Legal

Public health, racial equity, climate action drive Biden’s budget requests for healthcare

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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

How eConsent empowers more participant engagement in clinical trials

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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.

FDA warns of infection risk from reusable urological endoscopes

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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. 

Lawsuit: Like a “boa constrictor,” UnitedHealthcare squeezed anesthesia group out of competition

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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

Amazon Care and privacy: A host of unknowns

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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.

SEC charges uBiome co-founders with $60M securities fraud

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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. 

How Covid-19 is changing rare diseases research

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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.

4 signs your compliance program is out of date

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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.

The year to come in life sciences safety and regulatory practices

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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.

HHS issues HIPAA, CMS regulatory waivers to Texas hospitals

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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.

Short seller targets insurance startup Clover in scathing report

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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.  

Biden to reopen ACA marketplaces for 3 months

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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.

How Biden will restore the ACA: 4 potential changes

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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.

New CMS rule to enable immediate coverage for FDA-designated ‘breakthrough’ devices

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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

Can we warp-speed antibiotic development? 

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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.

46 hospitals file suit to reverse HHS bad debt policy

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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

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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

Walmart pharmacies fueled opioid crisis, DOJ lawsuit claims

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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.”

Provider groups, hospitals file motion to stop CMS from enforcing price transparency rule

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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

New stimulus bill to axe surprise billing practices

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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.

CMS proposed rule requires payers to streamline prior authorizations

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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.”

CMS’ new Geo care delivery model: 5 things to know

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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.

Biden to nominate California AG Xavier Becerra as HHS head

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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.

ACA could help millions of uninsured gain free coverage

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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.

 Zoom reaches settlement over encryption claims

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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.

Supreme Court justices seem unlikely to axe the ACA

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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.

Ransomware in healthcare: The inevitable truth

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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.

Medicare to cover all FDA-approved Covid-19 vaccines

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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 v. AmWell: 5 things to know

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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.

Premera to pay $6.85M fine for data breach

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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.

Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M

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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

The e-doctor will see you now

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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.

Court approves Otsuka’s bid to buy Proteus for $15M

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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.

District judge blocks HHS rule that would end transgender health protections

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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.

Whistleblower lawsuit accuses Cigna of Medicare Advantage fraud

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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.