Some federal antitrust laws could be waived if they hinder the creation of effective accountable care organizations, senior federal officials told healthcare leaders on Tuesday.
"From an antitrust perspective, we want to explore whether we can develop safe harbors so doctors, hospitals, and other medical professionals know when they can collaborate and when they cannot," Federal Trade Commission Chairman Jon Leibowitz said, in opening remarks at Tuesday's FTC/Centers for Medicare & Medicaid Service Workshop on ACOs.
"We are also considering whether we can put in place an expedited review process for those ACOs that fall outside of the safe harbors," he said.
Health and Human Services Inspector General Daniel R. Levinson told the workshop that fraud and abuse rules enforced by his office should not stand in the way of improving quality and reducing costs through ACOs.
"As the Medicare and Medicaid programs incorporate and test new payment and delivery models, there is a need for fresh thinking about program integrity and the types of risks faced by our programs and beneficiaries," Levinson said.
He noted that the Affordable Care Act gives HHS Secretary Kathleen Sebelius the authority to waive fraud and abuse laws "as necessary" and that "we and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively."
CMS Administrator Don Berwick, MD, told the group that flexibility was needed because ACOs represent a fundamental shift in the way healthcare is delivered. "The ACO is not the status quo repackaged. It is a new and better way to organize care and it involves changes for almost every stakeholder. Further, there is no one-size-fits-all model. I suspect there will be many different (models) needed to match the enormous diversity of settings and communities and histories in this textured nation," he said.
Leibowitz conceded that the healthcare sector holds a level of distrust towards the federal government in general, and the FTC in particular. "Too often, I believe, the healthcare community sees our antitrust enforcement actions as impeding improved care. If there is any stereotype I would like to disabuse you of today—that's the one," he said.
MEDNAX, Inc. subsidiary American Anesthesiology has acquired Southeast Anesthesiology Consultants, PA, a 90-physician group practice that provides anesthesia and pain management services at nine hospitals, 12 ambulatory surgery centers, and 10 pain management centers in the Charlotte, NC, area.
Financial terms were not disclosed, but Deutsche Bank Equity Research North America estimated that American Anesthesiology paid between $150 million and $200 million in the cash deal.
Deutsche Bank research shows Southeast Anesthesiology Consultants generates about $100 million in annual revenues and between $25 million and $30 million in trailing EBITDA. SAC, which does anesthesia volume of about 111,000 cases annually, is the fifth and largest group practice acquisition for MEDNAX, in terms of volume and facilities served.
SAC services eight of the 32 hospitals within Carolinas HealthCare System, the nation's second-largest not-for-profit healthcare system, including the system's largest hospital, the 874-bed Carolinas Medical Center.
SAC also provides anesthesia services at 11 ambulatory surgery centers in the Charlotte area, which includes part of South Carolina, and one facility in Virginia Beach, VA. The group also provides services at 10 pain management centers in Charlotte with annual volume of approximately 50,000 patient visits.
The group employs eight physician assistants and six certified registered nurse anesthetists. The physicians practice under an anesthesia care team model that includeshospital-employed CRNAs. SAC also has 45 clinical and administrative employees.
American Anesthesiology includes more than 620 anesthesia providers, including more than 275 physicians and 345 CRNAs and anesthesia assistants practicing in the Carolinas, Virginia, and Georgia, with administrative offices in Raleigh, NC, and Sunrise, FL.
This time it was Omaha, NE. You can read the local news accounts here.
It sounds callous, but I really don't care what prompted the gunman's bout with irrationality. My sympathy and concern for him ended when he picked up a gun to solve his troubles. Two police officers suffered "minor" gunshot wounds in the shootout that fatally wounded the gunman. Fortunately, no patients, visitors, or healthcare providers suffered physical injuries.
I hate to sound like a One Note Johnny on the issue of hospital violence, because there are a lot of other topics I would prefer to write about. But this just won't go away. It's hard to ignore this very disturbing trend when we're getting weekly reports of gunplay and other violence in places of healing.
A timely Emergency Nurses Association nationwide survey has found that between 8% and 13% of ED nurses say they are victims of physical violence every week. More than half (54.8%) of the 3,211 nurses ENA surveyed at three-month intervals between May 2009 to February 2010 reported physical or verbal abuse at work in the week before taking the survey.
The ENA's Emergency Department Violence Surveillance Study also found that 15% of the nurses who reported physical violence—slapping, shoving, spitting, punching, kicking, etc.—said they were injured as a result.
To me, the most disturbing factoid in the survey was that no action was taken against the perpetrator in 45% of the cases. In other words, the attacker went unpunished.
Three in four nurses who were victims of physical violence reported that the hospital gave them no response regarding that violence.
"We are extremely alarmed that there are so many cases in which hospitals do not respond to violence in the emergency department," said Diane Gurney, RN, president of the 37,000-member ENA.
"These incidents are not only frightening and dangerous for nurses, but also for patients in the emergency department. Hospital administration has a responsibility to keep patients and the healthcare providers who care for them safe. Every hospital should be required to adopt and implement policies to keep their emergency departments safer."
Gurney is exactly right. Hospital leadership can no long cling to the excuse that hospital violence is a random event that is impossible to prepare for, nor can leadership provide any excuse for failing to respond to acts of violence against staff.
Measures can be taken.
For example, the ENA survey found that ED nurses at hospitals with policies regarding violence reported experiencing fewer incidents of physical or verbal violence. Hospitals with zero-tolerance reporting policies had an 8% physical violence rate; hospitals with a non-zero-tolerance policy had a 12% physical violence rate; and hospitals with no policy had an 18% physical violence rate. Raise your hand if you spot the trend.
"These data underscore what nurses know first-hand," Gurney said. "Hospitals that have policies in place to respond to violence and to prevent it are safer for the healthcare professionals that work in them and the patients who seek treatment in them."
The survey revealed that simply strategies such as a panic button or silent alarm lower physical violence, and enclosed nurses’ station, security signs, and well-lit areas lower verbal abuse.
The survey also found that:
Patients and their relatives perpetrated nearly all physical violence (97%) and verbal abuse (91%).
Most physical violence occurred in patients' rooms (81%). Nearly a quarter (23%) occurred in corridors, hallways, stairwells or elevators and 15% occurred at the nurses’ station. *
The most frequently reported activities that emergency nurses were involved in when they experienced physical violence were triaging a patient (38%), restraining or subduing a patient (34%) and performing an invasive procedure (31%). *
Male nurses reported higher physical violence rates than female nurses (15% versus 10%); and physical violence rates tended to decline with older nurses.
Physical violence rates were higher in large urban areas (13%) than in rural areas (8%). Nurses working in EDs with more beds and treatment space, and those with higher numbers of visits were more likely to experience physical and verbal abuse than nurse in lower-traffic departments.
The ENA survey doesn’t provide a vaccine for the epidemic of hospital violence. It does give us a good idea of where hospital violence occurs, who the victims are, who the perpetrators are, and some basic strategies to reduce violence. It's a good starting point. Look at the survey and see how your hospital's antiviolence policies compare. You owe it to your employees. What are you waiting for?
* (Math majors may notice that these responses add up to more than 100%. ENA explains that for several of the survey questions respondents were allowed to select more than one response. For example, a violent incident could start in a patient’s room and spill out into the hallway as the incident progresses.)
A federal grand jury in Maryland has indicted five Baltimore-area residents on fraud and aggravated identity theft charges in a scheme to use patient personal information stolen from Johns Hopkins Hospital to open credit card accounts and make more than $600,000 in “instant credit” buys at retail stores.
Indicted were: Michael Allen, age 34; Jasmine Amber Smith, 25; Tyrell Douglas McCormick, 22; Ayanna Devon Johnson, 38; and Gloria Canada, 54. The superseding indictment was returned on Sept. 15, 2010 and unsealed last week with the arrest of Canada, the final defendant.
Officials at Johns Hopkins Medicine said they do not comment on ongoing litigation and referred all inquires to the U.S. Attorneys Office in Baltimore.
According to the 39 count indictment, while employed by Johns Hopkins Hospital from August 2007 to March 2009, Smith allegedly improperly obtained the personal identity information of patients and the parents and guardians of minor patients, including names, social security numbers, dates of birth and addresses. Smith allegedly gave the stolen information to Johnson and Canada.
From May 2008 to June 2009, Allen and McCormick allegedly used the stolen information to apply for instant credit at stores make purchases on “instant credit” before the fraudulently obtained credit cards were received by the victims. The indictment alleges that the defendants fraudulently obtained more than $600,000 in credit from over 50 stores and individuals.
The defendants face a maximum sentence of 30 years in prison for conspiracy to commit bank fraud and two years in prison consecutive to any other sentence for aggravated identity theft. McCormick and Allen face a maximum sentence of 30 years in prison for bank fraud and 15 years in prison for access device fraud.
Health and Human Services has awarded nearly $49 million in planning grants to help 48 states and the District of Columbia install health insurance exchanges in 2014.
The state-based exchanges will provide consumers and businesses with "one-stop-shopping" to compare and buy health insurance. Americans will have the same healthcare choices as members of Congress—who will also purchase coverage through the exchanges. Individuals and families purchasing health insurance through exchanges may also qualify for tax credits and reduced cost-sharing depending on their income, HHS says.
The grants of up to $1 million each will help the states' determine how their exchanges will be operated and governed, including:
Assessing information technology systems and infrastructure and determining new requirements.
Developing partnerships with community organizations to gain public input into the exchange planning process.
Planning for consumer call centers.
Determining the statutory rules needed to build the exchanges.
Hiring staff.
Planning the coordination of eligibility and enrollment systems across Medicaid, the Children's Health Insurance Program, and the exchanges.
Developing performance metrics, milestones and ongoing evaluation.
The Institute of Medicine will conduct a one-year study to determine if health information technology will achieve its full potential for improving patient safety in healthcare. The study will be carried out under a $989,000 contract from the federal Office of the National Coordinator for Health Information Technology.
"Since 1999, when the IOM published its ground-breaking study To Err Is Human, the Institute has been a leader in the movement to improve patient safety," said David Blumenthal, MD, national coordinator for HIT. "This study will draw on IOM?s depth of knowledge in this area to help all of us ensure that HIT reaches the goals we are seeking for patient safety improvement."
The study will examine patient safety-related issues, including prevention of HIT-related errors and rapid reporting of any HIT-related patient safety issues. It will make recommendations concerning the potential effects of government policies and private sector actions in maximizing patient safety and avoiding medical errors through HIT. The study will:
Summarize existing knowledge of the effects of HIT on patient safety;
Identify approaches to promote the safety-enhancing features of HIT while protecting patients from safety problems associated with HIT;
Identify approaches for preventing HIT-related patient safety problems before they occur;
Identify surveillance and reporting strategies for rapid detection and correction of patient safety problems;
Address the roles of private sector accrediting and certification bodies, and patient safety organizations and professional and trade associations;
Discuss roles for key federal agencies, including the Food and Drug Administration, the Agency for Healthcare Research and Quality, and the Centers for Medicare & Medicaid Services.
Donald Berwick, MD, CMS administrator said improving patient safety in healthcare depends on thoroughness in planning and execution, to find problems systematically and correct them decisively. "We have high expectations for patient safety improvement through HIT, but achieving those goals will require the same careful and vigorous approach that is needed to improve safety in any enterprise. The IOM can help us identify a productive path to better patient safety with the help of HIT," Berwick said.
The Health Resources and Services Administration has issued $17 million in grants to bolster primary care training programs in communities across the nation.
“(The grants) target community-level health professions shortages, support workforce diversity, and provide for retooling our workforce to meet the demands of an aging population, the chronically ill, and disabled,” said HRSA Administrator Mary K. Wakefield, RN.
The 99 grants, funded under 2010 appropriations, will support 21 Area Health Education Centers, 68 Geriatric Academic Career awards, and 10 Nursing Assistant and Home Health Aide Program awards.
Awards fall under two AHEC programs that will receive a total of $10 million: Infrastructure development grants go to four universities to establish and advance state-wide or multi-county AHEC programs; and point of service maintenance and enhancement grants support 17 universities that have established partnerships with community-based AHECs.
AHECs are interdisciplinary, community-based training programs led by academic and community leaders who collaborate to improve the supply, distribution, diversity, and quality of healthcare personnel, with a special focus on primary care personnel in rural and other underserved communities.
Sixty-eight GACA grants will share $5 million to support career development for academic geriatric specialists to help address the fast-growing 65-plus population, which is expected to almost double by 2030. In recognition of the importance of comprehensive care, the Affordable Care Act modified this program to expand eligible entities to include schools of medicine, osteopathic medicine, nursing, social work, psychology, dentistry, pharmacy or other allied health disciplines in an accredited health professions school that is approved by the HHS Secretary.
GACA grants focus on chronic disease management, geriatric ethics, palliative care, and health promotion. Award recipients also work with underserved and uninsured patients across many community settings including acute, ambulatory, and long-term care.
Ten NAHHA grants totaling $2.4 million will go to colleges or programs that provide community-based training to nursing assistants and home health aides who treat the elderly, chronically ill, and disabled. As nursing homes and home health agencies continue to have problems with recruitment and retention of qualified workers, there is growing concern over the current and projected shortages of these frontline direct care workers. Grantees project that these awards will enable them to train more than 4,000 nursing assistant and home health aide students over the 3-year project period.
Novartis Pharmaceuticals Corp. will plead guilty and pay criminal and civil fines totaling $422.5 million to resolve whistleblower claims that it used off-label marketing and paid kickbacks to doctors to illegally promote the antiepileptic Trileptal and five other drugs, federal prosecutors said Thursday.
The Food and Drug Administration approved Trileptal for the treatment of epilepsy, but federal prosecutors said Novartis created marketing materials promoting the drug for off-label uses, including neuropathic pain and bipolar disease, which were not FDA-approved. Novartis allegedly targeted psychiatrists and pain specialists, who used anti-epileptic drugs like Trileptal off-label. The other drugs that were allegedly illegally promoted were Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin.
Prosecutors allege that Novartis marketed and promoted Trileptal as a treatment for bipolar disease and neuropathic pain and told its sales representatives to visit doctors who would not normally prescribe Trileptal due to the nature of their practices. Novartis also allegedly funded continuing medical education programs that used medical professionals to promote off-label uses of Trileptal.
Prosecutors said Novartis made hundreds of millions of dollars in profits from the misbranding and off-label promotions. The criminal fines and forfeitures total about $185 million.
"Off-label marketing can undermine the doctor-patient relationship and adversely
influence the clear judgment that a doctor's patients have come to rely on and trust," said David Memeger, U.S. Attorney for the Eastern District of Pennsylvania, which led the federal probe.
"Pharmaceutical companies have a legal obligation to promote the drugs they manufacture only for uses that the FDA has deemed are safe and effective. That legal obligation takes priority over a company's bottom line."
In the civil agreement, Novartis will pay the federal government and participating states $237.5 million, plus interest, to settle invalid claims for payment for Trileptal and the other drugs that were submitted to Medicare, Medicaid, and other government-sponsored healthcare programs. State Medicaid programs will share $88.2 million of the settlement.
Novartis President for North America Andy Wyss said the U.S. subsidiary of Switzerland's Novartis International AG was "pleased" with the resolution. "(Novartis) will continue its commitment to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products," Wyss said. "Our goal is to ensure that patients receive the medicines they need and we will continue to work with the government and other organizations to improve healthcare for all Americans."
The civil cases were filed by former Novartis employees who will split $25.6 million from the settlement, under federal whistleblower statutes. Novartis also entered into a five-year corporate integrity agreement with Health and Human Services' Office of Inspector General.
The Shands Hospital board of directors has voted to restructure governance of Shands Jacksonville and Shands at the University of Florida so they can collaborate as “sister” entities with parallel roles, each with a direct relationship to UF leadership, Shands has announced.
David S. Guzick, MD, senior vice president for health affairs at UF, president of the UF&Shands Health System at UF, and chair of both Shands boards, says the decision is an important step in the evolution of the UF Academic Health Center and the Shands hospital.
“This action allows a natural evolution of our Jacksonville campus as a mature institution under the UF umbrella, and allows the leadership at the Gainesville campus to focus on our academic and clinical activities there, while still ensuring overall governance and strategic direction from the University of Florida,” Guzick says.
Both hospitals will operate independently, each with its own board. They will have a shared focused on the academic health center’s goals for patients, students and research programs. Timothy M. Goldfarb, CEO of Shands HealthCare, and James R. Burkhart, CEO of Shands Jacksonville, will report to their respective boards, and to Guzick as chair of each board.
UF President Bernie Machen and Guzick are convening a new Shands HealthCare Strategic Cabinet, through which all Shands hospitals and other facilities will work with the UF Health Science Center as part of the UF Academic Health Center. The new cabinet will provide advice on strategic and financial issues before action is taken.
“This change gives hospital leadership and its board the ability to address the needs of the Jacksonville community in a more nimble fashion, and to draw on its resources and those of the Jacksonville community to grow and prosper,” Burkhart says.
Goals include more efficient delivery of healthcare services, improved outcomes, stimulating educational programs for students, residents and fellows, and research that fosters novel discoveries and economic development, Burkhart says.
Rochester, NY-based emergency physician Sandra M. Schneider, MD, assumes a one-year term as president of the American College of Emergency Physicians this week.
Schneider is a professor and chair emeritus of the department of emergency medicine at the University of Rochester and attending physician at Strong Memorial Hospital in Rochester. She has been a leader on the issue of reducing overcrowding in the nation's emergency departments and on implementing high-impact, low-cost solutions to address the problem of holding or "boarding" patients in the emergency department.
"Patient boarding and overcrowding in emergency departments are critical problems that deserve attention at the highest levels," Schneider said. "It is imperative that we reduce the number of patients we board in our emergency departments to ensure that all patients get the timely care they need and deserve."
Schneider served as the founding chair of the department of emergency medicine at the University of Rochester from 1993-2007. She established a residency training program there in emergency medicine and fellowship programs in pediatric emergency medicine, sports medicine, international emergency medicine and EMS.
Schneider was elected to the ACEP Board of Directors in 2004 and re-elected in 2007. She previously served on the board of directors of the American Association for Emergency Psychiatry and as president of the Society for Academic Emergency Medicine and the Association of Academic Chairs of Emergency Medicine.
