About Covid-19
The C.D.C. now says fully vaccinated people should get tested after exposure even if they don’t show symptoms.: “‘Our updated guidance recommends vaccinated people get tested upon exposure regardless of symptoms,’ Dr. Rochelle P. Walensky, the agency’s director, said in an email to The New York Times…
Fully vaccinated people should wear a mask in public indoor spaces after exposure, the agency said. Three to five days later, they should be tested for the virus.
If the results come back negative, they can stop wearing masks indoors. If results are positive, the infected should isolate at home for 10 days.”
Bipartisan Senate infrastructure deal will not touch COVID-19 relief funds but delays Part D rebate rule: “A bipartisan group of senators announced an agreement on major pieces of the roughly $1 trillion infrastructure package. The deal will not touch COVID-19 provider relief funds to help pay for the package. However, in a major win for pharmacy benefit managers, it will delay a rule to get rid of the safe harbor for Part D rebates…”
J&J says U.S. FDA agrees to extend shelf life of its COVID-19 vaccine: “The U.S. Food & Drug Administration extended the shelf life for Johnson & Johnson's single-shot COVID-19 vaccine to six months from four-and-a-half months, the company said late Wednesday.”
White House tells agencies to mandate masks in federal buildings in hot spots: “Numerous U.S. federal agencies on Wednesday mandated masks at federal buildings in COVID-19 hot spots in line with instructions issued by the White House Office of Management and Budget (OMB), according to an OMB email seen by Reuters.
The move followed guidance issued by the Centers for Disease Control and Prevention (CDC) on Tuesday that vaccinated people should wear masks indoors in areas with substantial or high COVID-19 community transmission.
The White House said masks are required indoors in federal buildings for all employees and visitors, whether or not vaccinated, in those areas.”
Covid-19 Breakthrough Infections in Vaccinated Health Care Workers: “Among 1497 fully vaccinated health care workers for whom RT-PCR data were available, 39 SARS-CoV-2 breakthrough infections were documented. Neutralizing antibody titers in case patients during the peri-infection period were lower than those in matched uninfected controls… Higher peri-infection neutralizing antibody titers were associated with lower infectivity…Most breakthrough cases were mild or asymptomatic, although 19% had persistent symptoms (>6 weeks). The B.1.1.7 (alpha) variant was found in 85% of samples tested…No secondary infections were documented.”
About pharma
FDA Approves First Interchangeable Biosimilar Insulin: “The US Food and Drug Administration (FDA) has approved the first interchangeable insulin, Semglee (Mylan Pharmaceuticals), which can be substituted for glargine (Lantus, Sanofi) at the pharmacy without the need for a separate prescription.
The approval will allow Semglee to function like a generic drug in the market and may reduce insulin costs.”
Children’s Hospital of Philadelphia Researchers Develop “Dimmer Switch” to Help Control Gene Therapy: This discovery could have a huge impact on and create the next generation for gene therapies:
”In a major advancement in the field of gene therapy for rare and devastating diseases, researchers at Children’s Hospital of Philadelphia (CHOP) have developed a ‘dimmer switch’ system that can control levels of proteins expressed from gene therapy vectors. The system is based on alternative RNA splicing using an orally available small molecule and works effectively in tissues throughout the body, including the brain. The first research regarding this innovation was published today in the journal Nature.”
Eli Lilly bets $70M upfront and another $2B in biobucks for Kumquat's immuno-oncology small molecules: “The deal sees Lilly partner with Kumquat—run by a pair of serial entrepreneurs—to develop small molecules that stimulate tumor-specific immune responses, according to a statement. In return for the upfront payment, which consists of a cash payment and an equity investment, Lilly secures an option to a ‘certain number’ of drug candidates.”
July 2021 Pharmacy Market Outlook: Worth a quick read…the “bottom line” on cost is that the total weighted average drug price inflation estimate for 2022 is 3.10%.
About health insurance
Sign-Up Window for Free COBRA Coverage for Many Laid-Off Workers Closes This Week: “Under the American Rescue Plan Act that President Joe Biden signed in March, COBRA premiums for laid-off workers are covered in full by federal funding for six months from April through September…
For people… who lost their jobs before April 1, the window to take advantage of the subsidized coverage is closing. They have 60 days from the date their employer notified them of the COBRA subsidy to sign up for it — that’s July 31 if their employer notified them at the end of May. People notified earlier may have already missed their opportunity.”
About healthcare IT
Most Americans Want to Share and Access More Digital Health Data: One of the biggest impediments to interoperability has been peoples’ reluctance to have a unique identifier. According to this Pew Foundation survey, this sentiment has changed: “By a roughly 2-to-1 margin, respondents were comfortable with their health providers scanning patient fingerprints or assigning individuals a unique number or code to ensure that different EHR systems correctly match records for the same person, a long-standing challenge of data exchange.”
Parent of 1,000-physician network acquires digital health firm: The trend of cross-functional healthcare organizations’ consolidation continues: “The parent company of Catalyst Health Network, a 1,000-physician network based in Plano, Texas, acquired digital health company MediBookr, according to a July 27 news release.”
About hospitals and health systems
14 hospitals, systems sue HHS over graduate medical education payments: A group of 14 hospitals and health systems, including Michigan Medicine in Ann Arbor and Hospital for Special Surgery in New York City, is suing HHS over a calculation used to determine payments for physician training programs, according to court documents.
In the July 26 lawsuit, the hospitals claim they have been underpaid for several years due to a regulation implemented by HHS.
The regulation at the center of the lawsuit changed the weight assigned to full-time equivalent residents and fellows in the calculation to determine direct graduate medical education payments. Under the regulation, if a resident's training time exceeds the number of years designated as the "initial residency period," the resident's time is weighted at 0.5. Additionally, the regulation established a cap on the number of full-time equivalents that a hospital may claim in a given fiscal year.”