The San Francisco-based EHR vendor admitted that it took $1 million in kickbacks from opioid makers in a scheme to increase prescriptions.
Electronic health records vendor Practice Fusion Inc. will pay $145 million for its role in a five-year criminal scheme that colluded with opioid makers to trick physicians into prescribing their addictive pain medications, the Department of Justice announced.
The case is the first ever criminal action against an EHR vendor.
According to federal prosecutors, the San Francisco-based software vendor accepted "sponsorship" payments of $1 million from pharmaceutical companies between 2014 and 2019 that allowed the drug makers to design and develop and implement clinical decision support alerts that recommended the companies' products.
Prosecutors said Practice Fusion bragged to drug makers about the expected profits that would come from gaming CDS alerts.
The opioid makers selected the guidelines used to develop the alerts, set the criteria that would determine when a healthcare provider received an alert, and even drafted the language used in the alert itself, DOJ said.
"Practice Fusion's conduct is abhorrent," said Christina E. Nolan, U.S. Attorney for the District of Vermont, who led the investigation.
"During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids," Nolan said.
"The companies illegally conspired to allow the drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient's medical care, including the need for pain medication and prescription amounts," she said.
Attempts to contact Practice Fusion for comment were unsuccessful.
Under a deferred prosecution agreement with DOJ, Practice Fusion will admit that it asked for and received the kickbacks in exchange for rigging the software and will pay more than $26 million in criminal fines and forfeiture.
In separate civil settlements, Practice Fusion will pay $118.6 million to the federal government and states to resolve the kickback allegations that caused the software's users to submit false claims for federal incentive payments by misrepresenting the capabilities of their EHR software
The Deferred Prosecution Agreement requires Practice Fusion to ensure acceptance of responsibility and transparency as to its underlying conduct, and to invest in compliance overhauls and independent oversight.
The agreement also requires Practice Fusion to make documents relating to its criminal conduct available to the public through a website.
The new format is designed to facilitate access through a single-entry point.
The Medicare website will combine its eight separate Compare tools under one combined, standardized and simplified format in the coming months, the Centers for Medicare & Medicaid Services announced.
In a blog posting this week, CMS Administrator Seema Verma said the new format will launch this spring, and will "allow users to access the same information through a single point of entry and simplified navigation to find the information that is currently divided in places like Nursing Home Compare and Hospital Compare."
"The new 'Medicare Care Compare' on Medicare.gov will offer Medicare beneficiaries and their caregivers and other users a consistent look and feel, providing a streamlined experience to meet their individual needs in accessing information about healthcare providers and care settings," Verma said.
Currently, Medicare uses eight separate Compare tools – Hospital, Nursing Home, Home Health, Dialysis Facility, Long-term Care Hospital, Inpatient Rehabilitation Facility, Physician and Hospice – on Medicare.gov to find and compare doctors.
"In the new, unified experience, patients will be able to easily find the information that is most important to help make healthcare decisions, like getting quality data by the type of healthcare provider," Verma said.
Verma said CMS is also developing an improved "companion portal" that Medicare researchers and stakeholders can use to access the more detailed data, that will also launch this spring.
"This new 'Provider Data Catalog' will reside on CMS.gov," Verma said. "It will have an improved interface and intuitive search features to allow users to easily search and download CMS' publicly reported data, better serving stakeholders who use the interactive and downloadable datasets like those currently found on data.Medicare.gov."
All of the data sets will be made available through an Application Programming Interface from the Provider Data Catalog.
"Even though we’re making these enhancements, it doesn’t change our public reporting requirements, and we will continue to meet every reporting mandate," Verma said.
Following a transition period after the launches, the existing tools will be terminated.
The model will expand and improve the Primary Children's Hospital care network for Intermountain West, which now serves children in six states.
Intermountain Healthcare has committed $500 million to build "the nation's model health system for children."
"To address the growing need for health issues facing children, we must create a new model of pediatric care that will cater to the unique challenges that we see across our large geographic area," Katy Welkie, RN, MBA, CEO of Primary Children's Hospital and Vice President of Intermountain's Children's Health, said in a media release.
"In building the nation's model health system for children, we are positioning Utah as the home for the nation's healthiest kids," she said.
The plan, financed in part by a $50 million donation from Utah Jazz owner and businesswoman Gail Miller, will invest $500 million to launch, advance, and coordinate pediatric-specific programs around the Salt Lake City-based health system's free-standing Primary Children's Hospital and a network of 160 clinics and 24 hospitals, and pediatric specialty expertise from University of Utah Health.
The model will expand the Primary Children's care network for Intermountain West, which now serves children in Utah, Wyoming, Montana, Idaho, Nevada, and Alaska.
The model will include: a new 66-bed pediatric hospital in Lehi, Utah; an enlarged and upgraded Level 4 Neonatal ICU; an advanced fetal care center that will offer in-utero treatments' advanced and innovative pediatric cancer therapies; improved access to behavioral and mental health services; improved telehealth and response capabilities; and targeted chronic disease management.
Intermountain Foundation will be tasked with raising the bulk of the money for what the health system called "the largest commitment to the care and health of the region's children since Primary Children's was envisioned in the early 1900s."
"This effort comes at a critical time," Welkie said, "as the number of children served by Intermountain Healthcare continues to rapidly grow, and their needs continue to change and become more complex."
The two health systems say the stronger ties will help each health system address the care needs of vulnerable populations in Alabama.
Ascension St. Vincent's and the University of Alabama at Birmingham Health System have formed a "strategic alliance" that they say "will increase access to high-quality, innovative medical care through multiple outlets and health programs."
In a media release, UABHS and Ascension St. Vincent's said the alliance, which will required regulatory approval, enhances their "longstanding relationship and affirms each organization's ability to help patients receive the right care in the right setting at the right time, including those who need highly specialized care."
Currently, Ascension St. Vincent's hospitals receive patients from UAB's Gardendale Emergency Department and UAB physcians perform surgery at Ascension St. Vincent's One Nineteen.
"As healthcare continues to evolve, it is important for health systems to work with each other to provide innovative, person-centered care," UAB Health System CEO Will Ferniany said. "Through closer alignment of each organization's many locations, specialties and expertise, the health systems will strive to better accommodate patients."
The alliance hopes to address and improve health disparities, including improving access to mental and behavioral health, and diabetes care, particularly for poor and underserved populations.
"These positive changes will strengthen our ability to better serve our community," said Jason Alexander, CEO, Ascension St. Vincent's and Ascension Providence. "Our expectation is that, through this alliance, both the UAB Health System and Ascension St. Vincent's will be better positioned to carry out our missions."
UABHS facilities will retain the UABHS or UAB Medicine brands. Ascension St. Vincent's facilities will be Ascension St. Vincent's.
Co-CEO Lloyd H. Dean will become the sole CEO at the Catholic health system, which was formed in February 2019 with the $29 billion merger of Dignity Health and CHI.
CommonSpirit Health Co-CEO Kevin E. Lofton is retiring at the end of June, the Chicago-based health system announced.
When Lofton retires, Co-CEO Lloyd H. Dean will become the sole CEO at the Catholic health system, which was formed in February 2019 with the $29 billion merger of Dignity Health and CHI.
Lofton, 65, was named CEO of Catholic Health Initiatives in 2003, and has a four decades-long resume as a healthcare executive.
"Kevin Lofton is an exceptional leader and one of the most influential in healthcare," CommonSpirit Board Chair Tessie Guillermo said in a media release, adding that Lofton will retire with the honorary title of CEO Emeritus.
"We have been lucky to be on this journey under the leadership and expertise of both Kevin and Lloyd as they worked side-by-side in the Office of the CEO. We are confident that under Lloyd’s leadership we will be well-positioned to transform how we deliver care across the 21 states we serve,” Guillermo said.
When the merger was finalized last February, Lofton and Dean were described by the heath system as "each a CEO in the Office of the CEO."
CommonSpirit has a footprint in 21 states, with more than 700 care sites and 142 hospitals, along with research programs, virtual care services, home health programs, and population health initiatives to tackle the root causes of poor health.
An investigation determined that some gowns made since September 2018 were produced in unapproved locations with unsanitary conditions.
Cardinal Health has announced a voluntary recall of 9.1 million surgical gowns that may have been contaminated at a contracted manufacturing plant in China.
Of the 9.1 million AAMI Level 3 gowns included in the recall, 7.7 million units were distributed to 2,807 facilities, and 1.4 million were not distributed, Cardinal Health said in a media release.
An investigation by the Dublin, Ohio-based medical supplier determined that some gowns were produced in unapproved locations with improper environmental conditions, were not registered with the U.S. Food and Drug Administration, and did not pass Cardinal Health standards.
"Based on the information we had, we determined it was necessary to proactively issue a hold for AAMI Level 3 surgical gowns produced by a contract manufacturer since September 2018. Those gowns are now subject to this voluntary recall," Cardinal Health said in a media release.
Cardinal Health quarantined the gowns, stopped distribution, and warned customers to remove the gowns from service. The medical supplier also terminated its contract with the gown manufacturer, which is no longer registered with the FDA.
"Our top priority is the safety of patients and healthcare workers. We apologize for the hardship caused by the recall, and are doing everything we can to help resolve this issue for our customers and the patients they serve," Cardinal Health said.
To address any supply shortages created by the recall, Cardinal Health said it would increase production of similar gowns, and would identify alternative products, including those made by "industry partners who offer competing products."
PSI coordinated with three pharmaceutical manufacturers – Insys, Aegerion, and Alexion – to facilitate paying kickbacks to Medicare patients taking their drugs.
The not-for-profitPatient Services Inc. foundation will pay $3 million to resolve allegations that it acted as a conduit that paid Medicare patients illegal kickbacks from drug makers, the Department of Justice said.
"Pharmaceutical companies cannot use foundations to funnel drug co-payments disguised as routine charitable donations, all to prop up excessive drug prices," Andrew E. Lelling, U.S. Attorney for the District of Massachusetts.
"PSI allegedly operated as a vehicle for specific pharmaceutical companies essentially to pay kickbacks at the ultimate expense of the American taxpayers who support the Medicare program," Lelling said.
DOJ said the amount of the settlement was based on PSI's ability to pay.
HealthLeaders' attempts to contact PSI for comment on Wednesday were not successful.
The government alleged that Midlothian, Virginia-based PSI coordinated with three pharmaceutical manufacturers – Insys, Aegerion, and Alexion – to facilitate paying kickbacks to Medicare patients taking their drugs, which are violations of the False Claims Act.
"PSI allegedly worked with these companies to design and operate certain funds that funneled money from the companies to patients taking the specific drugs the companies sold," DOJ said "These schemes allegedly minimized the possibility that the companies' contributions to the funds would go to patients taking competing drugs made by other companies and undermined the nature of these contributions as bona fide donations."
The ruling means the case would not reach the Supreme Court until this fall, at the earliest.
The U.S. Supreme Court on Tuesday shot down a request by a coalition of 20 states for a fast-track review of a Texas-led lawsuit challenging the constitutionality of the Affordable Care Act.
The California-led coalition of attorneys general defending the Affordable Care Act had asked the high court for an expedited review of the Fifth Circuit Court's ruling last month that sent Texas v. U.S. back to the trial judge.
The one-sentence denial means the case could go back-and-forth between the trial court and the appeals court for much of the year, and be heard by the Supreme Court in October, just weeks ahead of the presidential election.
A spokesperson for Texas Attorney General Ken Paxton said he would not comment on the ruling.
In a Twitter post, California Attorney General Xavier Becerra said: “We hope that the Court will grant review of our defense of the ACA because the lower court’s decision is wrong and creates uncertainty about the future of the Affordable Care Act. The health and wellbeing of millions of our loved ones who rely on the ACA for healthcare is too important. We will do everything in our power to keep fighting for them."
New York Attorney General Letitia James, one of 20 AGs defending the ACA, said that, while the Supreme Court refused to expedite its review, it could still hear arguments during its next term, which begins in October. If that occurs, the high court could rule on the case by July, 2021.
"Day after day, President Trump makes false statements, sends misleading tweets, and spouts outright lies about Obamacare and the many protections the law has provided to millions across the country," James said in a media release.
In a 2–1 decision December 18, the Fifth Circuit Court of Appeals agreed with the trial court that the ACA's individual mandate is unconstitutional, but it sent the rest of the expansive law back to the U.S. District Court for the Northern District of Texas for a more detailed analysis of which ACA provisions, if any, should be severed from the mandate and upheld.
ACA defenders howled at the ruling. Protect Our Care Chair Leslie Dach said the delay means that "Donald Trump and the Republican Party have succeeded in their quest to spare themselves the political consequences of their effort to take away health care from 20 million Americans and protections for 135 million Americans with pre-existing conditions."
"Instead, the healthcare millions of Americans remains under attack and the same judge who already declared the entire law null and void will remain in the driver’s seat,” Dach said.
African-Americans treated at non-minority hospitals experienced a 3% decline in mortality each year, compared to no decline in mortality when treated at minority-serving hospitals.
Hospital intensive care units with a larger percentage of African-Americans and Hispanics in their patient mix have not improved outcomes at the same pace as hospitals serving primarily white patients, a new study shows.
Researchers at Beth Israel Deaconess Medical Center in Boston examined trends in ICU mortality and length of stay in 200 hospitals from 2006 through 2016 and found a steady annual decline of 2% in ICU deaths at non-minority hospitals.
The same improvement in mortality rates was not seen at minority-serving hospitals, which the researchers defined as a hospital with a 25% or greater mix of African-Americans and Hispanics in their patient censuses.
However, African-Americans treated at non-minority hospitals experienced a 3% decline in mortality each year, compared to no decline in mortality when treated at minority-serving hospitals.
Minority-serving hospitals also reported longer lengths of ICU stay and critical illness hospitalizations than non-minority hospitals, according to the study, which did not speculate on the reasons for the disparity.
"Although our analysis does not resolve the reasons for differences in outcomes, it identifies minority serving hospitals as an area of great need," said study lead author John Danziger, MD, a nephrologist at BIDMC.
"Focusing research efforts to further address these inequalities is critical in mitigating the disadvantages minorities face and ultimately closing the healthcare divide," Danziger said.
The Dublin, Ohio-based medical supplier said took the action after learning of unsanitary 'environmental conditions' at a plant in China.
Cardinal Health is asking healthcare providers to stop using some types of surgical gowns and packs after learning of potential "cross contamination" at its manufacturing plant in China.
"We are advising customers to discontinue use and segregate all affected surgical gowns and procedure packs that include these affected surgical gowns from your current inventory," Cardinal Health said in a letter to customers this month.
"At this time, we cannot provide sterility assurances with respect to the gowns or the packs containing the gowns because of the potential for cross-contamination," Cardinal Health said. "The safety of our products is a responsibility we take very seriously. As such, we decided to issue the voluntary product hold."
The Dublin, Ohio-based medical supplier said took the action after learning of unsanitary "environmental conditions" at a plant in China that manufactures the supplier's AAMI Level 3 surgical gowns.
The notice affects certain lots of bulk non-sterile and single-sterile Cardinal Health™ surgical gowns.
"We have initiated an investigation, placed a hold on potentially affected product inventory, and are working with the U.S. Food and Drug Administration to address this issue. Cardinal Health intends to initiate a product recall and will provide you with instructions soon," the letter stated.
