Author: Peter

There were reports earlier this month that concierge primary care company One Medical was looking at potential suitors for a takeover deal...It seems Amazon made the right offer...The deal expands Amazon's reach into primary care as it also operates Amazon Care, which offers both virtual care services as well as in-home care to employees and other companies...Acquiring One Medical is part of Amazon's goal to "reinvent" healthcare..."Booking an appointment, waiting weeks or even months to be seen, taking time off work, driving to a clinic, finding a parking spot, waiting in the waiting room then the exam room for what is too often a rushed few minutes with a doctor, then making another trip to a pharmacy – we see lots of opportunity to both improve the quality of the experience and give people back valuable time in their days,”...READ MORE

Merck is suing the Biden administration to avoid potential fines for cutting off 340B contract pharmacies from getting discounted products...The pharmaceutical giant argues in a federal lawsuit filed Friday in the U.S. District Court for the District of Columbia that favorable rulings in similar cases make a warning letter from the federal government moot. The lawsuit is the latest in a feud between the federal government and drugmakers over the 340B program...In 2021, Merck became among nearly 20 drugmakers that cut off sales of 340B-discounted drugs to contract pharmacies, which dispense the products on behalf of covered entities. Merck told 340B entities that if they do not join the company’s integrity program and submit claims-level data then it will no longer provide the drugs to contract pharmacies...READ MORE

Watch out, pharma—the federal government has its eye on add-on drug patents that can lead to higher prices. In a new effort, the FDA and the U.S. Patent and Trademark Office (PTO) are teaming up to take a close look at patenting procedures...the PTO said it plans to crack down on patenting of “incremental, obvious changes to existing drugs that do not qualify" for new protections...The latest effort is the result of officials at the PTO and the FDA exchanging letters outlining their concerns about pharma patents. The joint work is set to expand their resources for patent regulation...READ MORE

California will start making its own affordable insulin as part of an effort to combat high drug prices for a lifesaving medication that's been made inaccessible for some Americans living with diabetes, Democratic Gov. Gavin Newsom announced...Newsom said in a video posted to Twitter that $100 million from the state budget he recently signed for 2022-2023 would be allocated for California to "contract and make [its] own insulin at a cheaper price, close to at cost, and to make it available to all." Half of the $100 million would go toward the development of a "low-cost" insulin, Newsom said. The other $50 million would go toward a facility in the state to manufacture insulin that would "provide new, high-paying jobs and a stronger supply chain for the drug."...READ MORE

Pharmacists say Georgia's evolving restrictions around access to abortion coupled with recent guidance from the federal government have created confusion over distribution of medication that can terminate pregnancies...The Biden administration earlier this month warned pharmacists nationwide that they are required to fill prescriptions for pills that can induce abortion. Refusing to give out the prescribed medication "may be discriminating" on the basis of sex or disability and could amount to a violation of federal civil rights laws...Bob Coleman, CEO of the Georgia Pharmacy Association, said the organization is working with national pharmacy associations to get clarity..."We understand that confusing and sometimes contradictory information is being shared," he said. "Unfortunately, the HHS guidance puts highly trained health care professionals...in a seemingly impossible situation."...Georgia Republican U.S. Rep. Buddy Carter, a pharmacist, called the HHS message to his colleagues a "gross abuse of executive authority."..."There is no constitutional right to an abortion, and as such, there is no constitutional obligation for pharmacists to knowingly dispense drugs intended for an abortion," Carter said in a statement. "This administration has a habit of using health care professionals as political pawns, from vaccines to abortions, and that abuse must come to an end."...READ MORE

America’s economically disadvantaged patients can point in two directions when talking about what is wrong with the 340B Drug Pricing Program, which is designed to help hospitals caring for underserved communities — and the patients they treat — keep necessary medicines reasonably priced: large supposedly “nonprofit” hospitals and for-profit pharmacy benefit managers that serve as 340B contract pharmacies, which together divert billions of dollars in savings that should be helping patients in need...The problem is that the 340B program has become a slush fund for its other participants, the large, supposedly nonprofit hospitals and health systems. They buy drugs at steep 340B discounts, then charge insurers, the uninsured, and cash-paying patients a huge markup. The profits pad the hospitals’ bottom lines and provide ample capital to take over and consolidate local markets, particularly in cancer care. And the result is shockingly little charity care...READ MORE

Apparently, a $107 million deal value isn't large enough to be considered anticompetitive when viewed in the context of delaying generics to a blockbuster brand...A Delaware federal judge reached that conclusion when he threw out an antitrust claim targeting a pay-for-delay deal between AstraZeneca and generic maker Accord Healthcare over the British pharma’s popular antipsychotic Seroquel XR...But that was only a half-win for AstraZeneca in a class action suit. The judge has allowed another similar claim brought by drug wholesalers, retailers and payers against a separate deal that AZ originally signed with Handa Pharma and later passed on to Endo’s Par Pharmaceutical...Both claims allege that the “reverse payment” agreements AZ inked with those generic makers to settle Seroquel XR patent disputes delayed and suppressed competition, causing higher prices...READ MORE

Despite what you may have heard, pharmacy participation in the 340B Drug Pricing Program continues to thrive...Drug Channels Institute’s latest analysis reveals that an astonishing 32,000 pharmacy locations—more than half of the entire U.S. pharmacy industry—now act as contract pharmacies for the hospitals and other healthcare providers that participate in the 340B program. Over the past 12 months, the number of pharmacies in the program has grown by more than 2,000 locations...What’s more, five multi-billion-dollar, for-profit, publicly traded pharmacy chains and PBMs...account for three-quarters of all 340B contract pharmacy relationships with covered entities. Is this really what Congress intended when the 340B program was established in 1992?...The 340B Drug Pricing Program has become the second-largest government pharmaceutical program, based on net drug spending. But unlike such programs as Medicare Part D and Medicaid, 340B lacks a regulatory infrastructure, well-developed administrative controls, and clear legislation to guide the program...READ MORE

A payment vendor was hit with a ransomware attack back in February that may have exposed patient data from more than 600 healthcare providers and organizations...Professional Finance Company...detected and stopped a sophisticated ransomware attack in which an unauthorized third party accessed and disabled some of PFC’s computer systems...During an ongoing investigation, it was determined that hackers accessed files containing certain individuals' personal information...the company is one of the nation’s leading debt recovery agencies, and its client list includes many healthcare providers, retailers, financial organizations and government agencies...The ransomware attack hit company computer systems that held data from clients such as Banner Health, Lifestance Health, Renown Health, DispatchHealth and hundreds of other provider customers...READ MORE

...the U.S. Food and Drug Administration took the unusual step of authorizing pharmacists to directly prescribe antiviral medication Paxlovid to patients testing positive for COVID-19...But don’t expect to get a prescription right away from your neighborhood pharmacist for the pills...Major pharmacy chains and a state regulatory agency said Friday that they’re continuing to work with the FDA on how to best implement the change, including whether any new costs will be passed on to patients. Although the details still need to be worked out, the change was applauded by the industry...“I’m elated,” said Christina Madison, an associate professor at the College of Pharmacy at Roseman University in Southern Nevada...The change eliminates a barrier to getting treatment, especially in rural areas and “medical deserts” where a pharmacy is “the only place a person can get medical information for miles,” she said...READ MORE