After filing a lawsuit in May to end its affiliation with Renton, Wash.-based Providence, Hoag Memorial Hospital in Newport Beach, Calif., is alleging it is now the target of retaliation, according to theLos Angeles Times.
Hoag Memorial said that Providence removed Hoag Memorial’s three facilities from its website of Southern California locations and terminated Hoag Memorial’s specialists from St. Joseph Heritage Healthcare, a network of medical providers for managed care plans in Southern California. Additionally, Hoag Memorial said that Providence informed Heritage members they would lose access to Hoag’s 13 urgent care centers by Dec. 31.
According to the report, Providence’s notice to patients that Hoag facilities and physicians would be dropped from its network all came in the fall of 2020, amid the COVID-19 pandemic.
“It was the most inappropriate, inexplicable and harsh thing to do to a lot of patients,” Hoag President and CEO Robert Braithwaite told the Los Angeles Times. “Finding a new physician or new specialist is particularly hard on seniors and any patient who has a chronic condition and has established a long-term relationship with an endocrinologist or rheumatologist or cancer doctor.”
Providence told the Los Angeles Times it disagrees that patients have been disadvantaged.
“We are committed to the well-being of our communities and to serving patients with high quality and compassionate care,” a Providence spokesperson told the Los Angeles Times.
Hoag Memorial has been affiliated with Providence, a Catholic health system, since 2016.
Hoag Memorial said the changes all came after the hospital sought to end its affiliation with Providence by filing a lawsuit. Hoag Memorial said in its lawsuit it is seeking to end the affiliation because Providence is undermining local decision-making and Catholic Church restrictions are expanding.
Providence has fought Hoag’s lawsuit to end the affiliation. The health system claims Hoag doesn’t have the right to unilaterally dissolve the affiliation, and its board members don’t have the authority to file the lawsuit. An Orange County Superior Court judge rejected Providence’s argument Feb. 1 and scheduled another court hearing for March.
Four companies that agreed to pay a combined $26 billion to settle claims about their roles in the opioid crisis plan to deduct some of those costs from their taxes and recoup around $1 billion apiece.
In recent months, as details of the blockbuster settlement were still being worked out, pharmaceutical giant Johnson & Johnson and the “big three” drug distributors — McKesson, AmerisourceBergen and Cardinal Health —all updated their financial projections to include large tax benefits stemming from the expected deal, a Washington Post analysis of regulatory filings found.
In one example, Dublin, Ohio-based drug distributor Cardinal Health said earlier this month it planned to collect a $974 million cash refund because it claimed its opioid-related legal costs as a “net operating loss carryback” — a tax provision Congress included in last year’s coronavirus bailout package as a way of helping companies struggling during the pandemic.
The deductions may deepen public anger toward companies prosecutors say played key roles in a destructive public health crisis that kills tens of thousands of Americans every year. In lawsuits filed by dozens of states and local jurisdictions, public officials have argued that the companies, among other corporate defendants, flooded the country with billions of highly addictive pills and ignored signs they were being steered to people who abused them.
Under the terms of the proposed settlement— which is being finalized and will ultimately be subject to federal court approval — the four companies would pay between $5 billion and $8 billion each to reimburse communities for the costs of the health crisis. Plaintiffs who support the proposal say it will resolve a highly complex litigation process and make funds available to communities and individuals still struggling with addiction.
Others including Greg McNeil, whose son became addicted to opioids and died from an overdose, have said $26 billion is only a small fraction of the epidemic’s financial toll and argue the proposal doesn’t include what many family members of opioid victims want the most: an admission of guilt.
All four firms disavow any wrongdoing or legal responsibility. The companies have said they produced government-approved prescription pills, distributed them to registered pharmacies and took steps to try to prevent their misuse.
U.S. tax laws generally restrict companies from deducting the cost of legal settlements from their taxes, with one major exception: Damages paid to victims as restitution for the misdeeds can usually be deducted. Still, Congress has placed stricter limits on such deductions in recent years, and some tax experts say the Internal Revenue Service could challenge the companies’ attempts to deduct opioid settlement costs.
Harry Cullen, a Brooklyn-based activist who has worked to hold drug companies accountable for the epidemic, said it is “incredibly insulting” that companies would try deduct the settlement payments. “As if they are donating it to these people who they harmed in the first place.”
Erich Timmerman, a spokesman for Cardinal Health, said in a statement that the company’s tax deductions are permissible under federal law. He also pointed to a statement chief executive Mike Kaufmann made in November, when he said Cardinal takes its role in the pharmaceutical supply chain seriously and remains “committed to being part of the solution to this epidemic.”
AmerisourceBergen declined to comment on its taxes but said in a statement the company takes steps to mitigate the diversion of prescription drugs, including by refusing service to customers it sees as a risk and by making daily reports to federal drug officials.
Johnson & Johnson declined to comment on the opioid settlement and tax deductions beyond its regulatory filings.A spokeswoman for McKesson did not respond to multiple requests for comment.
Cardinal Health’s use of the “carryback” tax break draws attention to what some see as a shortcoming of the $2 trillion U.S. coronavirus bailout known as the Cares Act. In their haste to funnel cash benefits to businesses facing economic peril, lawmakers made billions of dollars in tax breaks broadly available to any company, regardless of whether it suffered during the pandemic.
Cardinal, a company with a $15 billion market capitalization and $4 billion in available cash, surpassed Wall Street expectations for its most recent earnings period. Last week, CEO Kaufmann told investors a rebound in medical treatments and procedures had revived demand for Cardinal’s health devices and drugs. He said the company was boosting its investment in sophisticated supply-chain technology.
On the same day, Cardinal said it was filing for a tax break using the Cares Act provision and expected a nearly $1 billion cash refund from the IRS within the next 12 months. The company plans to pay $6.6 billion in the settlement.
Francine J. Lipman, a tax professor at the University of Nevada at Las Vegas, said Cardinal Health appears to be “getting a bit of a windfall from laws that Congress intended to help companies that are suffering due to a pandemic.”
The “carryback” tax break permits any company that lost money in 2018, 2019 or 2020 to apply those losses to previous, more profitable years. Some form of this provision has been permitted by the U.S. tax code for over a century to help businesses that face ups and downs to even out their taxes.
The Cares Act raised the limit on the amount of losses companies can use to offset taxes and permitted them to apply those losses to earlier periods. Because the corporate tax rate was higher before 2018, companies with recent losses can increase tax refunds they received before that year by up to 67 percent.
Cardinal estimated in August it expected to deduct $488 million from the expected opioid legal settlement. But in its Feb. 5 filing, the company said the amount probably would be higher in part because the Cares Act permitted it to carry back losses related to the opioid litigation to previous years when the tax rate was higher.
UNLV’s Lipman said Cardinal’s decision to apply for a tax refund before any legal settlement has been finalized could face scrutiny from the IRS. Deductions must be made against business expenses that are shown to have “economic effect,” she said, which may preclude deductions against future, unpaid legal settlements.
Timmerman, Cardinal’s spokesman, said the company has already recorded a loss related to the opioid litigation because Cardinal insures itself through a wholly-owned insurance subsidiary. The opioid litigation caused a loss to the insurance company’s reserve, and that is the loss that Cardinal is deducting, he said.
“Tax and accounting rules applicable to insurance companies, including self-insurance companies, require recognition of loss when an insurance reserve is set, thus establishing economic effect, even if the underlying settlement is not final,” Timmerman said.
The three other companies involved in the $26 billion settlement have estimated the tax benefits of the deal but have not filed for tax refunds. They all said the tax benefits could be lower if courts or regulators determined some or all of the payments are not tax-deductible.
McKesson, which expects to pay $8.1 billion in the settlement, said in a Feb. 2 filing that the actual cost of the deal would be $6.7 billion after taxes, implying a $1.4 billion tax benefit. The company also said $497 million in tax benefits were “uncertain” because of the “uncertainty in connection with the deductibility of opioid related litigation and claims.”
AmerisourceBergen, which anticipates a $6.6 billion settlement payment, said in November it expects a $1.1 billion tax benefit. The company said an additional $371.5 million tax benefit was possible but “uncertain.”
“A settlement has not been reached, and, therefore, we applied significant judgment in estimating the ultimate amount of the opioid litigation settlement that would be deductible,” the company said.
Matthew Gardner, a senior fellow at the nonprofit Institute on Taxation and Economic Policy, said these disclaimers suggest the companies are making conservative estimates. “That’s one way of saying they are likely going to claim even bigger tax benefits in their tax returns than they are showing on their financial statements,” he said.
Whether the payments will be deductible may hinge on specific word choices in the final terms of the settlement. Though recent changes to the tax code have attempted to close loopholes that permit companies to deduct taxes when they have committed wrongdoing, many companies now push to make sure their settlements include a “restitution” payment for victims — the “magic word” that often qualifies them for deductions, Gardner said.
In previous opioid-related settlements local governments reached with McKesson, Purdue Pharma and Teva Pharmaceuticals, the companies admitted no fault and agreed to restitution payments that appeared to qualify them for tax deductions, USA Today reported in 2019.
Johnson & Johnsonhas said it expects it could deduct as much as 21.4 percent of its $5 billion share of the settlement, which would mean a roughly $1.1 billion tax benefit. However, the company said last summer that the deductible amount may be lower if a regulation proposed by the IRS last year came into effect.
The rule, which did take effect Jan. 20, requires companies to meet a long list of specific criteria to qualify government settlements for tax deductions.
In 2019, The Post analyzed a database maintained by the Drug Enforcement Administration that tracks the path of every pain pill sold in the United States. The database shows that America’s largest drug companies distributed 76 billion oxycodone and hydrocodone pain pills across the country between 2006 and 2012 as the nation’s deadliest drug epidemic spun out of control.
McKesson, Cardinal Health and AmerisourceBergen distributed 44 percent of the nation’s oxycodone and hydrocodone pills — the two most abused prescription opioid drugs — during that time.
An investigation by The Post last year found that near the peak of U.S. opioid production, a Johnson & Johnson subsidiary was manufacturing enough oxycodone and hydrocodone to capture half or more of the U.S. market. The company also lobbied for years to help persuade regulators to loosen a narcotics import rule, allowing Johnson & Johnson’s U.S. subsidiary to produce rising amounts of opioids out of potent poppies harvested by its Tasmanian subsidiary, The Post found.
Attorneys for Johnson & Johnson have said its opioid-producing subsidiaries did not cause the United States’ addiction crisis, that the companies were heavily regulated, and that such companies play only a “peripheral role in the multibillion-dollar market for prescription opioids.”
On January 14, 2021, Planned Parenthood Southeast and the Feminist Women’s Health Center filed a lawsuit challenging the Trump administration’s approval of Georgia’s waiver under Section 1332 of the Affordable Care Act (ACA). The lawsuit was filed in federal district court in DC. This post summarizes that legal challenge as well as parts of President Biden’s recent proposed pandemic relief package that relate to the ACA and coverage. The $1.9 trillion American Rescue Plan includes several coverage-related proposals and would follow the pandemic relief passed by Congress in December 2020.
Advocates Challenge The Approval of Georgia’s 1332 Waiver
Regular readers know that the Trump administration—through the Centers for Medicare and Medicaid Services (CMS) and the Treasury Department—approved a broad waiver request from Georgia under Section 1332 of the ACA. The approved waiver authorizes the state to establish a reinsurance program for plan year 2022 and eliminate the use of HealthCare.gov beginning with plan year 2023. CMS and Treasury approved the waiver application on November 1, 2020. The history of Georgia’s waiver application and approval is summarized in prior posts as well as in the complaint filed in the lawsuit.
The reinsurance portion of the waiver is straightforward; of the 16 states with an approved Section 1332 waiver, all but one state has established a state-based reinsurance program. But the second part of the waiver application, known as the Georgia Access Model, is far more controversial. This is the broadest waiver yet to be approved under Section 1332 and relies on interpretations of Section 1332 made in much-criticized Trump-era guidance from 2018.
Critics have long argued that Georgia’s proposal fails to satisfy Section 1332’s procedural and substantive guardrails, meaning it could not be lawfully approved by the Trump administration. Given this controversy, legal challenges to the waiver approval were expected.
Planned Parenthood Southeast and the Feminist Women’s Health Center—represented by Democracy Forward—filed a lawsuit in federal district court in DC on January 14, 2021. The lawsuit alleges that the Trump administration’s 2018 guidance and approval of Georgia’s waiver are unlawful because these actions violate Section 1332 of the ACA and the Administrative Procedure Act (APA). The lawsuit also cites many of the Trump administration’s ongoing efforts to undermine the ACA as evidence that the 2018 guidance and waiver approval are part of a pattern of ACA sabotage.
In particular, the plaintiffs argue that the 2018 guidance and waiver approval are contrary to Section 1332, exceed the scope of the agencies’ authority (by allowing states to waive non-waivable provisions of the ACA), and are arbitrary and capricious. They also argue that the waiver approval failed to satisfy procedural requirements under the ACA and APA because Georgia and the Trump administration “rushed through the process without adequate time for public comment and without adequate clarification of how the state intends to approach key issues.” Here, the lawsuit points to the fact that Georgia went through four iterations of its waiver application, that its application was incomplete, and that only eight comments (less than one half of one percent) of the 1,826 total comments submitted during the most recent federal public comment period were in support of the Georgia Access Model.
As such, the plaintiffs ask the court to vacate both the approved waiver and the 2018 guidance and declare that they are unlawful. They also ask that the federal government be enjoined from taking further action on Georgia’s waiver or considering other waivers under the 2018 guidance. The plaintiffs acknowledge that the reinsurance portion of the waiver is uncontroversial and that the focus of the lawsuit is on the Georgia Access Model; however, the plaintiffs challenge approval of the waiver as a whole and ask the court to set aside the waiver in whole or in part. The plaintiffs have not sued Georgia, although it is possible that Georgia may ask to intervene in the litigation to defend its interests.
Much of the lawsuit turns on how the Trump administration interpreted the statutory guardrails under Section 1332 and long-standing concerns about direct enrollment and enhanced direct enrollment.Federal officials can grant a Section 1332 waiver only if a state demonstrates that their proposal meets certain statutory “guardrails.”These guardrails ensure that a waiver proposal will 1) provide coverage that is at least as comprehensive as ACA coverage ( “comprehensiveness” guardrail); 2) provide coverage and cost-sharing protections that are at least as affordable as ACA requirements (“affordability” guardrail); 3) provide coverage to at least a comparable number of residents as under the ACA ( “coverage” guardrail); and 4) not increase the federal deficit. The Obama administration issued guidance in 2015 on its interpretation of these guardrails.
In 2018, the Trump administration replaced that guidance and adopted its own interpretation, which manyargued was inconsistent with Section 1332. The 2018 guidance tried to pave the way for the Trump administration to approve waivers where only some coverage under the waiver (instead of all coverage) satisfied the comprehensiveness and affordability guardrails. Under this view, waivers could be approved even if only some coverage under the waiver was as comprehensive, as affordable, and as available as coverage provided under the ACA. The 2018 guidance would also allow waivers to expand access to plans that do not have to meet the ACA’s requirements. (Separately, the Trump administration issued a final rule to codify the 2018 guidance’s interpretations into regulations.)
The lawsuit argues that the Georgia Access Model violates all four statutory guardrails because it will “drastically underperform the ACA.” The waiver proposal could lead to net enrollment losses in Georgia, which violates the coverage guardrail. The waiver could lead some consumers to enroll in non-ACA plans (such as short-term plans) with benefit gaps, which violates the comprehensiveness guardrail. And consumers will have to pay higher premiums and out-of-pocket costs through higher broker commissions, reduced competition, and adverse selection against the ACA markets, which violates the affordability guardrail and potentially the deficit neutrality guardrail (since higher ACA premiums mean higher federal outlays in the form of premium tax credits).
As health care providers in Georgia, Planned Parenthood Southeast and the Feminist Women’s Health Center allege they will be harmed for several reasons. They argue that the Georgia Access Model will make it more difficult and expensive for their patients to obtain health insurance. Fewer patients with health insurance will result in higher levels of uncompensated care. More uncompensated care will strain the plaintiffs’ resources and limit other services, such as community outreach. The loss of coverage resulting from the waiver will leave their patients in worse health and develop more complex treatment needs, making it more expensive for plaintiffs to treat those patients as a result. And approval of the waiver will make it more complicated for the plaintiffs to assist their patients with enrollment.
What Happens Next
The lawsuit was assigned to Judge James E. Boasberg of the federal district court for DC. Health policy watchers know Judge Boasberg as the judge who repeatedly invalidated the Trump administration’s approval of state Section 1115 waivers with work and community engagement requirements. He is thus no stranger to assessing the legality of waiver approvals under the APA and other federal statutes.
The lawsuit will proceed, and the Biden administration will be responsible for filing a response in court. One potential option could be for the Biden administration to ask the court for a stay while it revisits the approved waiver and perhaps holds another round of public comment on the most recent version of the waiver (which, as the lawsuit points out, was never submitted for public comment). The Biden administration could consider any new comments in reevaluating approval of the Georgia Access Model.
If the federal government newly concludes that the proposal fails to satisfy the substantive guardrails, it could have grounds to amend, suspend, or terminate Georgia’s waiver, so long as certain procedures are followed. This is because the terms and conditions of the waiver agreement between the federal government and Georgia (as well as implementing regulations) always give the federal government “the right to suspend or terminate a waiver, in whole or in part, any time before the date of expiration, if the Secretaries determine that the state materially failed to comply with the terms” of the waiver.
Georgia’s waiver agreement includes some unique terms and conditions relative to waivers in other states. Those terms seem designed to limit the federal government’s ability to suspend or terminate Georgia’s waiver. But the federal government can do so as long as it complies with relevant procedures. This includes notifying Georgia of its determination, providing an effective date, and citing reasons for the amendment or termination (i.e., why the Georgia Access Model fails to satisfy Section 1332’s substantive guardrails). Georgia would have 90 days to respond, with the possibility of providing a corrective action plan to come into compliance with the waiver conditions. Georgia must also be given an opportunity to be heard and challenge the suspension or termination.
Alternatively, the Biden administration could regularly assess and monitor the state’s compliance with the terms and conditions and its progress, or lack thereof, in implementing the Georgia Access Model. Federal officials do this with all waivers. Under the waiver approval, Georgia must, for instance, satisfy requirements related to funding, reporting and evaluation, development of an outreach and communications plan, and operational standards for eligibility determinations. If Georgia fails to comply with these terms and conditions, that too would be grounds to initiate the process to amend or terminate parts or all of Georgia’s waiver.
Coverage Provisions In Biden’s American Rescue Plan
On January 14, a few days before taking office, President Biden issued a 19-page fact sheet outlining his proposed American Rescue Plan to contain the COVID-19 virus and stabilize the economy. The announcement praised the bipartisan package adopted in December 2020 as “a step in the right direction” but notes that Congress did not go far enough to fully address the pandemic and economic fallout. Following Inauguration Day, Biden is expected to lay out an additional economic recovery plan.
Among many other initiatives, the comprehensive $1.9 trillion plan would provide funding for a national vaccination program, create a new public health jobs program, provide funding for schools to reopen safely, extend and expand emergency paid leave, extend and expand unemployment benefits, raise the minimum wage, and deliver $1,400 in support for people across the country. The Biden plan also calls for preserving and expanding health insurance, noting that 30 million people were uninsured even before the pandemic and that millions may have lost job-based coverage in 2020.
First, the American Rescue Plan calls for Congress to provide COBRA subsidies through the end of September. Presumably, these subsidies would be available from the beginning of 2021, rather than subsidizing premiums from 2020. COBRA subsidies during an economic emergency are not new. Congress subsidized COBRA premiums during the 2008 recession, with mixed results. Full COBRA subsidies were included in the original Heroes Act passed by the U.S. House of Representatives in May 2020, although not in the revised Heroes Act that was passed by the House in October 2020. But neither bill was ever taken up by the U.S. Senate. It is not clear from the fact sheet whether the Biden administration is aiming for full COBRA subsidies where the government would pay 100 percent of the premiums for COBRA coverage for laid-off workers and furloughed employees—or some other amount (e.g., 80 percent of premiums).
Second, the American Rescue Plan would accomplish one of candidate Biden’s key campaign promises by expanding and increasing the value of premium tax credits under the ACA. Democrats in Congress have repeatedly passed legislation that would accomplish what the American Rescue Plan fact sheet seems to call for. For instance, the Patient Protection and Affordable Care Enhancement Act—passed by the House in July 2020—would have expanded the availability of premium tax credits to those whose income is above 400 percent of the federal poverty level and made those credits more generous by reducing the level of income that an individual must contribute towards their health insurance premiums to 8.5 percent for those with the highest incomes. This subsidy expansion and enhancement would improve the affordability of coverage for millions of Americans who purchase coverage in the individual market.
Beyond COBRA and ACA subsidies, the American Rescue Plan calls for additional funding for veterans’ health care needs and for the Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration to expand access to behavioral health services. The proposal would also increase the federal Medicaid assistance percentage (FMAP) to 100 percent for the administration of COVID-19 vaccines to help ensure that all Medicaid enrollees will be vaccinated. The proposal does not appear to otherwise mention Medicaid, which is serving as a key safety net as incomes have dropped for millions of Americans, despite bipartisan support for an enhanced FMAP during the pandemic.
The indictment describes an inside job involving Beaumont employees who sold stolen sponges, adhesives and instruments used to inspect eyes and ears. The equipment included cystoscopes, a thin tube with a camera that is inserted through the urethra and into the bladder.
“Some of the medical devices stolen and re-sold over the Internet were possibly contaminated devices that were previously used in various surgical and other medical procedures on patients,” according to the indictment.
The three individuals charged in the indictment are:
Paul Purdy, 49, of Bellbrook, Ohio
Valdet Seferovic, 32, of Auburn Hills
Zafar Khan, 40, of Fenton
Purdy and Seferovic not respond to messages seeking comment Thursday while Harold Gurewitz, a lawyer for Khan, declined comment. The three defendants are scheduled to make initial appearances Jan. 21 in federal court.
“These defendants used their employment status to circumvent the safety protocols established by Beaumont Hospital to profit from the theft of medical devices and put the health and safety of the general public at risk in doing so,” U.S. Attorney Matthew Schneider said in a statement.
The wire fraud and conspiracy charges listed in the 18-count indictment are punishable by up to 20 years in federal prison.
Beaumont officials have cooperated fully with the investigation, health system spokesman Mark Geary wrote in an email to The Detroit News.
“This kind of theft does a disservice to more than just Beaumont — it does a disservice to the community,” Geary wrote. “We have confidence in the legal process and trust a just result will be achieved.”
Purdy and Seferovic were friends who worked at Beaumont and had access to storage areas inside one of the system’s hospitals, prosecutors alleged. The duo gained access to medical supplies and devices, according to the government, and devised a plan to steal the equipment and sell the items throughout the U.S.
Purdy, who worked for Beaumont until resigning in 2017, never told buyers the items were stolen, prosecutors said. After he quit, Purdy recruited Seferovic to continue stealing items from the medical supply, cleaning and disinfecting rooms, according to prosecutors.
“Medical devices that are removed from their rightful place in a hospital or other medical setting put patients’ health at risk by denying them access to needed diagnostic imaging and treatment,” Lynda Burdelik, special agent in charge of the U.S. Food and Drug Administration’s Criminal Investigations field office in Chicago, said in a statement.
Purdy paid Seferovic for stolen items via PayPal and resold the devices on eBay and Amazon, according to the government. On March 28, 2018, the indictment alleges Purdy received a $4,800 wire payment from the sale of two cystoscopes.
That same day, Seferovic received a $2,550 payment via PayPal, according to the government.
In fall 2017, Seferovic also agreed to steal and sell medical devices and supplies to Khan, who owns Wholesale Medical & Surgical Suppliers of America, LLC in Flint, according to the indictment.
Seferovic would transfer stolen supplies to Khan during meetings in metro Detroit, including at a Walmart parking lot, according to the indictment. Khan, in turn, would sell the supplies and devices online at below retail price.
Seferovic’s job duties and status was unclear Thursday.
The investigation and alleged crimes have prompted internal changes at Beaumont.
“…Beaumont has enhanced security protocols and implemented additional checks and balances across the organization to reduce the chances of something like this happening again,” Geary said.
Drug companies AstraZeneca, Eli Lilly and Sanofi filed separate lawsuits seeking to preserve their ability to restrict offering 340B-discounted drugs to contract pharmacies.
The lawsuits, filed Tuesday in different federal courts, seek to get rid of an advisory opinion filed by the Department of Health and Human Services’ (HHS’) general counsel that says drug companies must offer 340B drugs to contract pharmacies, which are third-party entities that dispense drugs on behalf of hospitals participating in the program.
The drug companies argue that the advisory opinion contracts the statute for the 340B program, which requires manufacturers to offer discounted products to safety net hospitals and other providers in exchange for participation in Medicare and Medicaid.
“The statute, on its face, does not require manufacturers to recognize any contract pharmacies, much less unlimited contract pharmacies,” the legal filing from AstraZeneca said.
AstraZeneca wants a federal court to declare the advisory opinion didn’t follow proper procedure and exceeded HHS’ statutory authority. The manufacturer also wants a court to declare that companies are not required to offer 340B discounts to contract pharmacies.
The lawsuits come less than a week after the American Hospital Association (AHA) and five other groups and three individual systems sent letters to the drug companies that have halted or restricted sales to contract pharmacies. They wanted the drugmakers to reinstate sending the discounted products to their pharmacies and reimburse facilities for any damages.
AHA and several groups sued HHS to get the agency to clamp down on the drug manufacturers’ moves.
AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics have taken a range of actions to clamp down on sales to contract pharmacies, which a majority of 340B-covered entities use.
The companies have argued that the discounts do not filter down to patients, but hospital and advocacy groups charge that the discounts are vital, especially as safety net providers operate on thin margins.
“Make no mistake: the boom in contract pharmacies has been fueled by the prospect of outsized profit margins on 340B discounted drugs,”AstraZeneca argued in its court filing.
With just a dozen days left in power, the Trump administration on Friday approved a radically different Medicaid financing system in Tennessee that for the first time would give the state broader authority in running the health insurance program for the poor in exchange for capping its annual federal funding.
The approval is a 10-year “experiment.” Instead of the open-ended federal funding that rises with higher enrollment and health costs, Tennessee will instead get an annual block grant. The approach has been pushed for decades by conservatives who say states too often chafe under strict federal guidelines about enrollment and coverage and can find ways to provide care more efficiently.
But under the agreement, Tennessee’s annual funding cap will increase if enrollment grows. What’s different is that unlike other states, federal Medicaid funding in Tennessee won’t automatically keep up with rising per -person Medicaid expenses.
The approval, however, faces an uncertain future because the incoming Biden administration is likely to oppose such a move. But to unravel it, officials would need to set up a review that includes a public hearing.
Meanwhile, the changes in Tennessee will take months to implement because they need final legislative approval, and state officials must negotiate quality of care targets with the administration.
TennCare, the state’s Medicaid program, said the block grant system would give it unprecedented flexibility to decide who is covered and what services it will pay for.
Under the agreement, TennCare will have a specified spending cap based on historical spending, inflation and predicted future enrollment changes. If the state can operate the program at a lower cost than the cap and maintain or improve quality, the state then shares in the savings.
Trump administration officials said the approach adds incentive for the state to save money, unlike the current system, in which increased state spending is matched with more federal dollars.If Medicaid enrollment grows, the state can secure additional federal funding. If enrollment drops, it will get less money.
“This groundbreaking waiver puts guardrails in place to ensure appropriate oversight and protections for beneficiaries, while also creating incentives for states to manage costs while holding them accountable for improving access, quality and health outcomes,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services. “It’s no exaggeration to say that this carefully crafted demonstration could be a national model moving forward.”
Opponents, including most advocates for low-income Americans, say the approach will threaten care for the 1.4 million people in TennCare, who include children, pregnant women and the disabled. Federal funding covers two-thirds of the cost of the program.
Michele Johnson, executive director of the Tennessee Justice Center, said the block grant approval is a step backward for the state’s Medicaid program.
“No other state has sought a block grant, and for good reason. It gives state officials a blank check and creates financial incentives to cut health care to vulnerable families,” she said.
The agreement is different from traditional block grants championed by conservatives since it allows Tennessee to get more federal funding to keep up with enrollment growth. In addition, while the state is given flexibility to increase benefits, it can’t cut them on its own.
Democrats have fought back block grant Medicaid proposals since the Reagan administration and most recently in 2018 as part of Republicans’ failed effort to repeal and replace major parts of the Affordable Care Act. Even some key Republicans opposed the idea because it would cut billions in funding to states, making it harder to help the poor.
Implementing block grants via an executive branch action rather than getting Congress to amend Medicaid law is also likely to be met with court challenges.
“This is an illegal move that could threaten access to health care for vulnerable people in the middle of a pandemic,” Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Committee, posted on his Twitter account. “I’m hopeful the Biden Administration will move quickly to rollback this harmful policy as soon as possible.”
The block grant approval comes as Medicaid enrollment is at its highest-ever level.
More than 76 million Americans are covered by the state-federal health program, a million more than when the Trump administration took charge in 2017. Enrollment has jumped by more than 5 million in the past year as the economy slumped with the pandemic.
Medicaid, part of President Lyndon B. Johnson’s “Great Society” initiative of the 1960s, is an entitlement program in which the government pays each state a certain percentage of the cost of care for anyone eligible for the health coverage. As a result, the more money states spend on Medicaid, the more they get from Washington.
Under the approved demonstration, CMS will work with Tennessee to set spending targets that will increase at a fixed amount each year.
The plan includes a “safety valve” to increase federal funding due to unexpected increases in enrollment.
“The safety valve will maintain Tennessee’s commitment to enroll all eligible Tennesseans with no reduction in today’s benefits for beneficiaries,” CMS said in a statement.
Tennessee has committed to maintaining coverage for eligible beneficiaries and existing services.
In exchange for taking on this financing approach, the state will receive a range of operating flexibilities from the federal government, as well as up to 55% of the savings generated on an annual basis when spending falls below the aggregate spending cap and the state meets certain quality targets, yet to be determined.
The state can spend that money on various health programs for residents, including areas that Medicaid funding typically doesn’t cover, such as improving transportation and education and employment services for enrollees.
The 10-year waiver is unusual, but the Trump administration has approved such long-term experiments in recent years to give states more flexibility.
Tennessee is one of 12 states that have not approved expanding Medicaid under the Affordable Care Act, leaving tens of thousands of working adults without health insurance.
“The block grant is just another example of putting politics ahead of health care during this pandemic,” said Johnson of the Tennessee Justice Center. “Now is absolutely not the time to waste our energy and resources limiting who can access health care.”
State officials applauded the approval.
“It’s a legacy accomplishment,” said Tennessee Gov. Bill Lee, a Republican. “This new flexibility means we can work toward improving maternal health coverage and clearing the waiting list for developmentally disabled.”
“This means we will be able to make additional investments in TennCare without reduction in services and provider cuts.”
Five hospitals recently sued HHS over its calculation of Medicare Part A disproportionate share hospital payments for patients who were enrolled in Medicare Advantage plans under Part C of the Medicare Act.
The federal lawsuit was filed Dec. 21 by Duke Raleigh (N.C.) Hospital, Durham (N.C.) Regional Hospital, Geisinger Medical Center in Danville, Pa., Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa., and The Washington (Pa.) Hospital.
The hospitals’ lawsuit takes issue with a Medicare policy change, adopted in 2004, that included a new methodology for allocating Medicare Part C days in the disproportionate share hospital formula. The appeals court has ruled against HHS in three actions challenging its attempts to apply its Part C days policy to deny DSH payments to hospitals. However, the hospitals argue that HHS is disregarding those decisions and a decision by the U.S. Supreme Court.
“The agency has continued to apply the Part C days policy adopted in the now-vacated 2004 rule in violation of these decisions, including in the payment determinations at issue for the plaintiff hospitals in this case, in a recently issued proposed rule seeking to re-adopt the same 2004 policy retroactively, and in a ruling that would leave undisturbed the payment determinations from which hospitals have appealed and, as construed by the agency’s administrative Board, not permit further administrative or judicial review of those determinations,” the complaint filed Dec. 21 states.
The hospitals argue that HHS’ attempts to apply the policy should be rejected. The hospitals are asking the court to declare the final payment determinations reflecting the policy change invalid.
In late November, Cliff Willmeng’s wife handed him a sealed envelope at their Minneapolis home “with some trepidation,” he recalled. He looked at the sender printed on the front: “Minnesota Board of Nursing.” Willmeng, a registered nurse, openedtheletter and read that the board was investigating his conduct as a nurse at United Hospital in St. Paul, from which he’d been fired in May. Clearly his license was at stake.
Willmeng was disappointed, but not surprised. He believes the review is due to his standing up for his own safety and that of other nurses, and for filing a lawsuit and union grievance against United’s parent company, Allina Health, after his termination.
He also thinks the investigation, like his firing, has been orchestrated to scare other healthcare workers away from reporting safety violations and concerns as the pandemic rages, and to make an example out of the former union steward.
The investigation is being led by a former Allina executive: “It feels meant to intimidate me,” he said.
Taking a Stand for Safety
Willmeng is a 13-year nursing veteran, husband, and father, who began working at United in October 2019.
When the pandemic hit late last winter, managers instructed nurses to use and reuse their own scrubs rather than hospital-issued scrubs. They were asked to launder their scrubs themselves at home.
Willmeng and others worried about bringing the virus home and pressed for the hospital scrubs. These scrubs were available, he said, and healthcare workers were permitted to wear hospital gear at Abbott Northwestern, another Allina hospital in Minneapolis.
In addition, while United managers told staff their laundering co-op could not keep up with demand for all the scrubs, the co-op denied that assertion, said Brittany Livaccari, RN, an ER nurse and union steward at United.
Willmeng addressed his concerns with management, filed state OSHA complaints, and enlisted the Minnesota Nurses Association (MNA). “He was taking action 100% to protect himself and to protect his patients,” Livaccari said.
But management did not change its policy, which was devised before the pandemic, and pointed to early-pandemic CDC and Minnesota Department of Health (MDH) guidelines — even when Willmeng shared emerging reports suggesting the policy was jeopardizing safety.
“It did feel like a pissing match,” Livaccari said. “We didn’t feel like we were being protected. … We weren’t being valued.”
Managers repeatedly wrote up Willmeng and colleagues who wore the hospital scrubs despite the policy. “It definitely felt like an intimidation tactic — ‘You’re going to do this, you’re going to follow these policies,'” Livaccari said. “A lot of staff chose to stop wearing those scrubs because they needed their job, they have families to pay for, they were afraid.”
Willmeng continued to wear the hospital scrubs. “I had to decide whether that policy was most important, or the safety of my workplace and public health and my family,” he said.
On May 8, the hospital terminated Willmeng. He said its stated cause was violating hospital policies regarding uniform code and a respectful workplace.
Two weeks later, the local nurses’ union held a rally that drew hundreds of supporters for Willmeng and blasted the hospital’s scrub policy.
‘I’m Not a Bad Nurse’
In June, Willmeng sued Allina for whistleblower retaliation and wrongful termination. The case is scheduled to be heard next August.
His union grievance is set to be arbitrated in January. He maintains his firing was not for “just cause” because United’s uniform code policy violated standard nursing practices.
Willmeng has been running the website WeDoTheWork, which describes itself as “worker-run journalism.” It’s an independent but union-affiliated publication that “unflinchingly tells our side of the story, and takes the fight to management.”
Willmeng is applying for jobs, but despite his experience, a national nursing shortage, and reports of severe understaffing as hospitalizations surge again, Willmeng has not even been interviewed by any of the roughly 20 medical centers he has applied to.
He thinks he is being blackballed. “I’m not a bad nurse,” he said.
The board letter cited these concerns: “On April 16, 2020, you received a written warning for not following the uniform policy,” reads one item, citing a report shared with the board. “On May 5, 2020, you were issued a final written warning for repeatedly violating policy. … On May 8, 2020, you were terminated from employment based on violating hospital policies, behavioral expectations, code of conduct, and not following the directions of your manager.” The letter asks Willmeng to respond to eight questions.
“This looks like it was taken right out of my HR file,” he said. The board will not reveal who reported him, citing confidentiality policies. But he is certain — given the detail in the letter — that it was Allina/United management.
The nursing board cannot comment on Willmeng’s review to protect confidentiality, said executive director Shirley Brekken, MS, RN. The board receives about 1,200 complaints annually and first determines whether a complaint would merit disciplinary action if true. If so, it launches a review.
Allina declined to answer questions via a spokesperson, citing the lawsuit. “We cannot appropriately retain employees who willfully and repeatedly choose to violate hospital policies,” according to an emailed statement. Throughout the pandemic Allina has been following CDC and MDH guidelines, “which do not consider hospital issued scrubs as PPE [personal protective equipment].”
“In the early days of the pandemic, our local and national supply chain was extremely stressed,” the statement continues. “Our practices are aligned with other local and national hospitals … and have enabled us to allocate the appropriate supplies for daily patient care and ongoing care for COVID-19 patients.”
But United healthcare workers still lack hospital scrubs and enough N95 masks, Livaccari said, and the hospital is severely understaffed as the patient load increases. “We hear, ‘It’s a pandemic. You have to do more with less,'” she said. “It’s a really bad situation.”
Retaliation and Intimidation
Some think Willmeng’s review was initiated primarily to retaliate against him, not to protect public health and safety.
“Hospitals, they want a docile workforce, they want a workforce they can control,” said John Kauchick, RN, a retired 37-year nursing veteran who advocates for workplace rights. They do so “by fear and intimidation,” he added. “A nurse’s number one fear is to be turned in to a board of nursing for anything.”
“If you’re a whistleblower and you speak truth to power, that will get you a disciplinary hearing even more so than if there is patient harm.”
The letter was drafted more than six months after Willmeng was fired, and after he filed the lawsuit and union grievance. Just before he received the letter, he was elected to the MNA board. The timing strikes Willmeng and Kauchick as significant.
“If you think there’s been a violation, you are supposed to report that in a much shorter time period,” Kauchick said. Kauchick thinks Allina filed the complaint as leverage, to persuade Willmeng to drop the grievance and lawsuit.
But Livaccari noted the process can take up to six months, and that every firing is supposed to be reported to the board.
Like Kauchick, she takes umbrage with the review’s leader: Stephanie Cook, MSN, RN, a board nursing practice specialist who spent 24 years as a director with Allina. She was a member of multiple Allina committees, including its ethics committee, according to reports. She was with Allina as recently as 2018. Brekken confirmed her employment with Allina, noting that it’s “a very large system.”
Regardless, that’s a conflict of interest, Kauchick and Livaccari said, arguing that Cook should not be part of the review. “It’s just so blatantly obvious. How are you going to look at this with an unbiased lens when you worked for the organization that says Cliff was in the wrong?” Livaccari said. “It’s so inappropriate.”
This is not uncommon, Kauchick said, noting state nursing board reviews are “really just designed to get rid of whistleblowers. It’s like a buddy system. They hire higher-ups from big hospital systems. It’s just incestuous.”
Brekken was aware of Cook’s background before a colleague assigned this review to Cook, she said, noting the board vets staff for personal involvement in cases. Brekken “might consider” removing Cook from the review given her connection to Allina, she said, but added: “Many individuals on our staff may have worked for a particular health system throughout their career.”
The board could throw out the complaint or take action. Such actions typically range from a reprimand to revoking a nurse’s license, Brekken said. A staff member and board member together will review the report and Willmeng’s response, but she said the board itself makes final decisions.
Willmeng is also focused on the grievance, which asks Allina to provide full back pay and reinstate him.
“I would not feel comfortable; I’d feel very anxious” going back, he said. “But I’m an ER nurse. I belong in the ER…. It’s important for a frontline healthcare worker to demonstrate that when they stand up and speak truthfully and assertively about working conditions and patient safety, that they can’t just be triangulated.”
His salary — about twice his current unemployment benefits — is also a draw, he acknowledged.
Meanwhile, he continues applying for other jobs. His life insurance cost doubled and his family switched to his wife’s lesser health insurance plan, he said. A fourth-grade teacher with a local public school system, her salary is the primary support for themselves and their two children.
Willmeng also just hired an attorney at $250 an hour to help him respond to the board letter. “It’s not something I take lightly,” he said. “There’s cause for real concern. That’s my nursing license, that’s everything.“
A Florida man filed a class-action lawsuit against Aetna Life Insurance Co., claiming it systematically denied coverage for a cancer treatment called proton beam radiation therapy, according to court documents.
The lawsuit, which has been moved to the District Court for the Middle District of Florida, was filed by Scott Lake. Mr. Lake claims Aetna wrongfully denied coverage for proton beam radiation therapy to treat his prostate cancer. The denial, which deemed the treatment experimental, came despite recommendations from oncologists, he claims.
While some insurers have begun covering proton beam radiation therapy for certain cancers — for example, Medicare generally covers the treatment — it is not uniform across the commercial insurance industry. In 2019, UnitedHealthcare found itself in court over its denial of coverage to one of its members who also sought the treatment for prostate cancer.
Aetna’s proton beam radiotherapy policy, last updated in November, outlines when the insurer considers the treatment medically necessary. In the bulletin, Aetna said it considers proton beam radiotherapy “experimental and investigational” for prostate cancer in adults over age 21 “because its effectiveness for these indications has not been established.”
Becker’s reached out to Aetna for comment on this lawsuit. This article will be updated as more information becomes available.