Legal

CMS grants quality reporting exceptions for facilities recovering from Hurricane Ida

The agency has granted certain Medicare quality reporting exceptions to healthcare facilities in areas of Louisiana, Mississippi, New York and New Jersey that were battered by Hurricane Ida. By providing the exceptions, CMS aims to enable facilities to direct their resources toward recovery.

Better late than never? Eczema drug now approved, Incyte says warning unwarranted

Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.

Seagen, Genmab antibody drug conjugate gets FDA approval in cervical cancer

The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment with chemotherapy. Tivdak is Seagen’s third ADC; for Genmab, the drug will become its first commercialized product.

Health apps could face big fines if they don’t disclose privacy breaches 

The agency reminded health apps and wearables companies that they must disclose any breach of users’ health information, even if they are not a HIPAA covered entity. Companies that fail to disclose a breach could face thousands of dollars per day in fines.

Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug

The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.

CMS suspends enrollment in UnitedHealthcare, Anthem MA plans

The agency has suspended enrollment in three UnitedHealthcare plans and one Anthem plan for 2022 because the plans did not spend enough of their premium incomes on medical benefits and claims. The payers can contest the suspension, though it is unclear if they plan to.

FDA panel backs booster shots in high-risk groups after rejecting broader proposal

An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the …

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Racism, sexism and now fraud: Lawsuits pile up at New Jersey ‘AI’ firm

A previous investigation by MedCity News found that ElectrifAi was touting an improperly-developed algorithm during the earliest phase of the Covid-19 pandemic, with both the company and CEO defendants in an employment discrimination lawsuit. A year later, lawsuits are piling up as more former employees complain that the company and CEO lied about its AI …

Racism, sexism and now fraud: Lawsuits pile up at New Jersey ‘AI’ firm Read More »

Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature

Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.

Lawsuit: Aetna fertility coverage policy “an illegal tax” on LGBTQ people

The lawsuit alleges that an Aetna policy discriminates against LGBTQ people by requiring them to pay thousands in out-of-pocket costs for fertility treatments before becoming eligible for coverage. Though Aetna has agreed to pay the costs incurred by the plaintiffs, the suit aims to strike down the policy as a whole.

Astellas Pharma reports fourth patient death in gene therapy clinical trial

The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.

New HHS proposed rule requires payers to disclose broker rates, share air ambulance data

In a set of newly proposed rules, HHS wants insurers offering individual and short-term, limited-duration coverage to disclose to members the rates they pay to brokers who help people select health plans. The government also wants to collect air ambulance data to help curb the high and unexpected costs that arise from these services.

FDA sets expectations for pediatric Covid-19 vaccines; decision could come mid-fall

Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.

FDA warns Kaleido Bio to test its Covid-19 candidate as a drug, not a medical food

The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical trial application. Kaleido claims the filing was not required because the product is a medical food, but the regulator doesn’t buy that argument.

Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy

A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed …

Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy Read More »

Impel NeuroPharma’s drug-device combo product nabs FDA nod for migraine

The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.

Feds slap UPMC, cardiothoracic surgery chair with billing fraud suit

The lawsuit alleges that UPMC and the chair of its cardiothoracic surgery department knowing submitted false claims for concurrent surgeries that violated regulations. But, according to UPMC, there is no regulation that prohibits overlapping surgeries or billing for them.

FDA cracks down on JAK drug class, calls for new warnings of heart, cancer risks

The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency is requiring additional warnings flagging those risks. The updated warnings extend to AbbVie and Eli Lilly medicines in the same drug class.

Report: Medicare trust fund still expected to run out by 2026

The latest report from the Medicare Board of Trustees shows that the health insurance trust fund, also known as Medicare Part A, will run out in a mere five years, which is in line with reports released in 2018, 2019 and 2020, indicating that the Covid-19 pandemic has not hastened the fund’s depletion.

Sutter Health to pay $90M to resolve False Claims allegations

The California-based health system will pay a hefty price to resolve allegations that it knowingly submitted inflated diagnosis codes for certain Medicare Advantage beneficiaries to receive higher payments. Sutter Health does not admit any liability in the matter.

DeepMind has unlocked protein-based medicine – what does that mean for drug patents?

One of science’s great puzzles is being solved by artificial intelligence and the answers shared freely on the internet. How can life sciences companies make the most of DeepMind’s discoveries while protecting their own?

Hackensack Meridian Health, Englewood Health appeal court decision to block merger  

The FTC sued to block the merger between the two New Jersey-based health systems and won a preliminary injunction earlier this month. But the providers believe that the merger would not raise prices or stifle competition — like the FTC alleges it would — and have filed an appeal.

BioMarin stands tall with first approved drug for rare disease that causes dwarfism

The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.

FDA approves first drug for severe itching in chronic kidney disease patients

Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the FDA’s nod green light for its injectable drug, Korsuva.

Insurer price transparency rule faces legal challenges: 4 takeaways

Two lawsuits, filed by the U.S. Chamber of Commerce and the Pharmaceutical Care Management Association, allege that portions of the price transparency rule governing insurers are unlawful and would drive up healthcare prices, contrary to the rule’s stated aim.

Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval

Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.

Illumina’s Grail buyout beats deadline, but legal and regulatory hurdles remain

In closing its Grail acquisition before U.S. and European regulators sign off, Illumina is taking a chance the deal will pass regulatory muster. It’s a potentially pricey gambit, as Illumina could face fines for its early action and there are no assurances that regulators will agree that the deal is not anticompetitive.

FDA decision for GSK drug opens door to treatment of more cancer patients

GlaxoSmithKline drug Jemperli is now FDA approved for treating solid tumors throughout the body as long as they have a particular genetic signature. Expanding the drug’s approval means the drug can treat more patients who have more types of cancer, and it also gives GSK a way to grow revenue in its thin oncology portfolio.

Years after Pfizer merger, ex-Medivation exec gets insider trading charge

A Medivation executive at the heart of the company’s team that sold the company to Pfizer for $14 billion five years ago is facing allegations of insider trading. Matthew Panuwat A complaint filed by the US Securities and Exchange Commission (SEC) today accuses Matthew Panuwat, the then-head of business development at Medivation, of buying sizeable …

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Judge blocks HHS from requiring religious providers to perform gender-transition, abortion procedures

The permanent injunction prevents HHS from interpreting a section of the ACA, which bans discrimination, to include gender identity and pregnancy status. This move prohibits the federal agency from penalizing religious providers for refusing to perform or provide insurance coverage for gender-transition surgeries and abortions.

Sesen Bio says rejected bladder cancer drug may need new clinical trial

For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.

Merck drug acquired in $1B deal approved to treat tumors sparked by rare disease

FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.

UnitedHealth subsidiaries settle mental health parity allegations for $15.6M

UnitedHealthcare and United Behavioral Health agreed to the settlement to resolve allegations that they illegally denied coverage for mental health and substance use disorder treatments. The allegations are related to business practices they no longer use, parent company UnitedHealth Group said.

FDA authorizes Covid-19 booster shots, but only for the immunocompromised

Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the results of two small studies that tested third shots of the mRNA Covid vaccines from Moderna and Pfizer/BioNTech.

Second FDA clinical hold for Aprea cancer drug cites safety data in another study

For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.

Providers will likely face more lawsuits against vaccine mandates. But they are also more likely to win.

Providers’ legal defense against lawsuits aiming to tear down vaccine mandates is wide-ranging, from making the argument that allowing an unvaccinated worker into their facilities could pose a direct threat to the worker to invoking a 1905 precedent set by the Supreme Court.

CMS repeals MA rate disclosure requirement, boosts hospital payments by $2.3B

CMS has finalized its 2022 inpatient payment rule, which will not only repeal part of the price transparency requirements related to Medicare Advantage rates and increase payments to hospitals but will also require facilities to report Covid-19 vaccination uptake among its employees.

Justice Department joins False Claims lawsuits against Kaiser Permanente

The government has intervened in complaints alleging Kaiser Permanente entities defrauded Medicare out of “tens of millions of dollars” by knowingly submitting false diagnoses for Medicare Advantage beneficiaries. Kaiser denies the allegations, saying it is in compliance with program requirements.

FDA turns down Ardelyx’s chronic kidney disease drug and asks for another trial

Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two weeks after the company received an FDA letter citing deficiencies in the drug application.

Texas law eases prior auth burdens, but payers see it as a dangerous move

The law, which will take effect in September, prohibits payers from requiring pre-approval from certain providers. While providers believe the law will cut administrative burdens, and improve care delivery, payers say it could lead to patient harm.

Martin Shkreli’s $7.4m forfeit is paid, thanks to that Wu-Tang Clan album

The US government has sold off the one-of-a-kind Wu-Tang Clan album famously bought by ‘pharma bro’ Martin Shkreli, with the proceeds enough to wipe out his $7.4 million fine for defrauding investors. Shkreli, the pharma entrepreneur who became notorious in 2015 for hiking the price of a lifesaving drug, bought the Once Upon a Time …

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Martin Shkreli’s $7.4m forfeit is paid, thanks to that Wu-Tang Clan album

The US government has sold off the one-of-a-kind Wu-Tang Clan album famously bought by ‘pharma bro’ Martin Shkreli, with the proceeds enough to wipe out his $7.4 million fine for defrauding investors. Shkreli, the pharma entrepreneur who became notorious in 2015 for hiking the price of a lifesaving drug, bought the Once Upon a Time …

Martin Shkreli’s $7.4m forfeit is paid, thanks to that Wu-Tang Clan album Read More »

BCBS of Kansas City sues Covid-19 testing provider over alleged price gouging

GS Labs, a Covid-19 testing provider, has submitted over $9.2 million in claims to the insurer as a result of its grossly inflated prices, the lawsuit states. The testing company rejected the claims, saying its “prices accurately reflect the level of service” it provides.

Only 5% hospitals are compliant with price transparency rule. Here’s how they did it.

The hospitals that were found to be fully compliant with the federal price transparency rule had a few strategies in common, including picking the right technology partner and beginning their efforts early — in some cases before the rule was even proposed.

Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals

Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.

With eviction moratorium set to end, millions of people are still behind on rent

With the CDC’s eviction moratorium set to lift at the end of the month, many people are still struggling with rent payments and utility debt. Insurance and healthcare technology leaders shared how they’re preparing and what’s needed to address the housing shortage in the long term.

CMS proposes fining hospitals up to $2M annually for not following price transparency rule

CMS’ latest proposed rule, which includes stringent penalties for hospitals that are found to be flouting the price transparency rule, comes on the heels of an analysis showing that a vast majority of hospitals are not in compliance with the regulation that went into effect on Jan. 1.

CMS proposes to cover mental health virtual visits through 2022

In the 1,747-page rule, which will be finalized later this year, CMS proposes expanding access to telehealth for behavioral healthcare, including for the first time allowing Medicare to pay for mental health virtual visits when they are provided by rural health clinics and federally qualified health centers and letting providers offer audio-only telehealth visits for …

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A ban on surprise bills is just a Band-Aid

Until Medicare and commercial insurers link the reimbursement they pay providers to the things that matter to us as consumers and citizens, we will continue to have a dysfunctional system that abides appalling practices like surprise billing, and continue to spend time on band-aids like this interim final rule instead of fixing the real problem.

Biden’s latest executive order aims to boost healthcare competition

President Joe Biden has signed a new executive order to tackle anti-competitive behavior across American industries. With regard to healthcare, Biden is directing federal agencies to revise guidelines for hospital mergers, enable people to comparison shop health plans on the ACA marketplaces and work with states to import drugs from Canada.

Provention Bio drug for delaying type 1 diabetes hit with FDA delay of its own

Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that was evaluated in clinical trials. A larger study testing the prospective type 1 diabetes therapy teplizumab is ongoing and could provide the information the agency needs.

Federal agencies issue rule enforcing surprise billing ban

HHS, along with other federal agencies, have released the first set of regulations that ban surprise billing and out-of-network charges for several types of services. More regulations are expected, especially those pertaining to the independent dispute resolution process that providers and payers will have to undergo if they cannot agree on out-of-network claims payment.

CMS proposed rule aims to boost ACA enrollment, reinstate navigator duties

A new CMS proposed rule aims to make significant changes to Affordable Care Act marketplaces, including increasing the annual open enrollment period by a month and restoring the duties of navigators who help consumers from underserved populations enroll in plans on the federally facilitated exchange.

Supreme Court upholds ACA, dismissing constitutional challenge

The Supreme Court upheld the Affordable Care Act, dismissing the lawsuit brought by Texas, 17 other states and two individuals on the grounds that they were not able to prove they were harmed by the law. Industry stakeholders celebrated the court’s long-awaited decision.

Providers win deadline extension for use of CARES funds, but it may cause some confusion

The HHS has extended some of the deadlines for using provider relief funds and reporting on that use. Though the move is mostly positive for providers — who were clamoring for this extension — there may be some additional work required to prevent confusion.

CMS ups Medicare payment for at-home vaccinations to about $75 per dose

CMS is increasing the payment for administering at-home Covid-19 vaccinations from around $40 to $75 per dose. The move comes amid the Biden administration’s push to boost vaccinations nationwide, including among older adults who may not be able to access vaccine sites.

Coverage parity for mental health, substance abuse, a key focus for insurance regulators

Health insurers are prohibited from placing unfavorable limits on mental health and substance abuse benefits, and yet, many do. Federal and state regulators are taking aim at these practices and making the enforcement of the Mental Health Parity and Addiction Equity Act of 2008 a key focus.

100+ workers sue Houston Methodist over mandatory Covid-19 vaccination policy

The lawsuit alleges that the policy is akin to forcing employees to participate in a medical experiment as none of the vaccines available have received full FDA approval. But Houston Methodist rebutted these claims saying the vaccines are safe and effective, and requiring employees to get vaccinated is in the best interest of the patient.

FDA faces big questions as it takes a closer look at AI regulations

An action plan shared by the FDA earlier this year showed how the regulator is thinking about future regulations for AI and machine learning in healthcare. But the agency still has several big questions to address as it prepares to roll out new guidance.

MedCity Pivot Podcast: The stakes are high for getting AI right in healthcare, says Duke Forge director

It’s important for clinicians to consider AI recommendations with a critical eye, the same as they would for any other test, said Dr. Erich Huang, Director of Duke Forge. In our latest podcast episode, he spells out the stakes for implementing algorithms in healthcare, which can potentially affect thousands of patients.

CMS’ rule granting speedy coverage to FDA-designated ‘breakthrough’ devices delayed again

CMS delayed the start date of its rule that would provide expedited Medicare coverage for products the FDA deems “breakthrough devices” from May 15 to Dec. 15. CMS wants more time to examine concerns expressed about the rule, including that devices may gain coverage despite limited evidence of their use among seniors.

Texas lawsuit: Biden administration threatening funding to force Medicaid expansion

Filed by the Texas attorney general, a new lawsuit seeks to prevent the Biden administration from revoking the Trump-era approval of a Medicaid waiver extension that could cost the state billions in funds. The revocation was a political move intended to force the state to expand Medicaid under the ACA, the lawsuit claims.

32 hospitals in non-Medicaid expansion states sue HHS over payments for low-income patients

The hospitals are pushing HHS to recognize patients eligible for Medicaid under the ACA as “low-income” when calculating Medicare disproportionate share hospital payments in states that did not expand Medicaid. The agency’s refusal to do so resulted in the hospitals receiving lower reimbursements for three years, the lawsuit claims.

Hospitals caught in crossfire of battle between Rhode Island AG, PE-owned operator

Amid a heated battle over an ownership change, Prospect Medical Holdings has threatened to close two of its hospitals in Rhode Island in response to conditions the state’s attorney general proposed. The hospital chain’s private equity owner is looking to sell its majority stake but requires state approval to move forward.

CMS finalizes new rules for ACA exchanges in 2022: 5 key provisions

CMS has adopted several new rules that will change how the Affordable Care Act exchanges operate next year. These include rules that will lower out-of-pocket consumer spending by $400 and widen eligibility for gaining health coverage outside of the designated ACA open enrollment period.

Top 5 Medicare Advantage plan changes coming for 2022

The greatest uncertainty is members’ health status, which could impact MA organizations’ bidding submission process for 2022. Fortunately, fully vaccinated members are likely to resume in-person care this year, which means MA plans can expect a more consistent and reliable stream of data to form financial projections.

CMS proposes putting $2.5B into hospitals’ coffers, eliminating part of price transparency rule

CMS has released its proposed inpatient payment rule for fiscal year 2022, which includes a payment bump that could increase reimbursement for hospitals by $2.5 billion. Further, in a win for hospitals, the proposal aims to repeal a part of the price transparency rule related to Medicare Advantage plans.

Some proposed HIPAA changes could inadvertently expose the data it’s supposed to protect

The government’s proposed changes to HIPAA aim to provide guardrails against data breaches and misuse, but some of the modifications may not work as intended. Three healthcare experts delved into the ways in which certain proposals could provide inappropriate access to health data during a recent panel discussion.

Kaiser Permanente to shell out nearly $19M to settle discrimination lawsuits 

The California-based health system agreed to settle two lawsuits alleging unfair practices that resulted in Black and Hispanic workers being paid less and receiving fewer promotions than their white counterparts. In total, Kaiser Permanente agreed to pay $18.9 million as part of the settlements.

Dr. Micky Tripathi on interoperability, health equity & how his work with VCs will help him lead the ONC

In a wide-ranging interview, the National Coordinator for Health IT Dr. Micky Tripathi discussed his career and how his varied experiences have expanded his perspective. He also spoke about ONC’s plans for the future, which include “evangelizing” about the opportunities the federal interoperability rules will create for the industry.

HHS reverses previous administration’s push to deregulate more than 80 medical devices

In the final days of the Trump Administration, the Department of Health and Human Services sought to deregulate 83 different types of medical devices, citing a lack of reported adverse events. But the Food and Drug Administration put an end to the sudden reversal, saying the proposed exemptions were “flawed.” 

Stanford Health Care seeks up to $1.9M from Anthem in new suit

The California-based provider has filed a lawsuit against the payer, claiming Anthem has yet to pay for the care it provided to patients covered by its affiliate. Stanford and Anthem had an implied contract, and if it is not upheld by the court, the provider is seeking $1.9 million in reimbursement.

Regulatory progress for two biotechs stalls as FDA requests more information

The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.

Vertex to pay CRISPR Therapeutics $900M for bigger share of gene-editing alliance

Vertex Pharmaceuticals is amending its collaboration with CRISPR Therapeutics, paying $900 million now for chance to grab a bigger share of a gene-editing therapy’s profits later—if the treatment is approved. Clinical trials evaluating the CRISPR-based therapy are underway in sickle cell disease and beta thalassemia.

Compliance with HIPAA may offer some clues on how providers will fare with new info blocking rules

Despite a 20-year head start, providers still fall short of HIPAA requirements around fulfilling patient requests for their medical records. In light of the federal information blocking rules, providers should first examine their compliance with HIPAA and then address the new demands imposed by the recently enacted regulations.

Steward Health v Aya Healthcare: 4 things to know

The Texas-based health system first sued the staffing firm for “price gouging” amid the Covid-19 pandemic, as wages for nurses shot up from $75 to $160. But the firm countersued, claiming that Steward — which owes Aya over $40 million — previously did not raise objections to its prices.

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

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 Climate Change and Health Equity.

Illinois first state to offer full Medicaid benefits to women one year postpartum 

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 below the poverty line access to care every year.

Enforcement landscape for HHS data-sharing rules is hazy, experts say

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 providers and IT developers can do is be proactive, experts …

Enforcement landscape for HHS data-sharing rules is hazy, experts say Read More »

500,000+ Trinity Health patients affected in widespread Accellion data breach

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.

How eConsent empowers more participant engagement in clinical trials

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 refutes Ohio AG’s lawsuit, says it reflects misunderstanding of Medicaid billing

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.

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

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 to meet the anesthesia group’s high rate demands.

Illumina’s $7.1B Grail buyout is challenged by FTC on competitive grounds

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.

Lawsuit: Cerner systems’ failure drove Astria Health into bankruptcy  

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 alleges.

The “biggest thorn in President Trump’s side” is now HHS Secretary. What’s next?

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 Act and scrutinizing hospital consolidation.

Effort underway to help hospitals by suspending Medicare sequestration

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 fires ex-Warp Speed chief Moncef Slaoui after sexual harassment inquiry

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.

Hospitals to DOJ: UnitedHealth’s purchase of Change Healthcare will curtail competition

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.

Avoid legal pitfalls in developing innovative physician-hospital payment structures

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.

Biden’s American Rescue Plan Act aims to bolster the ACA. Here’s how.

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.

Centene’s “corporate greed” led it to allegedly overcharge Ohio’s Medicaid department

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.

Aetna accuses Mednax of destroying evidence in overbilling suit: 5 things to know

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.

Insurers sue ‘pharma bro’ Martin Shkreli, company for alleged price gouging

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 the drug by more than 4,000%.

Roche withdraws Tecentriq for bladder cancer, pullback comes amid FDA review

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 failed confirmatory studies.

In rebuke of One Medical’s alleged vaccine antics, CA counties sever relationship

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.  

Kathleen Sebelius at Health Datapalooza: To push ACA forward, forget bipartisanship

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.

Data breaches at UPMC, Nebraska Medicine affect 250,000+ individuals

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.

Short seller targets insurance startup Clover in scathing report

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.  

Tenet ordered to pay $10M+ to fired physicians, restore medical privileges

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 physicians $10.6 million and reinstate their medical privileges.

Democrats propose bill to protect privacy, data security amid growing use of pandemic-related tech

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.

EHR vendor athenahealth to pay $18M+ to settle illegal kickback allegations

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.”

In the final days of Trump administration, agencies clashed over how to regulate medical AI

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.”

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

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 that this could cause patient harm.

46 hospitals file suit to reverse HHS bad debt policy

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 some of the issues they contended with.

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

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 pandemic-related efforts.

Hospitals sue drug companies over discount program

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 picked to head the department under the incoming Biden administration.

5 big healthcare lawsuits of 2020

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 the ACA’s individual mandate.

CMS proposed rule requires payers to streamline prior authorizations

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

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.

UnitedHealth must reprocess thousands of illegally denied mental health claims, judge orders

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.

Purdue to plead guilty, pay $8.3B deal to resolve opioid charges

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.

Report: 21M people could lose insurance if ACA is overturned

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 by 70% if the ACA is overturned.

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 it rejected the allegations.

Lawsuit accuses HCA of failing to protect healthcare workers during pandemic

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 come back to work, even when they still had Covid-19 …

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District judge blocks HHS rule that would end transgender health protections

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.