The American Medical Association and other key stakeholders are calling for a coordinated effort to address a crippling nationwide shortage of drugs that include injectable opioid analgesics, IV fluids, and Epi-pens.
The nation's drug shortage has gotten so severe that hospitals are taking desperate measures to meet patients' needs, as emergency departments brace for the busy summer months.
"So many substances are short, and we're dancing every shift," James Augustine, MD, an emergency physician in Cincinnati told The New York Times.
Michael Cohen, president of the Institute for Safe Medication Practices, told AP that the shortages prompt potentially harmful medication mix-ups and workarounds when nurses or pharmacists substitute unfamiliar painkillers or ones with different concentrations.
Cohen cited reports of at least two surgical patients who had overdosed when fentanyl wasn't available and they were mistakenly given the same amount of much stronger sufentanil.
In June, the American Medical Association declared the drug shortages an "urgent public health crisis," and urged the federal government to review the issue as national security initiative.
"The fact that drug shortages worsened when major hurricanes struck drug production facilities on Puerto Rico highlights the need to evaluate and plan for hazards that pose a threat to critical infrastructure for manufacturing pharmaceutical and medical products," said AMA Board Member William E. Kobler, MD.
This spring, Pfizer issued an advisory to hospitals, that provided special handling instructions due to potential for cracked needle hubs and particulate in the drug maker's glass syringes.
A survey of 343 hospitals this spring by the American Society of Health-System Pharmacists found that 98% had moderate or severe shortages of morphine, fentanyl and hydromorphone, aka Dilaudid. Many hospitals were completely out of at least one. Hospitals also are grappling with shortages of local anesthetics: lidocaine, bupivacaine and a third type that is standard for eye surgery, orthopedic procedures, and knee and hip replacements.
Nine in 10 emergency physicians responding to a recent poll said that in the past month, they have experienced shortages or absences of critical medicines in their emergency departments. "Emergency physicians are concerned that our system cannot even meet daily demands, let alone during a medical surge for a natural or man-made disaster," said Paul Kivela, MD, president of American College of Emergency Physicians.
Food and Drug Administration Commissioner Scott Gottlieb, MD, said drugs shortages "are an inevitable consequence of an imperfect system. With better planning, we can minimize shortages throughout the supply chain. But, in the near term, we won’t be able to fully eliminate the possibility that new shortages will arise. Meaningfully impacting the structures and market challenges that can give rise to shortages will require more coordination among public and private stakeholders."
The urgent care clinic chain will serve as an extension of Atlantic Health, offering walk-in urgent care, employer health services, and basic wellness and prevention services.
Atlantic Health Systemhas formed a coordinated care collaborative with MedExpress, an urgent care provider with 11 locations across northern New Jersey, the two providers announced.
The jointly owned clinics will enable MedExpress' urgent care patients to seek care at an Atlantic Health System facility if additional care is needed.
"Our mission is to build healthier communities," Amy Perry, CEO Hospital Division at Atlantic Health said in an email exchange with HealthLeaders Media. "We chose to partner with MedExpress to avoid duplicating expensive resources in our communities. We are looking for opportunities to collaborate whenever possible."
"Adding urgent care to our continuum of services helps us improve accessibility and affordability, providing our patients with the right care, at the right time and in the right place," Perry said, adding that the collaborative means that MedExpress "can offer care coordination beyond traditional urgent care, improving outcomes and patient satisfaction."
MedExpress clinics will serve as an extension of Morristown-based Atlantic Health, offering walk-in urgent care, employer health services, and basic wellness and prevention services.
"Atlantic Health is listening to our customers and building an ambulatory network that provides the accessibility and affordability that they are seeking," Perry says. "With shifting payment models driving patients to urgent and primary care sites, the ultimate goal is to build an all-inclusive network that can care for every health need."
Perry says Atlantic Health will assess the success of the partnership with MedExpress using quality outcomes, service scores and frequency of use over more expensive care models.
"We also hope to improve care management, decreasing redundant testing, leveraging data, expanding patient communication and education," she said.
Federal regulators say a demonstration waiver is needed because physicians would otherwise be subject to MIPS, even if they participate in Advanced APM models under Medicare Advantage.
The Centers for Medicare & Medicaid Services is proposing a demonstration project that would waive Merit-Based Incentive Payment System requirements for clinicians who join some risk-bearing Medicare Advantage plans.
CMS Administrator Seema Verma said in a media release that the Medicare Advantage Qualifying Payment Arrangement Incentive Demonstration "aligns with the Agency's goal of moving to a value-based healthcare system, and aims to put Medicare Advantage on a more equal playing field with Fee-for-Service Medicare."
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) gives physicians two payment tracks under fee-for-service Medicare: MIPS, which requires clinicians to report quality data to CMS and have their payment adjusted; and Advanced Alternative Payment Models, which require clinicians to take on risk.
Some Medicare Advantage plans are developing arrangements that resemble Advanced APMs. Without the demonstration, however, physicians would still be subject to MIPS, even if they participate extensively in Advanced APM-like arrangements under Medicare Advantage.
"CMS intends to test whether MIPS exemptions provided to clinicians under MAQI will increase participation in Medicare Advantage plans that are similar to Advanced APMs, and thereby accelerate the transition to a healthcare system that pays for value and outcomes," Verma said.
Federal regulators pledge to continue to work with the state to address soaring costs in the Medicaid program that covers about 1.3 million residents.
The Centers for Medicare & Medicaid Services has rejected a Massachusetts plan to kick about 140,000 people off the Medicaid rolls and limit some expensive prescription drugs covered under the program.
Massachusetts had submitted a waiver request last fall, asking CMS for the ability to negotiate the price of about 30 high-price drugs that make up $600 million — or 30% — of pharmacy spending for MassHealth, the state's Medicaid program.
The state said the reforms are needed to address ballooning program costs. MassHealth's pharmacy spending has doubled from $1.1 billion to $2.2 billion in the past five years.
In a letter this week to Daniel Tsai, assistant secretary of MassHealth, CMS said the state's Medicaid program can collect drug rebates but only if state Medicaid plans cover all drugs approved by the federal government. Massachusetts gets $900 million annually in drug rebates, and $550 million is sent back to the federal government.
In a statement, Gov. Charlie Baker's administration said: "While it is disappointing that our request to more effectively control rising pharmacy costs was not approved at this time, we remain committed to finding more innovative state-based solutions to reduce the growth in drug spending while maintaining access to necessary medications."
Matt Salo, executive director of the National Association of Medicaid Directors, called the rejection of the waiver "disappointing because it was an extremely well-thought out proposal that would have brought some rationality into the current environment of outrageous drug pricing."
"The Massachusetts waiver was heavy on patient protections and ensuring access to necessary cures/treatments," Salo said. "It would have given them the leverage they needed to bring some much needed market leverage to bear on the new 21st Century Cures innovations that are going to break the system before too long."
Salo said it appears that CMS is trying to force Massachusetts to opt for the '5 state demo' that was first outlined in President Trump's Budget.
"But nobody wants that demo," he said. "Massachusetts is saying that the current system works well enough for most patients and most products, so there’s no need to throw the baby out with the bathwater."
CMS also shot down the state's plan to remove about 140,000 Medicaid enrollees who earn more than 100% of the federal poverty level and shift them to ConnectorCare, which would have paid Massachusetts about $120 million more in federal reimbursements.
Medicaid patient advocates cheered CMS's rejection. Health Care For All Executive Director Amy Rosenthal urged the Baker administration to work with the state legislature to strengthen MassHealth's ability to negotiate lower drug prices, and to find "alternative avenues" for reducing spending growth, rather than simply kicking enrollees off the program.
Lindsay Bealor Greenleaf, director atADVI Health, said "It's a relief to see the administration do the right thing and reject this waiver request, because if Massachusetts had gotten its way, Medicaid patients would have limited treatment choices and industry would doubt whether future deals struck with the government will hold up over time."
Blue Distinction Centers for Maternity Care hospitals lowered C-section rates to 23.7% for first-time mothers compared to 34.9% for hospitals that are not in the network, and saved about $4,000 per delivery.
The Blue Cross Blue Shield Association says its hospital maternity care program has reduced cesarean sections for first-time mothers by 32% when compared with hospitals not in the program.
According to BCBSA, Blue Distinction Centers for Maternity Care:
Lowered C-section rates to 23.7% for first-time mothers compared to 34.9% for hospitals that are not in the network;
Beat the Department of Health & Human Service's Healthy People 2020 goal to reduce C-section rates for first-time, low-risk mothers to 23.9% by 2020;
Saved money because the average cost difference between vaginal and C-section deliveries is more than $4,000 ($13,325 vs. $17,482, respectively);
Have 70% fewer early (37-39 weeks) elective deliveries and 53% fewer episiotomies, than non-network hospitals.
Nearly four million babies are born in this country each year, making childbirth the most common reason for hospitalization.
The maternity program started in 2016, and is now in more than 1,080 hospitals across the nation. To qualifya hospital has to achieve a C-section rate of 27% or lower, and other outcomes metrics.
Kari Hedges, senior vice president, commercial markets & enterprise data solutions for BCBSA, says the three key metrics for the program are early elective deliveries, episiotomies rates, and C-section rates.
"We put a threshold where the providers have to perform better in each of these categories," she said.
Hedges credited the success of the program on the member hospitals' efforts to proactively communicate with expectant mothers "around healthy maternity care and what they need to do to stay healthy."
Those conversations also "discourage early elective deliveries, and spell out the potential complications that come with scheduling and planning C-sections versus having them being used for their intended purpose," Hedges said.
ACOG Approved
The maternity program's criteria relies on safety bundled developed by several key stakeholders, including the American College of Obstetricians and Gynecologists. The bundles tap best practices to prevent or respond to common pregnancy-related conditions, such as hemorrhage and hypertension.
Barbara Levy, MD, ACOG's vice president of health policy, said her organization is "excited" about providing a link to its patient safety bundle to reduce maternal morbidity and mortality.
"Encourage hospitals to engage in behaviors that are safer for moms is what we are all about," she said. "If the hospitals invest in great nursing care and lots of support, then we know the outcomes will be better and more likely it will be a vaginal delivery."
Litigation Fears and C-Sections
Levy was asked how C-Sections became so commonplace in hospitals for non-complicated pregnancies.
"There are several issues there," Levy replied. "Women are older, they have more underlying medical conditions over the past 20 years, and quite frankly the liability risks for obstetricians is really scary."
"A doctor is never sued for doing a C-section too soon, but in retrospect, if there is an outcome that isn't ideal, those things lead to litigation," she says.
"Some expert will say 'you could have, should have, would have done a C-section and none of this would have happened.' The reality is that in obstetrics almost every doctor will be sued. It makes you think twice about what you're doing. That's not great, but it is reality. So, what we've seen in the last 25 years is a reduction in operative vaginal delivery."
"Almost directly related to medical liability, those operative delivery cases are disappearing and the skills to do them are disappearing, and that results in more primary C-sections for a first pregnancies, and then that leads to more repeat C-sections," Levy says.
The deal gives Sanford Health access to senior care services in 24 states, and provides Good Samaritan with a buffer against lower revenues and a declining patient census.
Sanford Health and senior care services provider The Evangelical Lutheran Good Samaritan Society will merge to form a $6 billion company with 47,000 employees nationwide, the two Sioux Falls, South Dakota-based not-for-profit providers announced.
Financial terms were not disclosed for the deal, which was made public this week shortly after the membership at Good Samaritan voted their approval.
"By bringing the expertise of the professionals at the Society together with the healthcare experts at Sanford, not only will there be benefits for those we serve but also the organizations are stronger together," David J. Horazdovsky, president and CEO of the Good Samaritan Society, said in a media release.
Horazdovsky will remain as president of Good Samaritan after the acquisition is completed.
Sanford CEO and President Kelby Krabbenhoft called the deal "forward-thinking" and said it will "become a national model to serve communities with exceptional care and value through the full spectrum of one's life."
Good Samaritan has 19,000 employees in 24 states providing senior care services. Sanford has 28,000 employees in nine states that provide clinic, hospital and health insurance services.
The Good Samaritan acquisition expands Sanford's fast-growing footprint into 200 senior care services locations across the nation. For Good Samaritan, the deal provides some relief from a declining patient census and budget deficits.
Good Samaritan is the latest acquisition in an aggressive growth strategy pursued by Sanford Health, that has also caught the attention of state and federal regulators.
The suit was brought by the North Dakota Attorney General's Office and the Federal Trade Commission, which contend that the acquisition would adversely affect competition in the Bismarck service area and increase the cost of healthcare for consumers.
Community Health Systems, Inc. continues its ongoing efforts to reduce debt with the sale of a community hospital in Oklahoma City. It's CHS's eighth hospital divestiture this year.
Financial terms were not disclosed. The sale was one of several planned divestitures discussed by CHS this spring in a first quarter earnings call.
Deaconess, a 291-bed community hospital, operates under CHS' affiliated AllianceHealth brand name in Oklahoma and the purchase does not include other AllianceHealth hospitals in the state. When the sale is finalized, CHS affiliates will operate seven hospitals in Oklahoma.
Tim Johnson, president of nearby INTEGRIS Baptist Medical Center, told The Oklahoman newspaper that Baptist has to turn away about 1,200 patients each year because of a shortage of critical care beds.
"What we really need is more critical care space," Johnson told the newspaper. "It really gives us some breathing room."
INTEGRIS said no layoffs are planned at Deaconess.
Franklin, Tennessee-based CHS has sold eight hospitals this year in its ongoing effort to reduce its debts that accrued after its $7.6 billion acquisition of Health Management Associates, Inc. in 2013.
The company reported a nearly 18% drop in net revenuesand a 21% drop in total admissions in the first quarter of 2018.
On June 1, CHS sold the 85-bed Tennova Healthcare – Jamestown in Jamestown, Tennessee, to West Palm Beach, Florida-based Rennova Health, Inc., which had been delisted from Nasdaqearlier this year for excessive stock splitting
The various iterations of the travel ban—which mostly target Muslim-majority nations—have been highly contentious among healthcare providers, many of whom worry it will worsen access to care.
The U.S. Supreme Court on Tuesday affirmed President Donald Trump's authority to restrict foreign nationals from entering the country, upholding a controversial ban on travelers from seven countries.
Some fear the ban, which applies mostly to Muslim-majority nations, could worsen an already-critical shortage of healthcare workers in the United States.
“We are deeply disappointed in the Court’s decision," Association of American Medical Colleges President and CEO Darrell G. Kirch, MD, said in a statement released shortly after the 5-4 ruling.
The AAMC had filed an amicus brief with the high court challenging a series of executive actions over the past 18 months that imposed nationality-based exclusions, asserting that the actions would worsen the nation's health-professions shortage and impair its ability to advance medicine and protect public health.
With the court's ruling that this proclamation is within the president's legal discretion, the debate now shifts to Congress, Kirch said.
"The AAMC will continue its efforts to educate legislators about the direct link between fair immigration policies and the health of Americans, and to advocate for immigration policies that recognize the critical role that health professionals from other countries play in safeguarding our nation’s health security,” he said.
The various iterations of the travel ban have been highly contentious among healthcare providers, many of whom believe it will only worsen access to healthcare in underserved areas, especially in rural America:
When the first ban attempt was announced in early 2017 shortly after Trump took office, the Migration Policy Institute noted that more than 22% of all healthcare workers were immigrants, and 28% of those healthcare workers were surgeons or physicians.
It's not clear how or if the travel ban will affect the Conrad 30 J-1 visa waiver, which allows international medical students to stay in the United States after residency for three years if they work in a rural or urban community where there is a physician shortage.
By some estimates, the Conrad 30 J-1 Visa Waiver by itself has brought nearly 10,000 physicians into rural and urban underserved communities over the past 10 years.
The American College of Physicians, which filed an amicus brief of its own opposing Trump's travel ban, released a statement Tuesday reiterating its disappointment.
"We urge the administration and Congress to affirm the paramount importance of non-discrimination against any person based on religion, ethnicity, gender, gender identity, and sexual orientation in all decisions relating to immigration policy, and particularly, to undo the harm to patients, the [international medical graduates] who treat them, and to medical education that will result from the President’s Executive Office and the Supreme Court’s decision to uphold it," ACP President Ana María López, MD, MPH, FACP, said.
The Knoxville-based, for-profit hospice chain says it disputes the allegations brought out in a whistleblower lawsuit, but settled the case to avoid costly litigation.
Caris Healthcare, LLC will pay $8.5 million to settle false claims allegations that it knowingly kept overpayments for patients who were ineligible for Medicare hospital benefits because they were not terminally ill, theDepartment of Justice said.
A federal complaint alleged that the Knoxville-based, for-profit hospice chain admitted patients whose medical records showed did not have terminal illness as part of an effort to meet the aggressive admissions and census targets set by the company.
The complaint also alleged that Caris' leadership was made aware of the overpayments, but ignored internal audits and warnings from staff.
"Caris not only continued to submit hospice claims to Medicare for the patients, but also took no meaningful action to determine whether it had previously received improper payments for these and other patients that should have been returned to Medicare," DOJ said.
"Today's settlement is an important reminder that compliance programs and activities cannot exist in name only," Acting Assistant Attorney General Chad A. Readler of DOJ's Civil Division said in a media release.
"When a healthcare provider is put on notice that a patient is ineligible for a particular Medicare benefit or service, the healthcare provider cannot turn a blind eye to that information but, instead, must take reasonable steps to stop the improper conduct and to determine whether that conduct resulted in prior overpayments," Readler said.
Caris, which operates 28 offices in Tennessee, Virginia, Missouri, South Carolina and Georgia, disputed the allegations brought out in a whistleblower lawsuit, but settled the case to avoid costly litigation.
"In recent years, litigation involving hospice providers has increasingly focused on the eligibility of patients to receive hospice services and often amounts to a second-guessing of the care provided to those patients, years after the fact," Caris said in a statement to the media.
"The settlement of the lawsuit brought under the False Claims Act (FCA) resolves these very sorts of allegations regarding care provided by Caris to a small fraction of patients between 2010 and 2013."
Caris Healthcare founder and board member Norman McRae said the hospice provider "has the utmost confidence in its processes for determining patient eligibility for hospice and in the clinical judgment of those within our company on the frontlines of providing care to our patients."
The settlement resolves allegations filed in a whistleblower lawsuit by a registered nurse who was a former employee at Caris Healthcare. The whistleblower will get $1.4 million of the settlement.
The downsizing over the next 18 months is expected to reduce debts by $25 billion, and comes as the storied company falls off the Dow Jones Industrial Average for the first time in 110 years.
GE announced Tuesday it would separate GE Healthcare into a standalone company and use the proceeds from the sale to pay down its debts.
Untangling the healthcare subsidiary from a conglomerate at this scale would generally take two years or longer, so GE's 18-month timeline is aggressive, said Brad Haller, managing director in M&A practice for the consulting firm West Monroe Partners.
The spinoff decision could offer an opportunity for the separate entity to funnel its energy into the most promising areas in which GE Healthcare currently operates, Haller said.
"The laboratory supplies business in particular is a crowded market, but as a standalone business we would expect the new company to focus its R&D efforts on supplies for the burgeoning genomics field," he added.
As part of a restructuring, the storied company said it would also sell its stake in the oil and gas company Baker Hughes and refocus on core high-tech areas of aviation, power, and renewable energy;
The strategy is expected to reduced debt by $25 billion, and create a "leaner corporate structure" with $500 million in savings by the end of 2020, GE said in a media release.
GE said it expects to generate cash from the disposition of approximately 20% of its interest in the GE Healthcare business and to distribute the remaining 80% to GE shareholders.
Today's announcement came on the first day in 110 years that GE was not on the Dow Jones Industrial Average, CNN reports. It was replaced by Walgreens Boots Alliance in the elite 30-stock index Tuesday.
GE Healthcare generated more than $19 billion in revenues in 2017 and posted 5% revenue growth and 9% segment profit growth, and accounted for 16% of the company's total sales.
GE has seen its stock value drop precipitously in the past year. However, GE shares jumped 6.4% to $13.57 in early trading Tuesday.
S&P Global Ratings responded to the news by placing GE's "A" long-term rating on CreditWatch with "negative implications."
"GE's divestiture of its core healthcare segment leaves the company with less business diversity, earnings and cash flow and as such, potential for heightened volatility in profits and cash flow. However, debt reduction and substantial cash balances will reduce balance sheet risk," S&P said.
John Flannery, chairman and CEO of GE, said in a media release that the spin-offs would "improve our operations and balance sheet as we make GE simpler and stronger."
"Today's actions unlock both a pure-play healthcare company and a tier-one oil and gas servicing and equipment player," Flannery said.
"We are confident that positioning GE Healthcare and BHGE outside of GE's current structure is best not only for GE and its owners, but also for these businesses, which will strengthen their market-leading positions and enhance their ability to invest for the future, while carrying the spirit of GE forward," he said.
Kieran Murphy, president and CEO of GE Healthcare, will continue to lead the standalone company under the GE brand.
"As an independent global healthcare business, we will have greater flexibility to pursue future growth opportunities, react quickly to changes in the industry and invest in innovation," Murphy said.
"We will build on strong customer demand for integrated precision health solutions and great technology with digital and analytics capabilities as we enter our next chapter,” he said.
GE Healthcare's core business is medical imaging, monitoring, and other high-tech hospital equipment. The company does business in 140 countries.
The sell-offs are expected to be completed over the next 12 to 18 months.
