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  • First-Ever Tests of Deep Brain Stimulation on Humans Poststroke Ready to Begin

    Researchers at the Cleveland Clinic are ready to begin human testing on the use of deep brain stimulation (DBS) for individuals poststroke, in hopes that the technology will help to "jump start" damaged areas of the brain and aid in physical rehabilitation.

    According to an article in TIME magazine, the clinic has been federally approved to begin a human trial of a DBS technique that previously has been tested only on rats. The procedure involves sending electrical pulses from a power source implanted in the subject's chest to electrodes implanted in the brain, a technology that has been successfully used for some time on individuals with Parkinson disease (PD).

    But the intent of using DBS poststroke is not the same as its use for PD, according to Andre Machado, who heads up the project.

    "The big difference is that when we are treating the motor symptoms of [PD], we’re trying to make the symptom, like a tremor, go away," Machado told TIME. "When we are treating stroke, we are really trying to make movement come back. There is something inherently different about that."

    Animal testing revealed that DBS "appears to promote the growth of new neurons in the brain," according to a 2015 article in the Wall Street Journal (WSJ), though Machado told WSJ that researchers have no expectation that the procedure will cure stroke. Instead, he said, "the expectation is that by applying stimulation, [DBS] will augment or boost the effects of physical rehabilitation."

    "The goal of this therapy is not to replace physical training, but rather to boost the effects," Machado told TIME.

    The human study is set to begin as soon as researchers identify a subject poststroke who is severely disabled and "has exhausted all other options without improvement," according to the TIME article. The focus of the initial work will be on individuals who have suffered an ischemic stroke.

    Proposed Home Health Rule Includes Planned $180 Million Reduction, Shift to Cost-per-Unit System for Outlier Payments

    The Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule for the 2017 Medicare home health prospective payment system (HH PPS) that would continue a planned series of cuts that began in 2014, with an estimated overall 1% reduction, or about $180 million, scheduled for next year. The proposal, released on June 27, also includes a move away from cost-per-visit in favor of a cost-per-unit system for outlier payments, a plan to make separate payments for negative pressure wound therapy (NPWT) devices, and refinements to a value-based purchasing model used in 9 states.

    APTA regulatory affairs staff is reviewing the proposed rule and will submit comments on the proposal to CMS. PT in Motion News will publish a report summarizing those comments; in the meantime, here are some key features of the changes that may be happening next year.

    Payment. Overall, CMS projects payment adjustments would result in an estimated 1% reduction, or $180 million, in 2017. This adjustment continues a set of reductions mandated by the Affordable Care Act, which have ranged from $60 million in 2015 to $260 million in 2016. CMS arrived at the overall estimate by weighing a 2.3% payment increase against various decreases, mostly related to reductions in the 60-day episode payment rate and cuts to account for nominal growth in case mix.

    Home Health Quality Reporting Program. The proposed rule would add 4 measures to the Home Health Quality Reporting Program, but not until 2018. The new measures focus on hospital readmissions, total estimated Medicare spending per beneficiary, discharge to the community, and medication reconciliation. The proposed rule also requires home health agencies (HHAs) to submit both admission and discharge outcome and assessment information set (OASIS) data for at least 90% of all patients whose episodes of care occurred during the reporting period.

    Outlier payments. CMS is proposing a change to the way it calculates the payments it makes for episodes that go beyond the typical range of care, moving from a cost-per-visit approach to a cost-per-unit approach, with 15 minutes comprising a unit. The proposal also includes an adjustment to the fixed-dollar loss ratio, intended to keep outlier payment ratios in compliance with requirements in the Social Security Act.

    NPWT payments. The proposed rule would create a system for separate payments to HHAs for disposable NPWT devices used with beneficiaries, no longer allowing for time spent furnishing NPWT to be a part of a home health visit claim paid under the HH PPS. Instead, that element of care would be paid for separately, in line with rates in the CMS outpatient prospective payment system.

    Value-Based Payment Model. HHAs in Arizona, Florida, Iowa, Maryland, Massachusetts, Nebraska, North Carolina, Tennessee, and Washington would continue their participation in a value-based payment system with a few tweaks to some reporting processes and timeframes. Beginning in 2018, the HHAs in these states will receive payment increases or reductions based on 2016 performance data. The adjustment process will continue each year from 2018 to 2022, with the range of payment adjustment increasing incrementally, from a potential 5% increase or decrease in 2018 to an 8% adjustment upward or downward in 2021 and 2022. CMS anticipates saving $380 million through reductions in unnecessary hospitalizations and skilled nursing facility usage through this model.

    New Reports Underscore the Severity of the Opioid Epidemic

    In what's becoming a grim and all-too-familiar pattern, new reports and studies continue to point to alarming trends in the use and abuse of opioids across the US. Combined, they create a picture of a country in the throes of an epidemic that reaches all societal levels, with laws that do little to curb the rise in abuse, and a federal drug regulatory agency that has "opened the gate wide" for the overproduction of prescription opioids.

    Here's a rundown of a few of the studies and reports that surfaced recently:

    Nearly 1 in 3 Medicare beneficiaries received an opioid prescription in 2015.
    A report from the US Department of Health and Human Services (HHS) estimates that 12 million Medicare beneficiaries—about 30%—received a prescription for a commonly abused opioid in 2015, at a cost of over $4 billion in Medicare part D spending. The 4% increase over 2014 rates represents a very modest slowdown from 2013, but the long-range trend shows a 165% increase from 2006. Each Medicare beneficiary who was prescribed a commonly abused opioid received an average of 5 prescriptions a year. The opioids with the highest part D spending were OxyContin, hydrocodone-acetaminophin, oxycodone-acetaminophin, and fentanyl.

    Nonmedical use of prescription opioids more than doubled between 2002 and 2013.
    According to a study in the Journal of Clinical Psychiatry (abstract only available for free), nearly 10 million Americans—about 4.1% of the population—reported using opioids without a prescription or not as prescribed in 2012-2013, a 161% increase from the 2001-2002 study period. Overall, 11% of Americans report nonmedical use of prescription opioids at some point in their lifetime, up from 4.7% in 2001-2002. The estimated number of Americans with prescription opioid use disorder has increased by 125%, with 2.1% of the population (4.8 million) reporting the disorder in their lifetime in the 2012-2013 study. Ten years prior, that rate was 0.9%.

    Tighter controlled substance laws aren't having an impact on opioid abuse, at least among Medicare beneficiaries with disabilities.
    A study in the New England Journal of Medicinelooked at opioid abuse and overdose rates among Medicare beneficiaries with disabilities, and compared those rates with various state laws enacted to curb abuse over a 7-year period. The study focused on beneficiaries aged 21-64 with disabilities—a population that accounted for nearly 1 in 4 deaths from opioid overdose in 2008. What they found was that laws that limit the prescribing and dispensing of controlled substances had little effect on outcomes. "Effective and safer alternatives for chronic pain management are needed, as is a comprehensive response to opioid addiction," authors write.

    The DEA is being questioned about its role in the growth of opioid use and abuse.
    The Washington Post reports that during a US Senate Judiciary Committee hearing, US Drug Enforcement Administration (DEA) Administrator Chuck Rosenberg received a harsh line of questioning from Sen Dick Durbin (D-IL) over the ways in which the agency may have contributed to the current opioid crisis through a decision to "flood America with opioid pills, far beyond any medical purpose." Durbin reported that DEA's production quotas for opioids increased dramatically from 1993 to 2015, with oxycodone production increasing from 3.5 tons to 150 tons, and the production of hydrocodone, hydromorphone, and fentanyl increasing by 12 times, 23 times, and 25 times, respectively. "I think we're part of the problem," Rosenberg admitted at the hearing.

    APTA has added its voice to the effort to curb opioid abuse through its national #ChoosePT campaign, an initiative to promote physical therapy as a safe and effective alternative to the use of opioids in the treatment of pain. Housed at MoveForwardPT.com/ChoosePT, the #ChoosePT campaign will unfold throughout 2016 and include national online advertising, TV and radio public service announcements, and other targeted advertising and media outreach. APTA is also a member of the White House’s working group addressing the opioid epidemic.

    Medicare Fraud Dragnet Identifies a Record $900 Million in Illegal Billing

    The federal government has announced the largest-ever Medicare fraud sweep, a takedown that involves 301 individuals connected to alleged fraudulent billing totaling $900 million.

    The defendants were announced by the US Justice Department on June 22 on charges including conspiracy to commit health care fraud, violations of antikickback laws, money laundering, and aggravated identity theft. In addition to violations connected to home health care, fraud charges were also associated with psychotherapy, durable medical equipment, drug prescribing, occupational therapy, and physical therapy. Home health-related fraud represents about 50% of the cases, with pharmacy fraud accounting for 25%.

    The sweep was led by the Medicare Fraud Strike Force in 36 federal districts, but also included 23 state Medicare fraud control units and cases brought by 26 US Attorney's offices. In terms of payments based on fraudulent claims, a CNN report shows that Florida led the list with $237 million, followed by Texas at $193 million, California with an alleged $162 million, and Michigan at $114 million. Other states associated with larger payment amounts were Illinois ($12 million) and New York ($86 million). The remaining $96 million was spread out over other states.

    Among the cases involving physical therapy were 5 individuals in New York charged with illegal activities involving some $86 million in fraudulent physical therapy and occupational therapy claims. According to a DOJ press release, the individuals under indictment in this case "filled a network of Brooklyn clinics that they controlled with patients by paying bribes and kickbacks. Once at the clinics, these patients were subjected to medically unnecessary therapy." The defendants are alleged to have used over a dozen shell companies to launder the money they received from Medicare.

    "As this takedown should make clear, health care fraud is not an abstract violation or benign offense—it's a serious crime," said US Attorney General Loretta Lynch in the DOJ press release. "Above all, [the alleged offenders] abuse basic bonds of trust—between doctor and patient, between pharmacist and doctor, between taxpayer and government—and pervert them into their own ends."

    The federal actions are supported by funding made available through the Affordable Care Act, which provides an additional $350 million for stepped up enforcement efforts, and toughens sentencing for those found guilty of fraud. To date, nearly 1,200 individuals have been charged through the national takedowns, which DOJ claims involve more the $3.4 billion in fraudulent billings. Last year, a similar dragnet uncovered an estimated $712 million in fraudulent billing.

    "These alleged actions by individual providers and facility owners are not reflective of the values of the professions they are a part of, and we commend the Obama administration for their efforts to root out fraud and abuse and protect taxpayer dollars," said Justin Moore, PT, DPT, APTA's executive vice president of public affairs. "The physical therapy profession has always taken a leadership role in advocating for responsible, patient-centered care—it guides everything we do, and APTA is constantly focused on supporting those values and ensuring the integrity of physical therapist practice."

    APTA has been active in the physical therapy profession's efforts to eliminate fraud, waste, and abuse, and in 2014 APTA launched the Integrity in Practice Campaign, a broad initiative that seeks to position physical therapy as a leader in responsible patient-centered care. At the campaign's center is the APTA Center for Integrity in Practice website, a 1-stop source for information on how PTs, physical therapist assistants (PTAs), and students can keep standards high. Resources include a primer on preventing fraud, abuse, and waste; a free course on compliance; and other information on regulation and payment systems, evidence-based practice, ethics, professionalism, and fraud prevention.

    From NYT: Nondrug Pain Approaches Not Always Easy to Pursue

    The idea that pain can be treated effectively through nondrug approaches—the crux of APTA's national #ChoosePT campaign—may be an idea that is gaining acceptance, but that doesn't mean payers are necessarily onboard just yet, according to a recent report in the New York Times (NYT).

    In "New Ways to Treat Pain Meet Resistance," reporters Barry Meier and Abby Goodnough take a look at how the health care system in general, and insurers in particular, are making it difficult for individuals to pursue pain treatments that aren't drug-based, even after the US Centers for Disease Control and Prevention released guidelines urging nonopioid alternatives for most long-term pain management.

    "In recent months, federal agencies and state health officials have urged doctors to first treat pain without using opioids, and some have announced plans to restrict how many pain pills a doctor can prescribe," the writers state. "But getting the millions of people with chronic pain to turn to alternative treatments is a daunting task, one that must overcome inconsistent insurance coverage as well as some resistance from patients and their doctors, who know the ease and effectiveness of pain medications."

    The NYT report highlights the story of Douglas Scott, 43, from Jacksonville, Florida. Scott was injured, and then re-injured in 2 separate car accidents that left him with intense pain in his back and neck. Scott initially went to a pain specialist who prescribed oxycodone and morphine at increasing rates, and Scott eventually found himself dependent on the drugs and facing potential family problems. After he was confronted by his wife, Scott enrolled in a local clinic that weaned him off the drugs and helped him manage his pain through physical therapy, relaxation, and cognitive behavioral therapy. Scott was able to get his pain under control.

    The problem, according to the article, is that payment for these so-called "alternative" programs are inconsistent or nonexistent, particularly when the program in question employs an interdisciplinary approach that may involve physical therapy, counseling, and other approaches such as acupuncture and yoga. The report estimates that programs such as the one Scott participated in could cost $20,000 or more.

    The hesitancy to pay isn't limited to private insurers, according to the NYT, but also affects Medicare and Medicaid. And while the report describes physical therapy as "an exception" in that it's now a treatment Medicaid is required to cover, the story adds that "the generosity of the benefit varies by state."

    APTA has added its voice to the effort to curb opioid abuse though its national #ChoosePT campaign, an initiative to promote physical therapy as a safe and effective alternative to the use of opioids in the treatment of pain. Housed at MoveForwardPT.com/ChoosePT, the #ChoosePT campaign will unfold throughout 2016 and include national online advertising, TV and radio public service announcements, and other targeted advertising and media outreach.

    Humana Expands TKA, THA Bundling Program in OH, TN

    The transition toward value-based payment systems marches on with the recent announcement from insurer Humana that it will expand its bundling programs for total knee arthroplasty (TKA) and total hip arthroplasty (THA) in 2 states.

    Partly funded by a Centers for Medicare and Medicaid (CMS) State Innovation Grant, the expanded Medicare Advantage program now includes 7 orthopedic groups in Ohio and 4 in Tennessee. The bundling model "closely mimics both states' existing [CCMS] State Innovation Models," according to an article in HealthLeaders Media.

    "The care model is designed to improve quality, outcomes, and cost across a person’s entire joint replacement episode of care, and it financially rewards orthopaedic surgeons for better outcomes," states Humana in a press release. "For the patient, this is expected to deliver a more coordinated care experience and reductions in readmission and complication rates."

    Under the program, participating orthopedic practices will receive patient data analytics to help them manage an entire episode of care, from diagnosis to recovery. In an interview with HealthLeaders Media, Chip Howard, Humana vice president of payment innovation, said that Humana will support "3 key levers" in participating practices: "quality, directing patients to the most efficient postacute setting, and reducing readmissions and postsurgical complications."

    APTA is tracking Humana's efforts and is in communication with the insurer.

    "We're producing a robust set of reporting packages to share with providers to show them where their opportunities are," Howard told HealthLeaders. "The hope is that our first foray into bundled payment is a beginning to engage specialists, but ideally once we've developed these programs on the specialist side, we'd like to bring our primary care and specialist partners together to better move the needle on value-based care."

    Humana's announcement follows the startup of the CMS Comprehensive Care for Joint Replacement (CJR) model in April, the first time CMS has required participation in a bundled payment system that includes outpatient therapy providers. The bundled program for TKA and THA is now in place in 67 metropolitan areas.

    Bundling and other value-based payment systems are expanding rapidly. Get up to speed on the changes by visiting APTA's webpages on bundled payment models in general, and the CJR in particular, including a free-to-members recording of a sold-out webinar that outlines the impact of the CJR on physical therapists.

    APTA Launches #ChoosePT Campaign to Battle Opioid Epidemic

    #ChoosePT

     

    One thing you can say about the opioid abuse epidemic: it doesn't discriminate. The destructive power of the drugs, often first prescribed to treat pain, has been felt from rural to urban areas, across all social and economic classes, and from factory workers to one-of-a-kind music icons.

    Already active in the battle against prescription opioid abuse and heroin use, APTA is now taking its efforts to the next level: a national campaign urging the public to consider physical therapy as a safe and effective alternative for the treatment of pain.

    This week, APTA unveiled a broad public relations effort to educate consumers about the opioid epidemic and urge them to choose physical therapy (#ChoosePT) to manage pain without the risks of opioids. Housed at MoveForwardPT.com/ChoosePT, the campaign will unfold throughout 2016 and include national online advertising, TV and radio public service announcements, and other targeted advertising and media outreach.

    APTA also will collaborate with chapters nationwide, beginning outreach with states identified by the US Centers for Disease Control and Prevention (CDC) as having either the highest numbers of drug overdose deaths or the highest opioid prescription rates in recent years—Tennessee, Alabama, West Virginia, Oklahoma, New Mexico, New Hampshire, Kentucky, Ohio, Mississippi, and Rhode Island.

    “Opioids come with numerous serious side effects and only mask the sensation of pain,” stated #ChoosePT campaign spokesperson Joseph Brence, PT, DPT, in an APTA news release. “Research shows that physical therapist treatment can reduce or eliminate the need for opioids by improving physical function, increasing range of motion, and decreasing pain."

    APTA President Sharon L. Dunn, PT, DPT, OCS, announced the launch of the campaign during her address to the APTA House of Delegates on June 6, describing the current situation as "a crucial window of opportunity for our profession – a chance to step forward and assume the massive responsibility of treating the millions of Americans in pain without the real dangers of prescription opioids, and a chance to let the public know that when it comes to treatment for pain, they do have a choice, and that choice can be physical therapy."

    The #ChoosePT campaign website includes facts about pain and the opioid epidemic, tips for avoiding chronic pain, and a toolkit where supporters can download graphics and other materials to extend the campaign’s reach. Those looking to support the campaign on social media or learn more should use the #ChoosePT hashtag and follow @MoveForwardPT on Facebook, Twitter, and Pinterest. For more information, contact APTA's Public Relations Department.

    #ChoosePT
    Monday, APTA's #ChoosePT campaign was featured on a billboard in Times Square.

    NYT Editorial Includes Wider Use of Physical Therapy Among Strategies to Battle Opioid Epidemic

    The editorial board of The New York Times (NYT) says that Congress has "snapped to attention" and produced a "flurry of legislation" aimed at battling the opioid abuse epidemic, but warns that the efforts need to be backed up by appropriate funding for prevention and treatment—including the use of physical therapy as an alternative approach to addressing pain.

    "The House last week passed 18 bills related to opioids, and the Senate approved a comprehensive bill in March," the NYT states in a May 16 editorial. "The question now is whether Congress will appropriate enough money to address the scale of the problem."

    In addition to pressing for more federal funding for treatment programs, the editorial also calls for greater attention to prevention strategies related to pain treatment, specifically mentioning physical therapy as a nondrug treatment that should be easier for consumers to access and pay for through insurance.

    "States, which have more sway over doctors and hospitals, need to do more on the prevention side by placing limits on opioid prescriptions," according to the editorial. "States can encourage doctors to order alternative pain treatments, like physical therapy, and require insurers to cover those services."

    The editorial's position is consistent with recent guidelines from the US Centers for Disease Control and Prevention and the National Institutes of Health, which have both pressed for the use of nonopioid treatments, including physical therapy, as a first-line approach to chronic pain.

    "Congress may be late to wake up to the epidemic, but it does at last seem prepared to open more paths to treatment," the editorial concludes.

    Coming to the NEXT Conference and Exposition, June 8-11 in Nashville? Don't miss this year's Rothstein Roundtable, "Opioids Versus Physical Therapy: Should Physical Therapy be the FIRST Option for Pain Management?," Friday, June 10, at 8:00 am.

    WSJ: Running's Popularity Drops as Millennials Opt Out

    Some might say it's too early to tell, but The Wall Street Journal (WSJ) believes that running's popularity may be on the decline, mostly because of decreasing participation among millennials.

    In her article "How Millennials Ended the Running Boom," WSJ reporter Rachel Bachman looks at statistics that point to a "sustained cooling off of footrace fever," based on the number of race finishers between 2013 and 2015. That number reached its peak in 2013, with 19 million finishers; by 2015 it dropped to 17 million, a 10% decrease.

    And according to the WSJ, it's not just races that are seeing declines: the number of individuals who reported running noncompetitively 50 times a year or more ("frequent runners") declined by 11% from 2013 to 2015.

    Bachman reports that the biggest reason for the drop has to do with falling participation among millennials, now the country's largest generation. The age group of 18- to 34-year-olds made up 33% of race finishers in 2015—down from 35% in 2014—and the frequent-runner number dropped by 21% between 2013 and 2015, a reduction of about 2.5 million people.

    The drop doesn't mean that millennials are less physically active, according to the WSJ. Instead, young adults appear to be opting for variation in their exercise, showing more interest in studio-based programs, such as CrossFit, that satisfy their "hunger for variety," Bachman writes. The dropoff in race participation in particular may also be linked to millennials' "greater fear of failure than older generations," according to a former president of Equinox gyms and SoulCycle interviewed for the article.

    Interestingly, while the popularity of running falls off among the 18-34 age group, it continues to rise among older groups. The WSJ reports that the number of frequent runners aged 45-64 "rose slightly" over the past 2 years, and the number of frequent runners 65 and older jumped by 25%.

    Zika in the News: Damage 'Worse Than Predicted,' Common US Mosquito Capable of Transmission

    Another week, another round of media coverage of the Zika virus. And so far, there's not much good news in sight.

    The last week of April brought reports of the first official Zika-related death on a US territory, statements that microcephaly and other birth defects associated with the virus may be the "tip of the iceberg," and a finding that a mosquito more common to the US can carry Zika. Here's a roundup of some of the most recent reports:

    The Asian tiger mosquito, common in the US, can carry Zika. (The Washington Post)
    A laboratory in Singapore has confirmed that the Asian tiger mosquito is capable of transmitting the virus, and was the species mainly responsible for an outbreak in Gabon, in Africa. Though not the most common variety of mosquito in the US, it is widespread and particularly tough to eradicate because of its ability to raise its young in small pockets of water. One expert quoted in the story says "It's like a hurricane. We know it's coming, we don't know where it will hit, but we'll see some indigenous cases here.”

    The severity of Zika-related brain damage in babies is "far worse than doctors expected." (Wall Street Journal)
    This article from April 28 looks at the range of brain defects associated with Zika in newborns, asserting that health care providers are dealing with problems that "are far worse than past birth defects associated with microcephaly," including unformed areas of the brain, and holes in the brain that fill with fluid. The report includes a few theories about how the Zika virus "that has appeared benign since first identified 70 years ago could now pose such a grave risk," and touches on multidisciplinary efforts that include physical therapists in working with the infants who suffered damage.

    The first Zika death in the US happens as Congress fails to agree on funding for Zika health efforts. (Voice of America)
    The death of an elderly man in Puerto Rico marked the first Zika-related death on US territory, reports Voice of America. Meanwhile, the US Congress is now in recess after failing to approve a White House request for nearly $2 billion in emergency funding to battle the Zika-carrying mosquito and develop a vaccine. In the meantime, the Obama administration is moving money that was not spent on the Ebola outbreak to fight Zika.

    Zika virus birth defects could be just the "tip of the iceberg." (NBC News)
    This May 1 story quotes a representative from the US Centers for Disease Control and Prevention telling a meeting of the Pediatric Academic Societies that "the microcephaly and other birth defects we have been seeing could be the tip of the iceberg." And though the article outlines the daunting challenges facing health providers and parents in Brazil and elsewhere, a few bright spots were identified: Zika infections don't seem to be occurring in children, the incidence of Zika-related Guillain-Barre syndrome seems rarer than once thought, and predictions are for rates of infection to drop in Brazil as the weather cools seasonally.