The partnership would affiliate stand-alone Boca Regional with the 10-hospital Baptist system, which is a dominant health system in South Florida.
Miami-based Baptist Health South Florida and Boca Raton Regional Hospital have signed a letter of intent to pursue a strategic partnership, the two health systems said Monday in a joint media release.
Baptist Health South Florida CEO and President Brian Keeley said the two health systems are completing due diligence now, and expect to have a definitive agreement in place early next year to finalize the affiliation by next summer.
“Like Baptist Health, Boca Raton Regional Hospital is a top-ranked organization with a not-for-profit mission and commitment to providing high-quality compassionate care," Keeley said. "We are confident that the synergies between our organizations will allow us to better serve our communities and increase access to affordable, high quality care for our patients."
Boca Raton Regional Hospital is a 400-bed, tertiary medical center with more than 2,800 employees and more than 800 primary and specialty physicians on staff. The hospital began looking for a partner last year and in July announced that it would negotiate with Baptist Health out of 12 prospective partners.
"Our goal was to use our success in recent years to attract other providers and establish a partnership that would enhance our capabilities and mitigate the challenges of a stand-alone hospital in a complex and evolving healthcare industry," said Jerry Fedele, president and CEO of Boca Raton Regional.
Keeley said the partnership makes sense at a time when Baptist Health expands its regional footprint.
"As Baptist Health has grown in recent years to meet the needs of our communities, we have clearly defined our service area as being from Palm Beach County down to the Florida Keys," Keeley said. "Boca Raton Regional Hospital will be a strong complement to the services we offer at Bethesda Hospital East and Bethesda Hospital West, along with our outpatient centers in the area."
Christine E. Lynn, Boca Raton Regional Hospital Board Chair Christine E. Lynn said the partnership "will serve to secure both our goals and objectives and those of Baptist Health South Florida."
"We have now advanced closer to a most important evolution for our hospital, one that will accelerate and elevate our position as a preeminent academic regional referral medical center," Lynn said.
Baptist Health South Florida is the largest health system in the region, and includes 10 hospitals, more than 40 physician practices, 50 outpatient and urgent care centers, more than 19,500 employees and more than 3,000 affiliated physicians.
The nine-member group wants Congress to protect consumers from excessive out-of-network charges and require provider transparency on treatment options and costs.
Healthcare makes for strange bedfellows.
A motley group of health insurance, business, and consumer protection organizations have formed a broad coalition against surprise medical bills.
"Every American deserves affordable, high-quality coverage and care, as well as control over their own healthcare choices," the nine organizations, which include America's Health Insurance Plans, Families USA, and the National Retail Federation, said Monday in a joint media release.
Federal laws are needed to protect patients from surprise medical bills.
Patients should be told when their services are out of network, and they have a right to know about the costs of their treatment and options.
Federal laws and policies designed to protect patients against surprise medical bills should not simultaneously raise premiums or care costs for consumers.
Out-of-network payments for physicians should be based on a federal standard, especially for the more than 100 million people enrolled in self-funded health plans.
The coalition cited a recent poll from Kaiser Family Foundation which found that one in 10 insured adults said they received a surprise medical bill from an out-of-network provider in the past year.
"Patients who are doing the right thing, going to in-network hospitals, often are surprised when doctors or hospitals send them large, unexpected bills," said coalition member Annette Guarisco Fildes, president/CEO, The ERISA Industry Committee.
"Companies that sponsor health plans for their employees believe that it is imperative that we protect patients from these bills, and that we do so by eliminating the bills—not forcing someone else to pay, rewarding providers who want to charge without regard to networks, contracts or patient care," she said.
Other members of the coalition include: American Benefits Council, Blue Cross Blue Shield Association, Consumers Union, National Association of Health Underwriters, and National Business Group on Health.
"Surprise bills are an unnecessary outrage presented to families at the worst of times," said Neil Trautwein, with the National Retail Federation. "The solution to surprise billing is not to shift the bills to employers or insurers. That will only increase costs for the families we cover, a fresh outrage no one can afford."
Legislation addressing surprise billing may be one of the few issues that has support from both sides of the aisle in what is expected to be a deeply divided Congress next year.
Members of the bipartisan Senate health care price transparency working group in September released draft legislation that they said was "intended to jumpstart discussions in Congress about how to best stop the use of balanced billing to charge patients for emergency treatment or treatment provided by an out-of-network provider at an in-network facility."
"Patients should have the power, even in emergency situations when they are unable to negotiate," said Sen. Bill Cassidy, R-LA, a physician and member of the working group.
"Our proposal protects patients in those emergency situations where current law does not, so that they don't receive a surprise bill that is basically uncapped by anything but a sense of shame."
Providers Blame Coverage Gaps
On the provider side, American Hospital Association President and CEO Rick Pollack and the Federation of American Hospitals President and CEO Chip Kahn issued a joint statement Monday insisting that hospitals, patients, insurers and employers agree that "a common ground solution" is needed to eliminate surprise bills.
However, the two hospital association leaders said the blame falls on health insurers.
"Inadequate health plan provider networks that limit patient access to emergency care is one of the root causes of surprise bills. Patients should be confident that they can seek immediate lifesaving care at any hospital," they said. "The hospital community wants to ensure that patients are protected from surprise gaps in coverage that result in surprise bills, and we look forward to working with policymakers to achieve this goal."
Earlier this month, the AHA and the American Medical Association this month joined with AHIP to produce a consumer guide against surprise billing, and those groups are urging hospitals and other providers to make the guides available to their patients.
Prosecutors allege the Johnson & Johnson subsidiary used a charity as a funnel to pay Medicare patients' copays for pulmonary arterial hypertension drugs.
Actelion Pharmaceuticals US, Inc. will pay $360 million to resolve claims that it illegally paid the copays of thousands of Medicare patients who used the drug maker's hypertension drugs, the Justice Department announced.
Federal prosecutors said the San Francisco-based Actelion usedCaring Voice Coalition Inc., a tax-exempt patient financial assistance charity as an illegal conduit to pay the copays for a number of expensive pulmonary arterial hypertension drugs, including Tracleer, Ventavis, Veletri, and Opsumit.
The illegal copays induce Medicare patients to buy the drugs that would be otherwise unaffordable.
The Anti-Kickback Statute bans drug makers from payment in any form to induce Medicare patients to purchase the company's drugs.
This week's settlement is the third time in the past year that a drug maker has been caught using charities to skirt anti-kickback laws.
In December, 2017, United Therapeutics Corp. agreed to pay $210 million to resolve claims that it used a foundation to pay the copays of Medicare patients taking UT’s pulmonary arterial hypertension drugs. Pfizer paid $24 million in Aprilto settle similar allegations.
"This settlement, like prior settlements concerning similar misconduct, makes clear that the government will hold accountable companies that pay illegal kickbacks," DOJ Civil Division Assistant Attorney General Jody Hunt said in a media release.
"Pharmaceutical companies cannot increase drug prices while engaging in conduct designed to defeat mechanisms put in place to check such prices and then expect Medicare to pay for the ballooning costs," Hunt said.
Actelion spokesperson Caroline Pavis on Thursday issued a brief statement noting that the allegations occurred before the company was acquired by Johnson & Johnson in 2017, and that the company is "committed to full compliance with all laws and regulations in our work to help patients get the medicines they need."
According to DOJ, from 2014 to 2015, Actelion made donations to Caring Voice Coalition, which used the money to pay copays of patients for the drugs. During the time covered in the settlement, prosecutors said Actelion raised the price of Tracleer by nearly 30 times the rate of inflation in the United States.
Actelion routinely obtained data from CVC detailing how much it had spent for patients on each drug, and then used the information to decide how much to donate to the foundation and to confirm that its contributions were sufficient to cover the copays of only patients taking Actelion's drugs.
Prosecutors said Actelion also would not allow Medicare patients to participate in its free drug program for financially needy patients, even if the Medicare patients couldn't afford the copays.
Instead, Actelion allegedly referred Medicare patients to CVC, which paid the copays, allowing the claims to be paid for by Medicare.
Actelion continued to do this even after CVC warned the company about the impropriety, DOJ said.
CVC's website published a notice last January that it would no longer offer financial assistance for drug copays.
Greg Smiley, CEO of Richmond, VA-based CVC, told HealthLeaders that the charity "cannot comment on ongoing legal matters."
"Still, we know people throughout the U.S. continue to struggle with healthcare costs and access," Smiley said.
"Although CVC is no longer providing financial assistance to patients for therapies, we continue to help as many patients as we can navigate challenges within the health care system.”
John O'Brien, a pharmacist with experience in the private sector and government, will serve as HHS' point man on drug pricing policy. He replaces Dan Best, who died unexpectedly last month.
Pharmacist and veteran drug policy expert John O'Brien has been named Senior Advisor to the Secretary for Drug Pricing Reform, Health and Human Services Secretary Alex Azar announced Thursday.
Previously, O'Brien was Azar's advisor for health reform and drug pricing, and deputy assistant secretary for health policy in HHS's Office of the Assistant Secretary for Planning and Evaluation.
"John O'Brien has already been an integral leader in HHS's efforts to bring down the high price of prescription drugs," Azar said in a media release.
"As a senior advisor, he will carry forward the legacy of our departed colleague Dan Best and build on the substantial progress that has already been made. John will continue to play an important role in our overall efforts to deliver Americans better, more affordable healthcare," Azar said.
Before joining HHS, O'Brien, was vice president of public policy for CareFirst BlueCross BlueShield. He has also worked at the Centers for Medicare & Medicaid Services, the Notre Dame of Maryland University College of Pharmacy, and other pharmaceutical organizations.
O'Brien has a master's degree in public health from the Johns Hopkins Bloomberg School of Public Health, a doctor of pharmacy degree from Nova Southeastern University, and studied pharmacy and public policy at the University of Florida.
Addressing rising drug prices has been a key issue for the Trump Administration, and Congress, and it is expected to gain even more attention over the next two years in the run-up to the 2020 election.
The former president of Eli Lilly & Co., Azar has floated a number of proposals, including: allowing Medicare Part D plans greater leeway to decline to cover certain protected-class drugs beginning in 2020;eliminating drug rebates; mandatory transparency in drug pricing; and linking Medicare Part B drug prices to an international index.
Although Azar has touting an aggressive agenda on drug pricing, he hasn't acted on it, and observers note he is careful not to get too far in front of President Donald Trump.
At this point, it's not clear if HHS will act on these initiatives or if they're merely well-vetted window dressing.
There's a lot of talk about the potential for personalized medicine to lower drug costs.
Genetic testing has been around for a few years, and it's being used to customize drug regimens for patients by better understanding how patients metabolize drugs. But proponents of individualized medicine are urging patience.
Konstantinos Lazaridis, MD, associate director of the Mayo Clinic's Center for Individualized Medicine in Rochester, Minnesota, says that genetic testing is readily available and relatively inexpensive, costing between $300 and $400 per patient, although it's not yet covered by insurance.
"It provides information about how you metabolize more than 300 medications that are commonly used in practice," Lazaridis says. "What we have not proven is whether this reduces costs, and it will take some time to do that because it requires testing a lot of people to prove the financial benefit."
"The other thing is that it doesn't give you information from every medication that is out in the market," he says. "There are some medications that are very expensive, such as medications used in oncology. This testing is not going to give you the answer, because it doesn't have a way to address the metabolism."
Another problem for genetic testing is that most clinicians wouldn't know how to interpret the results, "so they'll feel uncomfortable using the test."
Beyond that, advocates for genetic testing have not done a good job integrating the testing and results into the providers' workflow.
"It needs to be streamlined and, to be frank, we're working on it but we don't have a solution, because it's not an easy answer," Lazaridis says.
"If the interpretation and incorporation of testing into the practice is very cumbersome, nobody's going to use it. If something takes a lot of time to explain to the patient or to prescribe the right dose, nobody's going to use it," he says.
Lazaridis says genetic testing has value, but that stakeholders need to prove their point.
"We need to show that it improves the outcomes for medications," he says, "and we have to prove that we saved dollars, that we reduce readmissions, that our treatments become more effective so people don't come back with the same problem."
The one-two punch of exorbitant prices and sketchy access to inpatient drugs have left hospitals across the nation reeling. The shortages are often accompanied by dramatic price hikes. Sometimes the supply is readily available, but the price is prohibitively high, as is often the case when sole suppliers leverage their monopolies.
There's been a lot of talk around solutions at the macro-economic level, from calls for regulatory crackdown on price gouging, to more robust and timely reporting requirements for looming shortages, to modernizing the drug supply infrastructure.
What can hospital executives and clinicians do inside their hospital walls to tackle rising costs and inconsistent supplies? HealthLeaders spoke with pharmacy directors at three health systems who are grappling with these twin issues.
Successful systems communicate the extent and cost of the problem with their clinical and administrative stakeholders and methodically monitor medication usage every day on a patient-by-patient, dosage-by-dosage basis. It's not easy, and it's not glitzy, but it gets results.
Do it yourself
"The drug shortages of the last few years have been unprecedented," says Bob Ripley, chief pharmacy officer at Livonia, Michigan–based Trinity Health. "It is really beyond belief to walk in every day and hear about the next shortage and how are we going to manage that."
"Every hospital in our system has a different set of impacts," he says, "and they had to collaborate to use the resources they had and reconstruct care on a regular basis."
Ripley says the shortages for Trinity center around generic injectable medications that for years had been readily available from multiple vendors at reasonable prices.
"All of a sudden, we were not able to access basic medications that we need," he says. "We're not able on a regular basis to access electrolytes, or opiate injections for acute pain management."
Lou Fierens, Trinity's executive vice president of administrative services, says drug shortages also create a "shadow cost" for hospitals.
"It's not just the price hikes when you're trying to find something in shortage on the gray market or through other means," he says. "It's clinical leaders talking about, 'What are we going to do now? What have we got left? What's the new protocol?' It's the clinical implications. For providers, this shadow cost of the shortage is acute, if not more acute, than the cost."
Tired of getting slapped around by the invisible hand of the free market, Trinity and six other health systems across the nation took matters into their own hands this past summer and formed Civica Rx, a not-for-profit drug company.
The seven health systems in the consortium each ponied up $10 million to form the Utah-based nonprofit, and got another $30 million in backing from three endowments. Civica is expected to begin supplying drugs to its members sometime in 2019.
"Civica itself is a Delaware non-stock, nonprofit corporation. There is no equity in the company. We are funding the initial operations capital. Nobody owns it," says Fierens, who is Trinity's point man on the project.
"We very much structured this intentionally," he says. "The misbehavior of the market, the monopoly characteristics of the market, are the sorts of pressures that no one is immune to, in terms of wanting to make a margin and a profit."
"We felt like it would be important for this to be a long-serving asset to society, that we structured it in a way to avoid those temptations," he says.
Civica will focus on 14 pharmaceuticals that have been susceptible to price hikes, supply problems, or both. Fierens won't say what those products are.
"It's proprietary," he says. "There are concerns about market reactions, tying up critical agents, and some of the same monopolistic behavior we've seen in the market that we don't want to encourage."
"The vast majority of the reasons why these shortages exist are not natural causes," he says. "We're acutely aware of those causes and the motivations, and we want to avoid that."
With a target date to begin distribution in 2019, Fierens says Civica will likely contract out most, if not all, of its pharmaceuticals at first, but will likely begin manufacturing its own products as the company rolls out.
"Where we go in the future will be determined by the board as we evolve the business case and grow the company," he says.
The consortium is open-ended, Fierens says, and Civica is looking at various membership structures so "every hospital can participate."
"We're going to end up in a per-bed fee structure that we'll be rolling out, which will be a very reasonable membership fee," he says.
"As a member, you'll have the opportunity to commit your volume to any of the products we manufacture as a guaranteed source of supply, with no concern about shortages, at what we think will be a very reasonable cost," he says.
The consortium will also provide opportunities to participate for critical access hospitals and other low-volume or safety-net providers that may not be able to afford standard membership fees. "We'll be available to anyone who wants to participate, and based on early interest, we think there will be a lot of providers across the country," Fierens says.
That the Civica consortium represents diverse health systems from across the nation—public, private, for-profit, not-for-profit, faith-based—is a measure of both the scope of the problem, and the common commitment to build a solution, Fierens says.
"I can't think of another thing that would have brought this mix of characters together," he says. "We've tried as a health system, and me personally, to get things done across the industry, across providers, and it's really hard to do so. But this concept has been so favorably embraced. It reinforces that we're on the right track."
Grind out savings
Other than creating their own drug company, what can hospitals do to alleviate the growing burden of drug price hikes and scarcity?
Andrew J. Donnelly, PharmD, director of pharmacy services at the University of Illinois Hospital & Health Sciences System, uses commonsense, hands-on tactics identified by the health system's Pharmacy Value Analysis Committee that have wrung out about $3 million in drug savings over the past five years.
The committee, composed of clinical pharmacists, administrators, and materials managers, scour drug usage reports, and look for fluctuations and waste. They're constantly reading the literature on cheaper biosimilars and other lower-cost alternatives.
"I have 22 clinical pharmacists for the hospital, and they spend the majority of their time in patient care units or care services," Donnelly says. "They're rounding with the medical teams daily. They're being proactive in identifying the appropriate medicines in the appropriate doses. They're trying to make sure that we're as cost-effective as possible, that we aren't wasting, and that our patients are getting the best medications."
These savings often come one patient at a time, but they add up. It might be something as simple as keeping a lower inventory of higher-priced drugs, or using smaller IV infusion bags.
"We see how much the patient gets and we find out if they ever get more than half the quantity that we're sending upstairs," Donnelly says. "We can reduce the amount of the drug and the size of the infusion bag to more accurately match what the patient is using on a routine basis."
"Either by examining patients' medication usage, by doing various audits, or by examining the types and amounts of drugs that are being returned to our central pharmacy, we can oftentimes identify opportunities to change the way we're providing certain medications," he says.
The Pharmacy Value Analysis Committee also keeps close tabs on generic alternatives.
"We're taking advantage of biosimilars that are hitting the market right now," Donnelly says. "We switched from Neupogen to Zarxio, and we saved about $175,000 annually."
Another solution, dose rounding, isn't flashy or cutting-edge, but it works.
"On intravenous immune globulin, for example, we do dose rounding so that if we only need a little bit in another vial, we drop the dose down and make sure that is appropriate," Donnelly says. "You don't waste almost a full bottle when you only take a little bit out of it."
On some medications, UI Health pharmacists will prepack smaller doses from a vial. "We take a 2 mg vial of remifentanil and we prepare 50-microgram syringes out of that 2 mg vial, thereby eliminating waste," Donnelly says.
UI Health's central pharmacy compares prices of commercially prepared infusion bags versus the cost of compounding the product in-house.
"There was a commercially available nicardipine bag but we were able to save almost $300,000 by making it ourselves," Donnelly says. "You have to weigh the benefits of having it already made against the cost. In this instance, there was quite a difference that we could make up in-house."
UI Health also pushes clinicians to provide pharmaceuticals in the appropriate setting.
"An example would be infliximab, which is routinely administered for irritable bowel disease as an infusion on the outpatient side," Donnelly says. "We do not allow new starts for infliximab in the hospital. The patient has to be discharged. We've been able to save money by making sure it's appropriate for the medication to be started in the appropriate venue."
Anyone looking to UI Health for a magic-bullet solution to runaway drug costs and iffy supply chains may come away disappointed. The upside, Donnelly says, is that the meticulous, grinding, daily hunt for drug efficiencies at UI Health is something that many hospitals can replicate.
"Most of the things I've described could be done in a community hospital or an academic medical center," says Donnelly. "Given the issues occurring now, we're all just trying to be as effective as possible, focusing our attention, and putting enough people toward it to be successful."
Involve your clinicians
Bonnie Levin, corporate vice president for pharmacy services at MedStar Health, says pharmacists and clinicians at the Washington, D.C.–based health system use a number of strategies to contain drug costs and maintain supplies.
"There are several buckets that we use," Levin says. "Probably the most sophisticated would be utilization; working with our doctors, nurses, and IT folks to impact the way we use drugs; using less drugs, using a different drug, using it for a shorter amount of time, adjusting for patient variables that use less drugs."
"From a utilization perspective, we try to do antibiotic stewardship using less drug, using the right drug and using it for a shorter amount of time, or not using it at all," Levin says.
Two years ago, MedStar launched a medication use management program with a dedicated staff that included two pharmacists and a systems analyst.
"They work collaboratively with physicians and pharmacists using our electronic records so that we can impact the way drugs are used to make them less expensive, and it always works out safer," Levin says. "The great thing about these kinds of programs is that, if you do the right thing with medication, it's almost always less expensive and definitely safer."
The program constantly monitors adverse events to ensure patient safety.
"We look to see how patients react to the medication. We make sure that kidney and liver function aren't impacted," Levin says. "On the positive side, for antibiotics, we make sure that the temperature comes down, the cultures are good. We monitor whatever elements there are for that drug, looking for efficacy and adverse events."
The program is demanding, requires open and ongoing collaboration across the care continuum, and must be applied meticulously on a patient-by-patient basis.
"We put out these clinical practice guidelines after a lot of consultation and collaboration and a technology build," Levin says. "Then we provide our pharmacists and physicians with these standards. It's a journey. I can't say that we are at 100%, but every day we get better."
Physician acceptance for the initiative was achieved over time through clinical practice councils that represent all specialties.
A medication use management initiative typically starts with the pharmacy, but it also starts with the physicians who say, "We need guidelines for X,' " Levin says. "We evaluate the literature—that is the role of the drug information specialists and the drug policy person—and we look at the evidence. We come up with recommendations, and then we work with the provider groups to endorse it. It's collaborative
back-and-forth."
It works, Levin says, because physicians know they have a voice in the process.
"People revere what they're part of," she says. "Yes, there are some doctors who say, 'Don't mess with my job.' But for the most part there is a lot of collaboration, and as long as they approve it, it's easier to implement it."
As for return on investment, Levin says internal analysis suggests that the program saves between $8 and $10 for every $1 invested.
"It's an ongoing investment and it takes a whole lot of time, but it gets easier over time," Levin says. "We've been in the game a couple years now, and the clinical practice councils come to us and say, 'We want to do a guideline on this new drug. Will you help us?'"
Ev3 Inc. will plead guilty to criminal misdemeanor charges and pay $17.9 million for distributing adulterated devices; Covidien LP has paid $13 million to resolve civil kickback allegations for a second device.
Minnesota-based ev3 Inc. will pay the federal government $17.9 million to settle criminal allegations that it distributed an adulterated neurovascular medical device, the Department of Justice said.
Also this week, Covidien LP, paid $13 million to resolve civil False Claims Act allegations in a whistleblower suit that alleges the device maker paid kickbacks to hospitals that used its Solitaire mechanical thrombectomy device, DOJ said.
Both companies are subsidiaries of Medtronic, which acquired them in 2015, after the alleged infractions occurred.
"The Department of Justice will hold corporations accountable when they violate laws designed to protect consumers and protect public funds," said Assistant Attorney General Jody Hunt of the DOJ's Civil Division. "This resolution demonstrates the department's continued commitment to protect taxpayer dollars and deter companies from putting profits before patient safety."
In documents filed this week in a Massachusetts federal court, ev3 will plead guilty to a misdemeanor charge in connection with the company’s distribution of adulterated Onyx, in violation of the Food, Drug and Cosmetic Act.
As part of the criminal resolution, ev3 will pay a fine of $11.9 million and will forfeit $6 million, DOJ said.
Onyx was approved by the Food and Drug Administration as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations inside the brain.
Despite the FDA's limited approval of Onyx, ev3 sales representatives from 2005 through 2009 encouraged surgeons to use Onyx in large quantities for unproven and potentially dangerous surgical uses outside the brain.
"The company's sales force continued to tout unapproved and potentially dangerous uses of Onyx even after FDA officials told ev3 executives that they had specific safety concerns regarding uses of Onyx outside the brain at a 2008 meeting," DOJ said.
"Rather than conduct a study to ensure the safety and effectiveness of Onyx for uses outside the brain, ev3's sales representatives sometimes attended surgical procedures and provided explicit instructions to surgeons regarding how to use Onyx for unapproved surgical procedures outside the brain, including in quantities far larger than what would be used in the brain," DOJ said.
In addition, ev3's management used sales quotas and bonuses that incentivized sales representatives to sell Onyx for unapproved uses and trained the sales force how to instruct physicians on unapproved uses of the device, DOJ said.
"Ev3 disregarded laws designed to protect patient safety," said U.S. Attorney Andrew E. Lelling for the District of Massachusetts.
Covidien acquired ev3 in 2010, before the crimes covered in the plea agreement. Covidien was acquired by Medtronic in 2015.
Covidien Paid Kickbacks
Covidien separately will pay $13 million to resolve its civil liability for allegedly paying kickbacks to induce the use of its Solitaire mechanical thrombectomy device, which is designed to restore blood flow and retrieve a blood clot in certain stroke patients.
Federal prosecutors alleged that Covidien paid kickbacks to hospitals to induce them to use the Solitaire device, and thus file false claims to Medicare to pay for the device.
After receiving FDA clearance for Solitaire, Covidien launched a registry to pay hospitals and institutions to collect data about user experiences with the device. For two years, beginning in August 2014, Covidien paid hospitals that participated in a registry each time they used a new Solitaire device and reported certain clinical data about their practices for treating stroke patients to Covidien.
Prosecutors allege that Covidien solicited hospitals for the registry in order to convert their business from the competitor's product and persuade them to continue using Covidien products, using the registry to increase device sales.
"As part of an aggressive marketing campaign for its medical device, Covidien allegedly found a way to subsidize facilities that agreed to use its product—often convincing them not to use devices sold by another manufacturer," said U.S. Attorney Nicola T. Hanna for the Central District of California.
"Patients deserve to know that their medical providers are offering the best possible treatments and are not making decisions based on increasing the bottom line for healthcare providers," Hanna said.
The whistleblower in the lawsuit, Jeffrey Faatz, worked for Covidien from 2012 to 2014, and will receive $2 million from the settlement.
Medtronic Responds
Medtronic issued a statement noting that: "The plea agreement and settlements that the Medtronic entities agreed to all concern matters that took place either largely or entirely prior to Medtronic acquiring the businesses in which the activities took place."
"Medtronic has made significant investments in ensuring that it fulfills its obligations to all of its stakeholders and to do business the right way."
Medtronic also agreed to conduct compliance monitoring related to the Onyx sales.
The award is based on several metrics, including; preventing infections, reducing C-sections, use of technology to ensure safer care, and leadership policies and practices.
Florida, California, New Jersey and Texas had strong showings in The Leapfrog Group's 2018 Top Hospitals awards, with 13 or more hospitals in each of those three states earning the distinction.
Of the 118 Top Hospitals recognized in 23 states and the District of Columbia, 13 were children's hospitals, 35 were general hospitals, 53 were teaching hospitals and 17 were rural hospitals.
"We’re encouraged by the hard work of Top Hospitals, as well as all of the hospitals that compete for this award said Leah Binder, president and CEO of The Leapfrog Group. "Their transparency and determination delivers the best possible care in their communities."
The five states with the most Top Hospitals are: Florida (18); California (17); Texas (13); New Jersey (12); and Pennsylvania (8). Only one hospital in New York made the list.
The award is based on several quality metrics, including; preventing infections, reducing C-sections, use of technology to ensure safer care, and leadership policies and practices.
In addition, The Leapfrog Hospital Survey compares hospitals' performance on national standards of patient safety, quality, efficiency and management structures that prevent errors, which nonprofit The Leapfrog Group says provides a comprehensive picture of how patients fare at individual hospitals.
Leapfrog's Top Hospitals are not listed by rank, unlike other popular hospital rankings such as U.S. News & World Report's Best Hospitals rankings. In fact, top hospitals on one list are often not found on the other, owing largely to the use of different metrics.
The 119-page report is a rehash of ongoing administration efforts to deregulate the healthcare industry with the hope of fostering competition and lowering prices.
The Trump administration unveiled its blueprint Monday for reforming the nation's healthcare delivery system through freemarket principles and deregulation to encourage competition and consumer choice.
"This report identifies barriers on the federal and state levels to market competition that stifle innovation, lead to higher prices, and do not incentivize improvements in quality," the report's coauthors, Labor Secretary Alexander Acosta, Treasury Secretary Steven Mnuchin, and Health and Human Services Secretary Alex Azar, wrote in an introductory letter to President Donald Trump.
"It recommends policies that will foster a healthcare system that delivers high-quality care at affordable prices through greater choice, competition, and consumer-directed health care spending," the trio wrote.
Among the report's recommendations:
Foster policies that broaden providers' scope of practice and healthcare workforce mobility, including telehealth.
Streamline federal funding for graduate medical education to more efficiently address physician supply shortages.
Urge states to scale back or repeal Certificate of Need laws to encourage competition.
Encourage the development of flexible value-based care models that offer risk-based incentives for providers, without burdening small or rural practices.
Scale back government mandates on health insurance coverage.
Promote and expand Health Saving Accounts.
Implement reference pricing, and develop price transparency initiatives.
The top performing hospital in 2019 will receive a 3.6% net increase, and the lowest performing hospital will incur a net decrease of 1.59%.
More than half of the 2,800 hospitals participating in Medicare's Value-Based Purchasing Program will get more money in 2019, thanks to higher Total Performance Scores, the Centers for Medicare & Medicaid Services announced.
"This program is part of our long-standing effort to improve care across the entire healthcare delivery system, including hospital inpatient care, by tying Medicare payment to quality and cost measure performance," CMS said.
In total, more than 1,550 hospitals (over 55%) will share higher Medicare payments totaling about $1.9 billion in fiscal year 2019, the seventh year of the Hospital VBP Program, CMS said.
For FY 2019, almost 60% of hospitals will see a small change (between -0.5% and 0.5%) in their IPPS payments. The average net payment adjustment is 0.17%. The average net increase in payment adjustments is 0.61%, and the average net decrease in payment adjustments is -0.39%, CMS said.
The highest performing hospital in FY 2019 will receive a net increase in IPPS payments of 3.67%, and the lowest performing hospital will incur a net decrease in IPPS payments of 1.59%.
The Inpatient Prospective Payment System value-based incentives are based upon how the hospitals performed when compared with peer hospitals on quality and cost metrics, and how much they've improved care quality over time.
TheTotal Performance Score for each hospital is based equally on four measures; clinical care, safety, person and community engagement, and efficiency and cost reduction.
The value-based program is budget neutral, and CMS pays for it by cutting a portion of the base operating Diagnosis-Related Group payment amounts a participating hospital receives for each discharge by 2%. The estimated sum total of these reductions, $1.9 billion in FY 2019, is redistributed to participating hospitals based on their performance on quality and cost measures.
For FY 2019, the average TPS across all participating hospitals increased to 38.1 from 37.4 in 2018.
On average, rural hospitals performed better in the Safety, Person and Community Engagement, and Efficiency and Cost Reduction domains, while urban hospitals performed well in the Clinical Care domain.
For FY 2019, the average TPS across all rural hospitals of 42.4 was greater than the national average TPS. Similarly, smaller hospitals performed better in the Safety, Person and Community Engagement, and Efficiency and Cost Reduction domains, as well as overall TPS, while urban hospitals performed well in the Clinical Care domain.