Filefax, Inc. took medical records to a shredding facility but failed to properly dispose of the documents, which contained protected health information from about 2,150 patients.
A receiver appointed to liquidate the assets of a bankrupt medical records storage company will pay $100,000 to settle potential violations of the Health Insurance Portability and Accountability Act, the Department of Health and Human Services said.
Filefax, Inc., located in Northbrook, Ill., closed in 2016, while it was under investigation by HHS' Office of Civil Rights for HIPAA infractions that occurred in early 2015.
HHS received an anonymous complaint on Feb. 10, 2015 claiming that Filefax had taken medical records to a shredding facility earlier that month but failed to properly dispose of the documents, which contained protected health information from about 2,150 patients.
A subsequent investigation by OCR found that in January and February 2015 Filefax had left those patient medical records in an unlocked truck in the company parking lot.
"The careless handling of PHI is never acceptable," said OCR Director Roger Severino. "Covered entities and business associates need to be aware that OCR is committed to enforcing HIPAA regardless of whether a covered entity is opening its doors or closing them. HIPAA still applies."
In 2016, in unrelated litigation, a court appointed a receiver to liquidate Filefax's assets for distribution to creditors. In addition to a $100,000 settlement, the receiver has agreed to store and dispose of remaining medical records found at Filefax's shuttered facility in compliance with HIPAA.
When the deals are finalized, CityMD will have 100 urgent care centers in the New York Metropolitan area. CityMD has grown by more than 40% in the past year.
CityMD's aggressive expansion continues with the acquisition of STAT Health, an urgent care provider with 12 clinics on Long Island, and FirstMed Immediate Medical Care, an urgent care center in Queens, the company announced Tuesday.
Financial terms were not disclosed for either deal, both of which are expected to be finalized by the end of March.
When the two acquisitions are in the books, Manhattan-based CityMD will have 100 urgent care centers in the New York Metropolitan area. STAT had plans to open two more urgent care centers this year in Nassau and Suffolk Counties, and that plan will continue under the CityMD brand.
"I am thrilled to be reaching this milestone of 100 CityMD locations, and excited to welcome STAT Health and First Med to the CityMD team," CityMD CEO Richard Park, MD, said. "Our seamless integration will enable us to serve more patients in Eastern Long Island and Queens, and bring us closer to achieving our vision of building healthier, kinder communities."
Last year Warburg Pincus bought a majority stake in CityMD, which was founded in 2010. CityMD has grown 43% since then, and now includes more than 400 providers in its network.
STAT Health was founded in 2005 by Paolo Coppola, MD, who grew the company to include eight clinics on Long Island. Plans were underway to double the size of STAT Health after partnering in 2016 with the investment firm Spanos Barber Jesse & Co.
The two companies have also entered a seven-year agreement that makes Press Ganey's curriculum available exclusively on HealthStream’s workforce training platform.
Nashville-based HealthStream is selling its Patient Experience platform to Press Ganey Associates for $65.5 million in cash.
The two companies also announced that they have begun a seven-year deal that makes Press Ganey's curriculum, courses and certificate programs available exclusively on HealthStream's workforce training platform.
"Press Ganey is passionate about advancing patient-centered care supported by a high performing workplace," Press Ganey CEO Patrick T. Ryan said in a media release.
"We have great respect for the partnerships that HealthStream has developed with its patient experience and engagement clients and look forward to adding these organizations to Press Ganey's transformative platform," Ryan said. "We are committed to ensuring a seamless transition and to partnering in their mission to deliver safe, high-quality, patient-centered care."
HealthStream started PX in 2005 when it bought Data Management & Research Co.
In a separate announcement, the two companies said that all of Press Ganey's newly acquired Patient Experience Improvement and Engagement libraries will be available to HealthStream customers. Both companies will sell Press Ganey content through HealthStream-powered applications.
"Although we are divesting our PX business to Press Ganey Associates, we are entering into a new strategic collaboration with them," HealthStream CEO Robert A. Frist, Jr. said.
"HealthStream is pleased to add Press Ganey to its growing network of outstanding healthcare content providers—the industry's broadest selection of thought-leading content from among leading healthcare associations, medical publishers, and nursing associations," Frist said.
The budget deal passed by Congress delays for two years $2 billion in cuts to disproportionate share payments. Safety net providers say that the additional time can be used to fashion a long-term solution for uncompensated care costs.
The two-year delay in disproportionate share payments is a credit positive for the nation's safety net hospitals, Moody's Investors Service said.
The $2 billion in cuts representing 17% of the federal Medicaid DSH budget were mandated in the Affordable Care Act, and were supposed to take effect on Oct. 1, 2017, the start of federal fiscal year 2018. But Congress on Friday passed a budget that extends the life of the payments for another two years.
"This development restoring DSH payments is credit positive for safety net hospitals that treat large numbers of indigent patients and often rely on various supplemental payments or direct government subsidies," Moody's said. "It is also credit positive for states and local governments that own safety-net hospitals or that provide significant funding to local safety nets, including local governments in New York State, California and Texas."
About 2,700 hospitals across the nation get DSH money, although payments vary significantly. Safety-net hospitals that have high volumes of Medicaid and uninsured patients generally receive the bulk of DSH payments.
Medicaid and the Children’s Health Insurance Program Payment and Access Commission report that 37% of the hospitals most reliant on DSH funding are publicly owned and receive 80% of all DSH payments, improving margins by an average 6.4 percentage points.
Bruce Siegel, MD, president and CEO of America’s Essential Hospitals, said Congress "made the right choice" in delaying the DSH cuts. The additional time, he said, "gives hospitals and policymakers time to find a long-term solution to uncompensated care costs, which threaten access to care in communities nationwide."
"Essential hospitals provide high-quality care for all people, regardless of their health needs and financial and social status. To continue meeting this mission, these hospitals need stable, sustainable federal support," Siegel said.
The Jackson, Michigan–based health system agrees to stop coordinated anti-competitive business activities with competitors, but insists that it did nothing wrong.
Henry Ford Allegiance Health has settled its three-year antitrust fight with state and federal prosecutors, just weeks before the case was set for trial in federal court.
The Department of Justice and the Michigan Attorney General’s office filed suit in 2015, alleging that Henry Ford Allegiance Health and three other health systems in south central Michigan carved up the territory and insulated themselves from competition by agreeing to withhold outreach and marketing in each other's respective counties.
The three other health systems, Hillsdale Community Health Center; Community Health Center of Branch County in Coldwater; and ProMedica Health System in Toledo, OH, settled their suits two years ago.
"As a result of Allegiance's per se illegal agreement to restrict marketing of competing services in Hillsdale County, Michigan consumers were deprived of valuable services and healthcare information," Assistant Attorney General Makan Delrahim in DOJ's Antitrust Division said in a media release. "By prohibiting further anticompetitive conduct and educating Allegiance executives on antitrust law, this settlement will ensure that consumers receive the fruits of robust competition."
The proposed settlement was filed Friday in U.S. District Court for the Eastern District of Michigan, where the case was scheduled to go to trial on March 6.
Allegiance said in prepared remarks that it felt compelled to settle even though it did nothing wrong.
"We reluctantly chose to settle this litigation because continuing to defend ourselves against the United States and State of Michigan became too costly," the health system said. "This decision, regrettable but necessary, requires us to discontinue our defense of this case before the Court could rule on any of the highly contested issues raised in the litigation."
DOJ’s settlement with Allegiance expands on the earlier settlements with the other three health systems, which means that Allegiance cannot communicate, coordinate or limit marketing or business development with competitors. The agreement ends the health system’s carve out in Hillsdale County. Allegiance must also file annual compliance reports and submit to compliance inspections, and reimburse state and federal prosecutors for the court costs.
DOJ said the deal includes several new provisions that are now included in all new consent decrees that add greater specificity and accountability.
"The proposed settlement will make it easier and more efficient for the department to enforce the decree by allowing the department to prove alleged violations by a preponderance of the evidence," Delrahim said. "These provisions will encourage a stronger commitment to compliance and will ease the strain on the department in investigating and enforcing possible violations."
Patricia Wagner, an antitrust attorney with Epstein Becker Green and a disinterested observer, said DOJ is applying more rigorous benchmarks for its consent decrees.
"When you do your annual report you have to document that everybody got their four hours of training and you have to provide the materials that were used in those training sessions. If DOJ asks, you'd have to provide a lot of who had what conversations, and when," Wagner said. "Instead of just having a general 'you will comply with this consent order and verify annually that you are doing so,' it is giving organizations the steps that DOJ thinks they need to take in order to comply with the consent judgements."
"If I am a CEO of a hospital maybe I am thinking about how to get ahead of this situation. Should I have someone who is responsible for antitrust compliance?" she said. "All hospitals have large compliance programs that are usually focused, as they should be, on fraud and abuse and licensure issues. It seems like a natural evolution to say 'maybe we should be thinking about including antitrust in that larger compliance program.'"
Henry Ford Allegiance Health operates the only hospital in Jackson County, MI. The system also operates primary care, physical rehabilitation, and diagnostic facilities in several counties in south central Michigan. Allegiance joined Henry Ford Health System in 2016.
Allegiance’s statement in full reads as follows:
Allegiance Health and the Department of Justice have settled an antitrust case brought by the DOJ against Allegiance Health in 2015. The original complaint alleged that Allegiance Health entered into an agreement with Hillsdale Community Health Center to limit marketing in Hillsdale County.
We reluctantly chose to settle this litigation because continuing to defend ourselves against the United States and State of Michigan became too costly. This decision, regrettable but necessary, requires us to discontinue our defense of this case before the Court could rule on any of the highly contested issues raised in the litigation.
We still deny unlawful conduct of any kind, and the settlement does not include any admission of liability. Despite almost three years of litigation, there was no finding of wrong doing by the Court, and, as recently as December, the Court contemplated dismissing the action in its entirety. In addition, the Court has never ruled that the citizens of Hillsdale County were harmed by our marketing strategy.
We reaffirm our belief that we promoted competition in south central Michigan and benefitted the citizens of Hillsdale County in undeniable ways. The terms of the settlement allow us to continue our marketing strategies in order to best serve the people of south central Michigan including Hillsdale County.
NIH study finds effective surveillance efforts for drug-resistant organisms minimize patient infections, even close to a reservoir of resistant bacteria.
Hospitals do a good job killing antibiotic-resistant organisms in high-touch areas such as counter tops, doorknobs, computer keyboards, and sinks, a new National Institutes of Health study says.
However, drainage pipes under hospital intensive care units, and in outside sewers that collect hospital wastewater are teeming with those organisms, including bacterial plasmids that confer resistance to carbapenems, the "last-resort" antibiotics given to hospital patients who develop infections from pathogens that are multidrug-resistant, the researchers report in mBio.
"Strikingly, despite a very low prevalence of patient infections with blaKPC-positive organisms, all samples from the intensive care unit pipe wastewater and external manholes contained carbapenemase-producing organisms, suggesting a vast, resilient reservoir," the study said.
That comparison suggests that surveillance efforts to watch for resistant organisms minimize patient infections, even so close to a reservoir of resistant bacteria, says NIH microbiologist Karen Frank, who co-led the study.
"If you're tracking resistant bacteria, you might be able to prevent more infections in patients," she says.
The study also raises an important question.
"How much should we care that there are a bunch of plasmids down in the wastewater system if they're not infecting our patients?" Frank says.
The new findings add to growing evidence suggesting that the conduits of hospital wastewater serve as a vast, resilient reservoir for plasmids that can confer the genes responsible for antibiotic resistance.
Frank says these populations flourish in wastewater because of the common use of strong antibiotics in hospitals, which leads to an uptick in antibiotic-resistant microbes in the sewers.
"The bacteria fight with each other and plasmids can carry genes that help them survive," she says.
As part of a complex bacterial community, they can transfer the plasmids carrying resistance genes to each other, which means that the bacteria can gain resistance without exposure to antibiotics.
NIH researchers compared their data to five years' worth of patient data and samples collected from sinks and other high-touch areas, like countertops, door knobs, and computers. Remarkably, the high prevalence of carbapenem-resistant plasmids in the pipes and sewers wasn't seen in parts of the hospital to which patients had access. Of 217 samples analyzed from high-touch surfaces, only three (1.4%) tested positive for carbapenem-resistant organisms. Similarly, of 340 samples collected from drains, only 11 (3.2%) were positive.
Frank says understanding the plasmid exchange and when the plasmids get into the pathogens that infect our patients could help hospitals improve their monitoring of resistance-conferring genes.
"In the big picture, the concern is the spread of these resistant organisms worldwide and some regions of the world are not tracking the spread of the hospital isolates," she says.
Congress asked GAO to examine the effects on beneficiaries' costs if Medicare's fee-for-service cost-sharing included a single deductible, uniform coinsurance above the deductible, and an annual cap.
Modernizing and simplifying Medicare fee-for-service cost-sharing designs so that they resemble private plans is doable, but it comes with trade-offs, a Government Accountability Office studyshows.
Congress asked GAO to examine the annual and multiyear effects on beneficiaries' costs if Medicare FFS cost-sharing included a single deductible, uniform coinsurance above the deductible, and an annual cap.
GAO calculated the distribution of 28 million beneficiaries’ one-year, four-year, and eight-year annual cost-sharing responsibilities—including the median and maximum responsibility—under the current cost-sharing design and each of the four illustrative designs, compared these distributions, and found that:
During year one, the cost-sharing designs that feature relatively low deductibles and relatively high caps would result in a median annual beneficiary cost-sharing responsibility that is close to the current design.
In contrast, designs with relatively low caps provide greater beneficiary protection from catastrophic costs, but would increase annual cost-sharing levels above the existing design.
After eight years, there would still be differences in the median annual beneficiary cost-sharing responsibility across different designs, but they would be less pronounced.
Modernizing Medicare's cost-sharing design would have both direct and indirect effects on beneficiaries’ costs, GAO said in the study.
"The direct effect would be how the revised design would change beneficiaries' cost-sharing responsibilities for a given set of services," GAO said.
"The indirect effect would be that the altered incentives under a revised design would trigger behavioral responses, such as changes in beneficiaries' utilization of healthcare services, enrollment in supplemental insurance to help cover their Medicare cost-sharing responsibilities, or enrollment in Medicare FFS or Medicare Advantage."
Medicare's existing cost-sharing design is largely unchanged since the program was created in 1965. As a result, GAO notes, concerns have been raised that FFS design is confusing to beneficiaries, and leads to overuse of some services. In addition, the lack of an annual co-pay cap exposes some beneficiaries to catastrophic costs that can exceed tens of thousands of dollars each year.
As an example of the potential for confusion under the existing cost-sharing design, GAO noted that Medicare includes two separate deductibles: a relatively high deductible under Part A for hospital services, which are usually not discretionary and are less likely to be influenced by cost-sharing requirements, and a relatively low deductible for Part B outpatient services, which are more often discretionary and likely to be influenced by cost-sharing requirements.
The pharmacy giant saw net revenues up 4% to $185 billion in 2017, and anticipates at least $1.2 billion in cash benefits in 2018 from the Tax Cuts and Jobs Act, half of which will be used to pay down debt.
CVS Health CEO Larry Merlo says he "absolutely agrees with the goals and objectives" laid out in the healthcare partnership announced last week by Amazon, JPMorgan Chase and Berkshire Hathaway.
Now, like everyone else, he wants to see the details.
"We all saw the announcement last week," Merlo said in an earnings call with analysts on Thursday. "We absolutely agree with the goals and objectives that were outlined in that press release, but it’s important to acknowledge that the press release had few details and acknowledged that there isn't a plan."
Meanwhile, he says, the Woonsocket, RI-based company’s proposed $69 billion acquisition of Aetna will achieve many of the goals that Amazon/JP Morgan/Berkshire Hathaway hinted at, and that a potential partnership could emerge with Amazon if the proposal ever becomes reality.
"What that group aspires to is what we are going to deliver as part of this CVS/Aetna combination," Merlo says. "We have the infrastructure. We have the assets. We certainly have the healthcare expertise resident in both companies. And, we've demonstrated that we can execute on goals and objectives."
"We are chomping at the bit to get started," he says. "We want this new CVS/Aetna combination to be an open source model that, as we build out these capabilities, we can make them broadly available in the market. We are looking forward to partnering with all groups of individuals, including this new combination of Berkshire, JP Morgan and Amazon."
Thursday’s hour-long conference call was supposed to be about fourth quarter earnings and 2017 financial results. The company saw fourth quarter net revenues increase 5.3% to $8.4 billion, when compared to the fourth quarter of 2016.
For 2017, net revenues increased 4.1% to $185 billion. The company also expects a $1.2 billion windfall from the Tax Cut and Jobs Act. Half of that will be used to pay down debts, and the remainder will be used for in-store employee pay raises, and capital improvements.
However, the Aetna deal dominated the questions from analysts.
Merlo says the acquisition could create a broader, deeper footprint for the company’s Minute Clinic service line.
"Today we’ve got just over 1,100 clinics in 33 states and the District of Columbia," he says. "We see an opportunity to expand the breadth and the scope of practice that exists in Minute Clinics. There are a number of things we are thinking about, whether it's broader management of chronic diseases, or even the ability to do blood draws in the clinics."
Expanded services are needed, he says, to keep pace with an evolving retail environment.
"We are beginning a broader rollout of audiology and optical," he says. "We're making healthcare a retail option, recognizing that healthcare is becoming local. We are looking to deliver healthcare to where people are, whether it's in their local community or in many cases perhaps even in their homes."
Merlo also downplayed any concerns about the Department of Justice's request last week for more information about the deal.
"There is nothing that has surfaced that has come as a surprise. Things are moving forward as planned," he says. "Obviously, we've begun discussions. There is a good level of engagement. We feel good in terms of how the process is moving along at this point."
CVS's existing pharmacy benefits clients, which include Aetna competitors, are curious about the acquisition, Merlo says, because they understand that "the lines between competitors and partners are blurring like never before."
"We have examples of that in our own business today when you think about Medicare Part D and the fact that we manage the Part D component for more than 40 health plans," he says.
COO John Roberts says CVS is in an ongoing dialog with health plan clients about the Aetna acquisition "and I would describe the dialog as constructive."
"We serve Aetna today as a PBM and our goal would be to continue to serve Aetna and all of our healthcare clients," he says. "We have firewalls in place today that allow competition to occur as we support health plans on the pharmacy benefit to compete with each other."
A new biosurveillance system is helping Great Neck, NY-based Northwell Heath prepare for an influx of flu patients in the region. And that data is being shared with local authorities to pinpoint flu outbreaks in the community.
Just in time for the flu season, Northwell Health has a new dashboard that tracks and responds in real-time to the huge volume of influenza cases coming into its hospitals on Long Island and New York City.
Over the past week, the 12 Northwell hospitals that use the tracking system have seen more than 10,500 patients with flu-like symptoms, of which about 2,700 were admitted for inpatient treatment. Five other Northwell acute-care hospitals will be integrated into the system in the coming months.
Mark Swensen is an emergency management coordinator at Northwell and a member of the team that developed the dashboard. He spoke with HealthLeaders Media. The following is a lightly edited transcript.
HLM: How is Northwell's response different now using the dashboard?
Swensen: What we have now is a real-time look at case rate uptick and physical location of cases that we had no visibility for before. We are delayed by 24 hours, which is the time it takes our computer systems to sync the data into the data base. We're able to see, probably six to seven days ahead of time, where those cases rates upticks are more affecting our facilities and where we can devote resources.
HLM: What adjustments do you make when you have the data, that otherwise you would not be able to make?
Swensen: I credit our clinical staff in that they are capable of handling so much. We've been ready to deploy staffing but we haven't had to. We've moved some resources such as alcohol hand sanitizers and masks and courses of Tamiflu if necessary. We're prepared to act, as opposed to being reactionary. We've had plans in place if it continues to get worse. But because our staff is doing such a great job we haven't had to bring on additional staffing in anyone facility.
HLM: How does this dashboard work when a patient comes in with flu-like symptoms?
Swensen: All of our hospitals use electronic medical records. The dashboard uses text-based searching. The information is stored in the computer system based on chief complaint, admit or discharge diagnosis. We are using filters to capture people with things like fever, difficulty breathing, those types of influenza-like illnesses.
HLM: How do you determine ROI?
Swensen: That's a tough thing to quantify. If we are able to respond to the community and prevent additional exposures through education, because we're able to see where these case rate increases are happening, I would think the health system leadership would believe it pays for itself.
In terms of how much we spent on it, I can't answer that. This is one of a number of projects we are working on. All of these are investments in our health system and the community and it's important to spend the money and do these types of things because it helps us to be more proactive with public health.
HLM: What metrics do you use to determine if the dashboard is working?
Swensen: We're tracking emergency department hold times; the time it takes for a patient to be admitted until they find a bed. That's a good measure of hospital load. To be able to determine what the load is allows us to respond to the hospital. If we are able to prevent the load from exceeding certain markers, then we have used it to our advantage. If I am able to move resources in a controlled manner, then we’re taking advantage of the system, which is allowing us to respond more normally as opposed to reactively.
HLM: Can the dashboard be used to pinpoint flu outbreaks outside of the hospital walls?
Swensen: Our electronic record tracks the home Zip Code of the patient. So, we are able to determine where these cases are living, and in doing so we can determine which communities are more at risk. If we determined a community is more at risk we can notify schools, the local health department, and any number of agencies that can help with the education and the outreach.
HLM: Can you build a historical record on Northwell’s flu response that could be referenced in future years?
Swensen: Absolutely! We can't just flip the switch and start using it. We need a baseline. Over the past 24 months we've established the baseline and what is normal for our area. Without that baseline we don't have any visibility as to whether or not we are looking at something that could be abnormal.
HLM: Could the dashboard track other diseases?
Swensen: Yes, it could expand. This is filtering information in the medical record. If we change that filter to look at some other syndrome or chief complaint, we could use it in other areas. I don't know of any plans to do that at this time, but it's possible.
A review determined that the kidney, cardiac, and urgent care specialists failed on several occasions to heed HIPAA's risk analysis and management rules, HHS says.
Fresenius Medical Care North America will pay $3.5 million to the federal government and adopt corrective actions to address five separate data breaches, the Department of Health and Human Services announced Thursday.
HHS's Office of Civil Rights said their investigation showed that Fresenius failed to conduct an accurate and thorough analysis of risks and vulnerabilities to the confidentiality, integrity, and availability of all of its electronic medical records.
As a result of those procedural failures, HHS said, the Fresenius facilities improperly disclosed the electronic medical records of patients by providing unauthorized access, which is a violation of the privacy provisions of the Health Insurance Portability and Accountability Act.
Fresenius on Thursday issued the following statement: "We take the protection of our patients’ health information very seriously. It is a top priority for our company and a critical issue facing the entire healthcare industry."
"We recently entered into a settlement agreement with the U.S. Department of Health & Human Services Office for Civil Rights to informally resolve alleged HIPAA violations stemming from incidents that occurred in 2012, most of which involved theft of company computers and equipment."
"The settlement is not an admission that we violated HIPAA, and there is no evidence that any of our patients' health information was improperly accessed or misused. We have and will continue to take additional steps to protect patient data. We strive to enhance security, better train staff and reduce incidence of equipment theft.”
The breaches occurred between February and July of 2012 and were reported to HHS by Fresenius in January 2013.
The affected facilities are as follows:
Fresenius Medical Care Duval Facility in Jacksonville, FL, which failed to implement procedures to prevent unauthorized access, tampering, and theft;
Fresenius Medical Care Magnolia Grove in Semmes, AL which failed to properly oversee the receipt and removal of hardware and electronic media that contained patient information;
Fresenius Medical Care Ak-Chin in Maricopa, AZ, which failed to implement procedures to address security breaches;
Fresenius Vascular Care Augusta, (GA), which failed to implement safeguards against unauthorized access, tampering, and theft.
Fresenius Medical Care Blue Island (IL) Dialysis, which failed to implement safeguards against unauthorized access, tampering, and theft.
Fresenius’ Magnolia Grove and Augusta clinics also failed to install a mechanism to encrypt and decrypt electronic patient records, HHS said.
In addition to a $3.5 million fine, Fresenius will submit a corrective action plan that: addresses risk analysis and risk management; revises policies and procedures on device, media and facility access controls; develops an encryption report; and educates staff on policies and procedures, HHS said.
Fresenius provides kidney dialysis services for more than 170,000 patients in several states. Fresenius employs more than 60,000 people, with a care network that includes dialysis clinics, outpatient cardiac and vascular labs, urgent care centers, and hospitalist and post-acute providers.
