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.
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.
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.
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.
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.
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.
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 …
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 …
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.
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.
Enforcement of the No Surprises Act is still a work in progress, but CMS is ready to give out As for effort. Whether patients will agree with that grade still remains to be seen.
After pushing back the start date twice, CMS now wants to scrap the Trump-era rule, which provides an expedited pathway to Medicare coverage for devices that receive the FDA breakthrough designation.
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.
CMS has recently proposed essential and timely reimbursement changes to close the racial discrepancy gap around the mandatory payment model for kidney disease
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.
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.
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.
CMS, in collaboration with the CDC, is making it mandatory for staff at healthcare facilities participating in Medicare and Medicaid programs to get vaccinated against Covid-19. The move comes as cases rise to 150,000 and deaths to 1,500 per day.
The Biden administration has issued a legal challenge to invalidate the controversial Texas law that bans abortions after six weeks of pregnancy claiming that it will strip residents of their constitutional rights.
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 …
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.
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.
For HIPAA to remain relevant for the next 25 years, policymakers and healthcare providers will need to remain agile and alert; this groundbreaking legislation will only be effective for as long as it keeps pace with the newest technologies and security challenges.
It’s time to embrace electronic prior authorization that, according to a 2021 AHIP study, has been found to reduce the mean time from PA request to decision by 69%. In addition, 71% of providers using ePA reported “faster time to patient care.”
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.
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.
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.
CMS will provide $80 million to 60 organizations that train ACA navigators — who help consumers find coverage on the federally funded marketplaces — in the 2022 plan year, up from 30 organizations that received $10 million this year.
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?
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.
The Department of Justice and the Department of Homeland Security subpoenaed the company for information related to its reporting of injuries, Peloton disclosed in an SEC filing on Friday. The company recalled its line of treadmills earlier this year after multiple reports of injuries and one death.
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.
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.
Now, Covid-19 vaccine administrators can earn an additional $35 per vaccination for up to five Medicare beneficiaries who live in a communal living space, like smaller group homes or assisted living facilities. CMS aims to boost vaccination rates with this pay increase.
CMS recently revealed that the Patient-Driven Payment Model – intended to be revenue-neutral as compared to the previous payment model – increased reimbursements to SNFs last year by more than $1.7 billion, raising the specter of potential payment reviews around the corner.
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.
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.
The clock is ticking down for payers and providers to comply with the No Surprises Act, which protects patients from balance billing for the most common ancillary medical services. Here’s how to get your ducks in a row.
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.
Overturning a district court’s decision that had earlier vacated the Medicare Advantage Overpayment Rule, the DC Circuit opened a Pandora’s Box of DOJ False Claims Act litigation last week.
As plans struggle to decide how to comply with a badly-worded portion of the final rule on interoperability, they should be thinking about the broader changes at work and whether their choices now prepare them for the world ahead.
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.
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 …
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.
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.
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.
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.
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.
FDA approval of a therapy that pairs drugs from Eisai and Merck allows the combination to become a first-line treatment for renal cell carcinoma. It’s the latest approval for the partners, which have been working together since 2018.
The new CMS Mandate on CDSM takes effect on January 1, 2022. Is your organization ready for compliance when ordering outpatient advanced imaging?
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.
A class-action lawsuit, filed by six North Carolina residents, alleges that HCA Healthcare bought Mission Health to gain monopolistic control in the Western part of the state, enabling it to drive up prices while lowering the quality of care.
Following several legal battles and opposition from providers, CMS is proposing nixing the Most Favored Nation Model, which matches payments for Medicare Part B drugs to the lowest price paid by other wealthy countries.
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an important, controversial decision from the Federal Circuit.
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 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.
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.
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.
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.
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 …
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 …
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.
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 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.
An Incyte drug developed as a treatment for a rare type of anal cancer has fallen short of FDA approval. The regulator said it needs to see more clinical data that demonstrating clinical benefit for the antibody drug.
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.
Legislators threaten to ban settlements where branded companies “pay” generics makers to “delay” market entry, while drugmakers say the current framework balances competition and innovation. Who will prevail?
Many believe that the biosimilar industry can address the issue of spiraling drug costs, but first it has to make it through a thicket of challenges.
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.
Spearheaded by the Departments of Justice, and Health and Human Services, efforts to investigate and prosecute healthcare fraud resulted in the government recovering billions, including about $2.1 billion for the Medicare Trust Funds.
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 …
Health systems filed two separate class action lawsuits against surgical robot maker Intuitive Surgical. They allege that the company used its market power to force them to sign restrictive repair contracts and buy replacement parts at high prices.
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.
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 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.
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.
Despite mounting court and legislative scrutiny of pharmacy and prescription benefit manager practices, Amazon has chosen to throw its hat into the discount pharmacy ring. Could Amazon “disrupt” prescription drug delivery?
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.
After scrapping work requirements for Medicaid eligibility in four states, CMS has added Arizona and Indiana to the list. These requirements have long been controversial, facing litigation and strong opposition, but proponents say they incentivize people to find jobs.
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.
Hospitals and other covered entities are striking a growing number of agreements to use de-identified patient data for research or to develop AI tools. But they should carefully weigh the risks of sharing this data, experts said.
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.
Six years after initially filing suit against CVS, insured customers of the pharmacy giant who charge that it misrepresented the “usual and customary” prices of drugs are finally getting their day in court.
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.
Medication adherence startup PillDrill is suing a digital health company UpHealth, claiming it lied about plans to acquire the startup as part of a broader SPAC deal.
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.
To know how Chiquita Brooks-LaSure will lead the Centers for Medicare and Medicaid Services, we sat down with Matthew Hittle, a former senior adviser to Seema Verma, who led the agency under the former president.
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.
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.
While physicians face incredible pressures to consolidate or receive investment to survive, there are ethical, legal and practical considerations doctors must seriously consider before deciding to take private equity.
For the second time in the span of one year, a group of insurers has filed a lawsuit against CVS alleging it overcharged them for generic drugs. CVS refuted the claims, calling them “baseless.”
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.
Myovant hormonal drug Myfembree has won FDA approval as a treatment for uterine fibroid bleeding. The regulatory decision clears the way for the pill to compete against a similar AbbVie drug, but with dosing and pricing advantages.
We urge Congress to quickly pass the NOPAIN Act and help fight the opioid epidemic with the same fervor we’ve battled Covid-19.
Can an industry coalition help craft policy to support the use of Real-World Evidence? Five prominent real-world data and analytics companies are betting on it, launching the RWE Alliance.
In a move that ACOs found “disappointing,” CMS has declined to extend the Next Generation ACO Model beyond 2021. Though evaluations have found that the model did not generate net savings for Medicare, proponents argue that the program was successful.
Covid has pushed state health agencies to use Medicaid in ways that would never have been imagined before. With one in five Americans saying they are unable to afford healthcare, how are state governments using this historic moment to expand equitable access to care?
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.
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.
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.
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.
The Delaware Supreme Court ruled on Monday that Cigna can’t seek a $1.6 billion breakup fee after its failed merger with Anthem, upholding a judge’s decision last year.
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.
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 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.
Learn from our expert panel as they discuss the challenges and opportunities of value-based contracting.
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.
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.
The digital health company filed a complaint with the Federal Trade Commission last week, seeking a ban on the import of the Apple Watch. AliveCor cited copyright violations related to Apple’s ECG feature as the reason for seeking the ban.
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.
Unless the Supreme Court strikes down the ACA, it will remain in place for the foreseeable future and will see expansion.
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.”
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.
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 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.
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.
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.
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.
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.
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 …
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 to meet the anesthesia group’s high rate demands.
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 alleges.
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.
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 funds they paid to future conferences.
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 the drug by more than 4,000%.
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.
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 physicians $10.6 million and reinstate their 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 that this could cause patient harm.
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.
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.
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 pandemic-related efforts.
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 picked to head the department under the incoming Biden administration.
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 the ACA’s individual mandate.
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.
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 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.
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 …
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.