Outgoing CEO John Noseworthy, MD, will retire at the end of the year, after nine years leading the prestigious Rochester, Minnesota-based health system.
The Mayo Clinic has named Gianrico Farrugia, MD, as CEO and president.
Farrugia is the CEO of Mayo Clinic Florida, and he will succeed outgoing CEO John Noseworthy, MD, who retires at the end of this year after nine years leading the prestigious Rochester, Minnesota-based health system.
"I am humbled and proud to follow and build upon this success with the best staff in the world," Farrugia said in amedia release.
"While sea change continues to sweep through healthcare, I look forward to harnessing innovation, a hallmark of Mayo Clinic, to transform health care for the benefit of patients everywhere," he said.
Farrugia has been CEO of Mayo Clinic Florida, based in Jacksonville, since 2015, where he leads a staff of more than 6,400 people.
"Dr. Farrugia is a visionary and servant leader who brings with him a wealth of experience and knowledge ─ both as an innovator and an executive," Noseworthy said. "In partnership with our staff across Mayo Clinic, and with a deep commitment to our values and mission, he will affirm Mayo Clinic’s position as the global health care leader for generations to come."
Noseworthy is credited with leaving Mayo with a strong reputation as an elite, well-endowed health system. During his tenure as CEO, Noseworthy oversaw Mayo's transition from a holding company to a single operating company across all of its sites.
"We are deeply grateful for Dr. Noseworthy's outstanding patient-centered leadership and inspiration he provided over the past nine years,” Mayo Board of Trustees Chair Samuel Di Piazza said. "Mayo Clinic has had a tremendous track record under his leadership amidst unprecedented change in health care and is well-positioned for continued success as we make this transition."
A native of Malta, Farrugia has spent 30 years as a Mayo physician. He is jointly appointed in the Division of Gastroenterology and Hepatology, Department of Internal Medicine, and the Department of Physiology and Biomedical Engineering.
He is a member of the Mayo Clinic Board of Trustees and Mayo Clinic Board of Governors. He also is a professor of medicine and physiology, and a faculty member in biomedical engineering at Mayo Clinic Graduate School of Biomedical Sciences.
Researchers say behavioral 'nudges' could play a critical role in reducing the opioid epidemic.
Physicians are apt to reduce the number and dosage of opioids they prescribe after learning that a patient had died from an overdose, according to a study funded by the National Institute on Aging.
Researchers found that physicians in the San Diego area who were told of a patient's overdose death reduced the number of opioids prescribed by 9.7% in the following three months.
"This finding could be very useful in the effort to reduce inappropriate prescribing of opioids without severely restricting availability of legally prescribed opioids for patients who should be getting them," NIA Director Richard J. Hodes, MD, said in commentsaccompanying the study.
"It shows that physicians respond to information about adverse outcomes. Behavioral 'nudges' like these letters could be a tool to help curb the opioid epidemic," he said.
Over 12-months straddling 2015 and 2016, the county reported 222 deaths involving Schedule II, III or IV drugs as the primary or contributing cause. Of these, 170 deaths were listed in the Controlled Substance Utilization Review and Evaluation Systemdatabase.
The 861 prescribing clinicians reviewed by the researchers were divided into an intervention (388) and a control (438) group. The intervention group received a letter from the county medical examiner. The control group did not.
The letter identified the patient by name, address and age, and outlined the annual number and types of prescription drug deaths seen by the medical examiner. It also showed how to access California's prescription drug monitoring program and reviewed safe prescribing strategies.
The researchers said the notifications may not work for larger populations, but could work on the county level.
John Haaga, director of NIA's Division of Behavioral and Social Research, said the findings " illustrates one small and relatively inexpensive method of reducing the number of opioid prescriptions written, thus reducing the number of drugs available for misuse."
The Competitive Generic Therapy designation looks to encourage the development of alternatives for drugs with inadequate generic competition.
The Food and Drug Administration on Wednesday approved a potassium chloride oral solution as the first generic drug to receive a streamlined Competitive Generic Therapy designation.
The new approval process expedites the development and review of generic alternatives for products that lack competition, FDA said in a media release.
"Today's approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition," said FDA Commissioner Scott Gottlieb, MD.
"The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs," Gottlieb said. "So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo."
Gottlieb said the new generic drug was approved in its first review cycle.
"This approval demonstrates that the competitive generic therapy pathway is efficient and open for business," he said. "This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need."
Potassium chloride is an oral treatment for low potassium blood levels in patients who are on diuretics.
The FDA Reauthorization Act of 2017 can designate drugs as a Competitive Generic Therapy if there is not more than one approved drug in the active section of the Orange Book.
CGT-designated drugs are eligible for an expedited review and receive a 180-day exclusive marketing period if they are the first approved applicant for that CGT designation.
The FDA granted approval of the potassium chloride oral solution USP to Apotex Inc.
Association for Accessible Medicines President and CEO Chip Davis credited the FDA "for recognizing the critical role generics play in helping to control overall drug costs."
"Generic manufacturers have responded to the Administration's efforts to increase competition through the new CGT pathway and remain committed to working to ensure that safe, effective and more affordable FDA-approved generics are accessible to patients and providers," Davis said. "This pathway, created through FDARA, is a better long-term sustainable solution than considering bringing in drugs from foreign markets."
PhRMA said it "applauds the FDA's use of its new authority to designate and approve a competitive generic therapy where there is inadequate competition and no remaining patents or exclusivity."
Premier, Inc. Senior Vice President Blair Childs said that the FDA's actions on Wednesday "enhance access to affordable treatments for patients with low potassium blood levels."
"On a larger scale, FDA's use of this new expedited process will create competitive friction for single-source generic drugs to foster market forces, which can help drive down prices," Childs said.
The off-label marketing for antipsychotic drugs allegedly occurred while AstraZeneca was already under a 2010 federal corporate integrity agreement for Medicaid fraud.
AstraZeneca will pay the Texas $110 million to settle allegations that the drug maker illegally marketed two antipsychotic drugs to Medicaid providers in the state, Attorney General Ken Paxton announced.
According to Texas prosecutors, AstraZeneca ran the misleading marketing schemes at a time when the company was already under a 2010 federal corporate integrity agreement resulting from prior allegations of Medicaid fraud.
The federal agreement banned AstraZeneca from promoting its antipsychotic medication Seroquel and cholesterol-lowering statin drug Crestor for uses not approved by the Food & Drug Administration, but Texas alleged the company continued to do so anyway.
Paxton said the drugs were promoted primarily to treat children and adolescents and that AstraZeneca made hundreds of thousands of dollars in illegal payments to two former state hospital doctors to unduly influence the use of Seroquel in the state hospital system.
"The allegations that led to this settlement are especially disturbing because the well-being of children and the integrity of the state hospital system were jeopardized," Paxton said.
Paxton noted that AstraZeneca was accused of a similar nationwide marketing fraud scheme involving Crestor, that included a "plan of deception" targeting Texas Medicaid to expand statin use beyond what the science supported, while downplaying the risk of diabetes in some patients.
AstraZeneca Responds
AstraZeneca issued a statement Wednesday morning confirming the settlement, but adding that it "makes no concessions or admissions of fault."
"While AstraZeneca denies the allegations, it is in the best interests of the company to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines – while avoiding the delay, uncertainty, and expense of protracted litigation," the drug maker said.
The plan does not expand negotiating powers directly to the federal government and Part D drugs, which prompted one critic to call the policy shift 'small potatoes.'
The Centers for Medicare & Medicaid Services is rescinding an Obama-era policy that prohibits Medicare Advantage plans from negotiating lower Part B drug prices for their enrollees.
Under the revised policy announced Tuesday, enrollees starting in 2019 can choose Medicare Advantage plans that mandate the use of preauthorized but less-expensive drug formularies, with at least half of the savings generated by the "step therapy" passed back to enrollees, CMS said.
Medicare Advantage plans have been denied the negotiating tools for Part B drugs that commercial plans commonly use when negotiating lower drug prices, CMS Administrator Seema Verma told reporters Tuesday.
"What we are essentially allowing them to do is to introduce step therapy for Medicare Part B drugs," she said. "The plans have the option of using that tool. That might help them negotiate better discounts. It might encourage manufacturers to lower their prices. It will also encourage them to direct patients to high-value medications."
Medicare Advantage plans will have the ability to "cross-manage" drugs covered under different parts of Medicare, allowing them to pay for the most appropriate, most affordable drugs, regardless of whether patients receive them in a doctor’s office (Part B) or at a pharmacy (Part D), Verma said.
CMS estimates that the policy shift could generate between 15% and 20% savings within the $11.9 billion spent annually on prescription drugs in Medicare Advantage.
Verma was asked at the briefing why CMS limited the negotiating ability to Medicare Advantage, and did not expand those powers to include the federal government, which is the world's largest purchaser of prescription drugs.
"This will impact about 20 million Americans, about 33% of our Medicare enrollees," Verma replied. "This is just one of the many things we are doing with the president's blueprint. We will be continuing to make announcements over the coming weeks so that we can make sure we are getting the best deals for Americans on drug pricing."
The plan received mixed reviews from stakeholders.
"PhRMA has serious concerns with the new CMS guidance regarding Medicare Advantage coverage of Part B medicines and the implications for patients suffering from complex conditions," PhRMA said in a media release.
"Step therapy will delay many patients' access to medicines they need, interfere with the patient-physician relationship and increase burdens on physicians to comply with new, more complicated requirements. The bottom line is this guidance prioritizes the interests of middlemen while increasing out-of-pocket costs for some patients," PhRMA said.
However, the Pharmaceutical Care Management Association praised the new policy as "an important step toward reducing costs for the program and beneficiaries."
"Some of the highest priced drugs are found in Medicare Part B, where PBMs currently don't play any meaningful role," PCMA said.
The reaction was also mixed among consumer groups.
Peter Maybarduk, director of Public Citizen's Access to Medicines Program, called the policy "small potatoes" when compared to what the federal government could do to make drugs more affordable.
"Adjusting the rules for Medicare Advantage plans under the much smaller Part B program is a much smaller change than giving the government power to negotiate directly for Part D," Maybarduk said.
Instead, Maybarduk accused the Trump administration of "protecting Big Pharma."
"Even if Medicare Advantage plans for Part B somehow reduced their costs from $12 billion to zero, that still would produce less in savings than the government simply negotiating prices directly for the $100 billion Part D program," Maybarduk said.
However, David Mitchell, president and founder of Patients For Affordable Drugs, called the new policy "a small but positive step" that gives Medicare Advantage plans "greater leverage to negotiate with drug corporations."
Mitchell said that concerns about the potential misuse of step therapy are legitimate, "but as long as patients are protected with a timely and workable appeals process, allowing step therapy in Medicare Advantage is a step I can support."
First-of-its-kind initiative bypasses insurance middlemen and hopes to lower costs by improving access to primary care and pushing preventive medicine, wellness initiatives.
Henry Ford Health System and General Motors have signed what they're calling a first-of-its-kind "Direct to Employer" contract to provide care for the automaker's 24,000 employees and their families in Southeast Michigan.
GM employees who select the automaker's "ConnectedCare" plan can access Henry Ford healthcare services including primary care, more than 40 specialties, behavioral health services, hospitalization and emergency care, pharmacy and other services, according to a joint media release.
"GM's upcoming ConnectedCare option comes from our ongoing quest to improve employee health, while also seeking to offset rising healthcare costs for both the employee and the company," Sheila Savageau, US Healthcare Leader, General Motors, said in prepared remarks.
"Partnering with a regional healthcare leader like Henry Ford Health System enables us to provide an innovative new plan option for high quality, affordable care," she said.
Under the contract:
ConnectedCare will provide access to more than 3,000 providers from a network of primary care and specialty care doctors in communities where GM employees live. Open enrollment begins this fall, with service beginning in 2019.
Henry Ford will help GM enrollees track of their health with regular wellness exams, monitoring chronic conditions, and preventive screenings.
The health system will push members to less-expensive care venues, such as walk-in clinics rather than emergency rooms for minor illness and injury.
GM enrollees will have dedicated resources for appointment scheduling and other services and access to same-day or next-day appointments with a primary care physician and the ability to see a specialist within 10 business days."
"If you talk to a lot of brokers and consultants around the country, they've been pushing for this idea of direct contracting as a way to save money and narrow not only the healthcare spend, but their exposure to various levels of quality and cost variation,” Bret Jackson, president of The Economic Alliance for Michigan, told EBN.
"This is a move that we knew was coming. But [GM's move] to contract where their headquarters are, and being in a market where there is a lot of hospital competition, sends a strong signal of what the future means for employee benefits," Jackson said.
The hospital lobby has responded to CMS Administrator Seema Verma's invitation to review the Stark Law and adapt it to value-based care.
The American Hospital Association has made a patient-centered plea for Stark Law reforms.
In a 23-page letter to Centers for Medicare & Medicaid Services Administrator Seema Verma, AHA General Counsel Melinda Reid Hatton offered a detailed proposal that would allow hospitals and physicians to provide coordinated, value-based care and not run afoul of the Stark Law.
"To reach the full potential of a value-based health system, the Stark compensation regulations must be reframed to meet the objectives of the new system, through the creation of a new exception designed specifically for value-based payment methodologies," Hatton's letter said.
To demonstrate how each of the AHA's proposed amendments would directly benefit patients, Hatton used "Wayne," a hypothetical 75-year-old man with multiple chronic illnesses and a limited home care network.
AHA called on CMS to do the following:
Amend undue constraints on how hospitals finance infrastructure improvements, such as multi-site electronic health records. "For Wayne, shared electronic systems across his care team would mean no longer answering the same questions or completing duplicate paperwork every time he has an appointment or contact with someone on his care team."
Remove barriers to incentive programs that reward physicians who "adhere to defined care pathways." AHA says that current protections for incentive arrangements are "haphazard combinations of exceptions… anchored in 'hours worked' or 'resources expended'" and designed for independent physicians, not collaborators. "For Wayne, care pathways would mean having the most current treatment options available to meet his particular needs."
Enhance incentives for efficient treatment options, and provide specific exemptions that protect cost-saving arrangements. This could include sharing the bottom-line cost savings with collaborating physicians. For example, hospitals and physicians could establish specific cost-savings actions such a using standardized devices or drug formularies. "For Wayne, a formulary would mean he is prescribed a drug that is best suited to his needs and the most cost-effective for him."
Remove barriers that discourage team-based care, and allow for financial rewards to physicians for care coordination, which otherwise could run afoul of the volume/value prohibition that links payment to the volume of potential referrals for hospital services. "For Wayne, having a care team means he can make a call to multiple team members to discuss his concerns and avoid an unnecessary trip to the emergency department or prevent a cascade of difficulties that would land him back in the hospital."
"We believe that value-based arrangements protected by the new exception will not carry the risk of overutilization addressed by the Stark Law," Hatton wrote. "Our proposed exception draws on safeguards included in the Waivers for the MSSP, as well as certain other requirements intended to protect the Medicare and Medicaid programs against abuse in the fee-for-service context."
The physician gender pay gap is real, it's persistent, and it occurs across all medical specialties. The causes are complex, which makes finding solutions difficult.
A recent survey showing that male physicians in Maryland earn about 50% more in annual compensation than their female peers came as no surprise to Theresa Rohr-Kirchgraber, MD.
"Women physicians earn less than male physicians in almost every specialty and this is not new," says Rohr-Kirchgraber, executive director of the Indiana University National Center of Excellence in Women's Health, and a professor of clinical care and pediatrics.
She has been studying and speaking on gender pay inequities for years, and says that while the phenomenon is real, it defies an easy explanation.
In an email exchange with HealthLeaders, Rohr-Kirchgraber offered five reasons why the gap exists:
"Women physicians feel an additional burden when seeing patients and typically will feel as if we can never quite do enough," she says. "Therefore we may not bill at the level we should. We worry about the effect of the bill on the patient and then bill at lower levels."
"Even if the initial salary is the same as men, we are, in general, poor negotiators and may not negotiate up front for things that would improve our practice capability," she says. "For example, we had two researchers who came in on the same salary, one negotiated for larger research lab space and research techs, while the other did not. Guess who was further along in their career after 10 years?"
"The practice of medicine is not just about salary but about support. For example, if I only have one medical office assistant working with me, my patients wait longer and my turnaround times are longer," she says. "Most of our male physicians have a 'chaperone' in the room with them who can then help to speed things up especially with paps and pelvics."
"Women and underrepresented minorities score lower on patient satisfaction scores. For many of us, the patient satisfaction scores are a component of our reimbursement for salary," she says. "So, just being a woman, my scores will be lower, and I will make less at the end of the year. The assumption is not that we are worse physicians, but that the expectation is higher for us."
"We don't negotiate for higher salaries when it is time to re up," she says. "We think too much about what we did not do, or how we have come up short in our own expectations, and don't realize that each time our contract comes up for renewal we should discuss an increase in our salary and a consideration for other aspects of our income."
"For example, we just started an 'Affinity group' at Indiana University Health, which is supposed to improve our physician engagement. Women like community and we are encouraged to join. But we currently have no remuneration for such activities. If we join, it takes away from our clinical practice."
The takeaway, Rohr-Kirchgraber says, is that women physicians need to bill and code in a way that better reflects the services they provide, must demand more more transparency in the workplace around salaries, and push to remove patient satisfaction scores as a factor in salary determinations.
Beaumont says it has cooperated with prosecutors to uncover undue compensation to referring physicians allegedly made before the health system was formed in 2014.
Detroit-based William Beaumont Hospital will pay $84.5 million to resolve kickback allegations levelled by four former employees in whistleblower lawsuits, the Department of Justice said.
Prosecutors alleged that, between 2004 and 2012, Beaumont hospitals in Royal Oak, Troy, and Grosse Pointe compensated eight physicians with free or substantially discounted office space and employees in exchange for patient referrals, violating the Anti-Kickback Statute and Stark Law.
The health system then allegedly submitted claims for services provided to these illegally referred patients to Medicare, Medicaid and other federally funded healthcare programs in violation of the False Claims Act.
The settlement also resolves claims that Beaumont misrepresented a CT radiology center as a qualified outpatient department in claims to federal healthcare programs.
As a result of this settlement, Beaumont will pay $82.74 million to the federal government and $1.76 million to the state of Michigan. Awards for the four whistleblowers have not yet been determined, DOJ said.
Beaumont has also entered into a five-year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General.
"This result should impress on the medical community the fact that we will aggressively take action to recover monies wrongfully billed to Medicare, through the remedies provided in the federal False Claims Act," US Attorney Matthew Schneider for the Eastern District of Michigan said in a media release.
"I would like to commend the new leadership at Beaumont Hospital for making things right once its past wrongdoing was brought to its attention by federal investigators," Schneider said.
Beaumont issued a statement on its website noting that the allegations arose before the eight-hospital Beaumont Health was formed in 2014, "which created a new health system with new leadership and a new mission, vision and values."
"The resolution of these matters, some of which go back to contracts originating 14 years ago, reflects Beaumont Health's commitment to the future of health care in Southeastern Michigan," Beaumont President and CEO John Fox said.
"Since the formation of Beaumont Health in 2014, the new management team has implemented additional compliance and legal review processes to ensure our effective compliance with the complex regulations applicable to health systems and to provide additional assurance that these types of issues do not arise again," Fox said.
Chicago, Baltimore, Cincinnati, and Columbus claim the Trump administration's 'death-by-one-thousand-cuts campaign' is designed to weaken the ACA and 'deceptively shift blame' to the law itself.
Four cities filed a federal lawsuit Thursday against the Trump administration, claiming the president is intentionally undermining the Affordable Care Act and violating a Constitutional duty to "faithfully execute" existing law.
"Having failed to persuade Congress to repeal the Affordable Care Act, President Trump and his Administration are waging a relentless campaign to sabotage and, ultimately, to nullify the law," read the complaint, filed this week in U.S. District Court in Maryland by the cities of Baltimore, Chicago, Cincinnati, and Columbus, Ohio.
"To that end, President Trump and his Administration are deliberately trying to make the Act fail," the complaint continues.
"They are discouraging Americans from enrolling in comprehensive plans that protect them against debilitating medical expenses. They are working to raise prices and reduce choices for Americans seeking insurance in the Act's exchanges. And they are misappropriating funds Congress allocated to support the Act, instead using those funds to attack it."
Ultimately, the complaint read, the Trump administration hopes to "deceptively shift the blame from their own actions to the Act itself" and to pressure Congress to repeal the ACA or to achieve a de facto repeal through executive action.
"There's a clear case of premeditated destruction of the Affordable Care Act," Zach Klein, Columbus city attorney, told NBC News.
Health and Human Services Secretary Alex Azar, and Centers for Medicare & Medicaid Services Administrator Seema Verma are also named as codefendants with the president in the 130-page suit. The Executive Branch watchdog group Democracy Forward has joined the plaintiffs.
The cities offer a litany of complaints about the Administration's tactics to limit the ACA's effectiveness by making it more difficult to obtain coverage through exchanges, specifically:
Misusing federal funds for advertising campaigns that instead are "smearing the ACA," and "spinning false narratives" about the success of the act;
Shortening enrollment periods; and
Imposing documentation requirements the plaintiffs deem unnecessary and onerous.
The complaint further alleges that the administration has shirked oversight of insurance rate increases and reduced rebates to consumers, in an effort to raise premiums, create uncertainty, and cause insurers to flee the markets.
The cities said their case is easy to prove because Trump and his administration "have been remarkably transparent about their intent and approach."
"'If we don't get it done' in Congress, President Trump has said, 'we are going to watch Obamacare go down the tubes, and we'll blame the Democrats . . . and at some point, they are going to come and say, 'You've got to help us,'" the complaint alleges, adding that Trump has repeatedly stated that Obamacare is "essentially dead."
The suit alleges that the Trump Administrations actions are "an affront to the rule of law."
"The Administration's actions raise questions that go to the heart of our structure of government: whether the executive branch must 'take care that the laws be faithfully executed,' U.S. Const. art. II, § 3, and whether the Constitution therefore prohibits the President and his appointees from wielding executive power to destroy a duly-enacted law," the complaint states.
