Without insurance coverage, out-of-pocket costs for the drug will average about $26,500 per patient per year.
With the Food and Drug Administration granting fast-track approval on Friday of Eisai/Biogen's new Alzheimer's drug Leqembi, stakeholders are now urging the Centers for Medicare & Medicaid Services to follow suit and cover the pricey treatment.
The Alzheimer's Association called the FDA approval of the new drug for patients with mild cognitive impairment or in the early stages of Alzheimer's disease "a milestone achievement" for patients and their families. However, they warn that the cost of the drug – about $26,500 annually -- will limit access for many of the 6.5 million people in the United States who suffer from the disease. The advocates are pressing CMS to cover the costs.
"What the FDA did today in granting accelerated approval to Leqembi was the right decision. But what CMS is doing by severely restricting coverage for approved treatments is unprecedented and wrong," Alzheimer's Association CEO/President Joanne Pike, DrPH says.
"The FDA carefully reviewed the evidence for Leqembi before granting approval. CMS, in sharp contrast, denied coverage for Leqembi months ago before it had even reviewed this drug's evidence."
"CMS has never done this before for any drug, and it is clearly harmful and unfair to those with Alzheimer's," Pike says. "Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months — memories, skills, and independence. They're losing time."
CMS Administrator Chiquita Brooks-LaSure says the jury is still out on the efficacy of Leqembi, which has shown moderate success during clinical trials.
"We will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes," Brooks-LaSure says.
FDA Approval
The FDA used its Accelerated Approval pathway to approve Leqembi (lecanemab-irmb) saying the drug, which reduces the beta amyloid clumps linked to Alzheimer's, "represents an important advancement in the ongoing fight to effectively treat Alzheimer's disease."
Billy Dunn, MD, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, called the treatment "the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease."
The FDA approval follows clinical research that included a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer's disease (three of whom died during the trial, although it's not clear if the drug played a role), and which showed a 27% reduction in cognitive decline over 19 months among patients receiving the 10 milligram/kilogram intravenous dose of the drug every two weeks, when compared with those who received the placebo.
Upon learning Friday that the FDA had fast-tracked Leqembi, Eisai/Biogen immediately submitted a supplemental Biologics License Application to the agency for a traditional approval.
Costs
Leqembi is not cheap, which Tokyo-based Eisai and Cambridge, Mass-based Biogen acknowledge. However, the drugmakers cite an Alzheimer's Association estimate that Medicare, Medicaid, commercial payers and out-of-pocket spending would increase from $267 billion in 2020 to $451 billion in 2030 if no treatments exist to delay the disease.
With effective treatments, however, the drugmakers say they can reduce the average per-person cost of treating Alzheimer's patients from about $37,000 to $26,500 annually, and that the cost could be further reduced to about $15,000 a year for ongoing maintenance once the treatment is underway.
New research published in the Journal of the American Medical Association (JAMA) finds that telehealth was superior to in-person care in 11 of 16 quality performance measures for primary care.
The study, conducted by researchers at the Robert Graham Center in Washington DC and Pennsylvania-based Wellspan Health, focused on more than 526,000 patients receiving healthcare services at roughly 200 Wellspan Health outpatient sites between March 1, 2020, and November 30, 2021, and used HEDIS (Healthcare Effectiveness Data and Information Set) measurements.
UnitedHealthcare Inc. members logged more than 28 million virtual care visits in 2021, a 2,500% increase over pre-pandemic usage, the payer says.
"While the COVID-19 pandemic triggered an unprecedented spike in the number of virtual care visits, we are seeing that telehealth has staying power even as many people have returned to in-person appointments," UnitedHealthcare CMO Donna O'Shea, MD, tells HealthLeaders.
"Virtual care visits in 2021 by UnitedHealthcare members approximately matched the total for 2020, with continued significant use of telehealth so far in 2022."
Only 1,714 of the 742,000 providers who billed Medicare and Medicare Advantage for telehealth services for about 28 million beneficiaries during the first year of the pandemic "posed a high risk" to the program integrity, a federal audit shows.
Now the not-so-good news.
These high-risk providers represent only 0.2% of the audit sample, but they billed for about 500,000 beneficiaries and collected $127.7 million in Medicare fee-for-service payments for care provided between March 2020 and February 2021, according to an audit by the Department of Health and Human Services, Office of the Inspector General.
Congress is halfway toward extending telehealth flexibilities enacted during the pandemic until the end of 2024.
The US House of Representatives this week passed the Advancing Telehealth Beyond COVID-19 Act of 2021 (HR 4040) by a 416-12 vote, sending the issue on to the Senate. The bill, introduced more than a year ago by US Rep Liz Cheney (R-Wyoming), expands the definition of "originating site" to allow more locations to use telehealth, eliminates facility fees for new sites, expands the list of healthcare providers able to use telehealth, adds audio-only telehealth to the definition of "telecommunications system," and makes permanent the ability of federally-qualified health centers (FHQCs) and rural health clinics (RHCs) to use telehealth under the Medicare program.
Vermont’s governor has signed into law a bill amending the state’s assisted suicide statute to include telemedicine.
S.74, passed by the state House and Senate after an almost two-year process and signed by Gov. Phil Scott on April 27, amends the state’s medical aid in dying law, which was passed in 2013, allows a patient who meets specific criteria to request a prescription to aid in dying through telemedicine, eliminating the need for two in-person consults and a 48-hour waiting period. The bill also establishes legal immunity for licensed healthcare providers, including pharmacists.
The bill defines telemedicine for these purposes as an interactive audio-video platform that complies with the requirements of the Health Insurance Portability and Accountability Act (HIPAA).
Newly introduced bipartisan legislation to improve healthcare access for Medicare and Medicaid beneficiaries would expand authority for advanced practice RNs (APRNs) to treat those patients.
The legislation does not provide full practice authority (FPA) in all 50 states—individual states govern those guidelines—but it does reduce a number of federal barriers that impede access to care for millions who receive healthcare through Medicare and Medicaid. Read more here.
New York is the newest state to grant nurse practitioners (NPs) full practice authority, joining 24 other states and Washington, D.C.
New York Gov. Kathy Hochul signed the state budget into law on Saturday, that includes legislation that eliminates the requirement for NPs to have a written practice agreement with a physician and allows them to provide the full scope of services they are educated and clinically trained to provide. Read more here.
Hospital emergency departments have been under severe strain during the coronavirus pandemic, according to a pair of new research articles.
The new studies examine boarding of patients in emergency departments before they are moved to inpatient beds and patients who left without being seen (LWBS), the latter presumably because of ED crowding and long wait times. The Joint Commission has deemed extended boarding of patients in the ED as a patient safety risk, with boarding recommended not to exceed four hours. Relatively high LWBS rates can have significant negative consequences for patients if they are deferring care for acute conditions. Read more here.
Factors such as ability to grocery shop, whether and how often they smoked, and the amount of certain cholesterol particles present in their blood can help predict how likely an individual over 70 years old will live two, five, or 10 years into the future, researchers at Duke Health have found.
"This study was designed to determine the proximal causes of longevity—the factors that portend whether someone is likely to live two or more years or 10 more years," researcher Virginia Byers Kraus, MD, PhD, said in a statement. "Properly applied, these measures could help determine the benefits and burdens of screening tests and treatments for older people." Read more here.
A significant number of temporary nurse aides (TNAs) may lose their jobs Friday if the Center for Medicare and Medicaid Services (CMS) doesn’t reissue a blanket waiver.
The American Health Care Association (AHCA) and National Center for Assisted Living (NCAL) have asked the Center for Medicare and Medicaid Services (CMS) to reissue the blanket waiver originally intended to allow nursing homes to employ temporary nurse aides beginning during the pandemic.
TNAs handle non-clinical tasks, serving as companions for nursing home residents. In June, the section of the 1135 waiver permitting their employment ended, giving them four months to become certified nursing assistants (CNAs), which would allow them to remain at their facilities. Read more here.
A primary care clinic start-up is differentiating itself by staffing its facilities only with nurse practitioners (NPs).
Minneapolis-based The Good Clinic chain is designed to emphasize patient engagement, continuity of care, and an emphasis on wellness and convenience through a unique nurse practitioner-driven model, says Larry Diamond, CEO of Mitesco Inc., which operates The Good Clinic brand.
More than half of U.S. states—26 states, Washington, D.C., and two U.S. territories—have granted patients full and direct access to care by NPs in adopting Full Practice Authority (FPA), according to the American Association of Nurse Practitioners (AANP). Read more here.
UnitedHealth is the target of a lawsuit by Envision Healthcare and several other physician practices, who claim the country's largest health insurer engages in a nationwide practice of low reimbursement rates for providers to force them out of network.
In doing so, UnitedHealth is allegedly driving physicians to its subsidiary, Optum, and paying providers at rates lower than the company offered for in-network.
Once UnitedHealth forces providers out of network, it allegedly pays the provider less than its billed charges and then charges the patient's plan a commission or surcharge for the savings. UnitedHealth, however, has no intention of paying the billed charges for out-of-network services and denies entitlement to payment for those charges. Read more here.
The No Surprises Act may have the unintended effect of causing millions more emergency department (ED) visits, according to a study from the Agency for Healthcare Research and Quality.
Since going into effect on January 1, 2022, the federal ban protects patients from surprise bills for emergency services at out-of-network facilities or for out-of-network providers at in-network facilities.
The study, published in The American Journal of Medical Care, compares ED visits in 15 states with balance billing bans between 2007 and 2018 to ED visits in 16 states without bans to examine the ripple effects of a significant reduction in out-of-pocket payments under the No Surprises Act. Read more here.
Atrium Health—a Charlotte, North Carolina-based healthcare network with over 40 hospitals and $2 billion in net operating revenue—wants to turn its Harrisburg, North Carolina-based emergency room into a satellite hospital.
The health system submitted a "certificate of need" proposal to the Cabarrus County authorities for the $85.5 million expansion and is waiting on the state to approve the project.
"In an effort to bring high quality, convenient access to care to the residents of southern Cabarrus County that are already choosing AH Harrisburg for their health care needs, AH Cabarrus proposes to relocate 24 acute care beds and one operating room from its main campus to its existing Harrisburg hospital campus," Atrium said in a press release shared with HealthLeaders. "The proposed project also involves the replacement and relocation of an existing fixed MRI scanner to Atrium Health Harrisburg from Atrium Health MRI at its Concord Mills/Speedway location."
Additional inpatient, imaging, and surgical services will include 20 medical and surgical acute care beds, four ICU beds, a replacement CT scanner, a relocated and repaired MRI machine, fluoroscopy services, and the addition of a C-arm (a large, mobile imaging device) in the operating room.
The decision date for this project is set for the end of January. If approved, Atrium Health expects the satellite hospital to open on January 1, 2026. Read more here.
MA plans are under fire once again, this time with the introduction of new legislation that's aiming to take 'Medicare' out of the name.
The Save Medicare Act, sponsored by representatives Mark Pocan (D-Wis.) and Ro Khanna (D-Calif.), arrives just ahead of the open enrolment period, running from October 15 to December 7.
The bill would prohibit private insurers from using 'Medicare' in plan titles or advertising, and levy fines on payers that use the "deceptive practice."
"'Medicare Advantage' is just private insurance that profits by denying coverage and the name is being used to trick seniors into enrolling. That’s not right," Khanna said in a statement. "This bill will prevent these private insurers from labeling themselves as 'Medicare' and allow us to focus on strengthening and expanding real Medicare instead." Read more here.
The U.S. Department of Defense has awarded $136 billion for the "next generation" of TRICARE Managed Care Support Contracts that launch in 2024.
The T-5 MCS Contract maintains the requirement for two TRICARE regions in the United States – East and West. In addition, six states -- Arkansas, Illinois, Louisiana, Oklahoma, Texas, and Wisconsin with 1.5 million beneficiaries -- managed in the East Region will transfer to the West Region for a more equitable balance of the beneficiary population.
The $70.9 billion East Region T-5 MCS Contract was awarded to Humana Government Business of Louisville, KY. In the West Region the $65.1 billion T-5 MCS Contract was awarded to TriWest Healthcare Alliance of Phoenix, AZ. The new contracts will replace the T-2017 managed care contracts that provide care for the military and their dependents beginning in 2024.
"I am pleased that our new T-5 TRICARE contracts will continue to focus on enhancing the experience of care and great healthcare outcomes for our service members, retirees and their families," said Lt Gen. Ronald Place, director, Defense Health Agency.
The new contracts will continue to provide for the delivery of healthcare, customer service, claims processing and other administrative services to the estimated 9.6 million TRICARE beneficiaries. The new contracts do not change the TRICARE benefit and offer all the same TRICARE options.
"TRICARE is moving into a new era, making use of the lessons learned in the first three contract phases," Place says. "Defense Department leadership and the incumbent managed care support contractors are dedicated to managing a smooth transition to the new managed care support contractors, with minimum disruption to our beneficiaries."
The new contracts mandate improved integration between military medical facilities and the T-5 private sector care, with an emphasis on increasing interoperability with MHS GENESIS through Health Information Exchanges.
With T-5, beneficiaries can transfer care referrals when they move, whether their orders take them to a new duty station within their current region or to the other region. The DHA says that improving customer service also will be emphasized, with both regions required to reduce the average speed of answer calls to 20 seconds, matching general healthcare sector standards. In addition, the contract holders are mandated to improve call center resolutions and call backs, and first-call resolution requirements to align with industry standard for 85% of initial calls."
"We listened to our beneficiaries about what impacts their experience of care and address many of those concerns in T-5," Place says.
After the yearlong transition to T-5, military hospitals and clinics will have real-time access to medical management data, which increases data-sharing and promoting standardize care between civilian and military venues.
Blue Cross Blue Shield of Arizona says it will provide support for TriWest Healthcare Alliance’s new contract to administer the 26-state TRICARE West Region.
The U.S. Department of Defense's reconfigured "T-5" TRICARE program provides coverage for about active-duty service members, their families, National Guard and reserves and their families.
One bill would remove federal practice barriers for NPs. The other bill would restore collective bargaining rights for VA clinicians.
The nation's leading nursing associations are praising two bills advancing through Congress that would remove federal practice barriers for nurse practitioners and restore collective bargaining rights for nurses and other clinicians at the Department of Veterans Affairs.
ICAN Act
U.S. Sen. Jeff Merkley, D-OR, this month introduced theImproving Care and Access to Nurses (ICAN) Act (S.5212), which would remove administrative and practice barriers for advanced practice registered nurses (APRNs), which supporters say will improve access to healthcare for millions of Americans.
Companion legislation (H.R. 8812) was introduced in the U.S. House in September and assigned to the Health Subcommittee. It likely will not be heard before the lame duck Congress adjourns permanently this month. However, ICAN appears to have bipartisan support and could be taken up when House Republicans take control in January
April Kapu, DNP, APRN, ACNP-BC, FAANP, FCCM, FAAN, president of the American Association of Nurse Practitioners, notes that about 40% of Medicare and Medicaid patients receive care from nurse practitioners as their providers "and it is critical these patients receive timely, high-quality healthcare from their providers of choice."
"The ICAN Act will eliminate outdated barriers to care that impede the progress of our healthcare system," Kapu says.
Angela Mund, DNP, CRNA, president of the American Association of Nurse Anesthetists, says the bill will "eliminate burdensome laws and regulations."
"Allowing certified registered nurse anesthetists and other APRNs to practice to the full scope of their training and licensure will ensure that patients are put first, that competition drives down costs through the removal of artificial and unnecessary barriers, and that providers of all types are able to better serve their patients," Mund says.
This bill would authorize NPs to order and supervise cardiac and pulmonary rehabilitation, certify when patients with diabetes need therapeutic shoes, have their patients fully included in the beneficiary attribution process for the Medicare Shared Savings Program, refer patients for medical nutrition therapy, certify and recertify a patient's terminal illness for hospice eligibility, perform all mandatory examinations in skilled nursing facilities, and more.
The American Nursing Association says the bill "is consistent with the recommendations from numerous healthcare stakeholders, including the National Academy of Medicine in their The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equityreport," which recommends that "all relevant state, federal and private organizations enable nurses to practice to the full extent of their education and training by removing practice barriers that prevent them from more fully addressing social needs and social determinants of health and improve healthcare access, quality, and value."
American Nurses Association President Ernest J. Grant, PhD, RN, FAAN, says the ICAN Act means that APRNs, including nurse practitioners, nurse anesthetists, nurse-midwives, and clinical nurse specialists will be able to care for their patients at the fullest extent of their abilities.
"The ICAN Act is a significant bill that will eliminate many of the burdensome laws and regulations that have prevented patients from getting access to the kind of timely, evidenced-based care that APRNs are clinically trained and qualified to provide," Grant says.
"Allowing APRNs to practice at the top of their license, like they did during the height of the COVID-19 pandemic, will help to cultivate the kind of flexibility that modern healthcare requires. That flexibility will improve patient outcomes and lower costs. And in doing so it will ensure that more individuals, including those in rural and underserved communities, have access to the kind of healthcare that they deserve."
Collective Bargaining Rights
National Nurses United, the nation's largest nurses union, is cheering the House passage this month of the VA Employee Fairness Act of 2021 (HR 1948).
The bill, sponsored by Rep. Mark Takano, D-CA, chairman of the House Committee on Veterans Affairs, would reinstate collective bargaining rights for Veterans Affairs nurses and other clinicians. It passed the full House on Thursday on a 219-201 vote, with only four House Republicans signing on.
"VA nurses have dedicated their careers to serving veterans and have been instrumental in fighting the COVID-19 pandemic. Passing my VA Employee Fairness Act is a step towards recognizing this commitment to our veterans," Takano says
NNU Vice President Irma Westmoreland, RN, who works in the Charlie Norwood VA Medical Center in Augusta, GA, says the nurses play a critical role as patient advocates "and our input and insight is critical in determining best practices for patient care. Without full collective bargaining rights, VA nurses' ability to effectively advocate for the health and safety of our patients and ourselves is hindered."
Senate companion legislation likely will not be heard before the lame duck Congress adjourns this month. However, the pro-labor bill is expected to get a hearing when the Democrat-controlled Senate convenes next year. The bill has the support of the Biden administration.
The bill has been endorsed by every union representing VA clinicians and groups including the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the Congressional Labor Caucus, the American Legion, and the Vietnam Veterans of America.
Proponents of HR 1948 say it will help with nurse recruiting and retention by restoring bargaining rights to RNs and other clinicians in the VA, who are banned from bargaining over issues relating to professional conduct or competence, patient care, and peer review.
NNU says restoring those rights "would reduce turnover, increase staffing levels, and improve the care that veterans receive by giving VA clinicians the tools they need to speak up for patient safety and care.
"This bill will ensure the rights of bedside nurses in the Veterans Administration are protected and, in turn, will serve to increase the quality of patient care in VA facilities," she continued. "We are extremely pleased that our representatives are recognizing our role in ensuring our nation's veterans get the very best care that they so rightly deserve."
The CNO at CommonSpirit Health asks if you don't know where you want to go, how can you get there?
Editor's note:This article appears in the March 2023 edition of HealthLeaders magazine.
It’s not exactly a news flash to say that staffing will be a top issue for nurse leaders in 2023. Kathleen Sanford, RN, DBA, FAAN, FACH, CNO at CommonSpirit Health, tells HealthLeaders that the massive challenge of recruiting and retaining nurses can be made more efficient when health systems know their mission and have a strategy for achieving it. The following interview was edited for brevity and clarity.
HealthLeaders: What big issues will nurse leaders address in 2023?
Kathleen Sanford: They’re going to continue to help staff with change. And when I am talking about staff I’m not just talking about the nurses. We need to remember that there's a whole team of people in health systems who are getting to be good at change management. Nurse executives must think strategically and have a strategy that's over several years. A lot of people say, “Oh, that's old fashioned now because change is happening so quickly.” I don't agree with that. If we don't have an idea in nursing or healthcare in general of where we want to go, how on Earth can we figure out the right things to do to get us there?
HL: How do you develop that strategic plan?
Sanford: You can’t do strategy unless you have a vision. What do you want to do? What do you want to deliver? You also need to balance change because, while there are many things we need to change, you can't change everything at once. We're going to have to balance what's right for our staff, our patients, or consumers, for the organization, for our communities and for our leaders. That's a tough balancing act. We're going to have to think about that as we set our strategy.
We’ll also have to change the idea of where patients are being taken care of. I’ve been told that we're going to have 16% growth in care outside of the hospital, but we're still going to have a 12% inpatient growth, and probably with higher acuity, too.
HL: How do you see the staffing crisis developing in 2023?
Sanford: That’s the issue that is on everybody's mind right now and that nurse leaders across the country are going to have to deal with this next year, and probably for the rest of our careers. That's going to be the number one issue in 2023. None of those things I’ve talked about—preparing for change, having a strategy, and balancing needs—is going to happen if we don't have staff.
I get concerned when people talk about having the right number of staff. Nurses are not a commodity. Nurses are professionals who have expertise in different areas. So, it's not just “having numbers of staff.” It's having staff who have the right tools, who are well educated for the work, that they're enjoying their jobs, that they are invigorated by their work, all the things you want in the people who are taking care of you.
HL: What are CommonSpirit’s staffing challenges?
Sanford: There are not enough nurses and other team members to meet the needs of our patients and communities unless we do things differently, and we need to have strategies to do things differently. I've seen various numbers about how much worse this is going to get that range all over the place. The highest one is that we're going to need two million more nurses in the next 10 years, but we're only going to graduate 500,000.
Part of our strategic journey and our nursing strategy at CommonSpirit started with bringing together a large group of stakeholders two years ago and started working on our vision. Our diversity leaders from our various organizations talked about what they’d love to see our system become and what partnerships they would have in this vision. We came up with a long list of projects that were taken back to the CNOs in our seven divisions and reviewed by their nurse executive councils.
Then we held focus groups of nurses across the system to come up with ideas for what the vision should be. When we got down to two different wordings for a vision, we allowed our 45,000 nurses to vote on what they thought the national vision should be.
Kathleen Sanford, RN, DBA, FAAN, FACH, CNO at CommonSpirit Healthcare. Photo courtesy of CommonSpirit Health.
HL: How did you build on that newly agreed-upon vision?
Sanford: Once we had a national vision, we asked ourselves what's the strategy for getting on the list? We prioritized because you cannot do everything at once. Our priorities, given what was happening during COVID, was to come up with four actions.
First is a one-year nurse residency program, the largest finished residency program in the country.
Second, we started our own national staffing agency so that our nurses who wanted to could choose to travel and not lose their seniority.
Third, we developed a virtually integrated care unit that uses virtual care nurses.
Fourth, we started working more closely with academic partners to increase the number of graduates and the diversity of our nursing workforce.
For 2023, our nurses were asked about our second-year priorities, and they told us that they want to have shared governance across the entire system, to have individualized professional development programs for staff, to accelerate our academic partnerships, and to continue resilience and well-being programs, all in that order of priority.
Of course, with shared governance, 45,000 nurses can’t have a say in every decision, but you have to ensure that they know they have a voice at every level, that they have representatives that meet with management to talk about all things nursing.
HL: When we talk about nurse satisfaction, is the most important element compensation?
Sanford: It’s not about the money. Compensation is not what’s making people leave nursing. It's more about whether they feel appreciated and that they get to do the work that they want to do that they're educated to do, that they have a voice, and that they have a good relationship with their supervisor. Research has shown that most human beings, if the salary is fair and about equal to what other people get for the same jobs, then they’re going to stick with you because they love the work and they feel appreciated.
HL: How does your nurse residency program work?
Sanford: Hospitals across the country say their highest loss of nurses are in their first year out of school, so I would advise every CNO to look carefully at their residency programs or their orientation. We have revised ours to be one year long. The nurses are paid their salary during that time to take care of patients, but it's not just learning how to attend patients. It's about learning how to manage the intricacies of an organization. We have classes on how to work well with other people, how you get your voice heard, how you deal with violence in the workplace, and how you deal with bullying.
The other piece is that our nurse residents will have 24-hours-a-day virtual preceptors and floor preceptors who work with new nurses so they don’t feel alone.
HL: Can smaller health systems and hospitals that lack the resources and staff still create a vision and build a strategy around it?
Sanford: You can gather 10 people and have a vision of what you want, and a strategy that gets you to that vision. If I was in a small hospital or a small health system, I would look for other systems I could partner with. You don’t have to be huge to get this done. It's about looking at what your vision is for your size and what would work best for you.
The main thing is to remember that there is not a one-size-fits-all solution.
Prosecutors say the settlements resolve allegations of an 'organized scheme to wrongfully retain federal funds.'
Dignity Health and Tenet Healthcare Corporation subsidiaries will pay California and the federal government a combined $22.5 million to settle separate false claims allegations made for Medi-Cal "enhanced adult services," state and federal prosecutors announced.
Named in the settlement were Dignity Health's three hospitals and one clinic in Santa Barbara County and San Luis Obispo County and Tenet subsidiaries Twin Cities Community Hospital and Sierra Vista Regional Medical Center in San Luis Obispo.
Prosecutors say the settlements resolve allegations that Dignity, Twin Cities, and Sierra Vista ran an "organized scheme to wrongfully retain federal funds" from Medi-Cal's Adult Expansion program. California will get $2.25 million of the settlement.
The California Department of Health Care Services requires a California county organized health system to spend at least 85% of the funds it received for the Adult Expansion population on "allowed medical expenses." If not, they provider was required to pay back to the state the difference between 85% and what it spent. California, in turn, was required to return that amount to the federal government.
The two settlements resolve allegations that Dignity, Twin Cities and Sierra Vista knowingly submitted false claims to Medi-Cal for "enhanced services" provided to the expansion patients between Feb. 1, 2015, and June 30, 2016, and that Twin Cities and Sierra Vista purportedly provided to such patients between Jan. 1, 2014, and April 30, 2015, prosecutors say.
Prosecutors say the payments were not "allowed medical expenses" permissible under the contract; were pre-determined amounts that did not reflect the fair market value of any enhanced services provided; and were duplicative of services already required.
"Every day, Medi-Cal provides support for Californians in need of essential healthcare, and when companies take advantage of this system at the expense of patients, they must be held accountable," says California Attorney General Rob Bonta.
Dignity will pay $13.5 million to the United States and $1.5 million to California, and Twin Cities and Sierra Vista will pay $6.75 million to the United States and $750,000 to California.
"These healthcare providers siphoned critical Medicaid funding for their own gain instead of using it to provide health care services to patients most in need," U.S. Attorney Martin Estrada for the Central District of California says. "These major settlements demonstrate our commitment to hold accountable healthcare providers that seek to exploit the Medicaid program and harm the American taxpayer."
The settlements were brought under the whistleblower provisions of the California False Claims Act by Julio Bordas, the former medical director of CenCal, which entitles him to 10% of the recovery – at federal cost – in cases involving allegations of losses to the Medicaid program.
Dignity Responds
Dignity issued the following statment on the settlement:
"On Dec. 7, the Department of Justice issued a press release announcing a settlement regarding alleged improper Medi-Cal claims submitted over seven years ago in connection with the Medicaid Adult Expansion under the Patient Protection and Affordable Care Act. During the period Dignity Health d/b/a Marian Regional Medical Center and French Hospital Medical Center, provided critically necessary population health management, patient navigation, homeless outreach, and health education programs and related services to this newly-eligible adult Medi-Cal population, in their spoken languages, in Santa Barbara and San Luis Obispo Counties.
Dignity Health provided these services in accordance with a previously established program and agreement and in addition to the underlying services agreements between the providers and co-defendant Santa Barbara San Luis Obispo Regional Health Authority (d/b/a CenCal Health), the county organized health system responsible for administering the Medi-Cal program in Santa Barbara and San Luis Obispo Counties. Under the program, Dignity Health submitted to CenCal Health detailed monthly reconciliation statements and annual reports, and was paid by CenCal in accordance with the agreements.
As such, Dignity Health received fair market value compensation from CenCal for services actually provided to this vulnerable population, and maintains all reimbursements were properly received.
Dignity Health entered into the settlement agreement with the United States and State of California to resolve the matter without the expense of litigation, and without admitting any liability."
Tenet Responds
Tenet Healthcare Corporation issued the following statement:
"We stand behind the efforts of our team to serve the Medi-Cal population in San Luis Obispo and Santa Barbara counties, California. Sierra Vista Regional Medical Center and Twin Cities Community Hospital strongly deny the allegations but resolved this matter to avoid the expense and distraction of further litigation. The hospitals used the Medi-Cal funds received from CenCal Health to serve Medi-Cal beneficiaries as intended.
Sierra Vista and Twin Cities remain committed to full compliance with all California and federal healthcare program requirements. Our hospitals and dedicated care teams remain committed to providing high quality care to Medi-Cal patients in our community."
Lawmakers are examining strategies drugmakers use to shield billions of dollars in profits from U.S. corporate taxes.
Senate Finance Committee Chair Ron Wyden this week made a final request to Amgen Inc. to "voluntarily" provide information about the drugmaker's tax-avoidance schemes that funneled $24 billion in U.S. sales to offshore havens in Puerto Rico and elsewhere.
The Oregon Democrat, in a Dec. 8 letter to Amgen CEO Robert Bradway, says "there appears to be a substantial discrepancy between where Amgen generates the vast majority of its prescription drug sales and where Amgen books profits from those drug sales for tax purposes."
Wyden says the Thousand Oaks, CA-based company, in its Sept. 16 response to the committee's August query, "declined to provide any specific information related to Amgen's pre-tax earnings, profit margins and tax paid in the United States."
"The response also failed to answer questions regarding where Amgen reports income for tax purposes, including how much of Amgen's taxable income is reported by offshore subsidiaries," Wyden says, adding that Amgen also refused to provide specific information related to pre-tax earnings, profit margins, and taxes paid in the United States.
The Senate Finance Committee is examining strategies Amgen and other drugmakers use to avoid billions of dollars in taxes generated by sales in the United States, including Amgen's pricy arthritis drug Enbrel, for which the drug maker charges about $8,700 a month.
Wyden says Amgen uses the global intangible low-tax income (GILTI) schedule to declare income from Enbrel and other drugs that "are overwhelmingly booked in jurisdiction treated as foreign for tax purposes, including Puerto Rico."
Under GILTI, foreign income is either fully exempt from taxes, or taxed at 10.5%, compared with the U.S. corporate tax rate of 21%.
Internal Revenue Service filings show that U.S. sales accounted for $18.2 billion of Amgen's sales in 2021, about 70% of its total sales, but reported only $1.85 billion in pre-tax income in the United States. In that same year, Amgen reported international pre-tax income of more than $4.8 billion on $7.7 billion in international sales. The IRS also claims that Amgen shifted nearly $24 billion in income to subsidiaries in Puerto Rico to avoid paying billions of dollars in federal taxes on U.S. prescription drug sales.
Wyden says in his letter that he was denied "country-specific information related to Amgen's pre-tax earnings, profit margins, employee headcount and tax paid for tax years 2018 - 2021."
"This included copies of Amgen's IRS form 8975, an annual country-by-country tax reporting required for large corporations with over $850 million in annual income. I also requested information related to Amgen's taxable income for years 2018 – 2021, including how much of Amgen's taxable income was reported by controlled foreign corporations," Wyden says in the letter.
"Unfortunately, Amgen declined to provide the committee this information, choosing to keep secret how much of its profits are reported by offshore subsidiaries that are treated as foreign for tax purposes."
"It is critical to understand how Amgen, a multinational pharmaceutical corporation based in the U.S. with annual sales of $26 billion primarily made to U.S. customers, paid a lower tax rate than a postal service worker or a preschool teacher."
Amgen did not immediately respond to requests for comment Thursday from HealthLeaders.
Consumers are willing to make the transition to retail settings in exchange for lower costs and better outcomes.
Nearly two-thirds of 1,006 adults (61%) in an online poll envision using primary care services at pharmacies, retail clinics and/or pharmacy clinics instead of going to a primary care physician.
The online survey, released Wednesday by Wolters Kluwer, shows that consumers are willing to make the transition to retail settings in exchange for lower costs and better outcomes.
However, the enthusiasm is generational, with 70% of Millennials, 66% of Gen Z and 65% of Gen X anticipating this transition, as opposed to only 43% of Baby Boomers or older Americans.
"Americans made it clear: it’s time for healthcare to get ready for big changes. Gen Z and Millennials are thinking differently about the who and where of healthcare and medication prescribing," says Peter Bonis, MD, CMO, Wolters Kluwer, Health.
The survey found that:
At least half of consumers see potential savings on medical expenses as an incentive to look beyond solely physician-credentialed providers.
Consumers would trust pharmacists (56%), nurse practitioners (55%) and physician assistants (50%) to provide healthcare and prescriptions if it meant lower costs.
Women are 20% more likely than men to trust a nurse practitioner (65% vs. 45%) and 9% more likely to trust a physician assistant (55% vs. 46%).
Three-quarters of Americans (72%) would be open to having medications prescribed by a specially-trained pharmacist instead of a doctor.
Gen Z, Millennials and Gen X are much more open (78%, 80%, and 74%) than Baby Boomers and older Americans (Boomers+) (58%).
More than 70% of consumers say they’d provide a blood sample for genomic analysis if it meant that they’d receive more personalized medical care.
Half of consumers worry about getting the wrong dosage, the wrong medication or the wrong instructions (47%).
Unknown drug interactions worry 65% or consumers, who are concerned that potentially adverse effects won’t be identified when the prescription is issued.
The vast majority (97%) of consumers say pharmacists should be responsible for telling them about the safety of their medications.
Half of Americans (51%) worry about accessing prescriptions from understaffed pharmacies. Gen Z and Millennials are even more likely (59% and 60%) to say they’re worried about pharmacy staffing gaps than Gen X and Boomers+ (44% and 38%).
More than two-thirds (68%) of consumers believe that their genomic information could influence their providers’ decisions about what medicines to prescribe.
Nurse leaders are also pushing to extend the relaxed care access policies issued during the COVID-19 PHE through at least 2024.
The American Nurses Association has launched a write-in campaign, urging stakeholders to contact their representatives in a lame-duck Congress and press them to enact before year's end five bills promoting the nation's nursing workforce.
"We know that personalized letters have an even greater impact – if this legislation will directly impact your work or the work of a nurse you know, please consider sharing your story in the note to Congress," the ANA says in its appeal to members.
"Throughout the last two years, Congress has seen firsthand how vital nurses are to the healthcare landscape," the ANA mass email states. "The legislative asks below represent key legislation supporting our nation's nursing workforce by providing stability, safety, and mental well-being for nurses and removing barriers to care faced by nurses and the patients they serve."
The bills supported by the ANA include:
R. 1195/S. 4182, the Workplace Violence Prevention for Health Care and Social Service Workers Act, which would require Occupational Safety and Health Administration to develop and enforce standards for healthcare and social service employers that will hold them accountable for protecting their employees from workplace violence.
"This issue has been a long-standing concern prior to the pandemic and recent increases in instances of workplace violence have shown why passage of this legislation is so critical," ANA says.
R. 8812, the Improving Access and Care to Nurses (I CAN) Act, which would permanently remove care and access barriers to Advanced Practice Registered Nurses under Medicare and Medicaid.
R. 851/S. 246, the Future Advancement of Academic Nursing (FAAN) Act, which would fund nurse education programs and increase the nurse faculty.
R. 6087, the Improving Access to Workers' Compensation for Injured Federal Workers Act, which would amend the Federal Employees' Compensation Act to authorize NPs to certify disabilities and oversee treatment for injured federal workers.
R. 7666, the Restoring Hope for Mental Health and Well-Being Act of 2021. ANA wants the bill to include H.R. 1384, the Mainstreaming Addiction Treatment Act, which would eliminate the duplicative and burdensome requirement that providers, including APRNs, apply for a Drug Enforcement Administration waiver to dispense buprenorphine.
The ANA is also pushing Congress to extend the relaxed policies issued during the COVID-19 public health emergency through at least 2024 and work with the Biden Administration to make them permanent.
"In particular, the Centers for Medicare & Medicaid Services waivers, removing scope of practice barriers for APRNs and expanding the use of and payment for services provided through telehealth technologies," ANA says. "All of which have demonstrated a positive impact on the health care delivery system for nearly three years."
