Author: Peter

Pfizer’s efforts to blunt the anti-kickback policies...took a hit...as a federal district court dismissed its plan to assist Medicare patients in paying for one of the company's most expensive drugs...In ruling in favor of the Department of Health and Human Services...New York Judge Mary Kay Vyskocil denied Pfizer clearance to run two programs that would reimburse patients for their pricey heart medications Vyndaqel and Vyndamax, which cost $225,000 annually..."Because...the intent of the payments Pfizer proposes here are to increase the number of Medicare beneficiaries who purchase the drug, the Court is unable to issue the declaratory judgment Pfizer seeks or to issue judgment in its favor," Vyskocil wrote...The fight is an old one for Pfizer. In 2018, it had to cough up $24 million to settle a government lawsuit over donations to patient charities. The recent push was an attempt to challenge the laws that the company previously violated...READ MORE

New York hospitals on Monday began firing or suspending healthcare workers for defying a state order to get the COVID-19 vaccine, and resulting staff shortages prompted some hospitals to postpone elective surgeries or curtail services...New York City Mayor Bill de Blasio told a news conference the city's hospitals were not yet seeing a major impact from the mandate, adding he worried about other areas of the state where vaccination rates are lower...A spokeswoman for Catholic Health, one of the largest healthcare providers in Western New York, said it had reached full compliance, counting staff members who had been vaccinated, those with exemptions and some who had been suspended without pay...READ MORE

Pfizer...announced that the U.S. Food and Drug Administration has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series...READ MORE

Results from a new HDA Research Foundation survey indicate that the pharmaceutical supply chain is entering a critical phase in achieving the transaction data connections required to comply with the Drug Supply Chain Security Act in 2023...The DSCSA requires transaction data with product identifiers to be provided with physical product on November 27, 2023...“many healthcare supply chain trading partners are realizing there is work to be done to establish proper business-to-business connections; ensure data are formatted, transmitted and received successfully; that processes for troubleshooting are created; and that products in inventory have the right data attached to them for shipping after November 27,” said Perry Fri...COO of the HDA Research Foundation. “The Foundation’s survey shows...what might be leading to slow implementation rates across the supply chain.”...READ MORE

A landmark opioid trial is getting underway in Cleveland. For the first time, pharmacies...will be on trial, and there will be far-reaching implications for big-ticket policy questions far afield of the opioid crisis...On one side will be Walgreens, CVS, and Walmart. On the other, two Ohio counties...The basic theory that will be trial-tested is whether pharmacies are legally responsible for creating a public nuisance by overlooking so-called “red flags” when filling customers’ prescriptions for FDA-approved opioids...READ MORE

Nearly a quarter of healthcare providers report increased mortality rates following ransomware attacks...Ransomware impacts patient care in more ways than one, with 70% or more of healthcare organizations reporting a longer length of stay or delays in procedures that lead to poor outcomes, according to a Ponemon Institute report...A majority of organizations also report an increase in patient transfers, while more than a third report increased complications from medical procedures...Healthcare delivery organizations are under siege, as 67% have been victims of ransomware attacks. One-third of those said they experienced two or more...READ MORE

National Community Pharmacists Association President Brian Caswell spoke to the Federal Trade Commission during its open meeting...about anticompetitive pharmacy benefit manager issues in the pharmaceutical supply chain...I have watched a steady increase of patients being forced or coerced into mail order which, more often than not, is owned by the (pharmacy benefit manager)...Also, a growing number of restricted medications which are classified as ‘specialty,’ with no clear clinical definition of why it is specialty, are contractually not allowed to be filled by the patient’s preferred pharmacist. Again, the prescription is steered towards the PBM’s own mail order....READ MORE

A number of Big Pharma companies, including Gilead and Merck, engaged in what’s known as “pay-for-delay” deals, settling with up-and-coming generic rivals to stall their market entry and costing drug buyers hundreds of millions in lost savings as a result, a handful of high-profile new lawsuits claim...two of the nation’s largest pharmacy chains—CVS and Ride Aid—are going head-to-head with Gilead, Bristol Myers Squibb and Teva for engaging in a “multifaceted scheme to suppress and delay” generic rivals of Gilead’s HIV meds, according to a filing in the U.S. District Court...READ MORE

Businesses with 100 or more employees will be required to mandate vaccination or weekly testing for their workers under a new rule announced by President Joe Biden...But many Nevada businesses and public institutions have already put their own employee vaccine mandates in place, with more in the works as the federal government finalizes the new rule and fleshes out its finer points. Some have gone further by requiring vaccinations not just for employees but as a condition of entry for members of the public, including at conventions, athletic events and concerts...At the same time, some rural governments have passed resolutions banning vaccine mandates to varying degrees...READ MORE

The National Community Pharmacists Association is using social media, digital advertising, and a grassroots effort to push congressional budget makers to include a provision eliminating pharmacy benefit manager spread pricing under the Medicaid program and reimburse pharmacies in a fairer and more transparent manner...“PBM spread pricing costs federal and state taxpayers hundreds of millions of dollars every year. It does nothing to reduce the cost of drugs for Medicaid patients, and it drives local pharmacies out of business,” said NCPA CEO B. Douglas Hoey...Spread pricing is what happens when pharmacy benefit managers, known as PBMs, charge insurance plans like Medicaid one price for prescription medications, reimburse pharmacies that dispense them a much lower price, and then keep a big chunk of the difference for themselves...READ MORE