About Covid-19
Moderna seeks authorization of coronavirus vaccine for youngest children “Vaccine maker Moderna requested emergency use authorization Thursday of its coronavirus vaccine for babies, toddlers and youngchildren — a highly anticipated step toward making shots available to the last group in U.S. society lacking access…
The full data supporting the application is expected to be filed by early in the second week of May, according to a senior Biden administration official, who spoke on the condition of anonymity because they were not authorized to discuss the matter publicly.”
AMA announces CPT update for COVID-19 booster candidates “The American Medical Association (AMA) …announced an editorial update to Current Procedural Terminology (CPT®)… for describing health care procedures and services, that includes newly assigned provisional CPT codes for COVID-19 booster candidates from Pfizer and Sanofi-GlaxoSmithKline.
The Pfizer booster candidate is proposed for use in children ages 5 to 11 who have completed a COVID-19 vaccine primary series, while the Sanofi-GSK booster candidate is proposed for use in persons age 18 and older who have completed a COVID-19 vaccine primary series.”
About health insurance
HHS Announces New Policy to Make Coverage More Accessible and Affordable for Millions of Americans in 2023 Some highlights:
The rule:
— “helps simplify the consumer shopping experience by establishing standardized plan options for issuers offering Qualified Health Plans (QHPs) on HealthCare.gov. With standardized maximum out-of-pocket limitations, deductibles, and cost-sharing features, consumers will be able to more directly compare other important plan attributes, such as premiums, provider networks, prescription drug coverage, and quality ratings when choosing a plan…
—requires QHPs on the Federally-facilitated Marketplace (FFM) to ensure that certain classes of providers are available within required time and distance parameters…
—aims to protect consumers from discriminatory practices related to the coverage of the essential health benefits (EHB) by refining the CMS nondiscrimination policy.”
By The Numbers: New AHIP Resource Illustrates How Employer-Provided Coverage Supports Better Health and Financial Stability This article provides state-specific data on employer-sponsored health insurance. Some “big picture” findings:
1. “Nearly half of Black Americans (47%) are enrolled in employer-provided coverage
2. More than 40% of Hispanic Americans are enrolled in employer-provided coverage
3. About two-thirds of Asian Americans and Native Hawaiian and Pacific Islanders are enrolled in employer-provided coverage
4. 50% of children (age 0-18) in the United States receive health coverage through a parent/guardian’s job
5. 60% of those with incomes between 200-399% of the Federal Poverty Line (FPL) — $20,578 for a family of 3 — are enrolled in employer-provided coverage”
The Facts About Medicare Spending From the KFF. “Medicare provides health insurance coverage for 65 million people, nearly 20% of the U.S population – a share which will grow larger in the coming decades. In 2020, Medicare spending comprised 12% of the federal budget and 20% of national health care spending.”
See the monograph for more details.
Some Medicare Advantage Organization [MAO] Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care From the HHS OIG:
”Key Takeaway
[Some] MAOs denied prior authorization and payment requests that met Medicare coverage rules by:
using MAO clinical criteria that are not contained in Medicare coverage rules;
requesting unnecessary documentation; and
making manual review errors and system errors.
…we recommend that CMS:
(1) issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews;
(2) update its audit protocols to address the issues identified in this report, such as MAO use of clinical criteria and/or examining particular service types; and
(3) direct MAOs to take steps to identify and address vulnerabilities that can lead to manual review errors and system errors.
CMS concurred with all three recommendations.”
Urgent Care Doctor and his Facilities Settle Allegations of Federal Health Care Fraud “Breon Peace, United States Attorney for the Eastern District of New York, announced today that Dr. Josef Schenker and two urgent care facilities owned by him, Josef Schenker, M.D., P.C., and Care Partners Medical Management, LLC, have agreed to pay $564,217.70 to resolve allegations that they submitted false claims to Medicare for services not provided in administering COVID-19 vaccines and tests.”
About hospitals and healthcare systems
CHS posts $1M loss in Q1 after COVID-19 surge as contract labor rates remain high “Hospital chain Community Health Systems posted a $1 million loss for the first quarter of 2022 after experiencing its largest COVID-19 surge to date and continued high rates for contract labor.
CHS generated $3.1 billion in net operating revenues for the first quarter and adjusted earnings before interest, taxes, deductions and amortization (EBITDA) of $409 million, including $47 million in pandemic relief funds. Admissions for the system also declined slightly by 0.3% compared to the same period in 2021…
Overall, CHS’ operating costs and expenses increased to $2.8 billion, slightly above the $2.6 billion it generated in the same period in 2021.”
About pharma
Amgen vows to fight $7.1B tax bill tied to Puerto Rico manufacturing unit “When Amgen released first-quarter results on Wednesday, its sales and profit numbers were again overshadowed by a bombshell tax disclosure.
Earlier this month, the company received a notice of deficiency from the Internal Revenue Service centered on the 2013 to 2015 period, Amgen said. The agency seeks to increase Amgen's taxable income for the period to an amount that would leave the company with a $5.1 billion bill, plus interest. On top of that, the IRS is proposing penalties of approximately $2 billion.
The notice is similar to the adjustments Amgen received from the IRS for the 2010 to 2012 period. In that case, the IRS handed Amgen a $3.6 billion bill. Amgen vowed to fight that bill as well.”
Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class “This cohort study of 45 RCTs found that a minority (24%) of new medicines were associated with improved QOL. Only 22% of trials showing improved progression-free survival also showed improved QOL, and approximately one-half of trials that failed to show improvement in QOL reported these outcomes positively.”
McKinsey rebuts conflict claims over work for health regulator and opioid makers “ McKinsey’s managing partner has pushed back against allegations that the consultancy breached conflict of interest rules by advising opioids producers on how to “turbocharge” sales while also working for US health regulators seeking to tackle a deadly painkiller overdose epidemic. Bob Sternfels told a US congressional committee on Wednesday that he regretted McKinsey did not act sooner to cut ties with opioid producers and help solve a crisis that has led to more than 500,000 American deaths in a decade. But he rejected the interim findings of a congressional report that suggested the consultancy’s work ‘appears potentially’ to have violated rules for federal contractors that require disclosures of potential conflicts of interest.”
Walmart, CVS Pharmacies Have Blocked or Delayed Telehealth Adderall Prescriptions “Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the last year from clinicians working for telehealth startups that have sprung up to treat attention-deficit hyperactivity disorder, according to pharmacies and people familiar with the issue.
The pharmacies in certain cases have expressed concerns that clinicians at Done Health and Cerebral Inc. are writing too many prescriptions for Adderall and other stimulants, the people said. The federal government considers the drugs controlled substances because of their potential for abuse and places them in the same category as cocaine.”
About the public’s health
In a milestone, FDA proposes ban on menthol cigarettes and flavored cigars “The Food and Drug Administration on Thursday proposed banning menthol cigarettes, a landmark action applauded by leading health and civil rights groups that say the industry has a history of aggressively marketing to Black communities and causing severe harm, including higher rates of smoking-related illness and death.
The FDA also proposed prohibiting flavors in cigars, including in small ones called cigarillos that are popular among teenagers.”
Which Animal Viruses Could Infect People? Computers Are Racing to Find Out. Interesting article about the use of machine learning to identify threats from animal viruses and trace sources for emerging known infections (like Covid-19).
Measles cases jump 79% in 2022 after COVID hit vaccination campaigns “ Measles cases jumped by 79% in the first two months of this year compared to 2021, after COVID-19 and lockdowns disrupted child vaccination campaigns around the world, according to data from UNICEF and the World Health Organization (WHO).
In January and February, there were 17,338 measles cases reported worldwide, up from 9,665 in the same period last year.”
Antibiotic Use and Vaccine Antibody Levels Another reason for judicious use of antibiotics:
”Antibiotic use in children <2 years of age is associated with lower vaccine-induced antibody levels to several vaccines.”
About healthcare IT
Teladoc slashes earnings outlook, takes $6.6B impairment charge on Livongo deal “In its first-quarter 2022 earnings press release (PDF), the company reported losses in the first quarter of 2022 ballooned to $6.7 million, or a loss of $41.58 per share, compared to $199.6 million, or a loss of $1.31 per share, in the first quarter of 2021.
The company recorded a ‘non-cash goodwill impairment charge,’ which does not impact the company's cash or liquidity. Companies opt for impairment when the value of assets or goodwill on their books is no longer fully recoverable.
Teladoc shares plummeted 33% after-hours Wednesday.
Teladoc completed its massive $18.5 billion acquisition of digital chronic condition management company Livongo in October 2020…”
About health technology
OIG Approves Physician-Owned Medical Device Company “On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the Company’s products hold a majority ownership interest. The Company manufactures medical device products that may be ordered by the physician owners and a physician spouse of one of the physician owners.”
The Advisory Opinion is specific to this circumstance but may have broader application.
About healthcare finance
Healthcare M&A slowed in Q1, but investment in IT, telehealth is expected to remain hot “The pace of healthcare and life sciences mergers and acquisitions has slowed, according to KPMG’s latest report.
The report, which examines the dealmaking pace for the first quarter of 2022, found this quarter’s deal volume has declined by 34% to 427 deals compared to the fourth quarter of 2021. Private equity has pulled back the most, making 50% fewer deals.”