone interview. Freedman called the case "the most significant False Claims Act case the court has heard" since amendments to the act were passed in 1986.
"The government wants to say that any [rule] a doctor is required to [comply with] under any state regulation that had to do with the claim -- 'We didn't mean to pay that claim if we knew you weren't in compliance with whatever it is,'" he continued. "The government wants discretion to take an incredibly broad view and say which things are related to the claim and which aren't, and could do it after the fact." The government itself was not a party to the lawsuit, but instead filed it on behalf of Rivera's family.
Differing Opinions
But David Colapinto, JD, general counsel for the Washington-based National Whistleblowers Center, which filed a "friend of the court" brief in the case, disagreed, calling what Universal and its allies are alleging a "Chicken Little" argument.
"It is almost beyond belief that a medical provider would go to the Supreme Court and argue that you can submit a bill for a doctor's services when in fact you know that no licensed doctor performed the services," he said in a phone interview. "How can you bill Medicaid or Medicare under those circumstances and it would not be fraud?"
Colapinto noted that the False Claims Act was passed by Congress in 1863 during the Civil War. "What Congress was concerned about was contractors who were unscrupulous; they were selling guns to the government that couldn't shoot straight, selling mules that couldn't walk, or providing food that was rancid."
In this case, Universal is "saying they never said anything false when they submitted the claim, but they didn't tell the government that unlicensed people were performing the service. So they omitted things that needed to be told," he said. "When the government got a bill under those billing codes, were they right to assume a licensed medical professional performed the service?"
Healthcare providers, on the other hand, say that they should know in advance what requirements they need to be following to avoid these kinds of claims, Freedman said.
"When I submit a claim, I'm the doctor; I should know in advance whether I will be subject to [a fine of] $11,000 per claim plus treble damages -- what is it I'm saying I'm complying with? For a lot of us, it seems too broad if [the answer] is 'Every federal and state regulation out there.' The government's view is, 'Yes it is every federal and state regulation, but trust us, we'll only proceed if we think it's related to payment.'"
"It is my view that the government's view is overbroad and would turn the statute into an all-purpose enforcement mechanism that it's not intended to be," he added.
Picking and Choosing
Colapinto, who attended Tuesday's oral arguments, said he was particularly surprised that the attorney for Universal told the Supreme Court that healthcare providers and other federal contractors should be allowed to pick and choose which regulations they follow (this argument is found on page 51 of the oral argument transcript). "I was startled by that because since when have doctors and hospitals been allowed to pick and choose what laws they comply with?" he said.
Attorneys on both sides of the issue agreed that this case could easily result in a 4-4 tie, in which case the decision would revert back to an appeals court finding in favor of Rivera's parents. But there are other possibilities too.
For example, the court "could limit the theory to when there are explicit or express conditions of payment, which would give some folks notice of what it is," said Freedman. "The state [would then] have to say, 'These are the conditions of payment and you're on notice these are linked to your claim.' But it really just depends on how the court goes. If the court upholds a very broad theory, anyone submitting claims, about all they can do is hold their breath."
If, on the other hand, the court made a definitive decision in favor of Universal, "They would drastically reduce the government's ability to sue contractors in all contexts if they were to succeed," said Colapinto.
He dismissed the idea that a definitive ruling the other way, in favor of Rivera's parents, would "open the floodgates" for lots of False Claims Act suits by private parties. "You have to prove fraud in these causes; you have to prove allegations with a certain level of particularity -- there's a heightened pleading standard."
As a result, "most of the cases the government declines to pursue don't proceed very far," Colapinto said, calling arguments by the other side that False Claims Act cases have exploded "overblown." He pointed to a "friend of the court" brief submitted in the case by David Engstrom, JD, PhD, of Stanford Law School. Engstrom reviewed suits filed under the False Claims Act and found that they remained flat or even declined from 1996 to 2009. "We haven't seen exponential growth," he said.
But Hooper warned that if the False Claims Act is expanded, it could be bad news for doctors. "What it means is that any expansion of the False Claims Act gives added fuel to potential whistleblowers to complain about what a doctor is doing," he said. "That's the biggest threat to doctors -- not so much from the government initiating a False Claims Act claim against a doctor, but from a disgruntled former employee, a competitor, or someone like that on behalf of the government. The more the False Claims Act is expanded, the more people are going to file those lawsuits."
A decision in the case is expected later this year.
Advocates are urging the Joint Commission and CMS to scrap policies that they say can lead to opioid overprescribing. In separate letters to both groups, signees asked the Joint Commission to re-examine its Pain Management Standards—which once helped push the idea of pain as the "fifth vital sign"—and asked CMS to strike patient satisfaction questions about pain from its reimbursement procedures.
Diet, exercise, stress management, and other lifestyle medicine interventions can have a powerful effect on disease, but how are new models of care changing the clinical incentives for offering them? From MedPage Today.
This article first appeared on MedPage Today April 4, 2016.
In this video, long-time proponent Dean Ornish, MD, provides a perspective on how lifestyle medicine might find its place in the changing healthcare landscape.
A transcript follows:
"We all know that lifestyle factors play a role in helping to prevent disease. But lifestyle medicine is about using lifestyle interventions to treat disease, and often to reverse it, either in combinations with drugs and surgery, or often as an alternative to them.
"You know, we tend to think of advances in medicine as being a new drug, a new laser, or something really high-tech and expensive. And we often have a hard time believing that the simple choices that we and our patients make in our lives each day -- like what we eat, how we respond to stress, how much exercise we get, and, perhaps most important, how much love and support we have -- that these simple changes can make such a powerful difference, but they often do.
"And in 39 years of research, my colleagues and I at the non-profit Preventive Medicine Research Institute published in all the leading peer-reviewed journals have been able to show that these simple choices that we make -- what we eat, how we respond to stress, how much exercise we get, and how much love and support -- can actually reverse the progression of severe coronary heart disease, of Type 2 diabetes, can slow, stop, or reverse the progression of men with early-stage prostate cancer, and by extension breast cancer, can actually change our genes, up-regulating the genes that protect us, turning off or down-regulating the genes that cause prostate, breast and colon cancer -- the ras oncogenes, over 500 genes in only 3 months. And in our latest research, we found that these same lifestyle changes may lengthen telomeres, the ends of our chromosomes that cause aging, in a sense, beginning to reverse aging at a cellular level.
"And as we move into the era of Obamacare, whatever people think about it, it's really turning all the incentives on their ear. In a fee-for-service environment, the more operations and drugs and hospitalizations, the more revenue is generated. But in the bundled payments of accountable care organizations and integrated delivery networks, there's 'X' amount of dollars to take care of somebody and you get to keep what's left over: The fewer procedures, the more revenue that's generated. And Medicare is now covering our program for reversing heart disease and others like it, and so it's really creating a new sustainable model that allows physicians to provide people the information and the time that they need in order to make sustainable changes. It's a whole new era, and it's one that I find terribly exciting."