Abortion travel benefits to become more common among employers after Dobbs decision
The survey reported 35% of respondents already offer travel and lodging benefits for abortions, while 16% plan to in 2023 and 21% are considering it.
Legal
House decision on drug price negotiations may have little impact on drug industry, some say
Many have celebrated the historic strides in healthcare made in the recent Inflation Reduction Act […]
AstraZeneca & Daiichi drug wins another FDA approval, this time in lung cancer
On the heels of receiving a landmark FDA approval in breast cancer, AstraZeneca and Daiichi Sankyo drug Enhertu won an additional approval in non-small cell […]
What do GCs need to know right now about abortion trigger bans, HIPAA and how to not break the law?
In an exclusive interview, an attorney at McDermott Will & Emery’s Post-Roe practice group answers questions about how Texas’ trigger ban laws will impact employers, […]
340B entities face increased challenges in a shifting regulatory and enforcement landscape
Concerns about who qualifies under the 340B Program, how drugs can be dispensed to patients, and how much entities will be reimbursed may significantly impact […]
After RNA therapy falls short in the eye, ProQR Therapeutics pivots to liver, CNS
RNA therapies developer ProQR Therapeutics is eying a future without ophthalmology. After receiving European Medicines Agency feedback for its lead program for a rare eye […]
10 things providers should know about monkeypox
Monkeypox was declared a public health emergency last week, but many healthcare professionals feel confused about how to best prepare for a potential outbreak in […]
FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed
Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted […]
With overdoses skyrocketing, Congress must consider non-opioid alternatives to pain management
Complementary and integrative healthcare providers, including chiropractic physicians, acupuncturists, and massage therapists, provide effective and safe treatments for pain. Yet, they are too often overlooked […]
FDA approval of AstraZeneca drug is first for a new group of breast cancer patients
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein […]
Another CA city votes to increase healthcare wages stirring controversy about where the funds will come from
Though the wage increase is a win for some, questions remain about where the money will come from and hospitals are concerned pay disparities will […]
With ‘bold experiment’ in drug pricing, Arcutis aims to stand out in plaque psoriasis
The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it […]
FDA hits pause on Beam Therapeutics’ off-the-shelf cell therapy for blood cancers
Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical […]
DOJ charges dozens for $1.2B in telemedicine fraud scheme
The charges involve some of the first cases in the country involving fraudulent cardiovascular genetic testing, a “burgeoning scheme,” according to a news release from […]
Lowering insulin prices isn’t the (only) answer to helping patients with diabetes
It is time to shift the conversation, incentives, and policy solutions to help people improve their health and get off of medications—not just make them […]
Texas sues HHS, claims the agency is trying to turn ERs into abortion clinics
The attorney general of Texas says the recent federal mandates and guidance issued to healthcare providers to protect abortion access are unconstitutional and conflict with […]
New York AG: Teva USA’s parent company shouldn’t be allowed to escape opioid liability
Without the parent company, there’s concern Teva won’t be able to pay billions in reward to NY state.
1 in 5 Americans received surprise bills despite law, many lack health insurance literacy, reports find
Skyrocketing medical bills and a lack of understanding in the healthcare system is putting financial stress on Americans in 2022, several recent reports have found. […]
How one company has moved to support reproductive rights despite looming regulatory uncertainty
The reversal of Roe v. Wade led Forma to make a series of changes to its reproductive health benefits on top of what it originally […]
Pfizer, BioNTech Covid-19 vaccine gets full FDA approval for adolescents
The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers […]
FDA says pharmacists can prescribe Covid treatment
The AMA believes physicians should still be the main prescribers, while advocates for provider status for pharmacists say it’s a win for health equity and […]
Data privacy in a potential post-Roe world
The Supreme Court’s majority opinion in Dobbs will create a big mess around what data will be revealed and the repercussions that will come when […]
North Korea cyber attackers target healthcare orgs, Gov’t agencies warn
The U.S. government agencies warned that Maui ransomware has been used by North Korean state-sponsored cyber actors since at least May 2021.
W. Va. judge sides with drug distributors in bellwether opioid trial
From 2001 to 2017, the fatal overdose rate in Cabell County increased from 16.6 to 213.9 per 100,000. Judge finds no evidence of causation.
A looming reckoning: Medicare Advantage audits will spike as feds scope out Covid-19 fraud
Seniors’ demand for Medicare Advantage plans shows no signs of slowing down any time soon, and that means CMS is likely to continue accelerating its […]
CureVac sues BioNTech, claiming Covid-19 vaccine infringes key mRNA patents
Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of […]
Novartis pays $100M to get Mallinckrodt’s ticket for a speedier FDA drug review
Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for […]
Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal
The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. […]
BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of […]
A myopic approach to merger regulation fails consumers instead of protecting them
Consolidated healthcare systems – even cross market systems – don’t have to raise their prices to have anticompetitive effects. They can leverage their size by […]
Following Roe decision, bad actors will try to target reproductive health data
State bans would mean sensitive patient data, such as interactions with a telehealth provider to obtain abortion drugs, could be used against someone as a […]
Conservative majority on Supreme Court, as expected, end nationwide right to abortion
The decision about whether to allow the procedure now falls to individual state governments, and only 16, plus the District of Columbia, have passed laws […]
Specialty pharmacy serving HIV patients wins arbitration against CVS in rare public case
Confidentiality agreements typically prevent the public from obtaining a window into the cases against pharmacy behemoths but a public court filing makes this one different.
Clarity will help stem the problem of ‘winners and losers’ in medical device safety and security
The Clarifying Remanufacturing to Protect Patient Safety Act was introduced by Reps. Scott Peters (D-CA), Kim Schrier (D-WA), and John Joyce (R- PA) to clarify the meaning […]
AbbVie’s blockbuster drug Skyrizi gets FDA nod for treating Crohn’s disease
AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation. […]
Report: Whistleblower accuses CVS of “calculated and widespread” drug pricing scheme targeting elderly patients
CVS Health intentionally prevented certain Medicare beneficiaries from accessing less expensive, generic prescriptions, according to […]
Pfizer, Moderna Covid-19 vaccines are now authorized for kids as young as 6 months
Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease […]
Project seeks to chart regulatory paths for digital products
The nonprofit Digital Medicine Society is partnering with the likes of Google and the FDA to develop a free resource designed to help digital health […]
November will bring political change. Will it also change drug prices and PDUFA?
Drug prices are on the minds of patients and politicians. The November election is expected to tip the balance of power in Congress and a […]
FTC blocks merger of two NJ hospitals less than a mile apart
This is the third complaint the FTC filed against proposed hospital mergers so far this year.
Prenatal to postpartum: Using healthcare data to improve maternal health
The maternal health crisis remains unsolved across most of the U.S. Our nation reports the […]
State high court says Eli Lilly warned doctor of drug risks, didn’t need to warn patient
Rejecting part of the decision, one justice said patients do not need a physician’s knowledge to understand a drug company’s warnings.
Roche bispecific drug Lunsumio lands European nod in follicular lymphoma
Follicular lymphoma patients in Europe now have a new treatment option. The European Commission approved Roche drug Lunsomio, a bispecific antibody designed to go after […]
Teladoc shareholders sue company claiming they were misled about finances
After failing to meet targets for first quarter revenue, shareholders say the company is not on track to reach the projected 2022 revenue.
Legal Ops Interview Series: Stephanie Corey of UpLevel Ops
A 20-year veteran in the legal operations field and co-founder of Corporate Legal Operations Consortium (CLOC) discusses how she sees the future of the industry […]
Building a national cybersecurity infrastructure is ‘virtually impossible’ without better federal collaboration
The federal government has established various departments and initiatives to promote cybersecurity among healthcare organizations, but experts say these efforts require more cross-agency collaboration in […]
Laid-off doctor who refused vaccine seeks legal relief after nurses similarly laid off are recalled to work
Ascension Health notified the employees that there was too great of a risk for them to return to work without being vaccinated, but the majority […]
FDA nod for Roche drug expands its use to babies with spinal muscular atrophy
Roche drug Evrysdi, one of three FDA-approved treatments for spinal muscular atrophy, is now approved for treating those younger than age 2. The regulatory decision […]
Digital endpoints: Global opportunities and clinical, data protection and other challenges
In December, the FDA published a draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations, signaling that regulatory […]
Biotech founder arrested in US amid murder-for-hire investigation
The co-founder of Los Angeles biotech Enochian Biosciences has been arrested in connection with a federal investigation into the murder of a Vermont man in […]
Heart trouble report & clinical hold spell end of Antios, Assembly Bio HBV alliance
A clinical hold on an Antios Therapeutics drug has led to the end of a collaboration with Assembly Biosciences less than a year after their […]
FDA sounds caution on Foghorn cancer drug with a partial hold after patient death
The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient […]
How legal analytics will transform the pharmaceutical industry
Pharma companies already rely heavily on data and predictive analytics to assess new drugs. In the same way, analytics can be used to enhance legal […]
House Energy and Commerce Committee passes bill outlining FDA procedures to withdraw a drug
To withdraw a drug from the market, the FDA will have to provide the drug sponsor with notice and an explanation as well as the […]
Natera fires more shots in ongoing patent battle with CareDx
In the latest salvo in the ongoing legal skirmish between the two companies, Natera accused CareDx of infringing two patents covering Natera’s DNA testing technology.
Pharma bad boy Martin Shkreli is on the streets again
Former pharma executive Martin Shkreli, who became notorious for raising the price of a lifesaving AIDS drug around 5,000%, has been released early from his […]
Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, […]
How to meet the demands of the No Surprises Act
Patients deserve high-quality care and better outcomes, as well as equitable, consistent and transparent billing experiences. So how do we get there?
Seagen CEO on leave amid domestic abuse allegations
Seagen’s chief executive Clay Siegall has taken leave of absence pending an investigation into an alleged domestic violence incident at his home. Siegall denies the […]
Regulatory recap: J&J vaccine limits, full Enhertu approval, a Vertex hold & more
The FDA amended emergency authorization of Johnson & Johnson’s Covid-19 vaccine. In other regulatory news this past week, drug approvals include a cancer drug that […]
Experts say final Supreme Court opinion will closely matched leaked one
“I don’t think Justice Samuel Alito could be persuaded to change anything. He’s got the votes. Unless Chief Justice John Roberts can convince him to […]
If “Roe v Wade” falls, more than half of states expected to ban or restrict abortion
If the Supreme Court’s conservative majority affirms the leaked decision overturning abortion rights in the U.S., the effects would be sweeping for 40 million women […]
Free market is at risk because of PBM titans’ anti-competitive behaviors
Congress must thoroughly investigate the anti-competitive behaviors of these conglomerates and act accordingly. Doing so will provide better outcomes both for patients and a more […]
California opens Medicaid to older unauthorized immigrants
Unauthorized immigrants over age 49 who fall below certain income thresholds are now eligible for full coverage by Medi-Cal, California’s version of Medicaid. If Gov. […]
At U.S. hospitals, a drug mix-up could be just a few keystrokes away
There have been several incidents of hospital staffers searching computerized medication cabinets with three or fewer letters and then administering or nearly administering the wrong […]
Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease
Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to […]
FDA lifts Pfizer gene therapy clinical hold, but trial adds new safety measures
Pfizer now has the regulatory O.K. to resume pivotal tests of its gene therapy for Duchenne muscular dystrophy—but with new limitations and safety measures. The […]
Congress considers health equity bill supported by more than 300 advocacy groups
“The Health Equity and Accountability Act will reduce racial and ethnic health inequities, address the maternal mortality crisis, strengthen health data collection & research, expand […]
Biohaven migraine drug partnered with Pfizer lands twin European approvals
The European Commission approved Biohaven Pharmaceuticals migraine drug rimegepant. While the regulatory decision marks another milestone for Biohaven, it’s also a win for Pfizer, which […]
Opioid addiction startup founder calls for better reimbursement and legal changes to improve access
Zack Gray, CEO of digital health startup Ophelia, aims to help “the invisible 80%” of opioid use sufferers in America who are unengaged with the […]
Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by […]
Battle lines are drawn over California’s deal with Kaiser Permanente
The deal, hammered out earlier this year in closed-door talks between Kaiser Permanente and Gov. Gavin Newsom’s office and first reported by KHN, would allow […]
Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more
Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid […]
Senators pressure FDA to lower cost of hearing aids
Only 1 in 5 Americans use hearing aids because of the prohibitive costs — an average of $2,500 — so two senators are telling the […]
CEO of upstart PBM: What CVS, Cigna and other PBMs are doing in drug pricing is neither sustainable nor ethical
A.J. Loiacono was speaking at MedCity INVEST in late March in Chicago when an audience member requested him to address whether it is sustainable to […]
FDA gives Gilead reprieve on partial hold for cancer drug studies
An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead […]
CMS is prioritizing healing heart valves over bolstering brain health
Our analysis demonstrates that CMS’s coverage processes for breakthrough devices demonstrate product class and disease state disparities. These disparities contradict mental health parity statute, CMS […]
Insurance company abuses are putting more patients’ care out of reach
Insurers’ abuse of prior authorization is creating health risks for patients and contributing to higher downstream costs for both beneficiaries and the larger health care […]
Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect […]
What’s at stake if Congress doesn’t extend Covid-era telehealth rules?
Congress will have to debate whether pandemic era telehealth reimbursement and relaxation of rules should be made permanent. Given that those rules helped historically underserved […]
Medicaid enrollees may have better provider options than Marketplace enrollees, study finds
The study authors concluded that “Medicaid enrollees on paper have stronger network adequacy protections than QHP enrollees” referring to those who are covered by Qualified […]
Novartis cancer drug is now first approved therapy for group of rare, genetic diseases
A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by […]
FDA places partial hold on Curis cancer drug after patient death in clinical trial
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The […]
INVEST panelist: Provider status is very necessary for pharmacists (and I will argue with AMA later on this)
James Lott, CEO of Script Health in Chicago, strongly favors the Pharmacy and Medically Underserved Areas Enhancement Act, the bill that would provide pharmacists expanded […]
Safety concerns sink Akebia drug for anemia from chronic kidney disease
The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety […]
At a Tennessee crossroads, two pharmacies, a monkey, and millions of pills
Federal prosecutors have unveiled a rare criminal case alleging that owners of a pharmacy in Celina, Tennessee intentionally courted opioid seekers by filling dangerous prescriptions […]
Senators request GAO to proble Medicaid’s low Covid vaccination rates
Two prominent Democratic senators – Robert Casey Jr. of Pennsylvania and Ron Wyden of Oregon – have requested a Government Accountability Office study of why […]
Data and regulatory roundup: Pfizer’s feat, an ADHD miss, Eli Lilly’s CRL & more
A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. […]
Supreme Court rejects Epic’s request to reinstate $420M payout from Tata instead of $280M
EHR powerhouse Epic Systems sued Tata Consultancy Services in 2014 for stealing trade secrets and the court awarded Epic $940 million, which was reduced to […]
Novartis targeted radiation therapy gets FDA nod for advanced prostate cancer
The FDA approved Pluvicto, a Novartis radiopharmaceutical, as a new treatment option for advanced prostate cancer. Novartis added the therapy via its $2.1 billion acquisition […]
Illumina sues former employees turned founders of Guardant Health
DNA sequencing power house Illumina sued liquid biopsy company Guardant Health, whose founders used to work for Illumina, claiming the two stole information from Illumina […]
FDA approves Marinus Pharma drug for rare, genetic form of epilepsy
Marinus Pharmaceuticals drug Ztalmy is now FDA approved for treating the seizures in patients who have CDKL5 deficiency, an inherited form of epilepsy. The drug […]
BMS nabs FDA nod for first drug in new class of cancer immunotherapies
Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The […]
Alnylam sues Moderna & Pfizer, claiming Covid-19 vaccines infringe lipid patent
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna […]
Jury orders Natera to pay $44.9M in damages to CareDx for false advertising
A jury ruled that Natera owes $44.9 million in damages to CareDx on grounds that Natera intentionally mislead the transplant community regarding its Prospera Kidney […]
Health interoperability with purpose: TEFCA’s impact & (maybe) the beginning of the end of impersonal care
Recently, the ONC revealed its most ambitious healthcare interoperability effort to date with the Trusted Exchange Framework and Common Agreement (TEFCA). It outlines a common […]
Bloomberg: Court docs reveal J&J’s role in prison tests comparing talc to asbestos
Research of Johnson & Johnson’s baby powder included a prison study in which inmates, mostly Black men, were injected with asbestos. The study was intended […]
Alpine Immune Sciences cancer drug trial placed on partial hold after patient death
The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer […]
FDA regulatory roundup: two approvals, three rejections & one clinical hold
The FDA approved drugs from Johnson & Johnson and CTI BioPharma in the past week. Complete response letters were issued to Gilead Sciences, Amryt, and […]
Despite $35 insulin cap being popular, and bipartisan, Congress may not pass it
The idea of helping millions of Americans with diabetes afford a crucial medicine has immense public support and even bipartisan adherents. But then, there is […]
Eli Lilly to stand trial over Medicaid rebate payments
A judge ruled the lawsuit against Eli Lilly for their Medicaid rebate payments will proceed to trial; Ely Lilly is accused of underpaying for Medicaid […]
J&J, Legend win FDA nod for cell therapy challenger to BMS in multiple myeloma
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple […]
FDA rejects Reata Pharma chronic kidney disease drug; new trial needed
The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in […]
The calvary has arrived for the kidney care revolution: Policymakers, start-ups join physicians’ longstanding fight to transform a troubled industry
To combat challenges facing the industry, both policymakers and entrepreneurs have been working on complementary strategies to help primary care physicians, nephrologists and other care […]
Why the FTC’s recent decision to not study PBMs might hurt consumers and independent pharmacies
With its ruling to maintain the status quo, the FTC has decided to take a back-seat and force independent pharmacies to fend for themselves in […]
Department of Justice sues UnitedHealth to stop it acquiring Change Healthcare
The Department of Justice filed a lawsuit in the U.S. District Court for the District of Columbia to stop the merger of UnitedHealth Group and […]
Progress report: Vast majority of hospitals still aren’t following the price transparency rule
In its second report evaluating where hospitals are with complying with the price transparency rule that went into effect Jan. 1, 2021, PatientRightsAdvocate.org found compliance […]
6 ways direct contracting is opening the door to direct primary care
While we can’t pretend that Direct Contracting is going to solve all of our problems, it does provide consideration for Direct Primary Care (DPC) practices, […]
Agios strategy shift pays off with FDA approval of first drug for rare anemia
Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment […]
Can telehealth be here to stay?
Telehealth has proven itself undeniably practical. However, ensuring its long-term survival will require ongoing work and revision, including broadband improvements, permanent Medicare reforms, Interstate Medical […]
Low Medicare ACO participation in 2022 bodes poorly for ambitious Biden goal
The National Association of Accountable Care Organizations would like to see higher participation of ACOs moving forward after a low number in the start of […]
Sanofi drug Enjaymo wins FDA approval to treat anemia from rare blood disorder
A rare disease drug that Sanofi added via its $11.6 billion Bioverativ acquisition is now approved for treating the blood disorder cold agglutinin disease. The […]
Audits and penalties possible for noncompliance with new notification, digital contact rules
A CMS rule, which went into effect December 31, requires that providers publish up-to-date digital contact information regarding their compliance, using approved methods. Noncompliant hospitals […]
Mental health therapists seek exemption from part of law to ban surprise billing
Therapists say their professional codes of ethics already require disclosure to patients of per-visit costs. Requiring diagnostic billing codes in the estimate before even seeing […]
Blue Cross settles class action suit naming ‘pharma bro’ Martin Shkreli for $28M
Shkreli controversially raised the price of the drug Daraprim, which is used to treat a potentially fatal parasitic infection, by 4,000%, from $13.50 to $750 […]
Effective governance: Charting the future of responsible healthcare AI innovation
The power and promise of artificial intelligence comes in a Pandora’s box full of novel and multi-dimensional enterprise risks—legal, regulatory, financial, operational, ethical and reputational—that […]
Steadfast Medical Staffing ordered to compensate aides, nurses over $7.2M in back wages and damages
U.S. District Court for the Eastern District of Virginia-Norfolk Division ruled that Steadfast Medical Staffing knowingly and illegally classified workers as independent contractors instead of […]
Georgia bill aims to limit profits of Medicaid managed-care Companies
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 […]
3 forecasts for the PBM industry in 2022
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 […]
What does the federal ‘No Surprises Act’ mean in California?
Betty Chow, a Los Angeles resident, had a cervical disc replaced in August 2020 at […]
Why CMS is giving chronic care management reimbursements a boost in 2022
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 […]
Gilead Sciences cancer drug hit with partial hold due to adverse event concern
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, […]
Texas Medical Association continuing opposition to No Surprises Act ruling for determining out-of-network pricing
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 […]
Federal report: Mental health coverage is still not on par with other benefits
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 […]
Why Medicare does not cover rapid at-home Covid tests
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 […]
FDA rejects Merck chronic cough drug, asks for more info on efficacy
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 […]
How payment integrity tools can help payers to tackle fraud, waste and abuse
Although telehealth offers many benefits for patients, it introduces operational complexities for providers and creates legitimate concerns about fraud, waste and abuse for payers.
Pfizer’s growth hormone deficiency drug comes up short at the FDA
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 […]
Kura Oncology leukemia clinical trial to resume after FDA lifts partial hold
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 […]
FDA has no appetite for Levo’s metabolic disorder drug and asks for new trial
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 […]
FDA presses pause on test of Alzheimer’s drug from Denali before study even starts
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 […]
Supreme Court allows health worker vaccine mandate to proceed while blocking it for other workers
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 […]
CMS proposes limited coverage of Biogen Alzheimer’s drug, only in clinical trials
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 […]
Physicians group files brief supporting AMA/AHA Lawsuit
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 […]
Report finds states with the most restrictive telehealth laws appear to be hardest hit by Covid
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 […]
Supreme court weighs Biden’s workplace vaccine requirements
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 […]
In 2022, California’s ballot will be heavy on healthcare
When Californians go to the polls later this year, they will confront contentious healthcare choices. […]
FDA expands Covid-19 boosters for kids using real-world data in much older adults
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 […]
Cancer therapies lead way as FDA tallies 60 drug approvals in 2021
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 […]
Are we entering an age of full price transparency in healthcare?
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 […]
FDA sets decision date for Amylyx Pharma ALS drug that improves neuron survival
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 […]
Leo Pharma’s FDA nod adds a challenger to Dupixent’s dominance in eczema
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 […]
FDA authorizes Merck antiviral, which joins Pfizer pill as oral option for Covid-19
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 […]
FDA nod for Novartis sets up cholesterol drug showdown with Amgen, Regeneron
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 […]
Patient death prompts FDA halt on Pfizer’s Duchenne gene therapy study
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 […]
Biogen slashes price of Alzheimer’s drug by half as CMS coverage decision looms
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 […]
FDA approval of Argenx neuromuscular disease therapy is first in new drug class
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 […]
Humana, Centene file antitrust suit against Gilead for HIV drug agreements
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 […]
Medtronic hit with FDA warning letter for diabetes devices
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 […]
FDA decision for BMS drug Orencia marks a first for acute graft versus host disease
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 […]
Appeals court declines to reinstate CMS’ vaccine mandate
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 […]
Provider groups sue as surprise billing enforcement nears
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 […]
AstraZeneca’s long-acting antibody drug lands FDA authorization for Covid-19
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 […]
21st century cures: What ONC and CMS final rules mean for your ambulatory care practice
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 […]
A title fight pits physician assistants against doctors
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 […]
Infants, kids now have a Covid-19 therapy as FDA expands use of Eli Lilly drug
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 […]
Conservative justices appear poised to overturn Roe’s abortion rights
Judging from the questions asked by the justices, it appeared possible — even likely — that a majority of them could vote to turn the […]
FDA turns down BeyondSpring chemo complication drug, asks for another trial
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 […]
As CMS drives cost and quality improvements, here’s why glucose management is the newest focus
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 […]
California joins other states trying to reduce wait times for mental healthcare
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 […]
Jury rules pharmacy chains liable in landmark opioid trial
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 […]
Patient death prompts clinical trial pause for Kura Oncology leukemia drug
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 […]
FDA hands out approvals to Takeda transplant drug, Aadi Bio cancer therapy
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, […]
5 things U.S. government can do to fix our broken healthcare system
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 […]
BioMarin Pharma sees big things for first FDA-approved dwarfism drug
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 […]
Preparing for the No Surprises Act: How automation can help solve the provider directory problem
The deadline to comply with the No Surprises – January 1 – is practically around the corner. Payers that want to be in compliance with […]
FDA approves PharmaEssentia interferon drug for a rare type of blood cancer
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 […]
Congress: Block Medicare cuts to support patient access to physical therapy
We again need Congress to intervene in order to protect patients and providers and stop any further cuts to specialty care.
How patient safety is being hampered by rampant ransomware attacks
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.
Congress must regulate medical device repair to protect patients
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 […]
Biden got it right on the Right-to-repair conversation by excluding medical devices
President Biden and his administration were right to exclude medical devices from the executive order on Promoting Competition in the American Economy.
Oak Street Health stock drops on DOJ investigation
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 […]
Regulators get it right in Optum-Change case, a proper target for antitrust enforcement
In both word and action, the Biden administration has ushered in an aggressive new era […]
Legislative victories fuel advocates for coverage of biomarker testing
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 […]
Vaccine requirements incoming for healthcare facilities, big businesses
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 […]
UnitedHealth, Change meet requirements for DOJ investigation, agree not to merge before February
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 […]
Medicare drug price negotiation gets new life under Democrat-brokered deal
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 […]
ALS drugmaker steps up with FDA filing, but yet another biotech stumbles in clinic
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 […]
A new California law aims to strengthen access to mental health services
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 […]
Clinical decision support guidance tops FDA’s agenda for 2022
At the top of the Food and Drug Administration’s agenda for the next 12 months: […]
DOJ accuses Kaiser Permanente of Medicare Advantage fraud in new complaint
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 […]
Bill aiming to streamline MA prior authorization gains House majority support
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 […]
FDA refusal of Stealth Bio drug shows challenges of ultra-rare disease studies
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 […]
In rural communities, Covid relief and broadband investment can’t be competing priorities
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 […]
CMS chief at HLTH: We need to stop taking it for granted that people know they are eligible for coverage
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 […]
FDA approves Humira biosimilar as first-ever interchangeable monoclonal antibody
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 […]
Oyster Point dry eye drug is approved, but omission in label crimps financing plan
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. […]
FDA panel supports J&J Covid-19 vaccine booster; no vote on mixing and matching
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after […]
Mayo, Kaiser, Medically Home launch advocacy effort to extend hospital-at-home flexibilities
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 […]
In a first, Colorado gets CMS approval to make gender-affirming care an essential health benefit
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 […]
The health tech and medtech investment landscape in the age of Covid-19 [Sponsored]
Fredrikson & Byron attorneys Ryan Johnson and Jeffrey Steinle share insights on how Covid-19 is continuing to transform the health tech and medtech landscape.
With FDA nod, ChemoCentryx pill stands out in a sea of injectable & infused meds
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 […]
FDA halts all Allogene cell therapy trials after chromosome problem detected
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 […]
Aetna’s prior authorization policy harms California patients
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 […]
Medtronic expands recall of MiniMed insulin pumps
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 […]
Pharmacists join chorus calling for DOJ to stop Optum-Change Healthcare merger
Independent and community pharmacies seek to prevent UHG and Change merging into a “corporate monster” that will stifle competition.
Why the right-to-repair conversation needs to extend further
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 […]
CMS lowers MA premiums amid insurer plans to grow offerings
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 […]
Why contracts play a key role in overcoming the pharma industry’s data challenges
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 […]
Feds provide payment resolution process in new surprise billing rule
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, […]
MedCity Spotlight Video: Fredrikson & Byron attorneys discuss Covid-19’s impact on deal-making and value-based care [Sponsored]
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 […]
Google’s DeepMind faces suit over access to NHS patient records
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 […]
Former Shire asset becomes Mirum’s first FDA-approved rare disease drug
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 […]
AbbVie drug approval sets up competition with Biohaven in migraine prevention
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 […]
Provider groups back Hackensack Meridian Health, Englewood Health’s appeal against merger delay
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 […]
CVS sues pharmacy benefit startup Capital Rx over ‘unenforceable’ non-compete clause
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 […]
HHS rule bolsters health equity, Brooks-LaSure tells state rulemakers
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 […]
OIG: MA companies used chart reviews, health risk assessments to boost CMS payments
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 […]
FDA authorizes Pfizer Covid-19 vaccine booster shots, but only for certain groups
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 […]
CMS grants quality reporting exceptions for facilities recovering from Hurricane Ida
The agency has granted certain Medicare quality reporting exceptions to healthcare facilities in areas of Louisiana, Mississippi, New York and New Jersey that were battered […]
Better late than never? Eczema drug now approved, Incyte says warning unwarranted
Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the […]
Seagen, Genmab antibody drug conjugate gets FDA approval in cervical cancer
The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment […]
Health apps could face big fines if they don’t disclose privacy breaches
The agency reminded health apps and wearables companies that they must disclose any breach of users’ health information, even if they are not a HIPAA […]
Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug
The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic […]
CMS suspends enrollment in UnitedHealthcare, Anthem MA plans
The agency has suspended enrollment in three UnitedHealthcare plans and one Anthem plan for 2022 because the plans did not spend enough of their premium […]
FDA panel backs booster shots in high-risk groups after rejecting broader proposal
An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots […]
Racism, sexism and now fraud: Lawsuits pile up at New Jersey ‘AI’ firm
A previous investigation by MedCity News found that ElectrifAi was touting an improperly-developed algorithm during the earliest phase of the Covid-19 pandemic, with both the […]
Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature
Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With […]
Lawsuit: Aetna fertility coverage policy “an illegal tax” on LGBTQ people
The lawsuit alleges that an Aetna policy discriminates against LGBTQ people by requiring them to pay thousands in out-of-pocket costs for fertility treatments before becoming […]
“No Surprises” enforcement left to states, big questions left unanswered in HHS rule
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 […]
CMS wants to repeal breakthrough device coverage rule, dashing med device industry hopes
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 […]
Astellas Pharma reports fourth patient death in gene therapy clinical trial
The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy […]
CMS is finally bringing health equity into the equation
CMS has recently proposed essential and timely reimbursement changes to close the racial discrepancy gap around the mandatory payment model for kidney disease
New HHS proposed rule requires payers to disclose broker rates, share air ambulance data
In a set of newly proposed rules, HHS wants insurers offering individual and short-term, limited-duration coverage to disclose to members the rates they pay to […]
FDA sets expectations for pediatric Covid-19 vaccines; decision could come mid-fall
Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing […]
FDA warns Kaleido Bio to test its Covid-19 candidate as a drug, not a medical food
The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical […]
Covid-19 vaccination required for staff in most healthcare settings
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 […]
Justice Department sues Texas to block restrictive abortion law
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 […]
Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy
A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study […]
Impel NeuroPharma’s drug-device combo product nabs FDA nod for migraine
The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It […]
Feds slap UPMC, cardiothoracic surgery chair with billing fraud suit
The lawsuit alleges that UPMC and the chair of its cardiothoracic surgery department knowing submitted false claims for concurrent surgeries that violated regulations. But, according […]
25 years of HIPAA: How the groundbreaking statute has kept pace with technology
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 […]
It’s time to relieve electronic prior authorization bottlenecks
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 […]
FDA cracks down on JAK drug class, calls for new warnings of heart, cancer risks
The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency […]
Report: Medicare trust fund still expected to run out by 2026
The latest report from the Medicare Board of Trustees shows that the health insurance trust fund, also known as Medicare Part A, will run out […]
Sutter Health to pay $90M to resolve False Claims allegations
The California-based health system will pay a hefty price to resolve allegations that it knowingly submitted inflated diagnosis codes for certain Medicare Advantage beneficiaries to […]
CMS to fund 60 ACA navigator orgs next year
CMS will provide $80 million to 60 organizations that train ACA navigators — who help consumers find coverage on the federally funded marketplaces — in […]
DeepMind has unlocked protein-based medicine – what does that mean for drug patents?
One of science’s great puzzles is being solved by artificial intelligence and the answers shared freely on the internet. How can life sciences companies make […]
Hackensack Meridian Health, Englewood Health appeal court decision to block merger
The FTC sued to block the merger between the two New Jersey-based health systems and won a preliminary injunction earlier this month. But the providers […]
Peloton subpoenaed over reporting of treadmill injuries
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 […]
BioMarin stands tall with first approved drug for rare disease that causes dwarfism
The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common […]
FDA approves first drug for severe itching in chronic kidney disease patients
Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the […]
CMS offers additional Medicare payments for at-home Covid-19 vaccinations
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 […]
Are you prepared for a post-pandemic surge of PDPM audits?
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 […]
Insurer price transparency rule faces legal challenges: 4 takeaways
Two lawsuits, filed by the U.S. Chamber of Commerce and the Pharmaceutical Care Management Association, allege that portions of the price transparency rule governing insurers […]
Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval
Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart […]
Avoid surprises by preparing to implement the No Surprises Act
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 […]
Illumina’s Grail buyout beats deadline, but legal and regulatory hurdles remain
In closing its Grail acquisition before U.S. and European regulators sign off, Illumina is taking a chance the deal will pass regulatory muster. It’s a […]
DC Circuit: Insurers have to report Medicare Advantage overpayments to CMS
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 […]
What payers need to know about CMS’ Payer-to-Payer Data Exchange requirement
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 […]
