Plaintiffs say clinicians at the Evanston, Illinois health system failed to recognize signs of fetal distress that led to oxygen deficiency and devastating brain injuries for a newborn.
A Chicago jury on Tuesday awarded $50 million to the family of a child whose delayed diagnosis of severe oxygen deficiency before birth at NorthShore University HealthSystem led to severe and permanent brain injuries.
When Julien Florez was born on March 22, 2009 at NorthShore, in Evanston, Illinois, he was blue, had an uneven heart rate, and was unable to breathe on his own, according to a complaintfiled with Cook County Circuit Court.
The attending physicians and nurses performed chest compressions on the newborn and worked to get oxygen to his brain and organs for an hour, but the newborn suffered a hypoxic ischemic encephalopathy due to the lack of oxygen to his vital organs, the Florez family's physician said, according to the complaint.
Because of the HIE, Julien developed cerebral palsy. He's now nine years old and struggles with basic tasks. His English and Spanish vocabularies are limited to about 30 words and he communicates primarily through gesturing with his hands. Additionally, Julien has decreased motor skills, bilateral hearing loss and difficulty walking, the complaint read.
The complaint charged that the attending clinicians failed to recognize signs of fetal distress shown on a fetal monitor strip prior to his birth, and made matters worse by prescribing Pitocin for his mother Aimee Florez to speed up and strengthen contractions, which put more stress on the baby in the womb.
In addition, the complaint charged that the medical staff waited too long to call for a C-section, which kept the child in an unsafe environment for several hours and led to the brain injury.
"Had Aimee never been given Pitocin and been administered a more-timely C-section, Julien's injury could have been prevented altogether," plaintiff's attorney Patrick A. Salvi II said in a media release.
"Medical records show Aimee was given Pitocin despite the warning signs that Julien may not be tolerating the stresses of labor," Salvi said. "Instead of letting her body figure it out, her doctors started a medicine that runs the risk of resulting in increased stress to the baby."
Salvi said the plaintiff's declined a $10 million settlement offer during the trial.
NorthShore issued a statement saying it was "disappointed with this decision and intend to appeal the matter."
"We support the clinical care provided by our labor and delivery team who continually places the utmost priority on patient care and safety," NorthShore said.
The five-year program involves 832 acute care hospitals and 715 group practices representing 1,547 Medicare providers and suppliers in 49 states.
Nearly 1,300 providers have signed on to participate in Medicare's newest at-risk bundled payment initiative, the Centers for Medicare & Medicaid Services announced Tuesday.
The BPCI Advanced Model was unveiled in January and runs from October 1, 2018 through December 31, 2023, building on the Bundled Payments for Care Improvement Initiative (BPCI) that ended September 30.
The participantsin the five-year program include 832 acute care hospitals and 715 physician group practices representing 1,547 Medicare providers and suppliers in 49 states and the District of Columbia, CMS said.
Under the new payment model, providers are at risk for financial losses if they can't contain patient care costs within a spending range set by Medicare. They keep a share of what they save on costs, as long as quality metrics are met.
BPCI Advanced will include 32 bundled clinical episodes—29 inpatient and three outpatient. The top three clinical episodes are major lower joint replacement, congestive heart failure, and sepsis.
"To accelerate the value-based transformation of America's healthcare system, we must offer a range of new payment models so providers can choose the approach that works best for them," CMS Administrator Seema Verma said in a media release.
"The Bundled Payments for Care Improvement – Advanced model was the Trump Administration's first Advanced Alternative Payment Model, and today we are proud to announce robust participation," Verma said.
"We look forward to launching additional models that will provide an off-ramp to the inefficient fee-for-service system and improve quality and reduce costs for our beneficiaries," she said.
The BPCI program qualifies as an Advanced Alternative Payment Model under the Medicare Access and CHIP Reauthorization ACT, which means that providers in the model will be exempted from reporting requirements under the Merit-based Incentive Payment System.
After hearing complaints from providers, CMS said it will issue preliminary target prices before each model year of BPCI Advanced to allow for planning.
At a conference in Washington, D.C., this week, American Hospital Association CMO Jay Bhatt, DO, said hospitals' success in bundled payment models requires access to timely data for evidence-based decisions on changes to care delivery, and cooperation across care settings.
"We especially need payers to routinely provide timely—if not real-time—data in a readily usable format to hospitals and others participating in bundled payment models so that these participants can make evidence-based decisions on changes to care delivery," Bhatt said.
Bhatt said stakeholders should also communicate about what works, and what doesn't, reduce regulatory burdens, balance risk and reward, and integrate accountability for quality and financial incentives across care venues and payer models.
Clarification: The wording of this story has been updated to clarify that participants share a portion of the money they save, if they meet quality goals.
Analysts are looking askance at the C-suite turnover at the Ft. Lauderdale-based health system, which has had four CEOs in the past three years.
The ongoing leadership turnover at Broward Health has not gone unnoticed by financial markets.
Standard & Poor's Global Ratings said this week that the sudden departure of Broward Health CEO Beverly Capasso "does not immediately affect" the bond rating agency's BBB+ long-term rating, but "reinforces our negative outlook."
"The negative outlook reflects Broward Health's continued void in permanent senior leadership with many positions filled on an interim basis during a period of significant challenges and heightened external scrutiny," S&P said in a ratings brief.
Capasso, a former board member at Fort Lauderdale-based Broward Health, was named CEO in January and resigned abruptly last Wednesday. A system spokesperson told HealthLeadersthat Capasso had cited personal reasons.
"Having signed a three-year contract, we believed that Ms. Capasso would be in the role for a longer period to bring stability to the organization," S&P said.
Capasso and four other Broward Health leaders—General Counsel Lynn Barrett, board Chairman Rocky Rodriguez, and board members Christopher Ure and Linda Robison—face misdemeanor charges for allegedly mishandling the dismissal of former interim CEO Pauline Grant in 2016 in violation of Florida's Sunshine Law, which requires public entities to conduct their business publicly.
Capasso was on the board when Grant was fired over kickback allegations in late 2016, as the Sun Sentinel reported. All have pleaded not guilty.
S&P said that permanent leadership appointments and management stability are key factors when assessing health systems' credit ratings.
"In our opinion, the turnover in the CEO position—four CEOs in the past three years—highlights further instability in senior leadership and a heightened credit risk from ineffective management and governance practices," S&P said.
"We will continue to monitor developments as they evolve and expect to have an in-depth discussion with management during our next annual surveillance update."
The order follows a federal judge's ruling last month that CMS was still responsible for cost-sharing payments to Montana Health Co-op, even though Congress provided no funding.
A federal claims court has ordered the Centers for Medicare & Medicaid Services to pay Montana Health Co-op more than $1.2 million in cost-sharing payments that the Trump Administration and Congress reneged on last fall.
Judge Elaine D. Kaplan had ruled that the federal government was statutorily obligated to make good on the CSR payments for the fourth quarter of 2017, which Kaplan said "was not vitiated by Congress’s failure to appropriate funds for that purpose."
The $1.2 million payout was the amount that CMS said it would have paid Montana Health for the quarter had the funding not been cut off.
The CSR payments lowered premiums, copays and deductibles for eligible enrollees in the Affordable Care Act Marketplaces.
CMS had been making the payments from 2014 through October 2017, but stopped after Congress refused to appropriate the money. Montana Health and other stakeholders filed suit seeking the payments for the fourth quarter.
Even without the CSR funding, health insurers still had to provide the coverage at a reduced rate for the eligible enrollees, which prompted silver plan premium hikes for non-eligible enrollees to offset the lost CSR payments.
Julius W. Hobson, Jr., a senior policy advisor with Washington, DC-based Polsinelli, says the claims court ruling is not the end of the fight.
"Until, and unless, the U.S. Supreme Court finally rules on this matter, we will continue to see suits filed and considered by lower federal courts," he says.
"The question is whether the Administration will seek to expedite appellate review on this matter. Otherwise, we will continue to see state-by-state judicial decisions. I have no expectations that Congress will address the matter now or in the near future."
Top hospitals vary in their HIPAA-mandated responses to patient records requests, and researchers suggest it may be time for the government to toughen penalties for noncompliance.
Many of the nation's top hospitals are doing an uneven job of following federal rules for providing patients with their medical records, a new "secret shopper" study in JAMAshows.
Researchers at Yale University Medical School faced obstacles when attempting to get patient records from 83 hospitals in 29 states that were named as among the nation's best by U.S. News & World Report.
The researchers were trying to determine if the hospitals were complying with federal Health Information Portability and Accountability Act mandates for accessing patient medical records.
Study senior author Harlan M. Krumholz, MD, a cardiologist and researcher at Yale University and Yale-New Haven Hospital, said the problem could be much worse nationwide because the "secret shopper" used to compile responses intentionally targeted well-resourced hospitals.
"This is going on at top hospitals that should be able to invest in these things," Krumholz says. "That's why we thought this was a good place to start, because this should be the best case scenario."
The study sought patient records two ways: using telephone calls, and filling out records request forms.
For the phone calls, a researcher reading from a script called the records departments at the hospitals over a three-month span last fall, asking for the entire medical record of a patient that included lab tests, medical history, physician exam results and discharge notes.
The researcher asked about if the cost and time it would take to obtain the records, and if the records could be picked up in person, mailed, emailed, faxed, placed on CDs or accessed through a patient portal.
"There was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs," the study said.
"On the forms, as few as nine hospitals (11%) provided the option of selecting one of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record," the researchers said. "On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients."
Even then, there were discrepancies in the information provided by hospital records keepers in telephone calls versus what the hospitals' records request forms said. For example, 83% of the hospital administrators said on the telephone that the patient records could be picked up in person, while only 48% of hospital records request forms said that was the case.
HIPAA requires that patient records be supplied in the format requested by the patient.
"For some places it's a strategy," Krumholz says. "One health system told me that they didn't have an interest in making it easy for people get the records because then people might go to the place across town. I actually heard someone say that!"
"But for most places it's not part of a strategic effort. It's more benign neglect," he says. "The people in the records room don't necessarily seem up to date with the regulations that were instituted a decade ago and they haven't configured a system that makes it easy for people."
There was no accounting for the prices hospitals charged to access the records. The study found that 48 hospitals charged well above the federal recommendation of $6.50 for electronically maintained records. In one instance, a hospital charged $541.50 for a 200-page record.
Krumholz says the study findings on fees are consistent with many complaints he's heard from acquaintances trying to access medical records.
"I know someone whose mother was in a top New York hospital and she said 'I need to take her records back with me,'" Krumholz said. "They brought out a big box and said 'We can give you all these records, but it will be $600.' She said 'I'm not paying that much,' and they said 'How about $300?'"
Krumholz says federal and state regulators haven’t enforced existing laws on accessing patient records, but that may change.
"CMS Administrator Seema Verma has had her own experience of having trouble getting the medical records for her husband, and she's talked about this," Krumholz says. "She's going to get CMS behind improving this situation, either through better incentives or stronger penalties."
"I am hoping that the hospitals, once they realize what's going on, will want to address this themselves."
The five zones saw 40,000 additional ER visits, 18,562 fewer inpatient stays, and a net savings of $108 million over four years for a program that cost the state $15 million to implement.
Maryland's state-funded Health Enterprise Zones have seen large reductions in inpatient stays in the underserved communities where they provide care, a new study shows.
However, the study, published this week in Health Affairs, also found that emergency room visits rose dramatically within the HEZs.
Overall, researchers at the Johns Hopkins Bloomberg School of Public Health found that the zones saw a drop of more than 18,000 inpatient stays that generated about $108 million in net savings over four years.
"We see a large cost saving here from a relatively small investment," said study lead author Darrell J. Gaskin, director of the Hopkins Center for Health Disparities Solutions at the Bloomberg School.
Five years ago, Maryland created Health Enterprise Zones in Annapolis/Morris Blum, Capitol Heights, Caroline and Dorchester counties, Greater Lexington Park and West Baltimore, with goals to improve health and reduce unnecessary hospitalizations.
The state brought in primary care physicians and other health workers to improve care access and promote healthier behaviors in the Zones, which had higher rates of Medicaid use, lower-than-average life expectancy and other poverty indicators.
Gaskin says the key to success for the five HEZs, which are led by local health departments or hospital authorities, is to understand the care needs for their particular zone.
In the Annapolis area, for example, the HEZ installed a primary care clinic in a senior citizens' center. In the Lexington Park area, the problem was a lack of reliable transportation to healthcare facilities. So, the HEZ bought vans to transport people to healthcare appointments.
"Each zone tailored their program to meet the needs of their particular population. The state didn't tell them what to do. They just held them responsible for the healthcare outcomes," Gaskin says.
To gauge the success of the HEZs, the Johns Hopkins researchers analyzed state data on hospital inpatient stays, readmissions, and ER visits between 2013—2016. They compared the metrics in 16 zip codes in the HEZs and in 94 zip codes that were not covered but had similar demographics.
The rate of inpatient stays per 1,000 people declined in both populations during the study period—but declined more in the population served by the HEZs.
Over the four-year study period there were 18,562 fewer inpatient stays than would otherwise have been expected. Relative declines were even greater for the chronic conditions, such as diabetes, hypertension and chronic obstructive pulmonary disorder, that the HEZ initiative was specifically meant to reduce.
Unexpectedly, the analysis also linked the HEZs to 40,488 extra ED visits during the study period, but Gaskin says that statistic should be put in context.
"Some of this is emergency physicians not admitting patients, which they normally would have done, because now they're comfortable with sending those patients home," he says.
"Now they know the patient has a care coordinator or primary care provider in that in the community who they can immediately connect that patient with to help them manage their care," he says. "So, what we would have seen in our data as an inpatient stay, instead we see an ED visit."
Gaskin says the 40,488 extra emergency room visits cost $60 million, but the reduction of 18,562 inpatient stays saved $168.4 million, for a net savings of $108.5 million in the HEZ program that cost $15 million over four years.
Stakeholders call the 340B program 'a tremendous success' as Congress considers legislation that would raise the eligibility threshold and cut the number of eligible hospitals in half.
CEOs representing more than 700 hospitals in the 340B drug pricing program are urging Congress to protect their discounts.
In a letter this week to U.S. House and Senate leaders, the CEOs said that recent proposals to cut back the 340B program would worsen the high prices charged for drugs.
"We are concerned about recent regulatory actions that have reduced the reach of this vital program and by legislative proposals that would undo more than two decades of bipartisan work to preserve the healthcare safety net," they said.
The 340B requires drug makers to provide discounts to hospitals and other healthcare providers that serve high volumes of low-income or rural patients.
The CEOs did not identify specific threats to the 340B program, but their letter was delivered as Congress considers legislation that would raise the eligibility threshold for 340B hospitals, which safety-net advocates say would cut participation in half.
They note that 340B hospitals represent 38% of all acute-care hospitals but account for 60% of all uncompensated care. In addition, they note that the program discounts represent less than 2% of drugmakers' revenues, and supports safety-net care at no cost to taxpayers.
"Because of the savings from 340B, we are able to offer vital but often money-losing services including obstetrics, trauma care, opioid addiction treatment and HIV/AIDS care," the letter said. "In many rural communities, 340B savings are the difference between hospitals staying open and closing."
Critics say the 340B program is deeply flawed, ultimately leads to higher drug costs for consumers, and creates perverse incentivizes for hospitals to drive up treatment costs and increase profits.
A June audit by the Government Accountability Office found lax oversight of the 340B program by the Department of Health and Human Services' Health Resources and Services Administration.
HHS Secretary Alex Azar told the 340B Coalition Summer Conference in July that reforms were coming for the program, but reassured the advocates that 340B-covered providers who responsibly invest their savings have nothing to fear.
An OIG audit found widespread noncompliance with IRF guidelines, with providers and CMS sharing the blame.
Medicare paid hospital-based inpatient rehabilitation facilities $5.7 billion in one year for care that was not reasonable and necessary, a new audit shows.
The review, done for the Office of the Inspector General at the Department of Health and Human Services by an independent auditor, examined $6.75 billion in Medicare payments to 1,139 IRFs nationwide for 370,872 IRF stays in 2013.
The audit used a random sample of 220 IRF claims totaling $11.3 million in payments to 164 IRFs in calendar 2013, which is the most recent claims data available when the audit began.
The auditors were asked to determine if the medical records in the sample met federal coverage and documentation requirements for IRF fee-for-service claims in 2013.
According to the audit findings, may IRFs did not. Only 45 of the 220 sampled IRF stays complied with all Medicare coverage and documentation requirements.
"For 175 of the sampled stays, corresponding to 135 IRFs, medical record documentation did not support that IRF care was reasonable and necessary in accordance with Medicare's requirements," OIG said.
"On the basis of our sample results, we estimated that Medicare paid IRFs nationwide $5.7 billion for care to beneficiaries that was not reasonable and necessary," OIG said.
OIG noted a number of problems with the IRF program that led to the spotty regulation, such as:
Inadequate internal controls at IRFs that failed to identify and prevent inappropriate admissions.
Inadequate Medicare Part A FFS prepayment reviews for IRF admissions.
Ineffective educational efforts and post-payment reviews at Centers for Medicare & Medicaid Services that haven't controlled increasing improper payment rates reported by Comprehensive Error Rate Testing (CERT) since the 2013 audit.
Administrative hearings for IRF appeals that did not always include CMS to ensure that Medicare requirements were accurately interpreted.
A poorly designed IRF payment system that did not align cost with payments, which OIG said may have provided IRFs with a financial incentive to admit patients inappropriately.
While not calling for a return of the $5.7 billion, OIG did recommend that CMS:
Educate IRF clinical and billing personnel on Medicare coverage and documentation requirements and work with providers to develop best practices.
Increase oversight for IRFs, such as post-payment medical review.
Work with the Office of Medicare Hearings and Appeals to ensure that Medicare coverage and documentation requirements for IRF care are fairly represented at administrative hearings.
Re-evaluate the IRF payment system, which could include a demonstration project requiring preauthorization for Medicare Part A FFS IRF stays modeled on Medicare Advantage practices.
CMS agreed with the findings and recommendations in its written response to the audit, and said it was taking action to address the problem areas identified by OIG.
Molina CEO Joe Zubretsky says the deal gives the Long Beach-based managed care company 'flexibility to invest and refocus resources in our core health plan business.'
Molina Healthcare, Inc. has completed the previously announced $231 million sale of subsidiary Molina Medicaid Solutions to DXC Technology Company, the two companies said this week.
"The proceeds will provide additional resources and flexibility to invest in and focus on the Company's core health plan business and to continue executing on its margin recovery and sustainability plan," Molina said in a media release.
MMS provides technology platforms for Medicaid agencies in five states and the U.S. Virgin Islands to assist in claims processing, benefits management, administration and other business operations.
When the sale was announced in late June, Molina CEO Joe Zubretsky said the deal would give the Long Beach, California-based managed care company "flexibility to invest and refocus resources in our core health plan business."
DXC Technology provides IT services for government health agencies in 42 states.
"The combination of DXC and MMS significantly strengthens DXC's ability to provide the highest-quality services to state agencies in the administration of Medicaid programs, including what MMS now brings to the table—business processing, information technology development and administrative services," DXC Chairman, President, and CEO Mike Lawrie said in a media release.
Molina is still recoveringfrom a rocky 2017, which saw a companywide reorganization, top management turnover, and ultimately a $512 million loss for the year, which the company blamed on the cost of the restructuring and the federal government's refusal to pay subsidy payments.
So far, 2018 has been kinder to Molina, which posted Q2 net income of $202 million, compared to a net loss of $230 million in Q2 2017, and saw its net income per diluted share rise to $3.02 from $1.64 in Q1.
This week's civil settlement, and last year's separate $260 million criminal settlement, add up to $885 million in penalties for one of the nation's largest drug wholesalers.
AmerisourceBergen Corp. and its subsidiaries will pay $625 million to resolve civil claims that the drug wholesaler improperly repackaged cancer drugs into pre-filled syringes and sent them to physicians treating cancer patients, the Department of Justice said.
According to federal prosecutors, the drug wholesaling giant profiteered by skimming drug "overfill" contained in the original FDA-approved sterile vials and creating pre-filled syringes through a subsidiary, the now-shuttered Medical Initiatives Inc., that ABC claimed was a pharmacy.
Prosecutors said Alabama-based MII shipped millions of repackaged pre-filled syringes to oncology practices, with drugs that included Procrit, Aloxi, Kytril and its generic form granisetron, Anzemet and Neupogen.
As part of the scheme, ABC purchased original vials from manufacturers, broke their sterility, pooled the contents, and repackaged the drugs into pre-filled syringes, DOJ said.
All the while, ABC submitted no data to the FDA to show that it had ensured the safety and efficacy of the repackaged drugs, which prosecutors said were sometimes prepared in non-sterile conditions and contaminated.
ABC used the overfill to create more doses than it bought from the manufacturers. Federal prosecutors allege that ABC's scheme allowed it to bill multiple providers for the same vial of drug. Those providers then billed Medicare, Medicaid, TRICARE, the VA and other federal healthcare programs for the same vial.
The scheme also enabled ABC to boost its market share with product discounts, which it leveraged to lure new customers and to keep existing customers, DOJ said.
Last year, AmerisourceBergen Specialty Group, a subsidiary of AmerisourceBergen Corp., pled guilty to illegally distributing misbranded drugs and paid $260 million to resolve criminal charges for distributing drugs from a facility that was not registered with the FDA.
This week's settlement resolves ABC's civil liability under the False Claims Act for billing federal healthcare programs for the repackaged drugs. In total, the drug wholesaler will pay about $885 million in civil and criminal penalties.
"ABC placed corporate profits over patients’ needs, endangering the health of vulnerable cancer patients," said Richard P. Donoghue, U.S. Attorney for the Eastern District of New York.
ABC, one of the nation’s largest wholesale drug companies and ranked No. 11 on the Fortune 500 list, will pay the federal government $582 million, and will pay state Medicaid programs $43 million, plus accrued interest, as part of the civil settlement.
The deal with prosecutors resolves claims made in three whistleblower lawsuits, and those plaintiffs will receive $93 million of the federal recovery.
The settlement also resolves allegations that ABC paid kickbacks to physicians to induce them to purchase Procrit in pre-filled syringes. The kickbacks came as general pharmacy credits provided to customers, but which were not identifiable as specific to Procrit on invoices.
ABC on Monday issued the following statement: "By resolving this matter and entering into the Corporate Integrity Agreement, ABC acknowledged that some of its practices at MII were not consistent with AmerisourceBergen’s approach to corporate compliance."
"Medical Initiatives was voluntarily closed in 2014 and by entering into the corporate integrity agreement now, we are confirming both our commitment to compliance and to the continual evaluation and enhancement of our already robust compliance programs."
