Georgia lawmakers will consider a bill that could force the state’s Medicaid managed-care insurers to repay millions of dollars if their spending on medical care doesn’t reach a certain threshold.
Georgia lawmakers will consider a bill that could force the state’s Medicaid managed-care insurers to repay millions of dollars if their spending on medical care doesn’t reach a certain threshold.
The current landscape heading into 2022 will keep pharmacy benefits under the microscope. Plan sponsors will evaluate their PBM’s pricing model to determine if their contract will deliver predictable costs, more opportunities for increased savings and improved care for their members.
Betty Chow, a Los Angeles resident, had a cervical disc replaced in August 2020 at […]
Six years in, the subtext of the scheduled reimbursements increase for 2022 is that CCM has proven to be an essential part of the care continuum, particularly in the wake of the Covid-19 pandemic, and has real value for patients, providers, and payers.
Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that’s a known problem for all drugs in this class.
The Texas Medical Association (TMA) filed a brief on Monday to further oppose the ruling on the No Suprises Act that currently allows aribtrators to use the average in-network rate to determine out-of-network cost.
Lagging behavioral health and substance use treatment benefits are a major barrier to care, especially for those already struggling to get help. The Departments of Labor, Health and Human Services and the Treasury shared their findings with Congress Tuesday.
It turns out that the laws governing traditional Medicare don’t provide for coverage of self-administered diagnostic tests. Medicare patients are left to seek free tests other ways, including through the administration’s new website, covidtests.gov, and at community centers.
Merck is still at the front of the pack of companies developing new medicines to treat chronic cough, but the company was dealt a setback as the FDA turned down the pharma giant’s application and asked for additional efficacy data. No safety issues were raised, according to Merck.
Although telehealth offers many benefits for patients, it introduces operational complexities for providers and creates legitimate concerns about fraud, waste and abuse for payers.
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Health that is also designed for once-weekly dosing.
The FDA placed the partial hold on the study last November following a patient death suspected to be linked to a known complication of leukemia therapies. Kura Oncology said it has reached agreement with the FDA on a mitigation strategy for that complication.
The FDA rejected the new drug application for a Levo Therapeutics treatment for the rare metabolic disorder Prader-Willi syndrome. According to Levo, the agency said the data submitted were insufficient to support approval and the regulator wants the company to run another clinical trial.
The FDA placed a clinical hold on Denali Therapeutics’ application to begin Phase 1 testing of an antibody drug for Alzheimer’s disease. The Denali drug uses the biotech’s proprietary technology to deliver therapeutic cargo across the protective blood-brain barrier.
Te justices blocked a key Biden administration Covid-19 initiative — putting a stop, for now, to a rule requiring businesses with more than 100 workers to either mandate that employees be vaccinated against covid or wear masks and undergo weekly testing. But said that a separate rule requiring Covid vaccines for an estimated 10 million […]
The Center for Medicare and Medicaid Services proposes covering Biogen Alzheimer’s disease drug Aduhelm only for people enrolled in a clinical trial. In explaining this proposal, the agency cited the unclear benefit to patients as well as the documented safety risks associated with the drug, which can be best monitored within the context of a […]
Physicians Advocacy Institute, American Association of Neurological Surgeons, and Congress of Neurological Surgeons lead a coalition of physicians groups in filing an amicus curiae brief backing the American Medical Association and American Hospital Association’s lawsuit opposing the dispute regulation guidelines of the No Surprises Act that went into effect January 1.
Reason Foundation, Cicero Institute, and Pioneer Institute released a report that rates each state’s current telehealth policy both in terms of ease of offering virtual care as well as patients’ ability to access telehealth.
Lower courts have split on whether the federal government has the authority to issue such rules and whether they can take effect while the cases are argued.
When Californians go to the polls later this year, they will confront contentious healthcare choices. […]
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The decision is based on a study that found boosting reduced deaths by 90%, but that Israeli analysis only evaluated these shots in people 50 and older.
As in previous years, cancer products topped the list of new FDA-approved therapies in 2021. But the list of drug approvals is notable for other trends, including developments in rare diseases and regenerative medicine.
While hospitals are slow to comply with the price transparency rules, full compliance will eventually mean hospitals provide “machine readable files” with thousands of lines of pricing data.
The FDA has accepted Amylyx Pharmaceuticals’ submission for amyotrophic lateral sclerosis drug AMX0035 and it expects to issue a regulatory decision by late June. A lot will happen before then. Amylyx recently filed for an IPO and the company’s drug is slated for an advisory committee meeting ahead of an FDA decision.
With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that addresses the same target. LEO will also able to offer patients an alternative to the blockbuster Sanofi/Regeneron Pharmaceuticals drug Dupixent.
Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer antivirals appear to work against the omicron variant, FDA officials stressed that these drugs are authorized only for certain patients and they are not a substitute for vaccination.
Novartis drug Leqvio now has the FDA’s green light, making it the first RNA interference medicine approved for lowering cholesterol. The regulatory decision sets the stage for competition against cholesterol medicines from Amgen and Regeneron that also address liver protein PCSK9.
The FDA has halted tests of a Pfizer gene therapy for Duchenne muscular dystrophy. The clinical hold is one of several placed on gene therapy tests in the past year due to safety concerns.
The price of Biogen Alzheimer’s disease drug Aduhelm will be cut in half at the start of 2022, a move that comes as a Medicare recommendation on coverage is expected early next year. Meanwhile, Biogen is preparing corporate measures projected to save $500 million annually, cost-cutting made necessary in part due to slow market uptake […]
Myasthenia gravis patients now have a new FDA-approved biological treatment. Argenx drug Vyvgart provides a treatment alternative for patients who have the rare autoimmune disorder and also marks the first approved product in a new class of medicines.
The insurers referred to deals Gilead struck with Janssen, Bristol Myers Squibb to prevent the generic version of its retroviral medications from being used as part of combination treatments. They also allege the company struck a deal with Teva to delay the release of its generic drug.
The company received a warning letter on Wednesday related to inadequate quality requirements at the headquarters for its diabetes business. It comes after Medtronic expanded a recall of its MiniMed 600 series insulin pumps.
Bristol Myers Squibb has notched another FDA approval for its blockbuster immunology drug Orencia, this time for preventing acute graft versus host disease in bone marrow and stem cell transplant patients. The decision makes the BMS drug the first one approved for preventing this complication of transplant procedures.
A panel of judges on the 8th Circuit Court of Appeals declined to reinstate a vaccine mandate for healthcare workers that was set to go into effect in January. A federal judge had blocked the mandate last month from the Centers for Medicare and Medicaid Services after 10 states filed suit.
The American Medical Association, American Hospital Association and other provider groups are suing the Department of Health and Human Services over a small but important detail of how it is implementing surprise billing legislation. They argue that the arbitration process for unresolved disputes currently favors insurers.
FDA authorization of AstraZeneca drug Evusheld makes it the first antibody therapy for preventing infection before exposure to Covid-19, providing an option for immunocompromised patients who won’t mount a strong immune response to vaccination. The antibodies that comprise the AstraZeneca drug are engineered with technology that makes the therapy long lasting.
Since ONC is the certifying body for EHRs, providers must be prepared to transition to a new “Cures Edition” version of its software before the end of 2022.
Seeking greater respect for their profession, physician assistants are pushing to rebrand themselves as “physician associates.” Meanwhile rechristening the P.A. name has spiked the blood pressures of physicians.
Eli Lilly’s authorized antibody drug for treating and preventing Covid-19 infection in adolescents and adults is now authorized for pediatric patients, including newborns. While tests are still assessing whether the drug works against omicron, early data suggest a Vir Biotechnology antibody can address the new variant but Regeneron Pharmaceuticals’ antibody drug might not.
Judging from the questions asked by the justices, it appeared possible — even likely — that a majority of them could vote to turn the thorny question of whether to allow abortion and under what circumstances back to individual states.
BeyondSpring Pharmaceuticals said the FDA wants another clinical trial to demonstrate patient benefit for its drug, a small molecule developed to treat a dangerous and life-threatening complication of chemotherapy. Shares of the biotech plunged more than 60% after the FDA’s complete response letter was announced.
The focus on glycemic management as a key indicator of patient safety was announced as part of CMS’s annual adjustment to inpatient payment policies, which are accompanied by updated rules for its Inpatient Quality Reporting (IQR) program.
California’s Senate Bill 221, which passed the state legislature with a nearly unanimous vote, requires health insurers across the state to reduce wait times for mental health care to no more than 10 business days.
A federal jury found pharmacy chains CVS, Walgreens and Walmart helped fuel the opioid epidemic in two Ohio counties. It’s the first trial pharmacy chains have faced related to the opioid crisis, though several other lawsuits have been filed.
The FDA placed a partial clinical hold on a Kura Oncology leukemia drug following the death of one patient in the early-stage study. Kura executives said the death may be related to differentiation syndrome, a known complication of leukemia therapies.
Takeda Pharmaceutical won FDA approval for Livtencity, an antiviral developed to treat cytomegalovirus infection in transplant patients. The agency also approved an Aadi Biosciences drug, making it the first therapy authorized for treating a rare type of soft-tissue cancer.
The very first would be to reimburse virtual care the same way in-person care is reimbursed. And here are four other simple things the government can do now to get U.S. healthcare on the right track.
BioMarin Pharmaceutical’s Voxzogo is the first FDA approved therapy for achondroplasia, an inherited disorder that causes the most common form of dwarfism. With approvals in Europe and the U.S., and more regulatory decisions expected in 2022, the biotech said the drug has blockbuster potential.
The deadline to comply with the No Surprises – January 1 – is practically around the corner. Payers that want to be in compliance with its provider directory provision must act now.
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the regulatory nod to a PharmaEssentia drug that reduces the levels of those blood cells.
We again need Congress to intervene in order to protect patients and providers and stop any further cuts to specialty care.
There is a lot of discussion on how ransomware costs healthcare billions of dollars and not enough discussion on how it impacts the patient’s safety.
By increasing oversight and regulation of independent service operators to ensure the quality, safety, and effectiveness of all device servicing Congress and the FDA can prevent future patients and providers from having to experience unnecessary harm caused by faulty medical device repair.
President Biden and his administration were right to exclude medical devices from the executive order on Promoting Competition in the American Economy.
In its earnings statement, the company disclosed that it received a civil investigative demand from the Department of Justice. Specifically, the agency was looking for information on Oak Street’s relationships with third-party marketing agents and transportation services.
In both word and action, the Biden administration has ushered in an aggressive new era […]
Lawmakers have acted to strengthen insurance reimbursement for biomarker testing in California, Illinois and Louisiana. Patient advocates and testing companies hope more will act in the coming year.
CMS set a deadline for staff at Medicare- or Medicaid- certified facilities to be fully vaccinated against Covid-19 by Jan. 4. Similarly, OSHA is also requiring large companies to vaccinate their workers by that date.
The companies have certified substantial compliance with a request for additional information from the Department of Justice, which opened an investigation of the merger in March. They struck an agreement with the agency not to merge until February of 2022, unless it drops its investigation before then.
Not all drugs will be subject to price negotiation under the revised legislation. But the agreement sets up a framework enabling Medicare to negotiate the prices of medicines that have been on the market for a long time, and also caps the monthly price of insulin, which has been a flashpoint of drug price debate.
Amylyx Pharmaceuticals has submitted its amyotrophic lateral sclerosis (ALS) drug for FDA review based on positive Phase 2 data after discussions with the agency over the summer. Meanwhile, a Clene Nanomedicine ALS drug failed its Phase 2 study, but the biotech points to encouraging results in a subgroup of patients.
A California law signed Oct. 8 by Gov. Gavin Newsom requires that mental health and substance abuse patients be offered return appointments no more than 10 days after a previous session, unless their provider OKs less frequent visits.
At the top of the Food and Drug Administration’s agenda for the next 12 months: […]
The California-based health system and insurer has bilked CMS out of “hundreds of millions of dollars” by submitting claims that were altered to make patients appear sicker than they were, a new complaint filed by the DOJ alleges. Kaiser denied these allegations saying it is confident in its compliance with Medicare Advantage program requirements.
The bill, if enacted into law, will establish an electronic prior authorization process and require Medicare Advantage plans to report on their use of prior authorization and the rate of approvals or denials to CMS. It has 227 co-sponsors in the U.S. House, indicating strong support from both Republicans and Democrats.
The FDA refused to review Stealth BioTherapeutics’ Barth syndrome drug, telling the company results in a study of just eight patients are insufficient to support its submission. The impasse highlights the challenges of testing drugs for ultra-rare diseases. Barth is so rare that Stealth is unsure it can recruit patients to run a new study.
Funding to keep hospitals solvent through the current crisis must continue unabated. At the same time, though, without the proposed investment in broadband infrastructure, rural hospitals and the communities they serve are destined never to rise above the crisis state in which they currently and barely exist.
There are about 17 million people eligible for coverage through Medicaid or the Affordable Care Act marketplaces, and one of CMS’ priorities is to make them aware of their insurance options, Administrator Chiquita Brooks-LaSure said at this year’s HLTH conference.
Boehringer Ingelheim has shown biosimilar manufacturers the way to win interchangeability with the world’s highest-grossing drug — but the company’s Cyltezo won’t come out until July 2023. Will future Humira competitors have better luck winning an earlier launch date?
An Oyster Point Pharma drug for dry eye disease has won FDA approval, the first treatment for the condition that comes as a nasal spray. In addition to that drug approval, the FDA on Monday rejected two drugs, one from Omeros and the other from United Therapeutics.
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.
Eleven health systems have joined the coalition, which aims to extend and expand the existing federal hospital-at-home waivers and create an advanced acute care-at-home delivery model at the Center for Medicare & Medicaid Innovation.
All individual and small group health plans in Colorado’s Affordable Care Act marketplace must cover a wide range of gender-affirming services, including breast/chest construction and reductions and laser hair removal, starting Jan. 1, 2023.
Fredrikson & Byron attorneys Ryan Johnson and Jeffrey Steinle share insights on how Covid-19 is continuing to transform the health tech and medtech landscape.
ChemoCentryx has spent decades developing oral alternatives to injectable and infused biologic drugs that treat chronic autoimmune conditions. The research finally paid off with FDA approval of Tavneos, a ChemoCentryx pill for a rare autoimmune disease.
All of Allogene Therapeutics’ clinical trials are now under an FDA clinical hold. The halt was handed down after one patient in the company’s most advanced study developed what the company described as a “chromosomal abnormality.”
Beginning July 1, Aetna now requires prior authorization for all cataract surgeries, across all its members and plans. Here in California and across the country, ophthalmologists are going to great lengths to secure approval from Aetna for cataract surgery, while the backlog caused by prior authorization and delayed elective care during the Covid-19 pandemic only grows.
Medtronic is expanding a recall of two of its MiniMed 600 series insulin pumps after reports found several had broken retainer rings cracked, resulting in insulin doses that were too high or too low.
Independent and community pharmacies seek to prevent UHG and Change merging into a “corporate monster” that will stifle competition.
President Joe Biden’s July executive order supported the repair and reuse of many different products but excluded that for healthcare products. It is disappointing that the President’s order ignores established healthcare re-use practices that pose no elevated patient risk and follow manufacturer standards.
CMS is lowering the average premium for MA plans to $19 per month in 2022 from about $21 this year. The news comes as several insurers announce new MA plan offerings for 2022, including Humana, which said it will launch 72 plans.
Modern technology can now be used to extract critical information from contracts through the use of an AI-enabled Contact Lifecycle Management (CLM) system, an intelligent tool that performs in-depth analysis of contracts
Per the new interim final rule, parties that cannot agree on out-of-network payment rates must enter into a 30-day open negotiation period. If that fails, an independent entity will be engaged to make the final decision.
In a Spotlight Video interview, Fredrikson & Byron Shareholders and Co-chairs of the firm’s life sciences group, Jeff Steinle and Ryan Johnson, talked about the deal-making environment in healthcare and how the Covid-19 pandemic has impacted it.
London-based firm Mishcon de Reya said it filed a claim in the U.K.’s High Court, alleging that Google’s access of 1.6 million people’s medical records broke privacy rules. NHS’ Royal Free London had struck an agreement with DeepMind in 2015 to build a system for alerting clinicians.
Mirum Pharmaceuticals drug Livmarli is now approved to treat pruritus caused by Alagille syndrome, a rare liver disease that can worsen to the point of requiring a transplant. Mirum licensed the drug from Shire in 2018.
AbbVie drug Quilpta, developed specifically for migraine prevention, is now FDA approved, the latest product in a new class of migraine medicines. The AbbVie drug is the second oral migraine prevention drug that the FDA has approved this year.
The American Hospital Association and Association of American Medical Colleges have filed an amicus brief in support of the New Jersey health systems that are appealing a court decision to delay their merger following a legal challenge from the FTC.
After Capital Rx’s former medical director of pharmacy services got a job offer at CVS, the PBM startup claimed he couldn’t work there because of a noncompete agreement. CVS recently sued the company, saying its non-compete clause was unenforceable.
New healthcare marketplace policies seek to make the ACA more equitable by investing in low-income and underinsured communities, changing the rules in ways that upset some insurers but delight many state and consumer health advocates.
Overall, MA companies generated an estimated $9.2 billion in risk-adjusted payments for diagnoses listed only on chart reviews and health risk assessments, with the top 20 companies receiving more than half of the payments. OIG is urging CMS to provide more oversight.
The FDA has authorized dosing of booster shots of Pfizer and BioNTech’s Covid-19 vaccine. Consistent with the recommendations of an FDA advisory committee, the agency’s amendment to the emergency authorization covers only certain groups at high risk of infection and complications from the virus.
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.