SightLine Health allegedly formed leasing companies and distributed the profits that its physician-investors generated by referring cancer patients for radiation therapy.
A Houston-based radiation therapy chain will pay the federal government $11.5 million to settle a False Claims Act suit alleging that they paid physicians kickbacks to draw referrals, the Department of Justice said.
Prosecutors said SightLine Health LLC, which was acquired by Oncology Network Holdings LLC in 2011, allegedly enticed physicians to refer patients to its cancer treatment centers, and paid those physicians a share of its profits.
Specifically, prosecutors alleged that SightLine formed several leasing companies that referring physicians bought into. SightLine then distributed the profits that its physician-investors generated by referring cancer patients for radiation therapy.
"Investment arrangements that are structured to improperly compensate physicians for referrals can encourage physicians to make decisions based on financial gain rather than the best interest of their patients," said Acting Assistant Attorney General Chad A. Readler in DOJ's Civil Division.
"As the professionals charged with recommending and referring medical procedures for our community, physicians' primary motivation must remain the well-being of their patients," said U.S. Attorney Erin Nealy Cox. "Today's settlement demonstrates our determination to eliminate complex business ventures that improperly interpose financial considerations into our physicians' medical judgment."
In addition to the settlement, ION and SightLine have entered into a five-year corporate integrity agreement with the federal auditors that will monitor relationships between ION and SightLine and referring physician investors.
The whistleblower who prompted the suit was not identified by DOJ, but that person will receive a $1.75 million share of the settlement.
SightLine, which operates nine radiation clinics in five states, did not return calls Friday morning seeking comment.
Drug overdose deaths in 2016 increased in all categories of drugs examined for men and women, people ages 15 and older, all races and ethnicities, and across all levels of urbanization.
Drug overdoses in the United States are a growing problem for every demographic and region in the nation, according to a study released today by the Centers for Disease Control and Prevention.
Drug overdoses killed 63,632 Americans in 2016. Nearly two-thirds of these deaths involved a prescription or illicit opioid. Overdose deaths increased in all categories of drugs examined for men and women, people ages 15 and older, all races and ethnicities, and across all levels of urbanization, CDC said.
The analysis confirms that recent increases in drug overdose deaths are driven by continued sharp increases in deaths involving synthetic opioids other than methadone, such as illicitly manufactured fentanyl.
"No area of the United States is exempt from this epidemic—we all know a friend, family member, or loved one devastated by opioids," said CDC Principal Deputy Director Anne Schuchat, MD.
CDC's analysis, based on 2015-2016 data from 31 states and Washington, DC, showed:
Across demographic categories, the largest increase in opioid overdose death rates was in males between the ages of 25-44.
Overall drug overdose death rates increased by 21.5%.
The overdose death rate from synthetic opioids (other than methadone) more than doubled, likely driven by illicitly manufactured fentanyl.
The prescription opioid-related overdose death rate increased by 11%.
The heroin-related overdose death rate increased by 19%.
The cocaine-related overdose death rate increased by 52%.
The psychostimulant-related overdose death rate increased by 33%.
Overdose death rates differ by state
Death rates from overdoses involving synthetic opioids increased in 21 states, with 10 states doubling their rates from 2015 to 2016. New Hampshire, West Virginia, and Massachusetts had the highest death rates from synthetic opioids.
Fourteen states had significant increases in death rates involving heroin, with Washington D.C., West Virginia, and Ohio having the highest rates.
Eight states had significant increases in death rates involving prescription opioids. West Virginia, Maryland, Maine, and Utah had the highest rates.
Sixteen states had significant increases in death rates involving cocaine, with Washington D.C., Rhode Island, and Ohio having the highest rates.
Fourteen states had significant increases in death rates involving psychostimulants; the highest death rates occurred primarily in the Midwest and Western regions.
The map divides the nation into 326 referral regions that link patient home counties to hospital counties and allow multiple patient home counties to join to the same hospital county.
Clinicians and scientists at the University of Pittsburgh School of Medicine and UPMC have mapped out a coordinated emergency and trauma care system for the nation.
The Pittsburgh Atlas, published today in the Annals of Emergency Medicine, divides the United States into 326 referral regions.
The atlas also creates the framework that will allow states and groups of counties to implement quality improvement programs accountable to regional performance measures instituted by state and local governments, the atlas's authors said.
"Recent proposed changes to healthcare could shift more responsibility to the state level with regard to who is insured or what services are offered," said lead author David J. Wallace, MD, an assistant professor in Pitt's Department of Critical Care Medicine.
"A set of regions that maintain state lines is essential in that circumstance," Wallace said.
More than a decade ago, a National Academy of Medicine reportendorsed coordinated, regional, accountable systems as an approach to improve healthcare for severe acute conditions requiring trauma and emergency services.
In 2013, the National Quality Forum highlighted the importance of region-level performance measures that promote timely, high-quality care.
The Pittsburgh Atlas was modeled on the Dartmouth Atlas of Health Care, a set of geographic regions based on Medicare and Medicaid hospital discharge claims that was created more than 20 years ago, and is used for epidemiological studies that compare the cost, quality and consumption of health care in different parts of the country, Wallace said.
However, the Dartmouth Atlas ignores state and county boundaries – resulting in a set of regions that do not promote coordination or accountability, the atlas authors said.
The Pittsburgh Atlas looks at nearly 731,000 Medicare patients who sought care for a heart attack, stroke or moderate to severe trauma in 2011. Referral regions were created by combining patient home counties to hospital counties, allowing multiple patient home counties to join to the same hospital county.
The researchers used six ways to divide the United States into emergency care referral regions and found one that keeps the vast majority of patients closest to home.
"We were surprised at how well our regions performed in terms of keeping patients close to home – they did as well as those in the Dartmouth Atlas," said Wallace. "We truly expected there would be a greater trade-off since the Pittsburgh Atlas faced the additional geopolitical boundary constraints."
Wallace said the Pittsburgh Atlas may not be representative for all patients. It was built using the largest collective source of hospitalizations for heart attack, stroke and major trauma in the nation but it is limited to patients 65 years old and older with data from 2011.
Referral patterns may have changed with population changes and hospital openings and closings – meaning the Pittsburgh Atlas would need periodic updates, he said.
The data files for the Pittsburgh Atlas are publicly available and give "researchers, policymakers, hospital systems and public health agencies a way to move beyond simply comparing apples to apples, and into thinking about orchards," Wallace said.
The federal investigation has resulted in 53 convictions – 38 of them doctors – in connection with the scheme, which involved millions of dollars in bribes and more than $100 million in payments from Medicare and private payers.
A federal judge in Newark, NJ on Wednesday sentenced a Bergen County physician to 18 months in prison for his role in a far-ranging test-referral bribery scheme, the Department of Justice announced.
Basel Batarseh, MD, of Franklin Lakes, NJ, is the 38th physician convicted in the scheme operated by senior executives at now-defunct, Parsippany-based Biodiagnostic Laboratory Services LLC, federal prosecutors said.
Batarseh previously pleaded guilty to one count of accepting bribes in violation of the Federal Travel Act. He was also sentenced to one year of supervised release, fined him $7,500 and ordered forfeiture of $104,611.
According to documents filed with the court, Batarseh, an internist practicing in West New York, NJ, located across the Hudson River from Manhattan, accepted bribes totaling more than $104,000 from BLS employees and associates between 2007 and 2010.
In exchange, Batarseh generated more than $1.3 million in lab business for BLS.
The federal investigation has thus far resulted in 53 convictions in connection with the scheme, which its organizers have admitted involved millions of dollars in bribes and resulted in more than $100 million in payments to BLS from Medicare and private insurance companies.
It is believed to be the largest number of medical professionals ever prosecuted in a bribery case, DOJ said.
The investigation has recovered more than $13 million through forfeiture. BLS, which is no longer operational, pleaded guilty in June, 2016 and forfeited all of its assets.
S&P forecasts lower near-term statutory minimum requirements for defined benefit plans, which could help financial profiles for not-for-profit healthcare providers.
The nation’s not-for-profit healthcare sector has benefited from a boost in the funded status of its pension plans in fiscal 2017 due primarily to robust investment market returns, according to a report this week from S&P Global Ratings.
This boost is occurring, S&P said, despite lower assumed discount rates in recent years, which provide a more conservative liability measure.
In the near term, S&P said a higher funded status should mean lower statutory minimum contributions to defined benefit pension plans, which could help overall financial profiles as operating performance in the healthcare sector has come under stress.
"However, the projected benefit obligation for many plans has continued to increase and many have had to contend with updated mortality tables, which more accurately recognize longer lives -- which leads to increased pension liabilities," said S&P credit analyst Anne Cosgrove.
Cosgrove said many not-for-profit issuers have focused on lowering pension funding risks, including increasing annual contributions to improve the funded status, closing current plans to new participants, freezing plans, and in some cases terminating plans altogether.
S&P has tracked the funding levels of defined-benefit plans of not-for-profit hospitals and health systems since 2007, when, on average, they were at their highest level (at 90%).
Funded statuses declined sharply in 2008 and 2009, by 20 percentage points during the Great Recession and the cratering of global investment markets. After the recession, funded ratios were essentially flat at near 70% through 2012, despite hospitals' healthy contributions to plans, S&P said.
Public, not-for-profit West Tennessee Healthcare will acquire CHS's Tennova Healthcare subsidiary hospitals in Jackson, Dyersburg and Martin in a deal with an value estimated at $67 million.
Community Health Systems, Inc. continues to unload hospitals in its ongoing effort to reduce debt.
The Franklin, TN-based for-profit hospital chain announced that it would sell three hospitals in its Tennova Healthcare subsidiary to West Tennessee Healthcare, a Jackson-based public, not-for-profit health system.
The three hospitals are: 225-bed Tennova Healthcare Dyersburg Regional; 150-bed Tennova Healthcare Regional Jackson; and 100-bed Tennova Healthcare Volunteer Martin.
Financial terms were not disclosed, but local media estimated the value of the deal at $67 million.
The deal includes all physician clinics and outpatient services associated with the three hospitals, which will also become part of WTH’s 18-county network of medical centers and outpatient services.
WTH CEO James E. Ross called the acquisition is good news for consumers, employers, physicians and future patients.
"This transaction is consistent with our stated mission to improve the health and well-being of the communities we serve while providing exceptional and compassionate care," Ross said in amedia release. "It will enable us to provide expanded access to quality healthcare."
CHS said in a media release that the three hospitals are among the planned divestitures discussed on the company’s fourth quarter 2017 earnings call. CHS has been working to reduce the debt burden it accrued with the 2014 acquisition of Naples, FL-based Health Management Associates.
When the deal is finalized this summer, WTH will employ more than 7,000 people and operate seven hospitals across the region.
The marks the fourth divestiture of a Tennova hospital for CHS this year.
The Tennova hospitals were acquired and rebranded by CHS in 2014 when it bought out HMA. After the WTH sell-off, Tennova will operate 12 hospitals across Tennessee.
The deal would include St. Vincent's 473-bed community teaching hospital and a 76-bed inpatient psychiatric hospital, and would broaden Hartford HealthCare’s footprint in Fairfield County.
Hartford HealthCare has signed a nonbinding letter of intent to acquire Ascension's St. Vincent's Medical Center in Bridgeport, Connecticut, the two health systems announced jointly.
"Our goal, in coordination with the Board of St. Vincent's, has been to position St. Vincent's so its associates, physicians and volunteers can continue to provide safe, high-quality healthcare to the Bridgeport and Fairfield County community," said Ascension CEO Patricia A. Maryland.
"In our rapidly evolving healthcare environment, healthcare providers have a greater opportunity to successfully serve individuals and communities by working in clinically integrated systems of care. And Hartford HealthCare is Connecticut's most comprehensive healthcare network," Maryland said.
St. Vincent’s includes a 473-bed community teaching hospital, a 76-bed inpatient psychiatric facility in Westport, a large multispecialty provider group, and St. Vincent's Special Needs Services.
If the transaction is completed, Hartford HealthCare would continue to operate St. Vincent's in compliance with Catholic traditions. The transaction would not include St. Vincent’s College.
Hartford HealthCare has more than 19,000 employees and includes acute-care hospitals, a behavioral health network, multispecialty physician groups, a regional home care system, an array of senior care services, a physical therapy and rehabilitation network, and an accountable care organization.
"Hartford HealthCare would be privileged to partner with the people of St. Vincent's who have done so much for their communities," Hartford HealthCare CEO Elliot Joseph said. "Together, we can provide even broader access to St. Vincent's excellent care to residents of Fairfield County."
The proposal would exempt states with a Medicaid managed care penetration of 85% or more from some monitoring requirements, and provide flexibility to states when they make nominal rate reductions to fee-for-service payment rates.
A proposed rule change by the Centers for Medicare & Medicaid Services would exempt state Medicaid programs from some access-to-care reporting requirements.
Specifically, the proposal would exempt states with a Medicaid managed care penetration of 85% or more from some monitoring requirements, and provide similar flexibility to states when they make nominal rate reductions to fee-for-service payment rates.
"These new policies do not mean that we aren't interested in beneficiary access, but are intended to relieve unnecessary regulatory burden on states, avoid increasing administrative costs for taxpayers, and refocus time and resources on improving the health outcomes of Medicaid beneficiaries," CMS Administrator Seema Verma said in a media release.
Under CMS's Notice of Proposed Rulemaking:
States with an overall Medicaid managed care penetration rate of 85% or greater (currently, 17 states) would be exempt from most access monitoring requirements.
Reductions to provider payments of less than 4% percent in overall service category spending during a state fiscal year (and 6% over two consecutive years) would not be subject to the specific access analysis.
When states reduce Medicaid payment rates, they would rely on baseline information regarding access under current payment rates, rather than be required to predict the effects of rate reductions on access to care, which states have found very difficult to do.
Jeff M. Myers, president and CEO of Medicaid Health Plans of America, said the existing rules are not needed in states with a high penetration of Medicaid managed care plans because they already have robust provider networks.
"The exception lessens the burden on states and is in line with the overall effort to streamline some regulations and introduce more efficiency into the program," Myers said.
Jack Rollins, senior policy analyst at the National Association of Medicaid Directors, said the proposed rule change appears to address some concerns raised by the states.
"We are still reviewing but our preliminary impression, the caveat that we haven't had a conversation with our members, is that CMS appears to have taken state feedback into consideration and are making what looks to be some positive changes that will allow states to manage their programs effectively and still strike the balance between ensuring appropriate access and setting some guardrails around it without causing so much administrative complexity," Rollins said.
Rollins said the proposed rule change amends an Obama administration rule that established a Medicaid access monitoring for fee-for-service programs, but exempted managed care.
"What that rule did was identify a bucket of five or six core service areas where states needed to put together data packages that showed how their rates compared to other payers in the state and nationally," Rollins said. "They would compare their rates to what Medicare paid, what other state Medicaid programs paid, maybe some commercial payers in the private market paid. The intent behind that was to look at the comparison and show that Medicaid rates aligned or were relatively close to other payers, or maybe they were far off."
In addition to monitoring these core service areas, the rule also required states that were making rate reductions or restructurings in other services areas to produce an access monitoring plan to assess the impact on the rate change over three years, and to provide upfront projections on how the rate change would affect access.
"Our members took issues with some of that regulatory frame work," Rollins said. "The fact that it applied to fee-for-service and not managed care, when managed care programs are the primary delivery system for Medicaid these days."
"Many states might have the majority of their Medicaid populations covered under managed care and only a relatively small or vestigial fee-for-service," he said. "Those states felt it didn't make a lot of sense to invest a lot of time and staff resources and state dollars creating a comprehensive access monitoring plan for a program that in some states covered maybe 100 people."
In addition, providing state-by-state comparisons proved challenging.
"First of all, many states said they had trouble accessing any kind of private pay rates from Managed care plans in the private market. Understandingly, that information is proprietary," Rollins said.
"Second, Medicaid covers a lot of services that Medicare does not so there is not always a one-to-one comparison," he said.
"Third, it is difficult to compare your rate structures to other states, because if you've seen one Medicaid program you've seen one Medicaid program," he said. "There is so much variation in terms of the populations covered and how states cover them, the various waiver authorities they might use in their program designs, that states are finding it very difficult to make an apples-to-apples comparison."
The proposed rule was published last week in the Federal Register and public comments will be accepted for the next 60 days. Rollins said NAMD will offer comment on the proposal after speaking with its members.
Analysts say Amazon already has the core competencies to compete in healthcare: ready access to capital, a massive distribution infrastructure, a strong technology base, robust data analytics, and a deep executive bench.
The speculation is rife about how, when and where Amazon will plunge into the healthcare sector.
In a new reportthat describes five scenarios through which Amazon could enter and dominate the industry, Rob Haslehurst, a managing director at Boston-based L.E.K. Consulting, warns against pigeonholing the e-commerce giant.
"Anyone who thinks of Amazon as just a very big digital retailer needs to think again," Haslehurst said. "They have continually expanded their business model and today they are a leader in cloud computing, a provider of in-home services and a bricks-and-mortar food purveyor in addition to their ecommerce offerings."
"They have repeatedly shown that they have the capabilities, the patience, and the deep pockets to disrupt industry after industry," Haslehurst said. "Healthcare is no exception."
Amazon’s five possible entry points are:
Durable medical equipment and medical supplies. Amazon's core competencies in logistics and distribution, and its existing B2B ecommerce platform, will allow it to easily expand into hospital and provider supply, disrupting the traditional group purchasing organization contract model. Amazon has already obtained licenses to distribute medical supplies to providers in 43 states.
Mail order and retail pharmacy. Amazon has secured approval as a wholesale distributor from 12 state pharmaceutical boards. Drug storage is a hurdle, and there are regulatory challenges. But Amazon can build pharmacies into its recently-acquired Whole Foods stores. The company can also take advantage of its predictive analytics and customer data capabilities to build digital health tools that track and influence patient behavior — giving it a leg up over traditional pharmacy in working with the most challenging areas of healthcare delivery.
Pharmacy benefit manager. Amazon's most likely move into the field will be by partnering with a large PBM such as Express Scripts or by buying a smaller player like Prime Therapeutics. Amazon would gain a pharmacy network and a claims adjudication capability, and its partner would gain access to millions of Amazon Prime members.
Telemedicine or in-home healthcare. Amazon's Echo smart speaker (with 20 million units sold to date) and Alexa, its voice-controlled personal assistant service, give it an enormous platform for new voice-activated services. Healthcare could easily be among them. Alexa's first step would be to help book physician visits. But thanks to Echo Show's video capabilities, the next move might be in-home virtual house calls.
AI-powered diagnostics and continuous care. Amazon has deep AI capabilities — machine-learning already drives many of its offerings, from its customer recommendation engine to its service centers. The next step would be to harness that capability for first-line diagnostics, and services such as auto-refills for prescriptions, and medication reminders.
L.E.K. Managing Director and report co-author Joseph Johnson said these five potential inroads strategies "are not mutually exclusive."
"In fact, they represent a roadmap that Amazon can follow to move continually deeper into the healthcare industry," Johnson said. "All of them illustrate Amazon's ability to drive down prices and margins while fundamentally transforming customer behavior."
Prosecutors claim that Alere continued to sell its Triage cardiac and drug test kids even as providers made it known that the device was faulty. The FDA recalled Triage in 2012.
Medical device maker Alere Inc. will pay the federal government $33.2 million to settle False Claims Act allegations that it knowingly sold “materially unreliable point-of-care diagnostic testing devices" to hospitals, the Department of Justice said.
Federal prosecutors allege that, from 2006 through 2012, Alere sold hospitals its Triage devices, which are used in emergency departments for the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious condition.
Alere continued to sell the product, prosecutors said, even as it received multiple complaints from providers that "put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making."
Despite those warnings, prosecutors said Alere failed to take corrective action until the Food and Drug Administration issued a national product recall in 2012.
Of the $33.2 million paid by Alere, $28.3 million will be returned to Medicare, and $4.8 million will be returned to states that paid for Triage devices with Medicaid.
HealthLeaders Media's requests for comment from Alere were not immediately returned on Friday afternoon.
"Physicians who work to treat patients with suspected myocardial infarctions rely upon devices such as Alere's Triage Cardiac products for quick and accurate readings," said Stephen M. Schenning, Acting United States Attorney for the District of Maryland.
"When manufacturers such as Alere make changes to the specifications that affect the product’s reliability without informing physicians or the FDA, patient care is put at substantial risk," he said.
The settlement resolves a whistleblower lawsuit brought forward by Amanda Wu, a former senior quality analyst at Alere, who will receive $5.6 million of the settlement.
