An official touted the 'tremendous potential' of AI-powered tools in clinical settings, while cautioning that such tools should not supplant human review and judgment.
The Food & Drug Administration gave a software company the go-ahead to market a diagnostic program powered by artificial intelligence.
The software is designed to detect wrist fractures in adults, according to the FDA's announcement last week, which also emphasized that AI should not be used as a replacement for clinical review or judgment.
"Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions," said Robert Ochs, PhD, acting deputy director for radiological health for the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, in a statement.
What is it? OsteoDetect is a computer-aided program that uses an algorithm to review X-ray images for indications of a common type of wrist fracture, according to the FDA's announcement.
How'd it win approval? The company proved its product by submitting (1) a study of its performance against that of three board-certified orthopedic hand surgeons in a retrospective study of 1,000 radiograph images, and (2) a study of 200 patient cases reviewed by 24 providers. The FDA determined both studies supported the software's claimed benefit.
Low-risk approval process: OsteoDetect, which was submitted by Imagen, secured approval through the de novo premarket review pathway, which is used for new devices deemed low- or moderate-risk.
More on machine learning: OsteoDetect relies on an approach to software that's gaining steam in healthcare applications, making it easier for doctors to identify ailments and predict outcomes with advance notice, as The Wall Street Journal reported earlier this month.
Building on a solid foundation: In order for AI tools to live up to their potential, they need solid building blocks. That's a riddle researchers are actively working to solve, and they seem to be finding success, as Alexandra Wilson Pecci wrote earlier this year for HealthLeaders Media.
For more on AI in healthcare, be sure to revisit the September editionof HealthLeaders magazine.
The new top finance executive was hired by the system five years ago. His promotion sets off a chain of leadership changes.
The current CEO of Memorial Hermann Health System's flagship campus in Houston has been promoted to chief financial officer for the whole system, the organization announced Thursday.
Brian Dean, who has been serving as CEO of the Texas Medical Centercampus and as executive vice president of academic affairs and service lines for the system, joined the organization in 2013 as Texas Medical Center's CFO. He was promoted to campus CEO in 2015.
Dean's promotion will take effect August 1, setting off a chain of leadership changes.
His predecessor: Dean will take over for current Memorial Hermann Health System CFO Carrol Aulbaugh, as the Houston Business Journal reported. A spokesperson for the system confirmed to HealthLeaders Media that Aulbaugh will pass the baton to Dean.
His successor: The vacancy Dean leaves behind at Texas Medical Center will be filled by Greg Haralson, who is currently senior vice president and CEO of Memorial Hermann Southwest Hospital and Memorial Hermann Sugar Land Hospital. Haralson will be a senior vice president and CEO for the campus, the organization said.
His successor's successor: The vacancy Haralson leaves behind at the Southwest and Sugar Land hospitals will be filled by Malisha Patel, who is currently vice president of operations for Memorial Hermann Southwest. Patel will be a senior vice president and CEO of both the Southwest and Sugar Land hospitals, the organization said.
His successes: The statement released by Memorial Hermann praised Dean for his work history and on-the-job accomplishments, specifically citing his oversight of the Breaking New Ground project, a collection of major construction and renovation projects across five locations.
"During their tenures with our organization, each of these executives have demonstrated remarkable leadership capabilities, inspiring and engaging their employees to reach above and beyond to deliver the utmost in safe, high-quality care rooted in our promise to advance the health and wellness of Greater Houston," Memorial Hermann President and CEO Chuck Stokes said in a statement.
"Their commitment to our patients, physician partners, employees and the organization as a whole has been paramount in helping Memorial Hermann achieve several notable successes, including national recognition for our care and operational excellence."
Editor's note: A previous version of this story, citing the Houston Business Journal, stated incorrectly that Carrol Aulbaugh has announced his retirement. A spokesperson for Memorial Hermann says Aulbaugh's next steps have yet to be determined. Both this story and the Journal's story have been updated.
The drug-maker allegedly used a charitable foundation to boost its own revenues by covering the copays of Medicare patients taking the company's drugs.
For nearly $24 million, the pharmaceutical company Pfizer Inc. settled allegations it violated the False Claims Act by using a foundation to cover the copays of Medicare patients taking three of the company's drugs, the Department of Justice announced Thursday.
Rather than simply giving the drugs to patients who met the requirements for its free drug program, Pfizer allegedly used a specialty pharmacy to move some patients over to the foundation, which covered the Medicare patients' copays in violation of the anti-kickback statute, according to the DOJ's announcement. Pfizer was accused of donating funds to the foundation to cover the copay costs and securing confirmation through the specialty pharmacy that the foundation had, in fact, covered the copays.
"Pfizer used a third party to saddle Medicare with extra costs,” U.S. Attorney Andrew E. Lelling said in a statement. "According to the allegations in today’s settlement agreement, Pfizer knew that the third-party foundation was using Pfizer’s money to cover the co-pays of patients taking Pfizer drugs, thus generating more revenue for Pfizer and masking the effect of Pfizer’s price increases."
"The Anti-Kickback Statute exists to protect Medicare, and the taxpayers who fund it, from schemes like these," Lelling added. "At the same time, we commend Pfizer for stepping forward to resolve these issues in a responsible manner."
Undermines market forces: Acting Assistant Attorney General Chad A. Readler of the DOJ's Civil Division said kickbacks "undermine the independence of physician and patient decision-making," raising healthcare costs. The DOJ's announcement included a nod to the cost-containing power of "market forces," which the Medicare copay requirements were designed to encourage.
Violates basic trust: Harold H. Shaw, special agent in charge with the FBI's Boston division said Pfizer's alleged scheme "violates the basic trust patients extend to the healthcare system and threatens the financial integrity of the Medicare program."
Part 1: Two of the three drugs involved in this case were Sutent and Inlyta, which treat renal cell carcinoma. For these, Pfizer allegedly generated additional revenue by using its relationship with the foundation and third-party specialty pharmacy to cover Medicare patients' copays, rather than moving qualifying patients to its free program.
Part 2: The third drug involved was Tikosyn, which is used to treat an irregular heartbeat. For this, Pfizer allegedly raised the wholesale acquisition cost for a 40-capsule package by more than 40% in the fourth quarter of 2015, knowing it would make the drug unaffordable for some patients. The company then allegedly worked with the foundation to establish a fund for Medicare patients needing Tikosyn, coordinating the fund's opening with the planned price increase.
Corporate integrity agreement: As part of the settlement, Pfizer signed a corporate integrity agreement with the Health and Human Services Office of Inspector General. Gregory E. Demske, chief counsil to the HHS OIG, said the agreement "promotes independence between Pfizer and any patient assistance programs to which it may donate."
The investigation was conducted by the DOJ's Civil Division and the U.S. Attorney's Office for the District of Massachusetts in concert with the HHS OIG, FBI, Veterans Affairs OIG, and U.S. Postal Inspection Service.
In settling the allegations, Pfizer did not admit any wrongdoing.
The former executive has signed a consultancy contract with the organization he just left.
Despite announcing the sudden retirement this week of its top executive, Quorum Health isn't parting ways with its former president and CEO entirely.
In addition to more than $1.3 million in severance pay, Thomas D. Miller scored a two-year consultancy contract worth $1,000 per month plus $250 per hour, according to documents Quorum filed Wednesday with the Securities and Exchange Commission.
The contract caps Miller's hourly consultant work for Quorum at 20% of what his average workload has been over the past three years. It also allows Miller to be reimbursed for expenses related to his consulting work.
"It has been a privilege to lead Quorum and I am proud of all that we have accomplished since the spin-off," Miller said in a statement Monday, referring to the company's 2016 founding. "Quorum has a deep bench of talented employees and I look forward to seeing what they can achieveas they continue the Company’s commitment to improving patient safety and quality of care."
Miller's temporary replacement: Quorum's board of directors appointed Robert H. Fish as interim CEO. Fish served most recently as interim CEO of Millennium Health from January through March this year. His resume includes experience as a regional president and CEO at St. Joseph Health System and president and CEO at Valley Care Health System, according to Quorum's announcement.
Quorum's defensive note: In its SEC filing, Quorum notes that Miller's decision "was not related to a disagreement with the Company over any of its operations, policies, or practices." This comes as Quorum feuds with Community Health Systems, which spawned the organization two years ago.
Miller's slumping pay: Miller made 34% less last year than he did in 2016, as the organization has divested hospitals aggressively, according to records Quorum filed with the SEC last month.
Board implications: In addition to stepping down from his roles as president and CEO, Miller also resigned from his position as a member of the board of directors and as a director nominee for the election to be held during Quorum's annual stockholders meeting June 8. The board decided against nominating another candidate and will decrease the board's size to six members.
No competition: In signing his consultancy agreement last Friday, Miller agreed not to work for any other hospital or health system that competes with Quorum or that operates within 50 miles of a facility owned or leased by Quorum or any of its subsidiaries.
No mean words: In signing his separation and release agreement last Friday, Miller agreed to a nondisparagement clause, a confidentiality clause, and a provision waiving his right to sue under a variety of nondiscrimination statutes.
If he disparages Quorum, Miller risks losing his $1.3 million severance, which is to be paid out over the next 18 months.
Williston-based staffers see 'some vindication in the acknowledgment of these shared frustrations' with their colleagues in Bismarck.
CHI St. Alexius Health physicians working in Bismarck, North Dakota, aren't the only ones upset with the Fargo-based regional leadership team.
Medical staff in the organization's Williston facilities have added their voices to the chorus of complaints, as The Bismarck Tribune reported this week.
"Many of us thought these issues were limited to the Williston location, due to geographic and population issues, but there is some vindication in the acknowledgment of these shared frustrations," the Williston workers wrote in a letter to the board earlier this month, citing an earlier letter from their colleagues in Bismarck, as the Tribune reported.
Here's a timeline of recent events in this dispute:
May 1: Members of the Bismarck-based medical executive committee sign a blunt letter to the CHI St. Alexius Health board, calling for the ouster of four people from their regional leadership team in Fargo.
May 14: In a letter of their own, some of the organization's Williston-based medical staffers echo concerns raised in the Bismarck-based committee's letter, complaining that their workforce is "chronically overburdened," as the Tribune reported.
May 15: Thirteen members resign from the Bismarck-based committee, leaving only four members to serve on the panel.
May 22: The board convened a meeting with providers at the Williston Medical Center and said it plans to continue meetings with other providers in the system in the weeks to come.
Fargo, where the regional office is located, sits on North Dakota's border with Minnesota. Bismarck is located nearly 200 miles to the west, and Williston is another 220-mile drive northwest of Bismarck.
Proponents praised the measure as a way to give patients more options, while critics warned the move could unleash proverbial 'snake oil salesmen' on seriously ill patients.
A so-called "right-to-try" bill is on its way to President Donald Trump's desk, where it is expected to be signed into law, giving seriously ill patients greater leeway to undergo treatments that have yet to receive final approval from the Food & Drug Administration.
The House voted 250-169 on Tuesday in favor of the measure, which the Senate approved last August. Nine members did not vote.
“Terminally ill patients—and their loved ones—deserve the opportunity to try whatever option is available that may offer a chance for a longer life," Speaker Paul Ryan said in a statement. "For patients who may not qualify for certain trials—or who have tried all other options—this bill will allow them to access experimental treatments and therapies."
Under the legislation, patients with life-threatening conditions would be able to request permission from drug manufacturers to undergo treatments in active clinical trials. The treatments must have completed preliminary testing, and patients must have exhausted their other options.
Signature to come: Trump is expected to sign the bill into law because he endorsed the proposal, in principle, during his State of the Union address in January. Additionally, the White House gave the bill a boostearly last year, as The Wall Street Journal reported.
Existing FDA channel: During testimony before a House subcommittee last October, FDA Commissioner Scott Gottlieb, MD, expressed a willingness to work with a federal right-to-try law. But he noted the FDA's Expanded Access program already approves 99% of applications seeking permission to use investigational drugs and biologics in patient treatment. The FDA receives more than 1,000 such applications annually, he said. In an interview with STAT last week, Gottlieb said right-to-try would make the FDA's job harder.
Some question existing FDA channel: "Although FDA authorizes over 99 percent of expanded access requests, that figure is probably misleading," Roger D. Klein, MD, JD, a consultant with The Federalist Society's Regulatory Transparency Project, wrote in an op-ed for The Hill, arguing that a burdensome application process and discouragement from agency officials keep the number of applications quite low. Klein argued the federal right-to-try law would be an improvement.
Some question those who question the existing FDA channel: "Rather than prioritizing what’s best for the terminally ill, some leaders of the right-to-try movement may be more invested in chipping away at the FDA’s authority," Helen Knight, who graduates this week with an MD from the Johns Hopkins University School of Medicine, wrote in an op-ed for The Baltimore Sun arguing against the right-to-try law. "The movement’s champions, including Americans for Prosperity and the Goldwater Institute, have worked to reduce federal regulatory authority on other fronts. Indeed, the Goldwater Institute is concurrently campaigning to diminish FDA authority by advocating for legislation to rollback restrictions on how companies communicate about off-label uses of drugs."
Some patient groups, ethicists oppose: A long list of patient advocacy groups and medical ethicists has voiced opposition to the right-to-try proposals, arguing that it could put patients at greater risk. "If we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey on their desperation?" Dr. R. Adams Dudley, director of the Center for Healthcare Value at University of California, San Francisco, told Kaiser Health News in March.
Most states have right-to-try laws: In a letter signed by 40 fellow members in February, Republican Reps. Andy Biggs of Arizona and Brian Fitzpatrick of Pennsylvania argued a federal law is needed because laws on the books in 38 states are being preempted by federal policy.
Some governors support: A group of nine governors, led by New Hampshire Gov. Chris Sununu, sent a letter to Congress, urging lawmakers to enact right-to-try on the federal level. "Gridlock in Washington remains the only barrierstanding between terminally ill patients and the hope they both need and deserve," the governors wrote, as the New Hampshire Union Leader reported.
Not just for terminally ill: Although some right-to-try proposals have applied to "terminally ill" patients, this version applies to those who have been "diagnosed with a life-threatening disease or condition," which critics have argued is a significanlty broader definition.
Rep. Jan Schakowsky of Illinois was among a menagerie of Democrats warning the right-to-try bill would make it easier for bad actors to take advantage of seriously ill patients.
"This gives open license to snake oil salesmen," Schakowsky said during debate Tuesday afternoon. "Why should we put more patients at risk when the current process does work?"
Editor's note: This story was updated Wednesday, May 23, 2018, with additional information, including a statement from Speaker of the House Paul Ryan.
The brief message to global health leaders noted they should 'contribute their fair share to pharmaceutical innovation.'
Health and Human Services Secretary Alex Azar added $7 million Tuesday to the U.S. government's pledged financial assistance in the fight against Ebola in the Democratic Republic of Congo.
Azar made the announcement in a speech during the 71st World Health Assembly in Geneva, Switzerland, where he joined global health leaders to discuss the World Health Organization's priorities.
"One key priority must be infectious threats that can cross borders—especially influenza," Azar said in his prepared remarks. "One hundred years ago, the 1918 influenza pandemic infected a third of the global population and killed more than 50 million worldwide, showing how high the costs of poor preparation can be."
Touted the U.S. and its global commitment: "We are, thankfully, better prepared for a flu pandemic today, in part because the United States invests generously in pandemic preparedness at home and abroad," Azar said.
Added financial support to fight Ebola: The additional $7 million Azar pledged on behalf of the U.S. government adds to a $1 million pledge announced last week, and it "complements the work of American technical experts" already on the ground, Azar said.
Addressed prescription costs: Azar noted that President Donald Trump has prioritized lowering prescription drug costs for Americans and "condemned practices by which other countries command unfairly low prices [on] innovative drugs," adding that the U.S. government is working to make sure other countries "contribute their fair share to pharmaceutical innovation."
The 5-4 decision upholds legality of arbitration clauses in employment contracts.
The U.S. Supreme Court announced Monday morning that it has sided with electronic health records company Epic Systems Corp. in a dispute over arbitration clauses in employment contracts.
The 5-4 decision holds that federal labor laws do not prohibit employment contracts from banning class action litigation. The ruling sides not only with the EHR company but also with the Trump administration's Department of Justice.
"The policy may be debatable but the law is clear: Congress has instructed that arbitration agreements like those before us must be enforced as written," Justice Neil Gorsuch wrote for the majority, overturning the Seventh Circuit's prior decision in the Epic case.
Significant impact: Many cases pending in courts around the country could be impacted by this decision. A recent memo from the National Labor Relations Board general counsel listed 152 such cases, 52 of which were placed on hold in appellate court proceedings, as The National Law Journalreported.
What it means: This decision means employers are permitted to use arbitration clauses to bar employees from joining together in litigation over workplace complaints, as The New York Times reported.
The dissent: Justice Ruth Bader Ginsburg decried the narrow majority's decision as "egregiously wrong," calling on Congress to change the law to protect workers' rights.
In addition to the Epic case, the decision applied also to cases involving Ernst & Young and Murphy Oil USA.
Winners 'have unlocked some important secrets' in getting the most out of their physician assistants, the AAPA head said.
The way eight hospitals and health systems treat their physician assistants has earned them Employer of Excellence Awards from a national PA advocacy group.
The American Academy of PAs' (AAPA) Center for Healthcare Leadership and Management (CHLM) announced the winners Monday, during the group's annual conference in New Orleans. This is the first year for these awards.
"These eight hospitals and health systems have unlocked some important secrets to maximize the value of PAs to their organizations and their patients," said AAPA CEO Jenna Dorn in a statement. "PA-positive environments create a win-win situation for PAs and for employers."
The eight 2018-2019 winners are as follows:
Brigham Health – Brigham and Women's Hospital – Boston
The Cleveland Clinic – Cleveland
El Centro Family Health – Taos, New Mexico
Hospital for Special Surgery – New York
MidMichigan Health – Midland, Michigan
NYU Langone Health – New York
Seattle Cancer Care Alliance – Seattle
Wake Forest Baptist Health – Winston-Salem, North Carolina
The winners will each receive a package that includes public recognition of the honor, a speaking engagement at the CHLM Executive Leadership Conference, an article on the AAPA and CHLM websites, a communications and marketing toolkit to help the organization promote itself as an award winner, and more.
Winners were selected based on how well they exhibited five drivers of PA retention and engagement, the AAPA said: (1) fostering a positive and supportive work environment, (2) effectively managing conflict, (3) giving PAs opportunities to provide meaningful imput, (4) communicating in a way that keeps PAs in the loop, and (5) leading in a way that seeks to involve PAs in efforts to improve quality of care.
Applications for the 2019-2020 cycle are due this fall.
Thirteen committee members had resigned earlier in the week in protest of the organization's regional management, calling for the ouster of four divisional leaders by name. The mass resignation left just four physicians on the committee, according to a system spokesperson.
Regardless, the board released a post-meeting statement backing the current slate of administrators.
"We fully support the leadership of CHI St. Alexius Health as it continues to provide quality care and a viable health care facility for the future," the board said.
Problem solvers: To settle on a course of action moving forward, in light of the concerns raised, the board created a nine-member working subcommittee with representatives from the board, the medical executive committee, and the CHI administration, according to the board's statement.
Expression of gratitude: The board's statement acknowledged that "some members" of the medical executive committee had resigned, without indicating how many left or remained. "We respect their decision and thank them for their service," the statement said.
Functions continue: The statement emphasized that the physicians who resigned from the committee continue to treat patients and that the committee "continues to function with the prior members who did not resign." The remaining members will work to replace their colleagues who resigned, the statement said.
Keep the geography in mind: The doctors who resigned had sought to have the division office moved about 200 miles, from its current location in Fargo to Bismarck, where CHI St. Alexius Health operates. "We need administrators and physicians working side by side, as a team," they wrote.
Below is the full statement released by the CHI St. Alexius Health board of directors:
"We have created a nine-person working subcommittee that will be comprised of members of the Board of Directors, members of the Medical Executive Committee and CHI administration to engage in dialogue to work through the issues before us and determine next steps. We fully support the leadership of CHI St. Alexius Health as it continues to provide quality care and a viable health care facility for the future.
"We acknowledge that some members of the Medical Executive Committee resigned from the committee earlier this week. We respect their decision and thank them for their service. Importantly, we want the community to know that these physicians continue to treat patients at CHI St. Alexius Health. The Medical Executive Committee continues to function with the prior members who did not resign. The remaining MEC members will identify additional physicians to serve as department chairs and section chiefs to replace those physicians who have resigned.
"We know that transitions present challenges but working together we will continue our work for a strong future as we meet the needs of our patients and the community in a rapidly changing environment while our hard working, caring and dedicated staff and employees continue to provide quality care to our patients."
