About Covid-19
Insurers must cover at-home COVID-19 tests starting Jan. 15 under new CMS directive: “Insurers must cover at least eight at-home COVID-19 tests per covered individual starting on Saturday, per a new directive from the Biden Administration.
The frequently-asked questions document released by the Centers for Medicare & Medicaid Services (CMS) is an effort to improve access to at-home tests, which have been in short supply in recent weeks amid a surge of the virus fueled by the omicron variant.”
•N95 respirators were decontaminated with vaporous hydrogen peroxide 25 times.
•No alterations to respiratory integrity or filtration efficiency seen by 25 cycles.
•Vaporous hydrogen peroxide does not appear to impact fit or filtration efficiency using this defined process.
Merck Delivered 900,000 Antiviral Courses to U.S. Last Month: “Merck & Co. delivered 900,000 courses of its Covid-19 antiviral pill to the U.S. in December and is set to provide 3 million courses ordered by the government by the end of January, Chief Executive Officer Rob Davis said.
Despite the supply-chain issues that have plagued companies around the world, Davis said Merck was able to make 10 million courses of the drug, molnupiravir, as expected last year. They just need to be labeled and shipped, he said.”
Biden coronavirus vaccine-or-test mandate goes into effect: “Key components of the Biden administration’s COVID-19 vaccine or test mandate for more than 80 million workers went into effect Monday amid an ongoing Supreme Court battle that could ultimately doom the rule.
The months-long legal battle over the requirement, which was previously blocked by a federal court before being reinstated, has created confusion among employers about how to move forward. While Supreme Court justices expressed skepticism about the rule on Friday, they did not block its implementation by Monday’s deadline.
As of Monday, businesses with 100 or more employees were required to have a database of their workers’ vaccination status, post their company vaccine policy, provide paid leave to workers getting the vaccine and require unvaccinated employees to wear a mask at work.
The Occupational Safety and Health Administration (OSHA), the agency tasked with enforcing the rule, has said it won’t issue penalties for noncompliance until Feb. 9.”
Usability of COVID-19 Antigen Home Test Kits: “Because of the urgency in providing useful information to consumers as quickly as possible, ECRI selected the seven test kits based on retail availability.”
Good review.
HHS head defends CDC director: 'She doesn't have a degree in marketing': “[HHS Secretary] Becerra defended the leader, saying, ‘Dr. Rochelle Walensky is an infectious disease expert. She has a medical license and she also has a degree in public health. She doesn't have a degree in marketing.’ He then said, ‘Who do I want running CDC? Someone who knows infectious diseases, someone who understands this stuff. And so, while we may have issues with some of the marketing that's been done, I guarantee you, Dr. Walensky is someone we need at CDC.’”
Where is the communications director???
Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19: Highlights from this first-in-class product:
—”Topline results from the randomized EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo, met the primary endpoint of viral load reduction over eight days
—The secondary endpoint of hospitalization and/or ER visits related to COVID-19, or death showed an overall 78% reduction in risk of events across ensovibep arms compared to placebo
—A total of 407 patients were recruited in the Phase 2 study and ensovibep was safe and well-tolerated at all doses (75mg, 225mg and 600mg) – with 75mg the planned dose for further development
—Ensovibep continues to maintain potent in vitro pan-variant activity against all variants of concern identified so far, including Omicron
—Ensovibep is a multi-specific DARPin (Designed Ankyrin Repeat Protein), specifically designed to block the receptor binding domains of SARS-CoV-2 spike protein through highly potent and cooperative binding, making it challenging for escape mutants”
A market-based solution to the anti-vaxxer problem: From The Financial Times: “As the world grapples with the fast-spreading Omicron variant and its potentially devastating consequences, a major policy dilemma revolves around how governments might nudge the unvaccinated or partially vaccinated to join the ranks of those who are fully protected. Policies proposed range from fines (in Greece), and Covid passes to access public venues (in France and Switzerland), to nationwide mandatory vaccination (in Austria). Vaccination mandates in particular rankle liberals and libertarians alike and raise challenging ethical questions, while arguably entrenching the position of the unvaccinated…
One way to nudge the unvaccinated to get a jab is to require that those who remain unvaccinated by choice pay for the cost of their own medical care, in case of Covid-induced hospitalisation — a policy that Singapore introduced last year. Some will argue that such a requirement would hit the less well-off or ethnic minorities, who are disproportionally unvaccinated, while giving a free pass to wealthier individuals. To counter that, I would propose a charge philosophically similar to that applied to speeding fines: as a percentage of (in this case annual) income.”
About pharma
Medicare proposes covering expensive drug for early-stage Alzheimer’s, but with restrictions that will sharply limit use: “Medicare officials announced Tuesday they would cover a controversial Alzheimer’s drug — but only with restrictions that will sharply limit who receives the drug.
The Centers for Medicare and Medicaid Services proposed a national policy that would cover Aduhelm and similar drugs in development only for people enrolled in qualifying clinical trials.
The proposal is open to public comment for 30 days. The agency has said it plans to issue a final decision in April.”
114 drugs currently in shortage, per FDA: “Nationwide, more than 100 drugs are in short supply, including antibiotics, diuretics, opioids and heart failure medications, FDA data shows.
As of Jan. 11, 114 drugs were in shortage, according to the FDA's database of current and resolved drug shortages, which is updated daily. The current tally is a continuation of shortage levels seen last year. In November 2021, the FDA reported 112 drug shortages.”
Judge Allows Sacklers to Appeal Ruling on $4.5 Billion Opioid Settlement: “A federal judge is allowing the Sackler family and their company Purdue Pharma to appeal a ruling that overturned a $4.5 billion settlement resolving thousands of complaints alleging they helped fuel the opioid epidemic.”
Researchers find hormone in fat tissue that could help insulin-resistant patients with diabetes: “Insulin has been the primary way of treating diabetes and other high blood sugar conditions for nearly a century. Now, researchers say a molecule made in fat tissue could pave the way for new diabetes therapies and spark new metabolism research.
The discovery is FGF1, a hormone that regulates blood glucose by inhibiting the breakdown of fat, a metabolic process known as lipolysis. Insulin and FGF1 both inhibit lipolysis, but the hormones operate differently, which could lead to safe and successful lowering of blood glucose in people who are resistant to insulin, researchers at Salk Institute reported in Cell Metabolism this month.
The researchers found that the two diverge in similarity when it comes to signaling pathways. Insulin tamps down on fat breakdown through PDE3B, whereas FGF1 uses the pathway known as PDE4…
The PDE4 pathway can lead to new drug discovery and basic research focused around high blood glucose and resistance to insulin…”
About health insurance
Humana execs try to soothe skittish investors as new MA enrollment projections disappoint: “The insurer issued a filing with the Securities and Exchange Commission on Thursday that decreased its outlook for MA enrollment from between 325,000 and 375,000 new members to between 150,000 and 200,000 new members.
Humana added 130,000 members during the annual enrollment period for MA last fall. It said in the filing that it saw higher than expected terminations during the enrollment window and expects an elevated number of terminations through 2022.”
Centene execs tout strong MA enrollment period—though work remains on star scores: “The merger between Centene and WellCare Health Plans created the country's largest sponsor of government insurance, with a massive reach in the Affordable Care Act's exchanges, Medicare and Medicaid.
The company has also invested heavily in rebranding its disparate MA plans to align them across the portfolio and has brought on new ambassadors for outreach to seniors. Even prior to the merger, Centene was working on its digital distribution channels to improve the experience…
[T]he company is working on improving its star ratings. More than half of its members selected a four-star or higher plan for 2022.”
HHS: Nearly 14M people enroll on ACA's exchanges ahead of Jan. 15 deadline: “More than 13.8 million consumers have signed up for 2022 healthcare coverage on HealthCare.gov and state-run marketplaces, according to the latest federal figures.
The Department of Health and Human Services (HHS) delivered the latest sign-up numbers ahead of the Jan. 15 open enrollment deadline. The agency touted enhanced subsidies that are set to expire after this year as a key driver of the growth.”
In an unprecedented move, HHS asks officials to consider lowering this year’s Medicare premiums: “The nation’s top health official Monday directed Medicare to consider lowering the premium for the part of the program that covers visits to the doctor and other care outside hospitals. It marked the first time the vast federal health insurance system for older Americans and those with disabilities has rethought the monthly amount patients pay after a change has gone into effect.
Health and Human Services Secretary Xavier Becerra gave the instructions to the Centers for Medicare and Medicare Services (CMS), the agency that oversees the program, saying a review of the Part B premium is needed because of a price drop in a controversial Alzheimer’s drug that Medicare does not yet pay for but might begin covering soon.”
Gavin Newsom proposes health care access for all in plan to cover undocumented Californians: “Gov. Gavin Newsom is proposing to extend Medi-Cal coverage to all low-income, undocumented adults, a historic expansion that would make California the first state in the nation to provide universal health care access for all residents regardless of legal status. The plan is included in Newsom’s $286 billion state budget proposal, which is flush with a projected $45.7 billion surplus. Coverage would begin on Jan. 1, 2024 and would cost the state an ongoing $2.7 billion annually. The program’s launch in the 2023-24 fiscal year is expected to cost $819.3 million.”
In a related article: Single-Payer Healthcare Makes a California Comeback: This article is an editorial opinion by The Wall Street Journal. Well worth getting access to read, as it breaks down the costs of the proposal. With many high tech companies leaving the state, this measure may accelerate business flight.
About healthcare IT
HHS issues warning for healthcare ransomware threats: “The Department of Health and Human Services' Health Sector Cybersecurity Coordinator Center warned the healthcare sector about a cybercrime group targeting the industry.
In a Jan. 6 alert, the department detailed that financially-motivated cybercrime group Mespinoza is increasing its capabilities to target more frequently.
The group has developed its own ransomware variant, known as PYSA, that can encrypt victims' files.”
Loyola email breach exposes nearly 17,000 patients' info: Loyola University Medical Center in Chicago, a part of Trinity Health, recently notified patients of an October data breach that exposed patients' protected health information…
The exposed information included patients' full names, addresses, phone numbers, dates of birth, email addresses, medical record numbers, conditions, medications, test results, medical facilities, types of service and some health plan information.”
About hospitals and health systems
Staffing expenses led to an extra $440M in operating costs in 2021 for AdventHealth: “Major disruptions in the healthcare labor market cost hospital system AdventHealth an additional $440 million in operating costs last year.”
About healthcare personnel
Best Health Care Jobs: From US News. #1 is nurse practitioner.
About the public’s health
Prevalence and Predictors of Young-Onset Colorectal Neoplasia [CRC]: Insights from a Nationally Representative Colonoscopy Registry: “Increasing age, male sex, white race, family history of CRC, and examinations for bleeding or screening were all associated with higher odds of advanced premalignant lesions (APLs) and CRC. Among patients aged 45-49, 32% had any neoplasia, 7.5% had APLs, and 0.58% had CRC. Rates were almost as high in those aged 40-44. Family history of CRC portended neoplasia rates 5 years earlier. Rates of APLs were higher in Asians and American Indian/Alaskan Natives, but lower among Blacks and Hispanics, compared to white counterparts. The prevalence of any neoplasia and APL gradually increased between 2014-2020, in all age groups.
These data provide support for lowering the screening age to 45 for all average risk individuals.[Emphasis added] Early messaging to patients and providers in the years leading up to age 45 is warranted, especially in those with a family history of CRC.”
About healthcare technology
Medtronic to Acquire Affera: “Medtronic… announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology company. Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for the treatment of patients with cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). Medtronic, through its minority investment portfolio, has been a strategic investor in Affera and currently holds a 3% ownership stake in the company…”
The price of the acquisition, expected to close in 2023, is $925 million.