The health insurer had pledged a vigorous defense in the suit, but isn't saying what prompted the confidential settlement.
Aetna has reached an out-of-court settlement in a high-profile lawsuit that was sparked when a physician for the health insurer said he'd never looked at a patient's health records before denying coverage.
Plaintiff Gillen Washington sued the health insurer in 2016 after he was denied coverage for a rare immune disorder, the infusion treatments for which can cost up to $20,000.
Former Aetna medical director Jay Ken IInuma, MD, stated in a deposition that he did not examine Washington's records before deciding whether to deny or approve care, relying instead on information provided by nurses who reviewed the records.
The California Department of Managed Health Care and the California Department of Insurance subsequently launched an investigation into Aetna's policies and procedures for approving or denying claims.
Aetna, which was acquired by CVS Health last November in a $70 million megamerger, did not immediately respond Monday morning to HealthLeaders' request for comment on the settlement, which was reached in late March, just ahead of a planned trial.
However, T.J. Crawford, vice president of external affairs for CVS Health, told CNN that the company doesn't "comment on legal settlements, which are commonplace and by no means an admission of wrongdoing."
Washington's attorney, Scott Glovsky, told CNN through a spokesman that "the matter has been resolved to the parties' mutual satisfaction."
When the allegations were made public, Aetna said it would fight the suit.
"Our policies always have our members’ best interests in mind. When those policies are called into question, we will defend them," the company said in a media release.
The insurer charged CNN with biased reporting, based on the allegations made by the plaintiffs, and said IInuma's words were taken out of context, and that his later explanation was ignored by much of the media.
It's not clear what prompted the health insurer to agree to a settlement.
The two companies allegedly used independent foundations to pay Medicare beneficiaries' copays for their own products, an illegal inducement under the Anti-Kickback Statute.
Pharmaceutical companies Astellas Pharma U.S. Inc. and Amgen Inc. will pay a combined $124.7 million to resolve allegations that they each used independent foundations as conduits for illegal kickbacks, the Department of Justice said.
The two companies allegedly used the foundations to pay Medicare beneficiaries' copays for their own products, an illegal inducement under the Anti-Kickback Statute. Astellas has agreed to pay $100 million, and Amgen will pay $24.75 million, DOJ said.
The settlements are the latest in a string of lawsuits involving drug makers. Earlier this month—Jazz Pharmaceuticals plc, Lundbeck LLC, and Alexion Pharmaceuticals Inc.—agreed to pay $57 million, $52.6 million, and $13 million, respectively, to resolve similar allegations.
"According to the allegations in today's settlements, Astellas and Amgen conspired with two copay foundations to create funds that functioned almost exclusively to benefit patients taking Astellas and Amgen drugs," said Andrew E. Lelling, U.S. Attorney for the District of Massachusetts.
"As a result, the companies' payments to the foundations were not 'donations,' but rather were kickbacks that undermined the structure of the Medicare program and illegally subsidized the high costs of the companies' drugs at the expense of American taxpayers," Lelling said.
Astellas
Astellas, the maker of Xtandi, an androgen receptor inhibitor, allegedly asked two foundations about the creation of copay assistance funds to cover the copays for Medicare patients taking ARIs, but not for other types of prostate cancer drugs. In July 2013, both foundations opened ARI-only copay funds; Astellas was the sole donor to both funds.
Prosecutors alleged that Astellas knew that Xtandi would likely account for the vast majority of utilization from each fund. In fact, Medicare patients taking Xtandi received nearly all of the copay assistance from the two ARI funds.
Astellas allegedly promoted the existence of the ARI funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi.
Astellas issued a statement that "denies any wrongdoing. These donations were conducted with the understanding that our actions were lawful and appropriate."
"We are pleased to resolve this matter and remain focused on pursuing our mission of turning innovative science into value for patients around the world," the company said.
Amgen
Amgen allegedly used a foundation to induce Medicare beneficiaries to use its secondary hyperparathyroidism drug Sensipar and the multiple myeloma drug Kyprolis.
Amgen acquired Kyprolis with its acquisition of Onyx Pharmaceuticals Inc. in 2013.
Prosecutors allege that from 2011 through 2014 Amgen worked with a foundation to create a "Secondary Hyperparathyroidism" fund that would support only Sensipar patients.
Amgen allegedly made payments to the fund even though the cost of these payments exceeded the cost to Amgen of providing free Sensipar to financially needy patients. However, by using the foundation to cover the copays, Amgen caused claims to be submitted to Medicare and generated revenue for itself.
Prosecutors also alleged that Onyx asked a foundation to create a fund that ostensibly would cover healthcare related travel expenses for patients taking any multiple myeloma drug, but which was actually used almost exclusively to cover travel expenses for patients taking Kyprolis, which must be infused at certain health care facilities.
The government alleged that Onyx was the sole donor to this travel fund and that Amgen, after integrating Onyx into its operations in 2015, continued to donate to the fund. The foundation also operated a second fund that covered copays for multiple myeloma drugs, including Kyprolis.
Onyx allegedly got data from the foundation on the fund's anticipated and actual expenses for coverage of Kyprolis copays, which it used to tailor its donations to the fund to just the amount needed to cover the copays of Kyprolis patients.
Amgen issued a statement saying it "does not agree with the government’s view of the relevant facts or that its conduct was inappropriate; accordingly, the settlement does not contain or constitute an admission of liability."
"This settlement reflects Amgen's desire to put this legal matter behind it and focus on the needs of patients. Donations to independent charitable organizations can provide significant assistance to patients with their copayments for prescriptions, and Amgen continues to believe these programs help patients lead healthier lives. As an element of Amgen’s efforts to help ensure patients have access to critical medicines, Amgen continues to donate to independent charity patient assistance programs," the company said.
In addition to the financial settlements, Amgen and Astellas each signed five-year corporate integrity agreements with federal regulators.
Deal volumes declined in Q1, but they remained above 200 for the 18th consecutive quarter.
Health services sector mergers and acquisitions decreased in the first quarter of 2019.
The values tripled, when compared with the last quarter of 2018, however, driven largely by the $17.4 Billion Centene-WellCare megamerger, according to an analysis By PWC.
Although deal volumes dropped in Q1, it remained above 200 for the 18th consecutive quarter. The two biggest private equity deals were in the long-term care sector, with each valued at more than $100 million, including Next Healthcare Capital and Genesis Healthcare's $204 million acquisition of 15 skilled nursing facilities from Welltower.
Despite the relatively slow start in 2019, PWC U.S. Health Services Deals Leader Nick Donkar said he anticipates continued interest in deals from health services companies and private equity firms.
"Buyers are exercising patience and discipline given the uncertainty in the global economy and regulatory environment," Donkar said. "We expect deal volume to increase in the remainder of the year given capital availability, reimbursement pressure, and companies’ continuing interest in expanding services beyond their current capabilities."
The Q1 2019 analysis found that:
The Centene-WellCare transaction is the largest managed care deal since CVS/Aetna in Q4 2017, and the third-largest deal overall since 2014 (behind Cigna/Express Scripts).
Q1 2019 deal volume declined over the prior year and prior quarter by 21.2% and 28.3%, respectively. This drop should not necessarily be seen as suggestive of future declines.
Although the deal count of 231 was 8.2% Below the 2014-2018 quarterly average of 252, it was still 15.5% above the 200 level that the sector has seen since Q4 2014.
The sector saw similar deal volume in Q2 2017, then witnessed a rebound. A similar rebound is possible in Q2 2019, especially given sustained high levels of private equity capital.
Q1 2019 deal value tripled over Q4 2018, partly driven by a $17.4 billion megadeal (defined as exceeding $5 billion), which accounted for 57.5% of the quarter's value. Q1 2019 deal value was also 16.1% higher than the 2014-2018 quarterly average of $26.1billion.
Excluding megadeals in Both Q1 2019 and the comparison periods, deal value increased 33.5% over Q4 2018 and 122.8% over Q1 2018.
All sub-sectors experienced a decline in deal volume over the prior year, except for Long-Term Care (19.5% growth) and Managed Care (flat).
In terms of deal value, over the prior year, four sub-sectors grew: Physician Medical Groups, Hospitals, Labs, MRI & Dialysis, and Long-Term Care.
There have Been no health services IPOs since 2016.
Stakeholders back federal rules that factor in social determinants of health to create a more-level playing field for hospitals that provide care for sicker, poorer patients.
New Medicare reimbursement rules that account for socioeconomic factors shift the burden of financial penalties toward hospitals serving wealthier patients, and that helps safety-net hospitals, a new study suggests.
The new rules under the Hospital Readmissions Reduction Program also reduce the penalties on hospitals in states that have more generous Medicaid programs, according to the study, published in JAMA Internal Medicine this month by researchers at Washington University, the Missouri Hospital Association and the Henry Ford Health System in Detroit.
"The new rules recognize the reality that it is harder to prevent readmissions when people don't have stable housing or social support," said study first author Karen Joynt Maddox, MD, a Washington University cardiologist and assistant professor of medicine.
"If you have patients who struggle to put food on the table, it's going to be tougher for them to manage their end-stage heart failure," Joynt Maddox said. "The old system took money away from hospitals that serve the most vulnerable patients. It created a significant disincentive to provide healthcare to poor people, and that’s the last thing we want."
HRRP can cut a hospital's Medicare reimbursements by up to 3%, and it's been criticized for unfairly penalizing safety-net hospitals that serve a generally, poorer, sicker patient mix, and who are more likely to be admitted for reasons beyond the hospital walls.
Rather than comparing all hospitals directly, the new rules divide hospitals into five groups according to the proportion of their dual eligible Medicare/Medicaid patients.
Hospitals are now compared only with peer institutions that treat similar proportions of disadvantaged patients. Across the five groups of hospitals, the average proportion of dual eligibles ranged from a low of 9.5% to a high of almost 45%.
Under the new rules, penalties for the hospitals serving the fewest poor patients are projected to increase more than $12 million in total, the researchers estimate.
Penalties for the hospitals serving the highest proportion of poor patients are projected to decrease by more than $22 million in total. On an individual hospital level, the changes are projected to range from an increase in penalties of $225,000, to a decrease of $436,000, the study said.
Large hospitals and teaching hospitals are the most likely to see reduced penalties. The researchers also found reduced penalties among hospitals serving patients from the most disadvantaged neighborhoods and those serving the most patients with disabilities.
Maryellen Guinan, senior policy analyst at America's Essential Hospitals, called the new methodology "a step in the right direction," and said the study's findings "add to the growing body of evidence for what essential hospitals and other providers have long known: Patients' sociodemographic and other social risk factors can significantly influence assessments of hospital quality."
“Under the old HRRP, essential hospitals and other providers that serve vulnerable patients were forced to absorb a greater proportion of readmissions penalties, leaving them with even fewer resources to treat disadvantaged people," Guinan said.
Hospitals in states with more generous Medicaid enrollment also fare better than those in states with fewer poor patients enrolled in the Medicaid program.
"States differ widely in the percentage of people living in poverty who are able to enroll in Medicaid," Joynt Maddox said. "Since the new rules, as written by Congress, only give credit to hospitals for treating patients on Medicaid and not poor patients in general, the states with more people enrolled in Medicaid are going to benefit more from the new system."
Maddox said she was surprised at the extent of the state and regional differences in the shift in penalties, with more penalties for hospitals in the South and Midwest and fewer penalties for hospitals in the West and Northeast.
California, which has generous Medicaid enrollment, had the most reduced penalties. South Dakota and Florida, two states with fewer poor patients enrolled in Medicaid, had the greatest increases. Overall, much of the shift in penalties between states could be explained by differences in state Medicaid enrollment.
"This was a positive change for the HRRP," Joynt Maddox said. "Making the program more fair doesn't take away from its goal, which is to use financial incentives to make hospitals think differently about care beyond their walls. Hospitals are increasingly working to provide a soft landing, including discharge planning and communication with outpatient-care providers."
Joynt Maddox said there's work to be done, even if the new rules more fairly consider the socioeconomic reality of hospitals' patient populations.
“There are still marked disparities in readmissions related to social determinants of health,” she said. “We need to find innovative solutions to improve outcomes for our most vulnerable patients after they leave the hospital.”
Guinan agreed.
"Specifically, the peer-grouping methodology uses dual-eligibility as a proxy for poverty, which is less than ideal," she said.“Not accounting for all the differences in patients’ circumstances that might affect readmission rates inevitably will skew readmission measures against hospitals providing essential care to low-income people, including the uninsured," Guinan said.
"CMS must go a step further and incorporate risk adjustment for sociodemographic status, language, post discharge support structure, and other factors that reflect the challenges involved in caring for disadvantaged populations,” she said.
States are encouraged to adopt integrated care models for serving dual eligibles, with options that include capitated payments, managed fee-for-service, and state-specific models.
States are being invited to partner with the federal government in integrated care models designed to improve outcomes for the nation's 12 million dual eligible enrollees in Medicare and Medicaid.
"Less than 10% of dually eligible individuals are enrolled in any form of care that integrates Medicare and Medicaid services, and instead have to navigate disconnected delivery and payment systems," Centers for Medicare & Medicaid Services Administrator Seema Verma said in a media release.
"This lack of coordination can lead to fragmented care for individuals, misaligned incentives for payers and providers, and administrative inefficiencies and programmatic burdens for all. We must do better, and CMS is taking action, Verma said.
In a letter this week to state Medicaid directors, Verma encouraged them to work with the federal government to address the complex needs of dual eligibles, who often have multiple chronic and mental health and socioeconomic risk factors that can lead to poor outcomes.
"Historically, dually eligible individuals have accounted for 20% of Medicare enrollees, yet 34% of Medicare spending. The same individuals have accounted for 15% of Medicaid enrollees and 33% of Medicaid spending. Across both programs, that equates to over $300 billion in state and federal spending each year," Verma said.
"Improving care for this population provides opportunities for state and federal governments to achieve greater value from our Medicare and Medicaid investment," she said. "This is especially critical as Medicaid spending is already among the two largest items in most state budgets and as more of the baby boom generation ages into Medicare eligibility each day."
Verma told the state Medicaid directors that CMS was considering several care options for dual eligibles, including:
The Capitated Financial Alignment Model. Through a joint contract with CMS, states and health plans, this model option creates a way to provide the full array of Medicare and Medicaid services for enrollees for a set capitated dollar amount.
Managed Fee-for-Service Model. This model is a partnership between CMS and the participating state and allows states to share in Medicare savings from innovations where services are covered on a fee-for-service basis.
State-Specific Models. CMS is open to partnering with states on testing new state-developed models to better serve dually eligible individuals and invite states to come to us with ideas, concept papers, and/or proposals.
This week's letter complements a State Medicaid Director Letter CMS released in December 2018 that highlighted 10 opportunities to improve care for dually eligible individuals, including using Medicare data to inform care coordination and program integrity initiatives, and reducing administrative burden for dually eligible individuals and the providers who serve them.
The Primary Cares Initiative got a warm initial reception from key providers groups, but many still have questions about the details of the proposal.
Provider associations are praising the Centers for Medicare & Medicaid Services' plans to launch five at-risk primary care models.
"Providing adequate financial support for high quality primary care must be an essential element of any strategy to improve the quality and affordability of our country's healthcare system," Gerald E. Harmon, MD, Immediate Past Chair of the American Medical Association Board of Trustees said in prepared remarks.
"Many primary care physicians have been struggling to deliver the care their patients need and to financially sustain their practices under current Medicare payments," Harmon said. "The new primary care payment models will provide practices with more resources and more flexibility to deliver the highest-quality care to their patients."
Health and Human Services Secretary Alex Azar unveiled the voluntary initiative on Monday, saying theCMS Primary Cares Initiative for Medicare and Medicaid beneficiaries would transform primary care to a value-based system that rewards physicians who keep patients healthy and out of the hospital.
The AMA also praised CMS for basing the new payment models on proposals developed by practicing physicians and incorporating recommendations from the Physician-Focused Payment Model Technical Advisory Committee.
"Secretary Azar has said that the best ideas for improving outcomes often come from individuals and organizations on the front lines of the health care delivery system, and we agree," said Harmon.
"PTAC has identified a dozen payment models developed by physicians that it believes merit testing or implementation by HHS, and we hope today’s announcement will be the first of many efforts to implement PTAC's recommendations," he said.
Ashley Thompson, the American Hospital Association's senior vice president of public policy analysis and development, said the hospital lobby "appreciates CMS's continued efforts to create additional voluntary payment models for providers."
"We look forward to learning more about these new models and how they can support our collective efforts to improve the health and well-being of our patients and communities," she said.
Don Crane, president and CEO of America's Physician Groups, called the initiative "a win for patients and the physician groups who care for them."
"For years, our members have demonstrated that patient-centered, integrated, and accountable care can address the low-quality, high-cost care that comes with a fragmented fee-for-service healthcare system," he said. "We’re very pleased to see that many of our recommendations for improving value-based care were adopted throughout these new models."
Crane predicted the initiative "will open the throttle on the movement from volume to value and improve the health of populations across America."
"We look forward to meeting with CMS to better understand how benchmarking will be implemented within these payment models," he said. "And we’ll be taking a closer look at the beneficiary component to see how that might impact both patients and their physician providers."
The Healthcare Leadership Council President Mary R. Grealy said the council is "encouraged by the administration's continued efforts to shape a Medicare program that focuses on improving care while, at the same time, containing costs."
"We applaud efforts to make the antiquated fee-for-service model a part of healthcare's past while ushering in a future that focuses on value, and putting the patient at the center, rather than volume of services," Grealy said.
Grealy said the initiative correctly focuses on seriously and chronically ill patients, who account for the greatest proportion of healthcare costs.
"We strongly support the continued movement toward coordinated care for this patient population and the new payment models’ incentives for providers to treat these high-need patients," she said.
Ann Greiner, president and CEO of the Patient Centered Primary Care Collaborative, commended HHS "for focusing on the centrality of primary care to achieve enhanced patient value."
"This is a major step in the right direction by the nation’s largest payer, one that promises to transform the role primary care plays in our national healthcare system," Greiner said.
Travis Broome, vice president for policy and ACO administration at the primary care provider Aledade, called the initiative "a smart step in the right direction, further moving healthcare away from fee-for-service and toward paying for better health outcomes."
Broome said the initiative shows that federal policymakers "recognize the leading role that primary care physicians play in a value-based health care system that better serves patients, providers, and payers alike."
The Primary Cares Initiative was largely the brainchild of policy wonks at CMS' Center for Innovation, which was created under the Affordable Care Act.
HLC's Grealy said the initiative "underscores the importance of having a Center for Medicare and Medicaid Innovation, to have a testing ground in which new patient-centered models can be evaluated, advanced, and bring substantive improvement to patient care."
It's not clear what would happen to the CMMI—or how it would affect the primary care initiative rollout—if a federal appeals court sides with a Texas-led coalition of 20 state attorneys general who are challenging the constitutionality of the ACA.
CMS anticipates its new primary care payment models could better align and reduce cost of care for nearly 11 million Medicare fee-for-service beneficiaries.
Federal officials on Monday unveiled a voluntary, risk-based initiative to transform primary care to a value-based system that rewards physicians who keep patients healthy and out of the hospital.
Health and Human Services Secretary Alex Azar said theCMS Primary Cares Initiative for Medicare and Medicaid beneficiaries will also reduce administrative burdens and empower primary care providers to spend more time caring for patients while reducing overall healthcare costs.
Azar said he anticipates that 25% of traditional Medicare beneficiaries will opt into the initiative, which will launch pilot programs in January 2020.
"Primary care is a small slice of healthcare spending overall, but it has a significant impact on downstream cost and quality," Azar said at a press conference Tuesday.
"This initiative will radically elevate the importance of primary care in American medicine, move towards a system where providers will be paid for outcomes rather than procedures, and free up doctors to focus on the patients in front of them, rather than the paperwork we send them," he said.
"Basically, what this model is going to do is get us where providers are competing for beneficiaries. They're not gate keepers. They don’t control access to specialty physicians. They don’t control access to hospital admissions," he said.
Two Paths, Five Models
The CMS Primary Cares Initiative creates five payment models under two paths: Primary Care First and Direct Contracting. All five models focus on care for chronically and seriously ill patients.
TwoPrimary Care First models will pay practices a total monthly payment that Azar said allows clinicians to focus on caring for patients rather than their revenue cycle. The Primary Care First – High Need Populations, will offer more money to practices that specialize in care for high need patients, including those with complex, chronic needs and seriously ill populations.
Both Primary Care First models incentivize providers to reduce hospitalizations and cost of care by rewarding them through performance-based payment. PCF will be tested for five years beginning in January 2020, with applications accepted beginning this spring. A second round is also planned for January 2021.
"Both options allow practices to move away from fee-for-service and to eliminate their revenue cycle operations," said Adam Boehler, director of the Centers for Medicare & Medicaid Services Innovation.
"CMS will make monthly population based payments along with a simple, flat primary care visit each time a provider sees a patient. Providers will be eligible payments if their patients stay healthy and at home," he said.
There is downside risk of 10%, which Boehler said is about the equivalent to the revenue cycle costs today, and "an asymmetrical upside potential of 50%." The performance will be measured on risk-adjusted hospitalizations.
"For example, doctors who earn $200,000 today could earn up to $300,000 if their patients stay healthy," Boehler said. This model is scheduled to begin in January 2020.
The three Direct Contracting payment options offer Global, Professional, and Geographic models that engage organizations that have experience with financial risk and serving larger patient populations, such as accountable care organizations, Medicare Advantage plans, and Medicaid managed care organizations.
The Direct Contracting payments are designed to create a competitive delivery system that rewards organizations offering greater efficiencies and better care. The payment model options include a focus on care for seriously ill patients with complex, chronic needs, as well as a voluntary alignment option that allows beneficiaries to align with the health care provider of their choosing, Boehler said.
The Direct Contracting participants will get a fixed monthly payment that can range from a portion of anticipated primary care costs to the total cost of care. Participants in the global option will bear full financial risk, while those in the professional payment model will share risk with CMS.
Boehler said these options will provide participants a range of financial risk arrangements while providing a more predictable revenue stream and reducing healthcare provider burdens commensurate with level of financial risk.
"The professional option gives providers the opportunity to share 50% of the savings and the losses on risk-adjusted total cost of care," he said. "Providers in this option will receive predictable, monthly payments for enhanced primary care services."
The global option allows providers to take full 100% accountability for savings and losses, Boehler said.
The global and professional models will launch in January 2020, with applications reviewed in June.
The geographic option will organizations the opportunity to assume responsibility for the total cost of care and health needs of a population in a defined target region, and is expected to launch in January 2021, after reviewing request for public input.
"This would provide an unprecedented ability for that local organization to negotiate better rates than Medicare does today, take responsibility for outcomes and provide benefits that work for the local communities' needs," Azar said.
Practices that choose to care for seriously ill patients will be required to clinically stabilize the patient, and all payment models include enhancements to encourage provider participation for that population.
11 Million Lives
Boehler said empirical evidence has repeated validated the importance of primary care.
"Despite only being 2% to 3% of spend, primary care providers have an enormous influence over downstream costs," he said. "Our current payment systems do not recognize the essential role that primary care providers play. We're going to change that today."
The five payment options could provide better alignment for more than 25% of all Medicare fee-for-service beneficiaries—nearly 11 million people—with 5 million beneficiaries in the DC payment model options and 6.4 million in PCF payment model.
CMS is projecting that 25% of primary care practitioners will be drawn into the initiative, which would also create opportunities to coordinate care for Medicaid dual eligibles.
"Why we think there is so much interest is that: 1, providers like to practice and spend time with patients; 2, this simplifies their lives significantly. You're taking away revenue cycle, an unnecessary burden, and; 3, we're creating a significant amount of financial upside for doing the right thing," Boehler said.
To guard against cherry picking healthier patients, Boehler said providers won't be allowed to select a subset of patients.
"It has to be a panel with Medicare fee-for-service, so it keeps from totally cherry picking," he said.
A fraction of internal medicine interns' time is spent in face-to-face interactions with patients, and even then they're multitasking.
First-year physicians spend 87% of their work day away from patients, half of which is spent futzing with electronic health records.
Most of the remaining 13% of face time with patients is spent multitasking, according to a new study from Penn Medicine and Johns Hopkins University.
"This objective look at how interns spend their time during the work day reveals a previously hidden picture of how young physicians are trained, and the reality of medical practice today," said lead author Krisda Chaiyachati, MD, an assistant professor of Medicine in the Perelman School of Medicine of the University of Pennsylvania.
"Our study can help residency program leaders take stock of what their interns are doing and consider whether the time and processes are right for developing the physicians we need tomorrow," Chaiyachati said.
The researchers tracked the activities of 80 interns in six internal medicine programs over three months in 2016, gathering data on 194 shifts spanning 2,173 hours.
The activities were classified into categories, including direct patient care, indirect patient care, and education.
Interns spent the most time performing indirect patient care, taking up an average of 15.9 hours of a 24-hour period—almost five times more hours than the next most common activity, direct patient care, which accounted for three hours of the day. Education was the third-highest category of intern time, attributed to 1.8 hours.
Although interns are spending a significant amount of time not interacting directly with patients, Chaiyachati said it's too early to tell "whether or not how interns allocate their time is 'good' or ‘bad.'"
"Indirect patient care has tradeoffs," Chaiyachati said. "If it takes time away to the point that patients feel like we aren’t listening to their needs or we lose out on human interactions that provide physicians with a sense of purpose, that is a bad thing. But if it helps us diagnose diseases more efficiently, then maybe that's not that bad in the end."
When the researchers analyzed four different time periods (separated into six-hour periods: morning, afternoon, evening, and night), they found no significant differences. But multitasking was common throughout.
Roughly 25% of interns' time interacting with patients occurred at the same time as coordinating care or updating medical records.
"Increased multitasking is a side effect of our current system," Chaiyachati said. "It's not simply that we are doing more work or we have more tasks in our day-to-day. We are trying to do more in a fixed amount of time."
Chaiyachati said the study can provide an important baseline that training programs and hospitals may use when adjusting programs, shifting responsibility for tasks to other healthcare providers, or automating processes.
The study, published this month inJAMA Internal Medicine, is a part of a larger effort called the Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) study.
The multi-year study, funded by the National Institute of Health and the Accreditation Council for Graduate Medical Education, seeks to better understand the effects of shift lengths on young doctors and their patients.
Last month, two other studies published in the New England Journal of Medicine from iCOMPARE showed that first-year doctors did not experience chronic sleep loss nor was patient safety affected when doctors-in-training were allowed to work longer shifts than had previously been permitted by the ACGME
Lehi, Utah, referred to as 'Silicon Slopes,' was chosen because it is centrally located amid Utah's universities and has become a hub for the state's start-up and tech community.
Civica Rx, the health system-led supplier of generic medications, has opened its new headquarters in Lehi, Utah.
The company was created in September 2018 by 12 founding health systems across the nation to address spiraling costs and chronic shortages of essential generic medications. It has since grown to include an additional 12 health systems, representing about 750 hospitals nationwide.
Lehi, referred to as "Silicon Slopes," was chosen because it is centrally located amid Utah's universities and has become a hub for the state's start-up and tech community, Civica Rx said in a media release.
Civica Rx has identified –- but has yet to publicly name -- 14 hospital-administered generic drugs as its initial focus, seeking to stabilize the supply of essential medications, many of which face chronic shortages. The company expects to release its first products this year.
"Together we celebrate the reason why Civica Rx exists, in purpose and in brick and mortar, and that is to do what is in the best interest of patients by stabilizing the supply of generic medications," said Martin VanTrieste, Civica Rx CEO.
"Drug shortages strain hospital staff, lead to delayed surgeries and sub-optimal treatments for patients, and can lead to unpredictable price increases that result in budgetary instability in hospitals," he said.
VanTrieste was joined at a ribbon cutting ceremony on Thursday by a host of dignitaries, including Utah Gov. Gary Herbert, Intermountain Healthcare CEO Marc Harrison, MD, and Civica Rx Chairman Dan Liljenquist, who's credited as the "brainchild" of the Civica Rx initiative.
The Lehi office will employ 40 people and expansion opportunities in Lehi are expected to bring the office to four or five times that size within three to five years, Civica Rx said.
Charges involve more than 350,000 prescriptions for controlled substances and more than 32 million pills across eight states.
Sixty people in eight states face criminal charges for allegedly illegally prescribing and distributing opioids and other narcotics, and for healthcare fraud, the Department of Justice said.
The defendants include 31 physicians, eight nurse practitioners, seven pharmacists, and seven other licensed medical professionals, most of them practiciting in Appalachia, DOJ said in a media release.
"The opioid epidemic is the deadliest drug crisis in American history, and Appalachia has suffered the consequences more than perhaps any other region," Attorney General William P. Barr said.
Barr credited DOJ's four-month-old Appalachian Regional Prescription Opioid Strike Force with spearheading the investigations that led to this week's arrests.
The defendants were charged with unlawful distribution of opioids and other prescription narcotics, along with various fraud-related offenses in 10 federal districts in Ohio, Pennsylvania, Louisiana, Virginia, West Virginia, Kentucky, Tennessee, Alabama.
"Today's takedown demonstrates the FBI’s unwavering commitment to working alongside our Strike Force partners, including the HHS-OIG and DEA, to fight the opioid epidemic and related criminal activity in the Appalachian region," said FBI Executive Assistant Director Hess. "We will not stand by and allow the harmful and oftentimes deadly practice of over-prescribing highly addictive drugs to continue unchecked. The FBI will pursue medical personnel who misuse their positions of trust to blatantly disregard others' very lives for their own financial gain."
About 130 people die every day of an opioid overdose, according to the Centers for Disease Control and Prevention.
Among the more egregious allegations detailed by the DOJ:
In Ohio, a doctor who is alleged to have been at one time the highest prescriber of controlled substances in the state, and several pharmacists are charged with operating a pill mill in Dayton, Ohio. According to the indictment, between October 2015 and October 2017 alone, the pharmacy allegedly dispensed over 1.75 million pills.
In Kentucky, a doctor allegedly provided pre-signed, blank prescriptions to office staff who then used them to prescribe controlled substances when he was out of the office, and for directing staff at the clinic, including individuals not licensed to practice medicine, to perform medical services on patients.
A solo practitioner who operates a five-clinic family practice focusing on pain management allegedly billed Medicare for urine testing that was not done and for urine testing that was not medically necessary.
A dentist allegedly wrote prescriptions for opioids that had no legitimate medical purpose and that were outside the usual course of professional practice, removing teeth unnecessarily, scheduling unnecessary follow-up appointments, and billing inappropriately for services.
A doctor was charged for allegedly prescribing opioids to Facebook friends who would come to his home to pick up prescriptions, and for signing prescriptions for other persons based on messenger requests to his office manager, who then allegedly delivered the signed prescriptions in exchange for cash.
In Tennessee, two cases involve doctors who were previously sanctioned by the Tennessee Medical Board in connection with the overprescribing of opioids, one of whom was sanctioned for providing prescriptions to vulnerable patients, while the other allegedly prescribed opioid pills after serving a probation.
A nurse practitioner who branded himself the "Rock Doc," allegedly prescribed powerful and dangerous combinations of opioids and benzodiazepines, sometimes in exchange for sexual favors.
One doctor allegedly prescribed approximately 500,000 hydrocodone pills, 300,000 oxycodone pills, 1,500 fentanyl patches, and more than 600,000 benzodiazepine pills over three years.
In another case, a nurse practitioner charged with conspiracy to unlawfully distribute controlled substances allegedly prescribed over 500,000 Hydrocodone pills, approximately 300,000 Oxycodone pills, and approximately 300,000 benzodiazepine pills (mostly Alprazolam), along with a myriad of other controlled substances.
In another case, a physician charged with controlled substances and health care fraud violations allegedly prescribed approximately 300,000 hydrocodone pills, 200,000 oxycodone pills, 2,500 fentanyl patches, and 180,000 benzodiazepine pills, and prescribed medically unnecessary durable medical equipment that was billed to Medicare.
Another doctor charged with controlled substances violations allegedly prescribed approximately 4.2 million opioid pills, sometimes in dangerous combinations with other drugs, such as benzodiazepines, and prescribed opioids to known addicts.
In Alabama, a doctor allegedly prescribed opioids in high dosages, dangerous combinations, and in many cases, after having knowledge that patients failed drug screens and were addicts, preferring cash payments and charging a "concierge fee" that ranged from approximately $50 per visit or $600 per year.
In another case, a doctor allegedly recruited prostitutes and other young women with whom he had sexual relationships to become patients at his clinic, while simultaneously allowing them and their associates to abuse illicit drugs at his house.
In West Virginia, an orthopedic surgeon allegedly used fraudulent prescriptions to obtain tablets of acetaminophen-codeine for his own use. To obtain the pills, the surgeon allegedly wrote out prescriptions using his DEA number, and in the names of a relative, using a driver's license that he had stolen from a colleague to obtain the pills from pharmacy.