Dec 26, 2018 / By KEVIN TRUONG
As part of the federal government’s increasing focus on issues of healthcare fraud, particularly in the Medicare space, the U.S. Department of Justice recovered $2.5 billion in settlements and judgments from False Claims Act Cases over the past year.
According to the DOJ, this is the ninth consecutive year that the organizations’ civil health care fraud settlements and judgments have exceeded $2 billion.
While the $2.5 billion number represents federal losses, the DOJ also said it also helped recover significant funds for state Medicaid programs
“Every year, the submission of false claims to the government cheats the American taxpayer out of billions of dollars,” Principal Deputy Associate Attorney General Jesse Panuccio said in a statement.
“In some cases, unscrupulous actors undermine federal healthcare programs or circumvent safeguards meant to protect the public health … The nearly three billion dollars recovered by the Civil Division represents the Department’s continued commitment to fighting fraudsters and cheats on behalf of the American taxpayer.”
The False Claims Act has its roots in groups trying to defraud the military during and after the Civil War and was significantly strengthened since 1986 when Congress increased incentives for whistleblowers to file lawsuits alleging false claims.
In healthcare, organizations across the industry were hit with False Claims cases including drug companies, medical device manufacturers, payer organizations and healthcare providers.
Dec. 27, 2018 / By Anna Wilde Mathews and Melanie Evans
Phoebe Putney Health System doesn’t want its doctors to send business to competitors. If they do, Phoebe makes sure their bosses know about it.
Doctors working for the Albany, Ga.-based hospital system’s affiliated physician group get regular reports breaking down their referrals to specialists or services. One viewed by The Wall Street Journal included cardiology, colonoscopies and speech therapy, along with the share of each referred to Phoebe health-care providers.
If the share of in-house business wasn’t viewed as adequate, administrators would press them to improve, doctors said.
“They would let you know it wasn’t high enough,” said Thomas Hilsman, a primary-care doctor recently retired from the Phoebe medical group. He said he felt referrals should be based on which health-care provider was best for patients. “They keep the Phoebe physicians busy, they see more patients, they make more money.”
Phoebe officials said they use referral policies to improve quality and reduce costs, and physicians weren’t punished for their decisions.
Patients are often in the dark about why their doctors referred them to a particular physician or facility. Increasingly, those calls are being driven by pressure to keep business within a hospital system, even if an outside referral might benefit the patient, according to documents and interviews with doctors, current and former hospital executives and lawyers.
Losing patients to competitors is known as “leakage.” Hospitals, in response, use an array of strategies to encourage “keepage” within their systems, which in recent years have expanded their array of services.
The efforts at “keepage” can mean higher costs for patients and the employers that insure them—health-care services are often more expensive when provided by a hospital. Such price pressure and lack of transparency are helping drive rising costs in the $3.5 trillion U.S. health-care industry, where per capita spending is higher than any other developed nation.
For hospital systems, doctors’ referrals are a vital source of revenue. A hospital earns an average of $1.8 million annually in revenue from an internal-medicine physician’s admissions, referrals for tests and other services, plus practice revenue for employed doctors, a 2016 survey by recruiter Merritt Hawkins, a unit of AMN Healthcare Services Inc., found. The survey didn’t include hospital revenue from referrals by internal-medicine doctors to specialists, such as orthopedic surgeons or cardiologists.
Hospitals have gained more power over doctors with a wave of acquisitions of practices and hirings in recent years, and hospitals are getting more aggressive in directing how physicians refer for things such as surgeries, specialty care and magnetic resonance imaging scans, or MRIs.
by Paige Minemyer |
Providers have yet to slake their thirst for mergers—with several big-ticket mega-deals dominating headlines in 2018—but experts warn that there’s unlikely to be an immediate pay off for patients.
And despite the fast pace of consolidation in healthcare, there are no signs of the merger trend slowing down going into 2019, especially as private equity investors have their focus squarely on the opportunities in the industry.
Some of the most notable deals of 2018 included the $28 billion merger between Catholic Health Initiatives and Dignity Health, forming one of the largest non-profit systems in the country, and the ongoing regulatory review of the deal between Lahey Health and Beth Israel Deaconess Medical Center, which seeks to create a system in Massachusetts to rival giant Partners HealthCare.
For both deals, the involved health systems touted the potential financial benefits for patients. Lahey and Beth Israel said that having a challenger to Partners will significantly bring down prices in the greater Boston area.
But Ben Isgur, leader of PricewaterhouseCoopers’ Health Research Institute, told FierceHealthcare that while the jury is still out on whether these deals will benefit for patients in the long-term, significant cost savings haven’t appeared in the short-term.
“Especially in the short-term, there’s not a lot of data out there that shows it will reduce costs,” Isgur said. “It’s a market play.”
Other experts have expressed the same concern, and in some cases, have warned that these deals could even lead to higher prices. In addition, a study released earlier this year suggests that the rapid pace of consolidation may pose a risk to patient safety.
Isgur said, though, that immediate benefits could play out in an improved patient experience and access to more convenient sites of care, such as urgent care centers or telemedicine from home.
Consolidation can also make it easier for providers to jump into the latest technologies, he said, by enhancing their workforce and bringing in additional money, which could pay off for patients more immediately, too.
Dec 26, 2018 / By: Kaitlin Schroeder, Journal-News.com
Prices hospitals charge for their services will all go online Jan. 1 under a new federal requirement, but patient advocates say the realities of medical-industry pricing will make it difficult for consumers to get much out of the new data.
A federal rule requires all hospitals to post online a master list of prices for the services they provide so consumers can review them starting Jan. 1.
The health care industry nationally has a reputation for having little price transparency, which can make it difficult for consumers to price compare. But the hospital’s master list prices, sometimes called a chargemaster, is also not a complete look, consumer advocates say.
That’s because the final bill a patient receives is almost never the same as the sticker price for the services they received. Insurance companies negotiate discounts on the sticker prices. Co-pays, co-insurance, deductibles also add other layers of complexity that bring discounts or increased costs before a final charge is determined.
“The list prices are so high that the vast majority of hospitals don’t even try to collect list prices from uninsured patients,” said Benedic Ippolito, with the American Enterprise Institute, who has researched hospital list prices.
The federal rule is being brought out as a measure to improve competition and help educate consumers.
“We are just beginning on price transparency,” Seema Verma, head of U.S. Centers for Medicare & Medicaid told the Associated Press. “We know that hospitals have this information and we’re asking them to post what they have online.”
But real transparency comes when consumers can easily see what they will pay to a provider based on their insurance benefits, said Thomas Campanella, Baldwin Wallace University health care MBA program director. He said some insurance companies are providing that information through price comparison tools.
“I almost see it being more of a political ‘look at what we did,’” Campanella said of the requirement to post list prices.
Kettering Health Network, which has eight hospitals in the Dayton, Ohio area, said the chargemaster will be posted on its patient pricing webpage after Jan. 1. Premier Health, which has three hospitals in the same region, said the information will be on its hospitals’ websites by Jan. 1. and consumers will find the list of charges where they currently find other pricing, insurance and billing information.
Photo: Nick Graham/Staff
12-26-2018 / Kain, Zeev
I’m excited to announce the 3rd Interdisciplinary Conference on Orthopedic Value based Care taking place on January 18-20, 2018 in beautiful Newport Beach, California. We’ve planned this conference to be even better than last 2 years highly-rated event!
Here’s five reasons it should be on your to-do list:
- One Unique Team Concept
The mission of this conference is to break the silos that exist in a patient’s orthopaedic journey. This is the only conference that brings in speakers that represent players from across the episode: orthopedic surgeons, nurses, physical therapists, healthcare executives, anesthesiologists, patients, digital health experts and futurists. In the same vein, we expect surgical teams to attend and take this opportunity to learn from each other and work toward better patient outcomes together. This worked well at last year’s conference where 40% of the participants were part of a hospital team.
- Two Innovative Cadaveric Workshops
On Friday there are 2 cadaveric workshops that will focus on innovative surgical orthopedic procedures and US based regional anesthesia. Plenty of opportunity to experience new devices and surgical techniques as well the most innovative regional anesthesia techniques.
- Three Ambulatory Boot Camps
Orthopedic spines are heading to the outpatient area and we need to get ready. The first bootcamp will focus on the concept of fee for value in the ambulatory environment and will include practical approaches aught by all the stakeholders. The second bootcamp will focus on the nuts and bolts of building and maintaining an Orthopaedic ambulatory center and the third book camp will focus on building an enhanced recovery model for the patients who are undergoing ambulatory surgery.
- Four Complementary Tracks
To be successful in the world of fee-for-value, one needs to understand all the clinical, financial and operational aspects of this new developing world. This is the ONLY conference that offer three complementary parallel tracks that the various stakeholders can attend! We choose the 4th track, ambulatory, to be held on Friday with no other programing at the same time because of the high interest in this concept.
- Five Times the Networking
Each day offers four opportunities for networking, including breakfast, lunch and two breaks for exchanging best practices and comparing notes. Plus, a free meet and greet wine networking reception on Saturday night will offer a relaxed atmosphere to share insights from day one.
- A Six-Star Speaker Lineup
The agenda has 38 world-class, interdisciplinary speakers. Ortho experts include speakers such as Alexander R. Vaccaro, President and Surgeon-in-Chief at Rothman Institute Orthopedics; Joseph Iannotti, Chair at Cleveland Clinic, Kevin Bozic, Chair at Dell School of Medicine and Tony Romeo from the Rothman Institute of New York. The Executive leaders include individuals such as the CMO of Humana, CMO of Optum, COO of Rothman, Vice Chancellor of UC Davis and others.
Published Regenexx Research, Involving Stem Cells And Platelets, Shows Promise For Treating Osteoarthritis Of The Knee
BROOMFIELD, Colo., Dec, 21, 2018 /PRNewswire/ — New research from Regenexx®, which provides advanced interventional orthobiologics, shows greater potential for treating osteoarthritis of the knee with cell-based therapies. The study, published on December 13, 2018, in the Journal of Translational Medicine, was a randomized controlled trial of patients’ own bone marrow concentrate (BMC) and platelet-rich plasma products versus an exercise therapy regimen for patients with moderate knee osteoarthritis, with clinical outcomes documented over a two-year period.
The study included 48 patients, with 22 in the control group (exercise) and 26 receiving the treatment of bone marrow concentrate (which contains mesenchymal stem cells, platelets, and other cells with healing and regeneration potential) and platelet-rich plasma. All patients in the control group crossed over to the BMC treatment group at three months.
Patients who received the BMC treatment improved significantly in activity levels and stability at three months over those who followed the exercise therapy program. Over the two-year period, after receiving the BMC treatment, significant reduction in pain and increased functionality were maintained.
“To the best of our knowledge, this is the first randomized controlled trial comparing patients’ own bone marrow concentrate and therapeutic exercise for knee osteoarthritis,” said Christopher Centeno, M.D., lead researcher on the study. “While exercise therapy alleviated osteoarthritis symptoms and improved function, the specific BMC protocol, while warranting further investigation, had a greater positive impact on the patients.”
Osteoarthritis, one of the most common causes of chronic joint pain, affects more than 50 million adults in the United States. Annual costs due to medical expenses and lost wages exceed $100 billion. Current treatments include non-steroidal anti-inflammatory drugs, which are not curative and are associated with side effects; corticosteroid injections, which demonstrate only modest clinical benefits; aquatic therapies, which provide short-term benefits; and physical therapy.
While exercise or physical therapy has been shown to improve function and reduce pain, this study showed cell-based therapy to be more effective.
To review the full study and outcomes in the Journal of Translational Medicine, click here.
Regenexx provides advanced interventional orthobiologics (non-surgical stem cell and blood platelet treatments) for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone. The company also provides programs for self-funded employers, enabling them to offer their employees an additional choice in care for orthopedic issues. For more information, visit www.regenexx.com or www.regenexxcorporate.com.
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December 20, 2018 / Elizabeth Hofheinz, M.P.H., M.Ed.
Approximately two months ago, Zimmer Biomet announced the mymobility app which is meant to walk patients through pre- and post-op large joint arthroplasty care.
Joshua Carothers, M.D., an orthopedic surgeon at New Mexico Orthopaedics in Albuquerque, is one of the first users of this Zimmer Biomet/Apple product. He shared his early experiences with OTW. “While our experience in the study has been limited, with just a few patients enrolled so far, people are definitely excited.”
“mymobility feels cutting-edge. Patients like using the wearable technology to guide their activity pre- and post-surgery. The basic concept of using technology to make the experience better is resonating with patients and I’m excited about using mymobility to improve care for patients with insights on things like patient complications and re-admissions, to name a couple.”
This project is of particular importance to Zimmer Biomet’s CEO Bryan Hanson. “We are incredibly excited to work with Apple to transform the knee and hip replacement experience for patients and surgeons.”
The mymobility app captures data from knee and hip replacement patients and shares it seamlessly with their doctors so that, as Jeff Williams, chief operating officer at Apple explained “They can participate in their care and recovery in a way not previously possible through traditional in-person visits. This solution will connect consumers with their doctors continuously, before and after surgery.”
According to the terms of the deal, ConforMIS also plans to issue an additional 354,430 shares of common stock to Lincoln Park as commitment shares.
In total, the company said it will sell no more than 12,651,640 shares of common stock to Lincoln Park unless it obtains stockholder approval to issue more.
Also this month, ConforMIS announced that it would lay off roughly 10% of its workforce.
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
December 20, 2018 / FDA News Release
The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients. Genetech processed umbilical cord blood into unapproved human cellular products, which was distributed by Liveyon, LLC.
Additionally, as part of the FDA’s overall goal to support the responsible development of safe and effective products for patients, the agency is sending letters to reiterate the FDA’s compliance and enforcement policy to other manufacturers and health care providers who may be offering stem cell treatments.
“The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies. At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” said FDA Commissioner Scott Gottlieb, M.D. “We remain committed to supporting the development of safe and effective cell-based regenerative medicine and advancing our comprehensive regenerative medicine policy framework. These efforts include our work to encourage manufacturers to engage with the FDA early so that we can provide guidance about any applicable regulatory requirements. Even though a few sponsors have come to us, we are discouraged by the overall lack of manufacturers wanting to interact with the agency in this enforcement discretion period. The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion. We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”
As highlighted last year with the release of the FDA’s comprehensive regenerative medicine policy framework, including the FDA’s final guidance (Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use), the FDA intends to apply a risk-based approach to enforcement of cell-based regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended to be used. However, the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern to patients.
Under this policy, the agency noted that it intends to exercise enforcement discretion for certain products until November 2020 with respect to the FDA’s investigational new drug application and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns. Although the FDA has not evaluated the application of the compliance and enforcement policy to the specific manufacturers and health care providers who received the letters, or evaluated their products, the letters are intended to serve as a reminder of the enforcement discretion period and to encourage all affected manufacturers and health care providers to engage with the agency in advance of that date to determine if their products are subject to the agency’s premarket approval requirements.
The FDA offers opportunities for this type of engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. It also encourages the use of its expedited programs whenever applicable, in addition to the collaborative development of products as the FDA Commissioner and Center for Biologics Evaluation and Research director discussed in a New England Journal of Medicine perspective.
In the case of Genetech, the FDA inspected the company’s facility this past June and found the company was processing cellular products from human umbilical cord blood for administration by intra-articular (joint) injection, intravenous injection or application directly to the affected tissue to treat a variety of orthopedic conditions. These products were distributed by Liveyon in Yorba Linda, California as ReGen5, ReGen10 and ReGen30. The Genetech products are not intended for homologous use (products that are intended for the same function in the recipient as the donor), and while the products have a systemic effect, they are not intended for allogeneic (genetically similar) use in a first or second-degree blood relative. As such, the products are regulated as both drug and biological products. To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the Genetech-processed, Liveyon-distributed products.
During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products, including: deficient donor eligibility practices; unvalidated manufacturing processes; uncontrolled environment; lack of control over the components used in production and a lack of defined areas or a control system to prevent contamination and mix-ups. These deviations pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects.
The FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli), as described in a forthcoming Morbidity and Mortality Weekly Report (MMWR), titled “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.”
In September, Liveyon suspended shipment of all product pending an inquiry by the FDA into the source of the adverse reactions. Liveyon also voluntarily recalled all Genetech products it may have distributed.
“The FDA remains committed to taking action against products being unlawfully marketed and which pose a potential significant risk to patient safety at this time. However, the agency is also committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
The FDA requested a response from Genetech, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.
Health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed formcan be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.Read More
The former head of Cleveland Clinic Innovations, who pleaded guilty to defrauding the health system out of nearly $3 million, was sentenced to 30 months in prison.
Gary Fingerhut, 58, was also ordered to pay the more than $2.7 million that was diverted from the Cleveland Clinic as part of the scheme in restitution, the Department of Justice announced. Fingerhut pleaded guilty to one count of wire services fraud and one count of making false statements for his role in October 2017.
Fingerhut was expected to be sentenced in January, and attorneys anticipated that he could face between 41 and 51 months in jail.
Fingerhut was the executive director of Cleveland Clinic Innovations for two years before the FBI uncovered the fraud scheme in 2015. Fingerhut conspired with Wisam Rizk, chief technology officer of Interactive Visual Health Records, a spinoff of Innovations that was formed to build a digital charting tool for the clinic’s doctors.
Photo: (Getty Images/alfexe)