President Joe Biden has submitted his discretionary budget for 2022 to Congress. Among its healthcare provisions are funding requests for the CDC, mental health and social determinants of health programs. But there are some unusual requests as well, such as funding for an Office of… Read More »Public health, racial equity, climate action drive Biden’s budget requests for healthcare
As part of its ongoing effort to improve maternal outcomes in the country, the government has approved Illinois’ request to extend full Medicaid coverage for new mothers. The approval extends the coverage from 60 days to one year and will give about 2,500 women living… Read More »Illinois first state to offer full Medicaid benefits to women one year postpartum
The HHS’ new interoperability and information blocking rules have been in effect for one week, yet how they will be enforced is unclear. But there are some clues that could provide a glimpse into what the enforcement landscape might look like, and the best thing… Read More »Enforcement landscape for HHS data-sharing rules is hazy, experts say
Several healthcare entities that used Accellion’s file transfer software now find themselves the victims of a data breach, including Trinity Health. The software had vulnerabilities that were exploited by cybercriminals, resulting in the exposure of personal health information.
Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.
Centene has rebutted the accusations made in a sealed lawsuit filed by the Ohio attorney general that accused the insurer of over-billing the state’s Medicaid department. The lawsuit is based on a misunderstanding of how Medicaid billing operates and should be unsealed, Centene said.
While the Covid-19 pandemic has strained the healthcare industry, this administration has the advantage of being able to leverage everything we have learned over the past year to advance the next generation of value-based care.
Nadine Peters, chief legal officer of Cota Healthcare, shares her journey to leadership in health data privacy law and policy recommendations for the Biden Administration on achieving health equity through data use and education.
The agency said it had received more than 450 reports of infections or other issues in the last four years from reprocessed urological endoscopes, which are used to view or access the urinary tract. Three patient deaths were associated with these infections.
U.S. Anesthesia Partners has filed lawsuits against UnitedHealthcare in Colorado and Texas, accusing the payer of forcing it out of network and intentionally interfering with its relationships with providers in those states. But, according to UnitedHealthcare, the lawsuits are an attempt to get the insurer… Read More »Lawsuit: Like a “boa constrictor,” UnitedHealthcare squeezed anesthesia group out of competition
To maximize patient access to care, policies should be modernized to enable the broader digital health landscape
Only with proper coverage and access to the modern technologies that made their mark during Covid-19 can we truly democratize healthcare and make the promise of digital health available to all.
The Federal Trade Commission is opposing Illumina’s proposed $7.1 billion Grail acquisition, arguing that it will reduce competition for multi-cancer early detection tests. Illumina disagrees with the regulator’s position and will oppose the FTC’s challenge.
Now that trials can happen nearly anywhere, privacy teams and lawyers need to understand how data is collected, stored, managed, disseminated, and ultimately, archived or deleted.
The Washington-based health system has filed a lawsuit against EHR giant Cerner saying it intentionally misrepresented its products and services. Cerner’s systems did not operate as promised, leading to severe cash collection issues at Astria Health and forcing it into bankruptcy in 2019, the suit… Read More »Lawsuit: Cerner systems’ failure drove Astria Health into bankruptcy
California Attorney General Xavier Becerra may have won a narrow confirmation to be the Department of Health and Human Services Secretary, but if his past is any indication, his agenda will be bold when it comes to reining in pharma companies, boosting the Affordable Care… Read More »The “biggest thorn in President Trump’s side” is now HHS Secretary. What’s next?
If HIPAA does not apply to Amazon Care, then absent another privacy regulation applying, avoiding exploitation of the data relies on the good faith of the entity operating the service.
Medicare sequestration is making headlines this week, as legislation to pause the 2% payment cuts moves through Congress. Here is a recap of what the sequester cuts are, why hospitals want it gone and how lawmakers are working to make that happen.
GSK has terminated Moncef Slaoui as board chair of Galvani Bioelectronics after an investigation substantiated a sexual harassment claim dating to his tenure at the pharmaceutical giant. The company said the inquiry is continuing.
Becoming mired in discussions about public versus private options is not the best avenue, Instead, we can work to make Covid-related state executive orders permanent.
The American Hospital Association is urging the Justice Department to thoroughly review UnitedHealth’s intended acquisition of Change Healthcare. The transaction would reduce competition in the health IT arena and result in higher prices and lower quality of care, the hospital group says.
The agency charged the co-founders of the failed fecal microbiome startup with defrauding investors. The SEC is seeking a court order that would bar uBiome’s co-founders from serving as officers or directors, and require them to give up any ill-gotten gains.
While Covid-19 requires physicians and hospitals to be more efficient than ever, a number of legal structures must be considered before providers consolidate their resources. To optimize patient care and ensure rapid payment for services, avoid running afoul of these sometimes counterintuitive regulatory schemes.
President Joe Biden recently signed the $1.9 trillion Covid-19 relief package into law. The American Rescue Plan Act includes several provisions to boost coverage under the ACA, like widening eligibility for premium tax credits.
The state of California is suing Brookdale Senior Living for alleged patient safety violations at 10 nursing homes in the state and for providing false data to boost its CMS star rating. Brookdale denies both claims.
A district judge granted preliminary approval to a settlement for a class action suit brought against HIMSS by exhibitors for its conference last year. Per the settlement, HIMSS will create a $2.8 million fund to pay back exhibitors and will credit a portion of the… Read More »HIMSS to settle class action exhibitor lawsuit for $2.8M
CMS has increased the Medicare payment rate to $40 for administering single-dose Covid-19 vaccines and $80 for two-dose vaccines. The payment increase aims to support providers as they ramp up vaccine administration.
The Ohio attorney general has filed a lawsuit alleging that a Centene subsidiary, which provides Medicaid services in the state, hired multiple companies to administer pharmacy benefits in order to inflate costs. As a result, the state’s Medicaid department paid millions in overcharges.
Sutter would pay $575 million, and would have to limit out-of-network costs and cease “all-or-nothing” contracting with health plans, according to the settlement.
While Covid has made many aspects of living with a rare disease more difficult, it has inspired policies and techniques that could help rare disease research progress more smoothly both during and after the pandemic.
In a lawsuit filed three years ago, Aetna alleged that Mednax had overbilled for medical procedures and services. Now, the insurer is accusing the medical group of destroying evidence pertaining to the suit and has asked a federal court to sanction Mednax.
Blue Cross and Blue Shield of Minnesota has filed a class-action lawsuit — on behalf of itself and insurers from 30-plus states — against Martin Shkreli and Vyera Pharmaceuticals. The suit alleges the defendants intentionally monopolized the market for Daraprim to raise the price of… Read More »Insurers sue ‘pharma bro’ Martin Shkreli, company for alleged price gouging
Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later… Read More »Roche withdraws Tecentriq for bladder cancer, pullback comes amid FDA review
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences’ third approved indication for a CAR-T cell therapy.
Several California counties and Washington state dropped One Medical as a partner in distributing vaccines after reports that it let people who weren’t eligible for the vaccine jump the line. A House panel is also launching an investigation into the company’s practices.
The U.S. Supreme Court heard oral arguments Monday on the constitutionality of the Patent Trial and Appeal Board, an essential piece of the United States patent litigation puzzle and favored tool of generic and biosimilar patent challengers since its formation in 2012.
In a wide-ranging interview, a senior attorney at the state Health Department discusses the national pandemic response, the need to work across the aisle, and lessons learned during a clerkship in Israel.
Many players in life sciences and other sectors balk at updating their compliance systems because of the cost and resources involved. but addressing possible lapses now can save your company millions of dollars in fines and reputational damage.
President Biden used the Defense Production Act to direct Merck to convert two of its facilities into production sites for Johnson & Johnson’s Covid-19 vaccine. In addition, he said J&J will run its own vaccine production sites 24/7.
A new CMS rule would require insurers to cover Covid-19 tests, even for asymptomatic patients. It builds on previous legislation requiring payers to cover the cost of both testing and vaccines for their members.
The Federal Trade Commission is no longer opposing the proposed merger between Einstein Healthcare Network and Jefferson Health. Nearly three years after it was first announced, the deal can now move forward uncontested and will result in an 18-hospital system.
President Joe Biden’s pick for CMS administrator, Chiquita Brooks-LaSure, is slated to become the first Black woman to hold the post. Her policy priorities will likely center on healthcare access, including expanding insurance coverage, and health equity.
The life sciences industry will move toward more agile capabilities for regulatory operations and regulators toward an accelerated approval pathway in support of clinical studies, drawing from lessons learned during the pandemic around global collaboration.
As Texas reels from a devasting winter storm, HHS is issuing several waivers to help hospitals continue to provide care amid mounting challenges. These waivers allow non-compliance with certain HIPAA provisions and other federal regulations.
Hospital counsel, state advisors, congregate care advocates and university leaders believe that public health ethics must drive the next steps in vaccine distribution and not the constraints of the law.
At a Health Datapalooza session, former HHS head Kathleen Sebelius looked back on lessons learned in 2009 when the Affordable Care Act was moving through Congress. She cautioned the Biden administration against leaning on bipartisanship when restoring the healthcare law.
The Biden administration should recognize that including high quality, patient-centered comprehensive medication management (CMM) services as the national standard of care will improve patient outcomes, reduce health care costs and save lives.
In a wide-ranging interview, Maggie Huston, associate general counsel for precision medicine company Tempus, discusses how to balance innovation with safety as the FDA grapples with AI/ML and new, more complex technology, as well how her company quickly reacted to Covid-19.
Providers are the most common targets for cyber criminals attacking the healthcare industry, and now, two major health systems have added their names to the list of recent data breach victims. The recently divulged information breaches affected 255,000 individuals.
After a scathing report from short-seller Hindenburg claiming that Clover faced a False Claims Act investigation, the insurance startup’s stock plummeted. Clover went public last month after merging with a special-purpose acquisition company under billionaire investor Chamath Palihapitiya.
Two cardiologists claimed they were fired from Tenet’s Detroit Medical Center for raising concerns about patient care, though the medical center says they were let go for behaving unprofessionally. Following an arbitration process, a federal court in Michigan has ruled that Tenet must pay the… Read More »Tenet ordered to pay $10M+ to fired physicians, restore medical privileges
Meet Erich Drotleff, corporate counsel for health IT giant Availity, as he shares his thoughts on the role of data-sharing in public health, the impact of Covid-19 and his passion for bonsai gardening.
As the use of technology proliferates during the Covid-19 pandemic, concerns rise about privacy and health data security. Congressional Democrats have proposed new legislation that would protect individuals’ data rights amid the public health crisis.
Above the Law and Lake Whillans take a deep dive into multibillion-dollar disputes involving pay-for-delay agreements, opioids, and other areas.
Above the Law and Lake Whillans take a deep dive into multibillion-dollar disputes involving pay-for-delay agreements, opioids, and other areas.
The vendor has agreed to pay $18.3 million to settle allegations that it violated the False Claims Act by offering illegal kickbacks to boost EHR sales. The company denies any wrongdoing and said it agreed to settle to “put the matter behind us.”
The Biden administration established a special enrollment period to give uninsured Americans a chance to sign up for insurance on the HealthCare.gov markets. Providers and payers applauded the announcement, but it remains to be seen whether the move will encourage people to get insured.
With the Democrats leading the Senate and House, and Joe Biden installed as president, the Affordable Care Act will be restored and strengthened over the next four years, an expert from the Kaiser Family Foundation predicts.
Dr. Micky Tripathi will lead the ONC as the new national coordinator for health information technology, while agency veterans Liz Richter and Norris Cochranwill serve as interim leaders for CMS and HHS, respectively.
The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”
In its report released last Tuesday, a nonprofit drug pricing research group claims that seven drugs have prices that do not align with any newly discovered increase in clinical benefit, leading to over $1.2 billion in excess drug spending in 2019, alone.
An appellate court lifted a $4.3 million HIPAA fine imposed on the Texas-based cancer care center two years ago for losing the personal health information of more than 33,000 people.
Google announced it had closed its planned acquisition of Fitbit on Thursday, even thought the deal is still being investigated by the U.S. Department of Justice.
While the ultimate litigation effects of the COVID-19 pandemic remain to be seen, the current high-profile healthcare claims are as varied as product liability and mass tort actions, antitrust and patent cases, and disputes involving the Affordable Care Act.
The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned… Read More »New CMS rule to enable immediate coverage for FDA-designated ‘breakthrough’ devices
AI tools increasingly occupy a regulatory gray area in healthcare. For clinicians to assess whether they are trustworthy, they need transparency on how they work, said panelists at CES.
In a wide-ranging discussion at J.P. Morgan’s Annual Healthcare Conference, former CMS Administrator Andy Slavitt talked about the future of the ACA, telehealth and Medicare Advantage with a Democrat-led House, Senate and presidency.
Advocates, industry leaders and legislators have come to a consensus about the scope and urgency of the crisis related to inadequate development of antibiotics. They are calling for legislative fixes to protect public health.
States will get some much needed support to roll out a coronavirus vaccine. Last week, the Department of Health and Human Services shared it would roll out $22 billion in funding to support state testing and vaccination efforts.
A grand jury indicted Surgical Care Affiliates, a network of surgical centers and hospitals owned by UnitedHealthcare, for agreeing with competitors not to poach top-level talent.
A group of hospitals have sued HHS Secretary Alex Azar, arguing he should reverse a policy that prevents hospitals from getting reimbursed for Medicare-related bad debts pending at outside collection agencies. The policy has raised hospital debt payments by about $1.35 million, the lawsuit claims.
Behind the scenes: How health systems, EHR vendors will give patients unprecedented access to their data
Health systems and EHR vendors have been working for months to comply with the ONC’s final rule on interoperability and information blocking that goes into effect in April and is expected to grant patients unprecedented access to their health information. Here is a look at… Read More »Behind the scenes: How health systems, EHR vendors will give patients unprecedented access to their data
A federal appeals court has ruled against hospital groups in their legal challenge to the CMS regulation that would require hospitals to make pricing information publicly available. The rule is set to take effect Jan. 1.
A Bass Berry & Sims-hosted panel looks back at 2020 and forward to 2021.
After European regulators signed off on the deal, Australian regulators rejected a proposal by Google to assuage concerns about its proposed acquisition of Fitbit. They will continue their investigation of the merger through the end of March.
The Justice Department has sued Walmart for fanning the flames of the opioid crisis through its network of pharmacies, claiming that the retailer knowingly filled thousands of illegitimate opioid prescriptions. But Walmart says the lawsuit is “misguided.”
The American Hospital Association and several other entities, including some hospitals, filed an emergency motion to block CMS from enforcing the hospital price transparency rule set to take effect Jan. 1. Provider groups are arguing that complying with the rule would shift focus away from… Read More »Provider groups, hospitals file motion to stop CMS from enforcing price transparency rule
Congress finally reached an agreement on a $900 billion stimulus package, which includes a ban on surprise medical billing. A previous, but very similar version of the bill, raised concerns among providers and payers.
Here is our attempt to capture this bewildering and memorable year by highlighting the phenomena and personalities who made it so.
What lessons can future Covid vaccine candidates take from the FDA’s response to Pfizer and Moderna’s study data?
The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person… Read More »Hospitals sue drug companies over discount program
The HHS has proposed changes to the HIPAA Privacy Rule — the biggest in seven years, a healthcare lawyer said. But while the changes aim to improve information sharing, they could also bring about challenges for providers and payers.
Some of the biggest legal stories of the year include patients attempting to mount a class action lawsuit against Mayo Clinic after an employee improperly viewed more than 1,600 health records and the Supreme Court hearing opening arguments in a case challenging the constitutionality of… Read More »5 big healthcare lawsuits of 2020
The rule would require payers in the Medicaid, CHIP and QHP programs to build and maintain application programing interfaces to improve data exchange and the prior authorization process. But the rule does not include Medicare Advantage plans, which the American Hospital Association called “disappointing.”
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use in the U.S. Distribution, however, will remain a challenge.
A fiercely liberal state senator from Los Angeles and a moderate Assembly member from the Central Valley are joining forces to pressure Newsom to make California the first state in the nation to cover every income-eligible resident regardless of immigration status.
The new Geographic Direct Contracting Model aims to improve quality of care and slash costs for Medicare beneficiaries across an entire region. It involves setting up risk-sharing arrangements where participants will be responsible for the total cost of care for beneficiaries in the region.
President-elect Joe Biden named Xavier Becerra, the current California attorney general, as his nominee for HHS secretary. A 12-term congressman and vocal supporter of the ACA, Becerra would become the first Latino to lead the federal agency if confirmed.
Breaking Media’s MedCity News and Above the Law are collaborating to launch Healthcare Docket, a newsletter featuring the latest in litigation, regulation, transactions, and trends for in-house counsel in the healthcare and life sciences industries.
The contracts are complicated and full of risks for drug companies. But there’s also a risk to steering clear of the arrangements — reduced or restricted access to a company’s medication.
Millions of Americans without healthcare insurance could be eligible to get coverage for free, or nearly free, through financial assistance offered under the Affordable Care Act. But many who recently lost their employer-based coverage may not be aware of the options available to them.
CMS has finalized changes to the Physician Self-Referral Law, also known as Stark Law. Healthcare law experts say that these changes will generally make it easier for hospitals and physicians to remain in compliance with the statute.
The states are trying to prove they were harmed by the 2010 health law — and thus have “legal standing” to challenge its constitutionality.
Video conferencing company Zoom reached a settlement with the Federal Trade Commission over claims that the company used end-to-end encryption in its video calls, when it reportedly used a lower level of security.
Now with a 6-3 conservative majority, the nation’s highest court still seems reticent to throw out the Affordable Care Act altogether. If the law stays in place, it would be the foundation for many of President-elect Biden’s planned healthcare policies.
In a trial last year, a federal judge found that a UnitedHealth subsidiary had illegally denied mental health and substance use disorder claims. The same judge has now ordered the payer to reprocess all the claims and reform its guidelines.
The best path forward for healthcare organizations is first to understand the characteristics, causes, and indicators of ransomware attacks and then be proactive in taking preventative measures.
The final rule requires insurers to disclose information on prices for healthcare services and cost-sharing with patients. The government says it will help lower prices, but insurers aren’t so sure.
CMS’ interim rule states that Medicare will cover Covid-19 vaccines approved by the FDA, including those receiving emergency use authorization, in a reversal from its usual policy. The vaccine will be made available at no cost to Medicare beneficiaries.
Teladoc Health has sued competitor American Well for patent infringement. The company is seeking unspecified damages and a ruling that would prevent AmWell from using the telemedicine cart technology that Teladoc claims to hold the patents for.
In addition to monetary damages and the guilty pleas, the government is seeking to transform the maker of OxyContin into a public benefit company that would fund efforts to curb opioid abuse and give away drugs to prevent overdose deaths.
The health IT company filed a lawsuit against telemedicine startup CarePortMD as it looks to sell its similarly named post-acute care subsidiary.
With a new nominee as the Supreme Court prepares to hear a case that could determine the future of the Affordable Care Act, the health law’s future has been thrown into question. According to the Robert Wood Johnson Foundation, the number of uninsured could increase… Read More »Report: 21M people could lose insurance if ACA is overturned
Healthcare providers won’t have to start paying back Medicare advance loans until a year after they were issued. Under the original timeline, hospitals were supposed to start paying back the loans in August.
The investigation resulted in charges against more than 345 defendants for more than $6 billion in alleged fraud losses. Roughly $4.5 billion of that was connected to telemedicine, the Department of Justice said.
Premera will pay nearly $7 million in a settlement related to a security breach in 2014 affecting more than 10 million people. It will be the second-largest HIPAA fine to date.
The whistleblower case alleged that an electronic health records company acquired by Konica Minolta cheated on certification tests to hide software issues.
Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M
The charges, filed in Philadelphia federal court, allege that Teva conspired with four other generic drug companies to fix prices, rig bids and allocate customers. Teva – which the Justice Department and New York’s state government also sued this month for unrelated allegations – said… Read More »Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M
Fully-credentialled e-doctors still don’t exist, at least not in their entirety but major elements of the concept have already been deployed in the field, and progress toward a more comprehensive e-doc is well underway.
After four Riverside Community Hospital employees contracted Covid-19, they and their families sued HCA for failing to provide adequate protections. The plaintiffs said they were not given adequate access to PPE, not warned when they might have been exposed to Covid-19, and were encouraged to… Read More »Lawsuit accuses HCA of failing to protect healthcare workers during pandemic
A bankruptcy court in Delaware approved a stalking-horse bid from Otsuka to acquire Proteus Digital Health for $15 million. The company, which makes sensor that can be embedded in pills to track medication adherence, filed for bankruptcy in June.
Nearly all of the states, plus five territories and the District of Columbia, are seeking an aggregate of $2.156 trillion from the maker of the opioid painkiller OxyContin, according to documents filed in the U.S. Bankruptcy Court Monday.
A U.S. district judge blocked a rule by the Department of Health and Human Services that would end anti-discrimination provisions protecting transgender patients. In his decision, U.S. District Judge Frederic Block said that the rule violated a recent Supreme Court decision protecting LGBTQ workers’ rights.
A recent Pennsylvania appellate court opinion related to the Patient Safety and Quality Improvement Act (“PSQIA”) continues a trend of judicial erosion of patient safety privilege protections afforded to health care providers by statute.
A recently unsealed whistleblower case filed by the Department of Justice accuses Cigna of fraudulently overbilling for its Medicare Advantage plans. Allegations claim the company submitted unsupported diagnoses that resulted in “billions” in overpayments.