Today's News and Commentary

About Covid-19

Emergence in Southern France of a new SARS-CoV-2 variant of probably Cameroonian origin harbouring both substitutions N501Y and E484K in the spike protein: “Here we describe the emergence of a new variant. For twelve SARS-CoV-positive patients living in the same geographical area of southeastern France, qPCR testing that screen for variant-associated mutations showed an atypical combination. The index case returned from a travel in Cameroon.”

Israel reports world's first 'flurona' influenza-COVID double infection: “The world's first documented case of ‘flurona,’ or simultaneous infections of COVID-19 and influenza viruses, has been recorded in Israel, doctors said.
The first known case of the double infection was identified in a woman who was giving birth last week at Rabin Medical Center in Petah Tikva, Israel, the Times of Israel and the Yedioth Ahronot newspaper reported.
Hospital officials said the young mother, who was not vaccinated against either illness, did not suffer any permanent consequences and was released from the hospital on Thursday.”

Interval between Moderna COVID-19 vaccine second shot and booster still six months -FDA: “The interval between receiving a second dose of Moderna' s COVID-19 vaccine and a booster dose remains unchanged at six months, U.S. Food and Drug Administration Acting Commissioner Janet Woodcock said on Monday.
‘Right now if you got J&J you get a booster after two months, if you got Pfizer as your primary series you can get a booster at five months or beyond, if you got Moderna you can get a booster at six months or beyond whatever you decide to get a booster of,’ Woodcock said on a press call.”

Paradoxical sex-specific patterns of autoantibody [AAB] response to SARS-CoV-2 infection: “In multivariable analyses, we observed sex-specific patterns of autoreactivity associated with the presence or absence (as well as timing and clustering of symptoms) associated with prior COVID-19 illness. Whereas the overall AAB response was more prominent in women following asymptomatic infection, the breadth and extent of AAB reactivity was more prominent in men following at least mildly symptomatic infection. Notably, the observed reactivity included distinct antigens with molecular homology with SARS-CoV-2.”

Medication safety group issues alert on COVID-19 antiviral: “The Institute for Safe Medication Practices on Jan. 3 issued an alert warning pharmacists of potential error risks with Paxlovid, Pfizer's COVID-19 antiviral pill regimen. 
The alert states patients with severe renal impairment should not receive the drug, and patients with moderate renal impairment should receive a dose reduction. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken twice daily for no more than five consecutive days…
ISMP said additional potential safety issues include patients accidentally failing to take both tablets together and drug interactions.”

About health insurance

CMS wants insurers to offer standardized plan options on the ACA exchanges: The proposed ACA rules reported yesterday have a provision for standardizing offerings. Medicare supplements have had this feature for many years and it makes comparisons among plans much easier.

ACO Investment Model Produced Savings, But The Majority Of Participants Exited When Faced With Downside Risk: “Medicare’s Accountable Care Organization (ACO) Investment Model (AIM) provided up-front funding to forty-one small, rurally located ACOs to encourage their participation in the Medicare Shared Savings Program. We estimate net savings to Medicare of $381.5 million over three years, driven by utilization reductions in inpatient and other institutional care and by the absence of shared risk for potential increases in Medicare spending incurred by participants. These savings suggest that population-based payment models can enable providers to better meet the needs of rural populations through greater flexibility in care delivery. However, nearly two-thirds of AIM ACOs exited the Medicare Shared Savings Program when faced with the requirement to assume downside financial risk, starting in year four of participation.”

About healthcare technology

Jury finds Theranos founder Elizabeth Holmes guilty of fraud: “After seven days of deliberations, a federal jury found Holmes, 37, guilty of defrauding investors while raising money for Theranos. Holmes was convicted of conspiracy to defraud investors and three counts of wire fraud. The jury found her not guilty of conspiring to defraud patients and cleared her on two individual patient-related charges and one count of lying in paid advertisements. The jury couldn’t reach a unanimous verdict on three counts of defrauding individual investors, possibly leaving the door open for a retrial on those specific charges.”
No word yet about appeals or the government going to trial again on the undecided counts.

About healthcare IT

Differences in estimates for 10-year risk of cardiovascular disease in Black versus White individuals with identical risk factor profiles using pooled cohort equations: an in silico cohort study: Another example of an algorithm that produces inaccurate results because of faulty race data. [Emphasis added below].
“Sex-specific and race-specific pooled cohort equations (PCEs) are recommended for estimating the 10-year risk of cardiovascular disease, with an absolute risk of more than 7·5% indicating a clinical decision threshold. We compared differences between Black and White individuals in PCE-estimated absolute cardiovascular disease risk across various plausible risk factor combinations with the aim of evaluating if using the PCE might result in different clinical decisions in Black versus White individuals with identical risk profiles….
There are several clinical implications of our findings. First, the use of PCE could result in Black individuals with select risk factor combinations becoming more eligible for receiving statin treatment than their White counterparts with identical risk profiles. Although the direction of this potential bias might seem somewhat reassuring (relative to the opposite scenario of Black individuals not receiving statins relative to their White counterparts), the risks associated with over-treatment—ie, financial, psychological, side-effects, and quality of life—are not trivial.”

About pharma

2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs: “All told, the industry nabbed 55 FDA approvals in 2021. They include the controversial accelerated approval for Biogen's Alzheimer's drug Aduhelm, Pfizer's record-shattering COVID-19 vaccine, Comirnaty, and many others.
Not all 2021 approvals commanded as many headlines as Aduhelm and Comirnaty. Aside from those notable companies, also represented in 2021's crop of new approvals were Amgen, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Regeneron.”
The article has details on each drug.

List prices for 460 drugs increased Jan. 1: “Drugmakers on Jan. 1 increased the list price of 460 medications by a median of 4.9 percent, according to data from 46brooklyn, a nonprofit drug research firm. 
The price hikes are comparable to those seen at the start of previous years. On Jan. 1, 2021, drugmakers increased the price of 629 drugs.”

Today's News and Commentary

HAPPY NEW YEAR!

About Covid-19

FDA authorizes coronavirus vaccine boosters for 12- to 15-year-olds as schools reopen amid omicron surge: “The agency also said everyone at least 12 years old could get a booster dose five months after receiving the second Pfizer-BioNTech shot; previously, boosters were stipulated for six months. And it cleared booster shots for some children ages 5 to 11 who have compromised immune systems.
The FDA actions are expected to be reviewed by the Centers for Disease Control and Prevention and its panel of outside vaccine advisers this week. Assuming the Advisory Committee on Immunization Practices, which is scheduled to meet Wednesday, signs off on the additional shots, CDC director Rochelle Walensky is expected to officially recommend them later that day.”

States report record COVID-19 cases entering 2022: “The United States reported 2.7 million new COVID-19 cases in the week ending with New Year's Eve on Friday, up 105% from the previous week, as the nation has reported a total of 54,771,160 infections and 825,561 coronavirus-related deaths since the start of the pandemic, according to data gathered by Johns Hopkins University.”

CMS releases guidance on healthcare worker vaccination mandate: “CMS has released guidance and survey procedures for the 25 states where its COVID-19 vaccination mandate for healthcare workers is not currently blocked…
The guidance does not apply to 25 states where the mandate is blocked: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming. However it does apply to the remaining 25 states.”

Fauci: CDC mulling COVID test requirement for asymptomatic: “Dr. Anthony Fauci said the Centers for Disease Control and Prevention is now considering including the negative test as part of its guidance after getting significant ‘pushback’ on its updated recommendations last week.
Under that Dec. 27 guidance, isolation restrictions for people infected with COVID-19 were shortened from 10 days to five days if they are no longer feeling symptoms or running a fever. After that period, they are asked to spend the following five days wearing a mask when around others.”

Israel now offering fourth covid shot to anyone 60 and older: “Israel on Monday began offering anyone over 60 a chance to get a fourth shot of a coronavirus vaccine, greatly expanding a double-booster effort that previously included just older residents with compromised immune systems and some health-care workers.”

About pharma

Private-equity firm interested in Walgreens' U.K. drugstore chain: “U.S. private equity firm Bain Capital recently approached Walgreens Boots Alliance Inc. about a potential purchase of its U.K. drugstore chain Boots, the Times of London reported, without saying where it got the information. 
Bain is positioning itself as a front-runner for an upcoming auction of the unit, the newspaper said. Boots only owns about a quarter of its stores and may be worth 6 billion pounds ($8.1 billion) to 7 billion pounds, according to the report.”

New York PBMs must get licensure, registration under new law: “The legislation — S.3762/A.1396 — signed by Gov. Kathy Hochul Dec. 31, aims to improve transparency surrounding prescription drug costs and establishes a set of duties and obligations PBMs must follow when performing services, according to a news release. It also enables the department of financial services to enforce the law and receive complaints of PBM violations…
PBMs largely operate without regulation, with the bill marking the first such legislation in the country.”

Facebook ad ban may squelch medical research recruitment: “Under fire from critics over its privacy practices, Facebook is implementing a sweeping ban on advertisers targeting patients with messages based on their health conditions. And that could be bad news for drug development.
The decision by the social media giant, which takes effect in January, is part of a broader push to remove ad-targeting options for what it calls ‘sensitive’ topics and is getting measured praise from patient privacy advocates. But critics of the restrictions say the move could have an unintended side effect: Slowing biomedical research by making it harder to use Facebook to recruit people for clinical trials.”

This final rule rescinds the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020: “The November 2020 MFN Model interim final rule established a 7-year nationwide, mandatory MFN Model to test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals), under section 1115A of the Social Security Act (the Act), with the model performance period beginning on January 1, 2021. The MFN Model was not implemented on January 1, 2021 as contemplated following four lawsuits and a nationwide preliminary injunction.”
This action is one of many that rolled back the Trump administration’s healthcare initiatives.

About diagnostics

When They Warn of Rare Disorders, These Prenatal Tests Are Usually Wrong: This article is an excellent review of for-profit labs that earn significant revenues from performing tests for rare conditions, the results of which are highly inaccurate.
”To evaluate the newer tests, The Times interviewed researchers and then combined data from multiple studies to produce the best estimates available of how well the five most common microdeletion tests perform.
The analysis showed that positive results on those tests are incorrect about 85 percent of the time…
The Times reviewed 17 patient and doctor brochures from eight of the testing companies, including Natera, Labcorp, Quest and smaller competitors. Ten of the brochures never mention that a false positive can happen. Only one mentioned how often each test gets positive results wrong.”

About health insurance

HHS Notice of Benefit and Payment Parameters for 2023 Proposed Rule Fact Sheet: “Centers for Medicare & Medicaid Services (CMS) proposed standards for issuers and Marketplaces, as well as requirements for agents, brokers, web brokers, and issuers assisting consumers with enrollment through Marketplaces that use the federal platform.”
The provisions in this proposed rule fact sheet are too numerous to summarize, but the document can be read quickly to get an idea of its contents.

Today's News and Commentary

Covid-19

F.D.A. Plans to Allow 12- to 15-Year-Olds to Receive Pfizer Boosters:“The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses on Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.”

Johnson & Johnson booster slashes risk of Omicron hospitalisation, study shows: “Two doses of the Johnson & Johnson Covid-19 vaccine cut the risk of hospitalisation by up to 85 per cent, according to a South African study conducted when the Omicron coronavirus variant was dominant. The findings of the real-world study, made public on Thursday and not yet peer-reviewed, provide a significant fillip to the J&J shot, widely used in South Africa and elsewhere.”

Omicron-Infected People Also Mount Strong Resistance to Delta, Study Finds: “People vaccinated against COVID-19 who get an Omicron infection appear to have a low risk of Omicron reinfection, as well as significantly increased resistance to the Delta variant, new South African data suggest.
However, immune response varies widely among unvaccinated people, suggesting that they may be susceptible to repeat Omicron infections as well as Delta reinfection, according to Alex Sigal, a virologist at the Africa Health Research Institute, Durban.”

Five tactics used to spread vaccine misinformation in the wellness community, and why they work: A really good explanation of the subject of the headline.

About pharma

HHS appeals judge's ruling that drugmakers can cut off 340B sales to contract pharmacies: “The Biden administration is appealing a federal ruling that said drugmakers have the authority to restrict sales of 340B-discounted products to contract pharmacies.
The Department of Justice filed an appeal Tuesday to a lawsuit brought by Novartis and United Therapeutics over drugmakers’ ability to cut off sales to contract pharmacies. It also appealed several aspects of other rulings in separate lawsuits brought by Eli Lilly, Sanofi and Novo Nordisk.”
And in a related article: AbbVie to restrict 340B discounts to safety net hospitals: “AbbVie said it will stop offering safety net hospitals 340B drug-pricing program discounts on drugs dispensed at contract pharmacies if the hospitals fail to turn over patient claims data for those pharmacies to the drugmaker.
AbbVie will begin the initiative Feb. 1, according to a Dec. 29 letter the drugmaker sent to safety net hospitals.”

New York jury holds drugmaker Teva liable in opioid crisis: “Drugmaker Teva Pharmaceuticals is responsible for contributing to the opioid crisis, a suburban New York jury ruled Thursday in one of few verdicts so far among thousands of lawsuits nationwide over the painkillers.
A separate trial will follow to determine what Teva will have to pay in the case…”

About medical devices

Chicago-based Hillrom faces antitrust lawsuit over hospital bed sales: “In the federal lawsuit filed Tuesday in Chicago, hospital bed-maker Linet alleges Hillrom, the main provider of hospital beds in the U.S., used ‘anti-competitive’ practices to slow Linet’s growth in the U.S. market, including “coercing” hospital administrators into locking entire health systems into long-term agreements. 
Hillrom, which the lawsuit calls a ‘serial abuser of antitrust laws,’ makes up at least 70% of standard, intensive care and birthing beds installed in U.S. hospitals, according to the complaint.”
Considering the recent Baxter announcement that it is purchasing Hillrom, the timing of the suit is “interesting.”

FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency: The FDA published “guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization (EUA) process (EUA Devices) and those under temporary FDA policies implementing specific enforcement discretion during the pandemic (Enforcement Policy Devices) once the Public Health Emergency for COVID-19 (PHE) ends. These guidance documents, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Transition Plan Guidances), are critically important for manufacturers that developed and produced new devices or modified legally marketed devices specifically in response to the pandemic to help diagnose, cure, treat, or mitigate the symptoms of COVID-19.”

About health insurance

Increasing Medicaid’s Stagnant Asset Test For People Eligible For Medicare And Medicaid Will Help Vulnerable Seniors: “We estimated that increasing Medicaid’s asset limit by the Consumer Price Index, to Medicare Savings Program levels, or to $10,000 for individuals and $20,000 for couples would increase Medicaid eligibility by 1.7 percent, 4.4 percent, and 7.5 percent, respectively. Simplifying Medicaid’s asset test to focus only on certain high-value assets would increase eligibility by 20.5 percent. Increasing asset limits would lessen restrictions on Medicaid eligibility that arise from stagnant asset tests, broadening eligibility for certain low-income Medicare beneficiaries and allowing them to retain higher, yet still modest, savings.”

About healthcare IT

AP-NORC SURVEY: USE OF TELEHEALTH BY OLDER ADULTS WIDESPREAD DURING THE PANDEMIC, BUT ADDRESSING ACCESS ISSUES AND QUALITY CONCERNS KEY TO SUSTAINING ITS USE: “According to the survey, funded by The SCAN Foundation, 62% of adults age 50 and older have received care through some form of telehealth since the beginning of the pandemic, especially for non-urgent health concerns and prescription consultations. Those who have received care through telehealth were generally comfortable doing so, and nearly two-thirds are at least somewhat likely to seek care through telehealth after the pandemic ends.
The convenience of finding an appointment, meeting with a specific provider, and getting an immediate response are the top reasons why adults age 50 and older choose telehealth over in-person care. On the other hand, about two-thirds express concerns about the quality of care received through telehealth.”

Association of Physician Characteristics With Early Adoption of Virtual Health Care: “In a cross-sectional study of 3473 physicians in a large regional health care system, more than 94% transitioned to include virtual health care in their practice by December 2020. Female, behavioral health, and primary care physicians were more likely to be early adopters, and physicians born between 1928 and 1945 (Silent Generation) and in surgical specialties were less likely to be early adopters.”

Today's News and Commentary

About Covid-19

New COVID-19 cases in US soar to highest levels on record: “More than a year after the vaccine was rolled out, new cases of COVID-19 in the U.S. have soared to their highest level on record at over 265,000 per day on average, a surge driven largely by the highly contagious omicron variant.
New cases per day have more than doubled over the past two weeks, eclipsing the old mark of 250,000, set in mid-January, according to data kept by Johns Hopkins University.”

Monitoring Variant Proportions: Latest CDC revisions on variant frequencies: Omicron is 58.6%. The rest is essentially delta.

FDA says antigen tests may be less sensitive to omicron: “The Food and Drug Administration (FDA) on Tuesday warned that antigen tests may be less effective in detecting the highly contagious omicron variant of COVID-19.
‘Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity,’ the FDA announced.”

Short Supply Limits Access to Newly Authorized COVID-19 Oral Pills: “Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year.
This even though the U.S. government has placed a $5.3 billion order for 10 million treatment courses of Paxlovid (nirmatrelvir, ritonavir) for shipments to states through 2022 and a $2.2 billion order for an estimated 3 million treatment courses of molnupiravir for delivery through early next year.”

Statement on the Status of the OSHA COVID-19 Healthcare ETS [Emergency Temporary Standard]: “On June 21, 2021, OSHA adopted a Healthcare Emergency Temporary Standard (Healthcare ETS) protecting workers from COVID-19 in settings where they provide healthcare or healthcare support services. 86 FR 32376. Under the OSH Act, an ETS is effective until superseded by a permanent standard – a process contemplated by the OSH Act to occur within 6 months of the ETS’s promulgation. 29 U.S.C. 655(c). OSHA [announced Monday] that it intends to continue to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards, and will do so as it also considers its broader infectious disease rulemaking. However, given that OSHA anticipates a final rule cannot be completed in a timeframe approaching the one contemplated by the OSH Act, OSHA also [announced Monday] that it is withdrawing the non-recordkeeping portions of the healthcare ETS.”

About health insurance

Patients won't have to fear as many surprise medical bills come January: “The No Surprises Act, which bans most unexpected medical charges from out-of-network providers, is scheduled to go into effect January 1. It will apply to about 10 million surprise bills a year, according to federal estimates.
The new law, which Congress approved in late 2020 after a multitude of delays, protects patients when they receive emergency care or scheduled treatment from doctors and hospitals that are not in their insurance networks and that they did not choose. Consumers would be responsible only for their in-network cost-sharing in these situations.”

Mental Health Support to Get Expansion Under New Medicaid Option: “States can integrate behavioral health services into their Medicaid programs under a new option meant to help people experiencing mental health or substance use crises.
The Medicaid option will allow states to support mobile crisis intervention services, which connect users to a behavioral health specialist on call, the Biden administration announced Tuesday.”

About the public’s health

Association of e-Cigarette Use With Discontinuation of Cigarette Smoking Among Adult Smokers Who Were Initially Never Planning to Quit: “In this US nationally representative cohort study of 1600 adult daily cigarette smokers who did not initially use e-cigarettes and had no plans to ever quit smoking, subsequent daily e-cigarette use was significantly associated with an 8-fold greater odds of cigarette discontinuation compared with no e-cigarette use.”

Today's News and Commentary

About Covid-19

U.S. sets record high for coronavirus infections: “The lightning spread of the coronavirus’s omicron variant in the United States pushed the seven-day average of new daily cases to 253,245 as of Tuesday afternoon, surpassing the previous high of 248,209 cases on Jan. 12.”

Booster protection wanes against symptomatic Omicron infections, British data suggests.: “New data from Britain suggests that booster protection against symptomatic Covid caused by the Omicron variant wanes within 10 weeks.
There have not yet been enough severe cases of Omicron to calculate how well boosters protect against severe disease, but experts believe the shots will continue to provide significant protection against hospitalization and death.”

Supreme Court sets Jan. 7 hearing on vaccine mandate rules: “The Supreme Court…announced it will hear oral arguments to legal challenges against the Biden administration's COVID-19 vaccination mandates covering both healthcare employers and employers of businesses with 100 or more workers.
The justices will consider whether the rules will take effect in a special hearing Jan. 7, amid a flurry of legal challenges to both state and federal vaccination mandates with looming deadlines for employers to comply.
The high court already blocked challenges to three states' vaccine mandates, upholding the requirement for the jab. Though two federal courts granted preliminary injunctions to some states challenging the CMS mandate that still stands.”

About the public’s health

Flu is making a comeback in US after an unusual year off: “The U.S. flu season has arrived on schedule after taking a year off, with flu hospitalizations rising and two child deaths reported.
Last year’s flu season was the lowest on record, likely because COVID-19 measures — school closures, distancing, masks and canceled travel — prevented the spread of influenza, or because the coronavirus somehow pushed aside other viruses.
‘This is setting itself up to be more of a normal flu season,”’said Lynnette Brammer, who tracks flu-like illnesses for the U.S. Centers for Disease Control and Prevention.”

Two New Pneumococcal Vaccines—Prevnar 20 and Vaxneuvance: “The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes of pneumococcus, and Vaxneuvance (PCV15; Merck), which contains antigens from 15 serotypes.”
Check Table 3 for new immunization recommendations.

About healthcare finance

Healthcare Underperformed S&P 500 In 2021 For Third Year Straight: “Poor performances in the biotech and digital health sectors dragged down the rest of the industry, the report found. Those losses were partially offset by strong gains across healthcare providers, insurers and life science tools and diagnostics. Overall, SVB Leerink found healthcare companies gained 22% in 2021 through Dec. 17, compared with 24% across the S&P 500. 
Within healthcare, life sciences tools and services saw the highest gains in 2021, at 35.5%, which was on par with the sector’s 2020 performance. Second was healthcare providers and services, which gained 30.7%, more than double its 2020 performance.”

About rural health

Rural Communities Left Hurting Without a Hospital, Ambulance or Doctors Nearby “About 20% of the nation lives in rural America, but only about 10% of U.S. physicians practice in such areas, according to the National Conference of State Legislatures.
And 77% of the country’s rural counties are designated as health professional shortage areas. About 4,000 additional primary care practitioners are needed to meet current rural health care needs, the Health Resources and Services Administration has estimated.”

Today's News and Commentary

About Covid-19

Israel begins studying the effectiveness of a 4th vaccine dose: “Officials at Sheba Medical Center, near Tel Aviv, said that their study was the first of its kind in the world and involved administering an additional shot to 150 medical personnel who had received a third dose of the Pfizer-BioNTech vaccine at least four months ago.”

CDC cuts isolation time recommended for people with asymptomatic coronavirus infections to five days: “Federal health officials shortened the recommended time Americans infected with coronavirus should isolate from 10 days to five if they are asymptomatic — a decision they said was driven by a growing body of research about when people are most infectious.
The Centers for Disease Control and Prevention also cut the quarantine time to five days for those exposed to coronavirus who are not boosted. In addition, they recommended such people wear masks around others for an additional five days.”

About pharma

Pharmacy of the world: China’s quest to be the No. 1 drugmaker: A great review of pharma development and plans in China.

About hospitals and health systems

LifePoint Health and Kindred Healthcare close deal to form new company: “LifePoint Health and Kindred Health closed the deal on Thursday to form a new company of 61 Kindred Long Term Emergency Hospitals and 18 LifePoint Community Hospitals.
ScionHealth, which is expected to generate approximately $ 3.5 billion in annual revenue, is independently managed by former LifePoint and Kindred executives and a new board of directors. Kindred CEO Benjamin Breuer left the company after the close of the deal, but executives said the company does not expect ‘significant job losses’ or consolidation of service lines.”

Today's News and Commentary

About Covid-19

Remdesivir can help keep unvaccinated, high-risk people with covid-19 out of hospitals, study finds: “The antiviral drug remdesivir can help keep unvaccinated people at risk of severe covid-19 out of hospitals, according to a study that found the treatment reduced hospitalization and death by 87 percent when given soon after diagnosis.”

Supreme Court to Hold Special Hearing on Biden Vaccine Mandates: “The Supreme Court said on Wednesday evening that it would hold a special hearing next month to assess the legality of two initiatives at the heart of the Biden administration’s efforts to address the coronavirus in the workplace.”

FDA authorizes Merck’s anti-coronavirus pill, a second at-home treatment option: “Doctors have clamored for easy-to-use medications throughout the pandemic, but the new drug, molnupiravir, has had an uneasy reception because of its modest efficacy and potential safety risks. Some experts say another tool will be helpful as the omicron variant, which is resistant to other key treatments, surges. But others say they would be hesitant to use the drug.
The Food and Drug Administration authorized the five-day course of treatment in patients 18 and older who are at high risk of severe covid-19 and ‘for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.’”

Early studies suggest a reduced risk of Covid-19 hospitalization when infected with Omicron compared to Delta: “Omicron is associated with a two-thirds reduction in the risk of Covid-19 hospitalization compared with Delta, suggests one study, released online Wednesday as a working paper by researchers at the University of Edinburgh in the United Kingdom. That research was based out of Scotland.
The other paper, posted Tuesday to the online server medrxiv.org, suggests that people with Omicron infections have had 80% lower odds of being admitted to the hospital compared with Delta infections. But once a patient was hospitalized, there was no difference in the risk of severe disease, according to that research, based out of South Africa.”

Hospitals Scramble as Antibody Treatments Fail Against Omicron: “Two of the three monoclonal antibody treatments that doctors have depended on to keep Covid-19 patients from becoming seriously ill do not appear to thwart the latest version of the coronavirus.
The one such treatment that is still likely to work against Omicron is now so scarce that many doctors and hospitals have already run through their supplies.”

About health insurance

ObamaCare open enrollment hits record numbers: “A record 13.6 million people have enrolled in health insurance coverage through the Affordable Care Act to date, with another month left before open enrollment ends, Biden administration officials said Wednesday.
According to the Centers for Medicare and Medicaid Services (CMS), more than 9.7 million Americans enrolled in coverage in the 33 states using HealthCare.gov for 2022 from the start of open enrollment through Dec. 15. 
CMS said there were over 900,000 more people compared to the previous all-time high of 8.8 million who signed up during the 2018 Open Enrollment Period, when there were 39 states using HealthCare.gov.”

IN NEW YORK CITY, RETIREES BRACE FOR SWITCH TO PRIVATIZED HEALTH CARE: “STARTING IN JANUARY 2022, over a quarter million former New York City government workers and their dependents are set to be shifted off Medicare and on to privatized health insurance. Mayor Bill de Blasio and the Municipal Labor Committee, which represents retired New York City employees, announced the move in mid-July, following several months of scrambled protest from bewildered retirees.
The plan has been cast as a necessary measure to rein in mounting health care costs and reduce strain on the city’s budget. While public sector retirees in New York City are currently insured by Medicare, the federal government’s program for people over 65, the city reimburses them for outpatient care, as well as for a ‘Medigap’ plan that offers additional services. City officials and union leaders have negotiated a deal that they claim will save upward of $600 million by switching to Medicare Advantage, the federally funded privatized health insurance program that launched ostensibly to give consumers more choice and reduce Medicare costs.”

About pharma

Novartis to Buy Gene-Therapy Company Targeting Eye Condition: Swiss healthcare giant to pay up to $1.5 billion for British biotech Gyroscope: “The acquisition will hand Novartis an experimental gene therapy for geographic atrophy, a form of age-related macular degeneration that can lead to permanent vision loss. The treatment, known as GT005, is designed to increase the production of a protein, called CFI, that is thought to reduce damaging inflammation. That treatment is in mid-stage clinical trials.”

Japanese Health Ministry Panel Rejects Biogen’s Aducanumab: “A Japanese Health Ministry expert panel has declined to endorse Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), citing inconclusive trial results and the need for more efficacy data before signing off on an approval.”

About hospitals and health systems

Tenet closes $1.1B surgery center deal: “Dallas-based Tenet paid $1.1 billion to acquire SurgCenter Development's ownership interests in 86 ambulatory surgery centers and related services, the company said in a Dec. 22 news release. USPI has offered to acquire a portion of equity interests in the ASCs from physician owners for $250 million.”

Today's News and Commentary

About Covid-19

Fauci says quarantines may be shortened for asymptomatic health care workers: “ Fauci told CNN that while there are ‘no decisions yet,’ changing the guidance is an "important consideration that is being discussed right now."
‘Rather than keeping [health care workers] out for seven to 10 days, if they are without symptoms, put a N95 mask on them, make sure they have the proper PPE, and they may be able to get back to work sooner than the full length of the quarantine period,’ Fauci said to CNN.”

FDA authorizes Pfizer’s anti-covid pill as omicron surges: “Tens of thousands of pill packs of Pfizer’s Paxlovid are sitting in a Pfizer warehouse in Memphis, ready to be loaded onto trucks and planes in anticipation of the green light from the Food and Drug Administration. But as omicron cases skyrocket nationwide, doctors are expected to quickly burn through that initial supply of Paxlovid, which has shown to be 89 percent effective at keeping high-risk patients from developing severe illness when given within three days of symptoms starting.”

Oxford and AstraZeneca developing Omicron-targeted version of vaccine: The headline is the story.

California to require boosters for healthcare workers: “The announcement came after California issued an order Aug. 5 requiring workers in healthcare settings to be fully vaccinated. [Gov.} Newsom is expected to make an official announcement about the move related to boosters on Dec. 22 as part of new state actions amid increasing COVID-19 case rates and hospitalizations.”

Biden seeks to recast pandemic fight, rejecting lockdowns and school closures as omicron surges: “Biden detailed new plans to expand coronavirus testing sites across the country, distribute a half-billion free at-home tests and deploy more federal health resources to aid strained hospitals as the omicron variant drives a fresh wave of infections.”

Israel to offer fourth COVID-19 vaccine dose in bid to outpace Omicron: “Israel is to offer a fourth dose of a COVID-19 vaccine to people older than 60 or with compromised immune systems, and to health workers, as part of a drive to ramp up the shots and outpace the spread of the Omicron variant of the coronavirus.”

Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma: [Preprint, not yet peer reviewed]
”Early administration of high titer SARS-CoV-2 convalescent plasma reduced outpatient hospitalizations by more than 50%. High titer convalescent plasma is an effective early outpatient COVID-19 treatment with the advantages of low cost, wide availability, and rapid resilience to variant emergence from viral genetic drift in the face of a changing pandemic.”

About health insurance

Medicaid Expansion May Be Associated with Lower Mortality Rates: “States that implemented Medicaid expansion saw reductions in all-cause mortality rates compared to nonexpansion states, a study from the Keck School of Medicine at the University of Southern California (USC) found…
Medicaid expansion states had lower mortality rates compared to nonexpansion states, the results revealed. All-cause mortality was 311 per 100,000 adults in expansion states and 365 per 100,000 adults in nonexpansion states. Expansion states also had 11 fewer deaths per 100,000 adults per year than nonexpansion states.”

About pharma

FDA approves first injectable HIV preventive, providing alternative to daily pill: “The injectable drug, Apretude, is given first as two injections one month apart and then once every two months. It was approved for use in ‘at-risk’ adults and adolescents weighing at least 77 pounds. Recipients are required to test negative for HIV before starting the drug and before each injection ‘to reduce the risk of developing drug resistance,’ the FDA said.”

More than 800 hospitals urge HHS to appeal controversial ruling in 340B lawsuit: “More than 800 hospitals are urging the Biden administration to appeal a federal court ruling that drugmakers have the power to restrict sales of 340B-discounted drugs to contract pharmacies.
The appeal comes as drugmakers are taking the Biden administration to court over its attempts to fine the companies for restricting sales to the contract pharmacies.”

About the public’s health

US population growth at lowest rate in pandemic’s 1st year: “U.S. population growth dipped to its lowest rate since the nation’s founding during the first year of the pandemic as the coronavirus curtailed immigration, delayed pregnancies and killed hundreds of thousands of U.S. residents, according to figures released Tuesday.
The United States grew by only 0.1%, with an additional 392,665 added to the U.S. population from July 2020 to July 2021, bringing the nation’s count to 331.8 million people, according to population estimates released by the U.S. Census Bureau.
The U.S. has been experiencing slow population growth for years but the pandemic exacerbated that trend. This past year was the first time since 1937 that the nation’s population grew by less than 1 million people.”

Life Expectancy in U.S. Declined 1.8 Years in 2020, CDC Says: “Final data released Wednesday by the Centers for Disease Control and Prevention show that Americans’ life expectancy fell 1.8 years to 77 years in 2020. The drop was 0.3 years more than that of provisional estimates released in July 2021 and remains the biggest life-expectancy decline since at least World War II. 
Covid-19 was the nation’s third leading cause of death last year, behind heart disease and cancer, and was the underlying cause in about 351,000 deaths, the new figures show. Increases in mortality from unintentional injuries—which include drug overdoses—as well heart disease, homicide and diabetes also decreased life expectancy.”

Trends in Public Stigma of Mental Illness in the US, 1996-2018: “To date, this survey study found the first evidence of significant decreases in public stigma toward depression. The findings of this study suggest that individuals’ age was a conservatizing factor whereas being in the pre–World War II or millennial birth cohorts was a progressive factor. However, stagnant stigma levels for other disorders and increasing public perceptions of likely violence among persons with schizophrenia call for rethinking stigma and retooling reduction strategies to increase service use, improve treatment resources, and advance population health.”

Today's News and Commentary

About health insurance

3 insurers to pay out $3.1M after health parity violations: “Aetna, Oscar Health and Wellfleet must pay $3.1 million after allegedly violating federal and New York mental health parity and cost-sharing laws.
A review by the New York Financial Services Department announced the payments after reviewing biannual parity reports from the payers, which found that the insurers had policies requiring members to illegally pay copays or coinsurance for mental health and substance use disorder benefits, according to a department news release. 
Between fines for parity and data-reporting violations, the payers owe $2.6 million in penalties and must return $473,565 to members.”

Public health emergency end could cause millions to lose Medicaid coverage: “The provision, a requirement under the Families First Coronavirus Response Act, which passed in March 2020, prevented states from removing Medicaid recipients from the program’s rolls. At least 11 million people have enrolled in Medicaid since February 2020.   
Up to 15 million people, including nearly 6 million children, could be at risk of losing their Medicaid eligibility when the protection expires [on January 15], according to the Urban Institute, an economic and policy research think tank. The change could have an outsize effect on communities of color, the Urban Institute concluded.
Many are likely to be eligible for other forms of subsidized coverage, the analysis found, but there is a concern that few people will know that they are in danger of losing Medicaid and are eligible for other types of health insurance. “
Although the emergency designation will probably be extended (given the omicron variant expansion of cases), coverage of these people will inevitably be a problem when the pandemic is back under control.

About Covid-19

CDC: Omicron now accounts for 73% of US cases; 1st US death reported: “The omicron coronavirus variant has quickly become the dominant strain in the U.S., accounting for 73.2 percent of new infections for the week ending Dec. 18, genomic surveillance data from the CDC shows. 
That's up from just 13 percent Dec. 11, the updated data reflects, underlining the strain's increased transmissibility. Before the data was updated on Dec. 20, the strain was believed to represent 3 percent of cases Dec. 14.”

Moderna steps back from Spikevax patent row with US government: “Moderna, which is locked in a dispute with the US National Institutes of Health (NIH) over who should be listed as co-inventors of its COVID-19 vaccine Spikevax, says it will not pursue issuance of a patent application for the jab's mRNA sequence "at this time." The company indicated that it made the decision in order to allow more time for discussions with the NIH.
Moderna has argued it was justified in listing its own scientists as sole inventors for Spikevax's mRNA sequence, while excluding three collaborators from the NIH who also worked on the vaccine. In its latest statement, Moderna reiterated that it believes company scientists "invented the specific mRNA sequence at the heart of the patent in question," although it "acknowledges that NIH feels equally strongly that its scientists should be listed as co-inventors for their contemporaneous work on the protein sequence."

About healthcare IT

HIPAA Privacy Rule and Disclosures of Protected Health Information for Extreme Risk Protection Orders: Guidance updated yesterday: “On June 7, 2021, the United States Department of Justice published model legislation to provide a framework for states to consider as they determine whether and how to implement their own “extreme risk protection order” (ERPO) laws. An ERPO is a court order that temporarily prevents a person in crisis, who poses a danger to themselves or others, from accessing firearms. ERPO legislation, which can vary in important ways among states, generally specifies certain categories of petitioners (e.g., law enforcement officers, family members, health care providers) who may apply to a court for an ERPO and includes requirements for affidavits or sworn oral statements from the petitioner or witnesses to support the application. This guidance addresses the requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule for covered health care providers in relation to ERPO laws.”

About the public’s health

988 suicide phone hotline getting $282M to ease July launch: “ People in crisis and those trying to help them will have a new phone number — 988 — to reach the national suicide prevention network starting in July. On Monday, federal health officials announced more than $280 million to smooth the transition from the current 10-digit number to three digits.”

About pharma

FDA Approves Second Biosimilar Insulin Product, Rezvoglar (insulin glargine-aglr) : ”The Food and Drug Administration approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). Rezvoglar (insulin glargine-aglr) is biosimilar to Lantus (insulin glargine).
Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus….
Rezvoglar is the second biosimilar insulin product and the 32nd biosimilar product approved in the U.S.”
More generics in a category causes prices to drop more.

About patient safety

Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety and Quality Improvement Act of 2005: “As required by the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act),a the Secretary of the Department of Health and Human Services (HHS) has prepared this Final Report to Congress on effective strategies for reducing medical errors and increasing patient safety in consultation with the Director of the Agency for Healthcare Research and Quality (AHRQ). It includes measures determined appropriate by the Secretary to encourage the appropriate use of effective strategies for reducing medical errors and increasing patient safety, including use in federally funded programs. As the Patient Safety Act also required, a draft of this report was made available for public comment and submitted for review to the Institute of Medicine, now the National Academy of Medicine. This Final Report, which is required to be submitted to Congress no later than December 21, 2021, includes updates and additions made to address feedback received from members of the public and the National Academy of Medicine.”
A “must-read” for those in charge of patient safety activities at their institutions.

Today's News and Commentary

About healthcare IT

 Oracle to buy medical records company Cerner in its biggest acquisition ever: “Enterprise software giant Oracle will buy electronic medical records company Cerner in an all-cash deal for $95 per share, or approximately $28.3 billion in equity value.
The deal, expected to close in calendar year 2022, could help Oracle boost its presence in health care by bringing troves of health data to its cloud services.
Oracle shares closed down 5% Monday after the companies announced the deal.”

Could facility fees for telehealth appointments return: “Facility fees can add hundreds or even thousands of dollars to a patient's bill and have come under criticism from patients and consumer groups. Hospitals argue these fees are necessary for keeping their facilities operational. Fees for video appointments are rare but have taken a few patients by surprise…
In 2021, only 1.1 percent of telehealth appointments included a facility fee. As telehealth continues to be used post-pandemic, it is unclear how appointments will be billed.”

 About health insurance

 Former West Hollywood Doctor and Company Associated with 1-800-GET-THIN Guilty of Massive Fraud Against Health Insurers: “ A former doctor and his company were found guilty today by a federal jury of scheming to defraud private insurance companies and the Tricare health care program for military service members by fraudulently submitting an estimated $355 million in claims related to the 1-800-GET-THIN Lap-Band surgery business…
Omidi used the sleep studies to find a reason – the “co-morbidity” of obstructive sleep apnea – that GET THIN would use to convince the patient’s insurance company to pre-approve the Lap-Band procedure.
After patients underwent sleep studies – irrespective of whether any doctor had ever determined the study was medically necessary – GET THIN employees, acting at Omidi’s direction, often falsified the results. Omidi then used the falsified sleep study results in support of GET THIN’s pre-authorization requests for Lap-Band surgery.”

CMS: Insurers paid out $2B in medical loss ratio rebates for 2020 claims:   “Insurers gave out approximately $2 billion in rebates for 2020 to nearly 10 million consumers under the Affordable Care Act’s (ACA's) medical loss ratio provision…
A plan must send rebates to customers by Sept. 30 via either a premium credit, lump-sum check, credit card or direct debit.
‘For the 2020 reporting year, health insurers provided approximately $1.3 billion in rebates in the individual market, $384 million in the small group market and $291 million in the large group market,’ CMS said.”

Many Medicare Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use Disorder: Findings from HHS OIG:
“ About 1 million Medicare beneficiaries were diagnosed with opioid use disorder in 2020. Yet less than 16 percent of these beneficiaries received medication to treat their opioid use disorder, raising concerns that beneficiaries face challenges accessing treatment. Furthermore, less than half of the beneficiaries who received medication to treat their opioid use disorder also received behavioral therapy. These services may be provided in-person or via telehealth; however, the full extent to which beneficiaries use telehealth for behavioral therapy is unknown, as Medicare does not require opioid treatment programs to report this information. 
In addition, beneficiaries in Florida, Texas, Nevada, and Kansas were less likely to receive medication to treat their opioid use disorder than beneficiaries nationwide. Furthermore, Asian/Pacific Islander, Hispanic, and Black beneficiaries were less likely to receive medication than White beneficiaries. Older beneficiaries and those who did not receive the Part D low-income subsidy were also less likely to receive medication to treat their opioid use disorder.”
Read the report for recommendations to address this problem. 

About Covid-19

Pfizer to test a third dose of coronavirus vaccine in young children after two-dose regimen falls short: “The companies reported that two doses of the pediatric vaccine failed in 2-, 3- and 4-year-olds to trigger an immune response comparable to what was generated in teens and older adults. The vaccine did generate an adequate immune response in children 6 months to 2 years old.
If three doses are successful at triggering a protective immune response, the companies expect to submit the data to regulators in the first half of next year.”

Moderna booster shot should provide ‘good level of protection’ against omicron, vaccine maker says: “A booster dose of Moderna’s vaccine — half the dose used in the original shots for adults — increased antibody levels against omicron by 37 times, the company said in a statement, citing preliminary data. 

Children exposed to covid can safely stay in class with in-school testing, CDC says: “Students who have been exposed to the coronavirus can safely continue in-person learning if they are regularly tested for the virus at school, avoiding disruptive at-home quarantines, the Centers for Disease Control and Prevention said Friday.
The CDC released two studies that show the effectiveness of what’s known as ‘test-to-stay.’ School districts across the country have tried this strategy, though it is not widely used.”

CDC narrows use of J&J vaccine due to concerns about rare blood clots: “The Centers for Disease Control and Prevention accepted advice from a panel of experts to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines over the Johnson & Johnson jab, following growing concerns about rare blood clots. 
The advisers said Thursday that vaccines from Pfizer and Moderna should be preferred by all adults, who may be at greater risk for developing severe blood clots from the J&J vaccine than those under age 18. Some committee members said the J&J vaccine should remain available for people who prefer it.
The recommendation was prompted by the occurrence of a rare and sometimes fatal blood-clotting problem called thrombosis with thrombocytopenia syndrome (TTS).”

Omicron thrives in airways, not lungs; new data on asymptomatic cases: “Compared to the earlier Delta variant, Omicron multiplies itself 70 times more quickly in tissues that line airway passages, which may facilitate person-to-person spread, they said. But in lung tissues, Omicron replicates 10 times more slowly than the original version of the coronavirus, which might contribute to less-severe illness.”

‘No evidence’ Omicron less severe than Delta, say UK researchers: “The Imperial College London research, which analysed UK infection data, casts doubt on the hopes of some experts, based on reports from medics in South Africa, that a change in the virulence of the new variant would limit pressure on health systems.”

Federal appeals court revives Biden's vaccine mandate for health workers in 26 states: “A federal appeals court has reinstated in 26 states a Biden administration vaccination mandate for health workers at hospitals that receive federal funding.
A three-judge panel of the 5th U.S. Circuit Court of Appeals in New Orleans ruled (PDF) that a lower court had the authority to block the mandate in only the 14 states that had sued and was wrong to impose a nationwide injunction.”

Covid Data Tracker Weekly Report: From the CDC: “The United States recently surpassed 50 million COVID-19 cases and 800,000 deaths since the start of the pandemic. This week also marks the first anniversary of the first COVID-19 vaccination in the United States. In recent weeks, COVID-19 cases and hospitalizations have increased, with many parts of the country experiencing substantial or high levels of community transmission. These increases and the recent emergence of the Omicron variant highlight the importance of prevention strategies to help people stay safe and reduce the spread of the virus that causes COVID-19.”

 7 signs those new N95s at your physician practice might be fake: A reminder from the AMA, as we face a resurgence of Covid-19 cases.
According to the National Institute for Occupational Safety and Health (NIOSH), “here are seven signs of counterfeit respirators that physicians and staffers at medical groups and health systems should look for:

·       No markings at all on the filtering facepiece respirator.

·       No approval number on filtering facepiece respirator or headband.

·       No NIOSH markings.

·       NIOSH spelled incorrectly.

·       Presence of decorative fabric or other decorative add-ons.

·       Claims of approval for children—NIOSH does not approve any type of respiratory protection for children.

·       Filtering facepiece respirator has ear loops instead of headbands”

OSHA vaccine mandate penalties to start Jan. 10: “The Occupational Health and Safety Administration said Saturday that it would not issue citations tied to its coronavirus vaccination mandate before Jan. 10, so that companies have time to adjust to and implement the requirements.
The federal agency separately said there would be no citations of companies regarding its testing requirements before Feb. 9.”

Novavax’s COVID-19 Vaccine Gets WHO Emergency Use Listing:  “The listing was supported by two phase 3 studies — a 30,000-person trial in the U.S. and Mexico and a 14,000-person trial in the UK — in which the vaccine, NVX-CoV2373, showed strong efficacy and a positive safety and tolerability profile.
The company is currently evaluating its vaccine against the Omicron variant and is also developing a separate shot targeted specifically at the mutant strain.”

About the public’s health

Biden administration details push to finally rid the nation of millions of lead pipes: “Half a dozen years after the water-contamination fiasco in Flint, Mich., shined a national spotlight on the persistent problem, the Environmental Protection Agency is set to write stricter standards for drinking water that would compel water utilities to dig up and replace lead lines from coast to coast.
Up to 10 million lead pipes still carry water to homes and businesses around the nation, the EPA estimates, carrying with them the risk of leaching the dangerous neurotoxin into drinking water. President Biden campaigned on removing all of the nation’s lead service lines as part of his plan to upgrade the nation’s aging infrastructure and alleviate the burden of pollution borne most heavily by poor and minority communities.”

 FDA eliminates key restriction on abortion pill as Supreme Court weighs case that challenges Roe v. Wade:  “The elimination of the rule by the Food and Drug Administration means abortion pills can be prescribed through telehealth consultations with providers and mailed to patients in states where permitted by law. Previously, the pills could not be mailed, though that regulation had been temporarily suspended by the FDA.”

About pharma

US judge strikes down Purdue's $4.5-billion opioid settlement: “A US federal judge late Thursday upended Purdue Pharma's opioid settlement, reversing a bankruptcy judge's earlier ruling, because of a provision that would shield the company's owners from facing litigation of their own. Judge Colleen McMahon for the Southern District of New York said that the $4.5-billion deal to resolve thousands of US opioid lawsuits should not go forward, arguing that the bankruptcy court lacked the authority to release members of the Sackler family from civil liability.”

Biogen slashes Aduhelm's price in half: Although the company defended the price as cost-effective, “Biogen reduced the price of Aduhelm, its controversial Alzheimer's drug, from an average annual cost of $56,000 to $28,200, the drugmaker said Dec. 20.
The change will take effect Jan. 1.” Now that the company has lost market credibility, how much lower can the price really go? 

About healthcare professionals

CMS Funding 1,000 New Residency Slots for Hospitals Serving Rural & Underserved Communities: “The Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) final rule with comment period establishes policies to distribute 1,000 new Medicare-funded physician residency slots to qualifying hospitals, phasing in 200 slots per year over five years. CMS estimates that funding for the additional residency slots, once fully phased in, will total approximately $1.8 billion over the next 10 years. In implementing a section of the Consolidated Appropriations Act (CAA), 2021, this is the largest increase in Medicare-funded residency slots in over 25 years. Other sections of the CAA being implemented further promote increasing training in rural areas and increasing graduate medical education payments to hospitals meeting certain criteria…
In allocating these new residency slots, CMS will prioritize hospitals with training programs in areas demonstrating the greatest need for providers, as determined by Health Professional Shortage Areas. The first round of 200 residency slots will be announced by January 31, 2023, and will become effective July 1, 2023.”

Doximety 2021 Physician Compensation Report: “Our findings show that average pay for doctors increased by 3.8% this year, which is up from an increase of 1.5% last year. Like last year, the increase did not outpace the rate of inflation. In 2021, the 12-month headline inflation rate was 6.2% [2] as measured by the Consumer Price Index (CPI). Thus, physicians on average experienced a decline in real income over the calendar year when compared with inflation.
In addition, our data showed that the gender pay gap among physicians was 28% this year. Male doctors currently earn over $122,000 more than their female counterparts.”
The report divides results by geography, subspecialty and sex; it is worth looking over.

Today's News and Commentary

National Health Care Spending In 2020: Growth Driven By Federal Spending In Response To The COVID-19 Pandemic: This annual article in Health Affairs (subscription only) is well-worth reading. Below is the abstract:
”US health care spending increased 9.7 percent to reach $4.1 trillion in 2020, a much faster rate than the 4.3 percent increase seen in 2019. The acceleration in 2020 was due to a 36.0 percent increase in federal expenditures for health care that occurred largely in response to the COVID-19 pandemic. At the same time, gross domestic product declined 2.2 percent, and the share of the economy devoted to health care spending spiked, reaching 19.7 percent. In 2020 the number of uninsured people fell, while at the same time there were significant shifts in types of coverage.”

About Covid-19

15 sobering stats that tell the tale of the coronavirus in the U.S.: An excellent summary of where we are now with respect to the Covid-19 pandemic. For example:
“1 in 420: The number of Americans who have died of the coronavirus.”
1 in 100 people over age 65 have dies from the virus

4th COVID shots likely soon for some immunocompromised Israelis, says top doc: “Some immunocompromised people in Israel are likely to be offered a fourth COVID-19 vaccine shot within weeks, according to a member of the government’s pandemic advisory panel, The Times of Israel reported.
Galia Rahav, head of Sheba Medical Center’s Infectious Disease Unit, on Tuesday said that while fourth shots for the general population have been ruled out for now, her ongoing research underscores their importance for some.”

CDC advisers to weigh limits on Johnson & Johnson vaccine because of continued rare blood clot issues: “Vaccine advisers to the Centers for Disease Control and Prevention are meeting Thursday to weigh possible limits on the use of the Johnson & Johnson vaccine because of continued blood clot issues, mostly in young and middle-aged women, according to clinicians familiar with the agenda.”

Alera COVID-19 Employer Pulse Survey, Part 3: “Since the last COVID-19 Employer Pulse survey was released in June 2020, even more companies have implemented formal infectious disease response plans, especially those with over 1,000 employees. Overall, 67% now have a plan in place, and another 18% are putting a plan in place now or are considering developing a plan, compared to 43% and 46% respectively. There are only a few companies that continue to not consider putting a plan in place.”

Assessing the impact of the COVID-19 pandemic on clinician ambulatory electronic health record use: “Clinician time spent in the EHR per day dropped at the onset of the pandemic but had recovered to higher than prepandemic levels by July 2020. Time spent actively working in the EHR after-hours showed similar trends. These differences persisted in multivariable models. In-Basket messages received increased compared with prepandemic levels, with the largest increase coming from messages from patients, which increased to 157% of the prepandemic average. Each additional patient message was associated with a 2.32-min increase in EHR time per day (P < .001).”

COVID-19 can be a disability, says EEOC: “The Equal Employment Opportunity Commission released updated guidance Dec. 14 saying that a person diagnosed with COVID-19 can be considered to have a disability under certain circumstances. 
According to the new guidance, a person diagnosed with COVID-19 who has mild symptoms that resolve in a few weeks without issue will not be considered to have a disability under the Americans with Disabilities Act. A person can be considered to have a disability when their COVID-19 symptoms cause mental or physical impairment that ‘substantially limits one or more major life activities,’ the EEOC said. 
The EEOC said that whether the Americans with Disabilities Act applies to individual workers will be determined on a case-by-case basis ‘that applies existing legal standards to the facts of a particular individual's circumstances.’”

4 most common symptoms of omicron variant: “The four most common symptoms of the omicron variant are cough, fatigue, congestion and runny nose, according to a CDC analysis of the first 43 cases investigated in the U.S. 
People with COVID-19 can report a wide range of symptoms, with cough and loss of smell emerging as two frequent indicators of the virus.”

Omicron spreading rapidly in U.S. and could bring punishing wave as soon as January, CDC warns: “Top federal health officials warned in a briefing Tuesday morning that the omicron variant is rapidly spreading in the United States and could peak in a massive wave of infections as soon as January, according to new modeling analyzed by the Centers for Disease Control and Prevention.
The prevalence of omicron jumped sevenfold in a single week, according to the CDC, and at such a pace, the highly mutated variant of the coronavirus could ratchet up pressure on a health system already strained in many places as the delta variant continues its own surge.”

HHS releases $9B in provider relief payments: “HHS is distributing $9 billion in payments to healthcare providers affected by the COVID-19 pandemic. 
The funds will be split among more than 69,000 healthcare providers. HHS said the average payment for small providers is $58,000 and the average payment to large providers is $1.7 million…”

Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection: Bottom line- incidence of these cardiac problems is higher with Covid-19 infection than after getting vaccinated.
”Our findings are relevant to the public, clinicians and policy makers. First, there was an increase in the risk of myocarditis within a week of receiving the first dose of both adenovirus and mRNA vaccines, and a higher increased risk after the second dose of both mRNA vaccines. In contrast, we found no evidence of an increase in the risk of pericarditis or cardiac arrhythmias following vaccination, except in the 1–28 days following a second dose of the mRNA-1273 vaccine. Second, in the same population, there was a greater risk of myocarditis, pericarditis and cardiac arrhythmia following SARS-CoV-2 infection. Third, the increased risk of myocarditis after vaccination was higher in persons aged under 40 years. We estimated extra myocarditis events to be between 1 and 10 per million persons in the month following vaccination, which was substantially lower than the 40 extra events per million persons observed following SARS-CoV-2 infection.”

About health insurance

Goldman Sachs Projects Rosy 2022 For UnitedHealth Group, Anthem, CVS: “Goldman initiated coverage of 10 insurers, half of which received ‘buy’ ratings in the newest report: UnitedHealth Group, Anthem, CVS Health, Molina Healthcare and Alignment Healthcare. Another four were rated ‘neutral:’ Humana, Cigna, Bright Health Group. Just one, Oscar Health, got a ‘sell’ rating. 
Goldman analysts Nathan Rich and Lindsay Golub wrote that they project 13% earnings per share growth for large-cap managed care organizations over the course of 2022 and 2023, more than double their expected earnings growth across the S&P 500 of 6%.”

Dual Eligible Beneficiaries Prefer Medicare Advantage Over FFS: “Dual eligible beneficiaries were more likely to choose a Medicare Advantage plan over a fee-for-service Medicare plan, a study commissioned by Better Medicare Alliance (BMA) found….
Researchers found that 44 percent of dual eligible beneficiaries were enrolled in Medicare Advantage compared to 35 percent who were enrolled in fee-for-service Medicare. Additionally, 23 percent of all Medicare Advantage members were dual eligibles whereas 17 percent of fee-for-service Medicare beneficiaries were dual eligibles.
Dual eligible beneficiaries who were enrolled in Medicare Advantage were more likely to have a usual source of care compared to beneficiaries enrolled in a fee-for-service Medicare plan, the report found. Medicare Advantage dual eligibles received preventive care services more often than fee-for-service dual eligibles as well.”

Deadline time for HealthCare.gov coverage that starts Jan. 1: “Consumers seeking government-subsidized health insurance for next year have through Wednesday to sign up if they want their new plan to start Jan. 1.
Independent experts say HealthCare.gov’s sign-up season doesn’t seem to be drawing as many new customers this year — 8% to 9% fewer than last year — but it’s too early to draw final conclusions because deadlines drive much of the enrollment.
Open enrollment for the Affordable Care Act is different this time because it’s an early test of President Joe Biden’s idea that the U.S. can get close to coverage for all by building on existing programs.
Wednesday is the first of two deadlines for HealthCare.gov coverage, with increased financial assistance available through Biden’s coronavirus relief legislation. The last chance will come Jan. 15, for coverage that takes effect Feb. 1.”

About the public’s health

Screening for Prediabetes and Type 2 Diabetes in Children and Adolescents: For asymptomatic children and adolescents younger than age 18 years, the “USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for type 2 diabetes in children and adolescents.”
The comment period is still open.

Today's News and Commentary

About healthcare policy

Biden releases 2,700-item to-do list: 5 healthcare updates: “President Joe Biden released a nearly 2,700-item regulatory to-do list Dec. 10 that targets mental healthcare, the 340B drug discount program and other healthcare issues through his administration's rulemaking authority…” Read the article for a summary of the 5 healthcare areas.

About health insurance

Employers' health insurance costs surge in 2021 as elective procedures resume - survey: “The survey by benefits company Mercer of firms that employ about 118 million people showed the average cost of employer-sponsored health insurance per employee jumped 6.3% this year to $14,542 - the largest rise since 2010.
The increase was just 3.4% in 2020 when the pandemic had strained hospital capacity and forced people to put off elective procedures.
‘I think that’s (catch-up care) certainly part of the cost driver,’ Kate Brown, Mercer’s Center for Health Innovation Leader, told Reuters.
Brown said several other factors, including claims related to the treatment of long-term effects of COVID-19 and specialty drug pricing, could also be driving the cost rise and may continue into 2022.”

Medicare urged to flex its power and slash back premium hike: Senate Finance Chairman Ron Wyden, D-Ore., “says the Biden administration should use its legal authority to cut back a hefty premium increase soon hitting millions of enrollees, as a growing number of Democratic lawmakers call for action amid worries over rising inflation.
Last month, Medicare announced one of the largest increases ever in its ‘Part B’ monthly premium for outpatient care, nearly $22, from $148.50 currently to $170.10 starting in January.
The agency attributed roughly half the hike, about $11 a month, to the need for a contingency fund to cover Aduhelm, a new $56,000 Alzheimer’s drug from Biogen whose benefits have been widely questioned. For most Medicare enrollees, the premium is deducted from their Social Security checks. Without further action, it would swallow up a significant chunk of seniors’ 5.9% cost of living increase.”

Four People Indicted in International Telemedicine Health Care Fraud Kickback Scheme: “Beginning in May 2014, the defendants and their conspirators began to use the telemedicine company to generate a high volume of prescriptions for compounded medications and, later, durable medical equipment (DME), without regard to medical necessity and through the payment of kickbacks. The defendants agreed and arranged for health care providers associated with the telemedicine company to write prescriptions for compounded medications and DME without the establishment of any provider-patient relationship, in exchange for kickbacks, and in violation of certain state telemedicine laws. Woroboff, Willard, and Mills agreed to pay [Dr. Le] Thu approximately $35 per prescription. Thu wrote prescriptions without speaking to patients in exchange for those payments.”

About Covid-19

Pfizer’s anti-covid pill prevents severe illness and should work against omicron variant, company says: “Reinforcing an earlier analysis from November, Pfizer’s drug cut hospitalizations and deaths by nearly 90 percent when taken within three or five days of the onset of symptoms, the company announced. Preliminary laboratory studies suggest the easy-to-take drug will hold up against the omicron variant.”

Merck’s Covid Pill Might Pose Risks for Pregnant Women: “Scientists are especially worried about pregnant women, they said, because the drug could affect a fetus’s dividing cells, theoretically causing birth defects. Members of the F.D.A. expert committee expressed those same concerns during a public meeting on Nov. 30.”

Vermont 1st state to mandate at-home COVID-19 test coverage: “The emergency rule covers approximately 140,000 Vermonters who purchase commercial insurance in Vermont’s individual, small and large group markets as well as the Vermont Education Health Initiative.
The rule has an eight-test monthly limit and is retroactively effective through Dec. 1…”

Omicron variant more resistant to vaccine but causes less severe covid, major South African study concludes: “The study by Discovery Health, South Africa’s largest health insurer, of 211,000 positive coronavirus cases, of which 78,000 were attributed to omicron, showed that risk of hospital admissions among adults who contracted covid-19 was 29 percent lower than in the initial pandemic wave that emerged in March 2020.
However, the study, released Tuesday, found that the vaccine from U.S. pharmaceutical giant Pfizer and German partner BioNTech provided just 33 percent protection against infection, much less than the level for other variants detected in the country.
At the same time, the vaccine may offer 70 percent protection against being hospitalized with omicron…”

Roche Gets CE Mark for Rapid Antigen Test Distinguishing COVID-19 From Flu A/B: “The test kit, which delivers results in less than 30 minutes, works with Roche’s Navify Pass software, enabling individuals and healthcare professionals to store and share their test results and vaccine status. Results from the test are available in less than 30 minutes.
The company said it intends to file for Emergency Use Authorization from the FDA early in the new year.”

Monitoring Variant Proportions: From the CDC: The delta variant accounts for about 97% of Covid cases, while the omicron variant makes up the other ~3%.

Supreme Court won’t stop vaccine mandate for New York health care workers: “The Supreme Court on Monday declined to stop New York’s coronavirus vaccination mandate for health care workers that does not include an exception for religious objectors.
As it has done in past mandate cases, the court rejected a request from doctors, nurses and other medical workers who said they were being forced to choose between their livelihoods and their faith. They said they should receive a religious exemption because the state’s rule allows one for those who decline the vaccine for medical reasons.
As is often the case in requests for emergency relief, the justices in the majority did not give a reason for declining the request to stop the order, which went into effect in November. Last month, the court also denied a similar request from health care workers in Maine.”
However: Appeals court refuses to reinstate CMS vaccine rule: “The 8th Circuit Court of Appeals on Dec. 13 denied the Biden administration's request to lift a district court's injunction that blocked the mandate, which requires COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs. The order comes after U.S. District Judge Matthew Schelp in the Eastern District of Missouri granted 10 states' request for a preliminary injunction on Nov. 29. 
The order from the appeals court applies to the 10 states that joined the lawsuit: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. A separate preliminary injunction granted in Louisiana blocked the vaccination mandate in all other states.”

Uptick in Concern over COVID Infection: “Thirty-six percent of Americans are extremely or very worried about themselves or a family member being infected with coronavirus. This is up from 25% who felt the same in October. In August, as the delta variant caused a spike in cases, 41% were concerned about infection.
While 71% of those who are vaccinated still say they’re at least somewhat worried about infections, 55% of those who are unvaccinated say they have little or no worry. Eighty-one percent of Democrats say they’re at least somewhat worried, compared with 49% of Republicans.
More than half of adults continue to stay away from large groups, wear a face mask, and avoid nonessential travel. However, fewer people are using these precautions than before vaccines were widely available. In February, more than 7 in 10 Americans reported staying away from large groups, wearing face masks, and avoiding travel.
Vaccinated Americans are more likely to take these precautions than the unvaccinated.  Democrats are also more likely than Republicans to say they’re regularly masking (72% to 33%), avoiding travel (63% to 36%), avoiding large groups (65% to 43%) and avoiding other people as much as possible (47% to 27%).”

The U.S. COVID-19 Vaccination Program at One Year: How Many Deaths and Hospitalizations Were Averted?: Highlights from a From the Commonwealth Fund report:

• “In the absence of a vaccination program, there would have been approximately 1.1 million additional COVID-19 deaths and more than 10.3 million additional COVID-19 hospitalizations in the U.S. by November 2021.

• Without the U.S. vaccination program, COVID-19 deaths would have been approximately 3.2 times higher and COVID-19 hospitalizations approximately 4.9 times higher than the actual toll during 2021.

• If no one had been vaccinated, daily deaths from COVID-19 could have jumped to as high as 21,000 per day — nearly 5.2 times the level of the record peak of more than 4,000 deaths per day recorded in January 2021.”

About pharma

10 of the largest pharma companies, ranked by 2020 revenue: FYI

About healthcare IT

Computer-, smartphone-based treatments effective at reducing symptoms of depression: “Researchers conducted a meta-analysis of 83 studies testing digital applications for treating depression, dating as far back as 1990 and involving more than 15,000 participants in total, 80% adults and 69.5% women. All of the studies were randomized controlled trials comparing a digital intervention treatment to either an inactive control (e.g., waitlist control or no treatment at all) or an active comparison condition (e.g., treatment as usual or face-to-face psychotherapy) and primarily focused on individuals with mild to moderate depression symptoms. 
Overall, researchers found that digital interventions improved depression symptoms over control conditions, but the effect was not as strong as that found in a similar meta-analysis of face-to-face psychotherapy. There were not enough studies in the current meta-analysis to directly compare digital interventions to face-to-face psychotherapy, and researchers found no studies comparing digital strategies with drug therapy.”

The Digital Experience is the Key Driver of Growth and Patient Retention, According to Press Ganey’s 2021 Consumer Report: “According to the analysis:

• All generations are increasingly shopping online for healthcare. 44% of baby boomers and 60% of millennials and Gen Z prefer researching healthcare providers on their smartphone or tablet, representing a 27% and 13% increase from 2019, respectively.

• Digital drives patient choice. In fact, they rely on digital resources more than twice as much as provider referrals when choosing a healthcare provider. On average, consumers use three different websites during their healthcare research process and five reviews before making a decision.

• Search engines are just the start. Among the top five websites used, consumers rely on a brand’s website, WebMD, Healthgrades and Facebook the most to research a provider.

• Online reviews prevent referral leakage. 83% of patients go online to read reviews about a provider after they receive a referral. 84% would not see their referred provider if they had less than a four-star rating.

• Customer service is the new bedside manner. Assuming quality care is received, patients rate ‘customer service’ (71%) and ’communication’ (64%) as more important than even ‘bedside manner’ when it comes to rating a five-star experience.

• Telehealth isn’t going anywhere anytime soon. More than one-third of patients have used telehealth in the past year—a 38% increase since 2019—and usage surged among baby boomers during the same period.”

A machine and human reader study on AI diagnosis model safety under attacks of adversarial images: “We perform a study to investigate the behaviors of an AI diagnosis model under adversarial images generated by Generative Adversarial Network (GAN) models and to evaluate the effects on human experts when visually identifying potential adversarial images. Our GAN model makes intentional modifications to the diagnosis-sensitive contents of mammogram images in deep learning-based computer-aided diagnosis (CAD) of breast cancer. In our experiments the adversarial samples fool the AI-CAD model to output a wrong diagnosis on 69.1% of the cases that are initially correctly classified by the AI-CAD model. Five breast imaging radiologists visually identify 29%-71% of the adversarial samples. Our study suggests an imperative need for continuing research on medical AI model’s safety issues and for developing potential defensive solutions against adversarial attacks.”

Scripps' Epic EHR automates supply price markups up to 675% : “Scripps Memorial Hospital's Epic EHR uses an automated tool to mark up prices of supplies between 575 and 675 percent in real time within the EHR…”

Satisfaction with telemedicine takes a tumble but still comes out on top, new report says: “Despite overall satisfaction of consumers with telemedicine, patients were less impressed by the services this year as compared to last, a new report from Rock Health published Dec. 13 reveals. 
Rock Health conducted a digital health consumer adoption survey that asked 7,980 U.S adults about their relationship to digital health. 
It found that satisfaction with telemedicine decreased in 2021. In 2020, 53 percent of respondents reported higher satisfaction with live video telemedicine compared to in-person interactions. However, in 2021, only 43 percent of respondents reported the same. 
Physicians also reported being less satisfied with telehealth, with 58 percent of physicians surveyed viewing telehealth more favorably since the pandemic in 2021 as compared to 64 percent in 2020.”

Today's News and Commentary

About healthcare M&A

Health services: Deals 2022 outlook: Some highlights from this PWC report:
”Deal volumes rose by an extraordinary 56% in the 12 months through November 15 versus 2020, with particularly high growth in physician medical groups, managed care and rehabilitation subsectors.
Deals appetite has persisted despite high multiples — the sector-wide mean enterprise value to EBITDA multiple for the period reached 15.2x.
In the same period, the sector has seen nine megadeals valued at $5 billion or more, plus traditional IPOs and IPOs backed by special purpose acquisition companies (SPACs).
Deals are being driven by forces including capital availability, regulatory pressures, searches for value, resilience imperatives and evolving value chain power dynamics.”

Baxter Completes Acquisition of Hillrom, Creating ~$15 Billion Global Medtech Leader: Read the announcement for details.

Pfizer spurs immuno-inflammatory pipeline with $6.7-billion Arena buy: “The deal announced Monday bolsters Pfizer's pipeline with the addition of development-stage therapeutic candidates in gastroenterology, dermatology and cardiology, including the next-generation oral S1P receptor modulator etrasimod that it expects will contribute to growth ‘through 2025 and beyond.’”

The top 10 M&A targets in medtech for 2022: Read the article for more information on companies in the list.

About Covid-19

U.S. COVID-19 deaths reach 800,000 as Delta ravaged in 2021: Data as of yesterday.

TWO-THIRDS OF STATE MEDICAL BOARDS SEE INCREASE IN COVID-19 DISINFORMATION COMPLAINTS: “The Federation of State Medical Boards (FSMB) has released findings from its 2021 annual survey of its member state medical boards….
When asked about complaints and disciplinary actions related to COVID-19, the survey found:

• 67% have experienced an increase in complaints related to licensee dissemination of false or misleading information

• 26% have made or published statements about the dissemination of false or misleading information

• 21% have taken a disciplinary action against a licensee disseminating false or misleading information”

The Big Vaccine Pivot: Merck Falters on Covid-19 Shots, Then Makes One for Rival J&J: “The Johnson & Johnson -Merck partnership, which the companies announced in March, is now bearing fruit to expand the world’s vaccine supply. After a frantic ramp-up that involved scouting for raw materials, buying equipment and upgrading plants all at the same time, the first Merck-made shots shipped Friday.
Merck is churning out more than 500,000 doses daily for use outside the U.S., including countries desperate for shots.”

Court ruling is a blow to restaurants' COVID claims: “In a sweeping set of rulings, the 7th U.S. Circuit Court of Appeals determined that governmental actions closing or restricting businesses in the early months of the pandemic weren’t losses that insurers have to cover.
The decisions in six cases, made public today, upheld decisions by lower courts to dismiss suits claiming damages by an array of plaintiffs, including the Ritz-Carlton Hotel in Dallas. But their sweeping nature means that the many other cases pending in lower courts… likely will fail over the same issues.”

About health insurance

Affordability of Medical Care Among Medicare Enrollees: “In a nationally representative survey of 13 171 Medicare enrollees that asked several questions about the affordability of their medical care, the overall reported prevalence of ever delaying care during 2017 owing to worries about cost was 11%; the prevalence of having problems paying medical bills was also 11%, and 16% of the respondents experienced 1 of these 2 concerns or both. Unaffordability of care was associated with lower incomes, worse health, and being younger than 65 years with long-term disability.”

MedPAC Likely To Support Pay Increase For Hospitals In 2023: Skilled nursing, home health and inpatient rehabilitation facilities could see 5% base pay decreases. Physicians, ambulatory surgical centers and hospices may see no change in pay from 2022.
Post-acute care providers and stakeholders that could be facing pay freezes said they’re disappointed in MedPAC’s draft proposals. MedPAC’s own commissioners agreed with most recommendations staff presented. However, several members had concerns about leaving physician pay flat in 2023. Recommendations will come to an official vote at next month’s meeting.
MedPAC staff suggested updating hospital payment by the amount determined under current law, which is expected to be 2% for 2023.”

Miami Resident Charged with Committing $38 Million Health Care Fraud Scheme, Spending Proceeds on Beachfront Condos and Luxury Vehicles: “According to allegations in the federal grand jury indictment, from February 2015 through July 2021, 63-year-old Armando Valdes owned and operated Gasiel Medical Services, Corp. (“Gasiel”) a medical clinic in Miami, Florida. It is alleged that Gasiel submitted approximately $38 million in false and fraudulent claims to United and Blue Cross for infusions of Infliximab which were medically unnecessary and not provided to patients as billed.”
Such fraud cannot occur in a capitated arrangement where the provider is responsible for in-office expenses.

Centene May Sell Its International Business As Health Insurer Expands In The U.S.: “Centene, which is known for providing government-subsidized health insurance in the U.S., said Friday it is “reviewing its non-core assets as part of its ongoing portfolio optimization processes, including evaluating strategic alternatives for its international business.”
The announcement, made as part of Centene’s annual investor day, comes as the company is on the verge of bolstering its U.S. health insurance offerings with Magellan Health, which sells and manages behavioral health services. Centene is hoping to close its Magellan Health acquisition by the end of this year, the company said.”

About the public’s health

Infant Mortality in the United States, 2019: Data From the Period Linked Birth/Infant Death File: Among the findings: “A total of 20,927 infant deaths were reported in the United States in 2019, down 3% from 2018. The U.S. infant mortality rate was 5.58 infant deaths per 1,000 live births, a historic low for the country, although not significantly different from the rate of 5.67 in 2018. The neonatal mortality rate declined to 3.69 in 2019 from 3.78 in 2018, while the postneonatal mortality rate was unchanged from 2018 at 1.89. The mortality rate declined for infants of non-Hispanic white women in 2019 compared with 2018; declines in rates for the other race and Hispanic-origin groups were not significant. The 2019 infant mortality rate for infants of non-Hispanic black women (10.62) was more than twice as high as that for infants of non-Hispanic white (4.49), non-Hispanic Asian (3.38), and Hispanic (5.03) women… Infant mortality rates by state for 2019 ranged from a low of 3.21 in New Hampshire to a high of 8.71 in Mississippi.”

Beware of Vaping Products with Unproven Health Claims: From the FDA: “The U.S. Food and Drug Administration wants consumers to know certain “wellness” vaping products containing vitamins and/or essential oils are being illegally sold with unproven claims and could be harmful if used. Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases.”

About hospitals and health systems

2 US health systems plan international expansions: Read the article for details of the UPMC and Cleveland Clinic plans.

About healthcare professionals

2021 Fall Applicant, Matriculant, and Enrollment Data Tables: Applications are up to record numbers for all categories. Currently,  52.7% of enrollees are women. “Black or African American” enrollment is up almost 10%.

About healthcare IT

Digital HTN, Diabetes Monitoring Program a Boon for Patients: “A digital health program for hypertension and diabetes was associated with improved patient outcomes, a clinical pharmacist reported.
While 26% of hypertension patients receiving usual care achieved blood pressure control after 6 months, 75% of those in the digital health program met that goal in the same time frame in 2018, Heather Aaron, PharmD, of Ochsner Health in New Orleans, reported…
Patients with diabetes experienced improved hemoglobin A1c as well, with the average going from 7.3% at baseline to 6.7% after 6 months in the digital health program…”

What devices like Apple, Google smartwatches are beginning to display about our health: “The global market for wearable health and fitness devices — including sensor-laden watches, wrist bands, rings, skin patches, eyeglasses and clothing — reached more than $36 billion in 2020 and is projected to reach over $100 billion by 2028…
Now, nearly 30% of Americans now use a wearable health care device, many of which now have the capabilities to track, monitor and transmit data on heart rate and rhythm, blood pressure, body temperature, blood sugar levels, quality of sleep and even early warning signs of Covid-19 infection.”
The article has many good examples of current and emerging technologies.

About healthcare quality

Longitudinal Content Analysis of the Characteristics and Expected Impact of Low-Value Services Identified in US Choosing Wisely Recommendations: “In this qualitative study of 626 recommendations, the plurality identified low-value imaging and laboratory studies, services in the clinical contexts of healthy patients or those with a chronic condition, and services that were low cost and revenue neutral for the given society. Nearly half of identified low-value services had high direct harm potential, while 62% had high potential for cascades (ie, triggering downstream services).”

Today's News and Commentary

About hospitals and health systems

How the 3 largest nonprofit systems fared in Q1: “The largest nonprofit health systems, Ascension, CommonSpirit Health and Trinity Health, reported higher revenue in the first quarter of fiscal year 2022 than in the same period a year earlier.” The article provides more details for each system.

The 11 most expensive hospital capital projects in 2021: “Eleven capital projects of more than $1.5 billion were announced, broke ground or were completed in 2021.” Amazing that these expensive projects went ahead during the Covid pandemic.

About healthcare technology

Chan Zuckerberg Initiative to pour $3.4B over 10 years into AI, imaging and other tech to unravel biomedical challenges: “The philanthropic initiative—led by the husband-and-wife duo of Facebook founder Mark Zuckerberg and Priscilla Chan, M.D., formerly a practicing pediatrician—unveiled this week a 10-year plan to invest $3.4 billion in the development of new technologies and tools that help improve our understanding of human health and disease.
Between $800 million and $1 billion of the new funds will go to the Biohub… {the] San Francisco-based research hub launched in 2016 with an initial commitment of about $600 million. Its first projects included the construction of the Cell Atlas, a map of the various types of cells that control each major organ, and the creation of the Infectious Disease Initiative to develop new diagnostic tests and vaccines to treat HIV, Ebola, Zika and other fast-spreading diseases.”

About health insurance

Senate votes to avert Medicare cuts: “The bill halts a mandatory 2 percent federal Medicare spending sequester until April 2022 and stops a 4 percent statutory pay-as-you-go sequester. Both sequesters are meant to limit federal spending.
The bill also reduces the mandatory Medicare sequester to 1 percent from April through June of 2022 and includes a 3 percent increase in pay for providers in the Medicare physician fee schedule. The package also delays the start of the radiation oncology model until Jan. 1, 2023, to give participants the best chance to improve cancer care outcomes…
The Senate approved the bill in a 59-35 vote. The House approved the bill Dec. 7 in a 222-212 vote. It now heads to President Joe Biden.”

Doctors and Hospitals Make Late Bid to Change Surprise Billing Ban: “Three weeks before a new ban on surprise medical billing is set to start, hospital and doctor groups have filed suit to block part of it.
The suit, from the American Medical Association, the American Hospital Association and a handful of individual hospitals and providers, argues that regulators in the Biden administration have misread the law’s language — and that their faulty interpretation will harm medical providers.
The lawsuit does not seek to gut the law’s consumer protections, but could influence contract negotiations between insurers and health care providers. If successful, the lawsuit could influence which doctors and hospitals choose to go in network with insurers, and could lead to higher insurance premiums.”

Affordable Care Act exchanges seeing record interest in heavily subsidized 2022 coverage: “Plan selections in the 33 states that use the federal exchange, Healthcare.gov, are up 5% from an essentially comparable period last year, the agency said. The data is for the first five weeks of open enrollment, which began November 1 and runs through January 15, a month longer than under the Trump administration.
In the 12 states that have not expanded Medicaid to low-income adults, sign ups have increased 9%. Plan selections are up 20% in Texas and 9% in Florida, the two largest markets on the federal exchange.”

5 payers tagged by OIG for coding, reimbursement errors in 2021: Read the article for details.

Anthem-backed Hydrogen Health rolls out virtual primary care services for insurers, employers: “Hydrogen Health rolled out its services with Anthem this past summer and is now expanding to multiple Fortune 500 employers and large regional health plans, company executives said, with a plan to be live for an additional 10 million people by the end of 2022.
Hydrogen Health is a new venture from New York-based K Health, backed by an Anthem investment and funds managed by investment firm Blackstone that aims to lower healthcare costs and make care more accessible.”

Geographic Variation in Medicare Fee-for-Service Health Care Expenditures Before and After the Passage of the Affordable Care Act: “This analysis of geographic variation in per-beneficiary health care expenditures within the Medicare fee-for-service system has 3 notable findings. First, we observed a decline in geographic variation in total expenditures from 2007 to 2018. Whereas per-beneficiary monthly expenditures were $415 higher in the top vs bottom deciles in 2007, they were only $361 higher in 2018. Notably, we found reductions in geographic variation were concentrated in the highest-spending decile—the ratios of the 9th and 8th to the lowest-spending deciles were more constant during this period—showing that reductions in relative spending were not uniform across all higher-spending deciles but rather focused on outlier regions. Second, the decline in geographic variation appears to have begun in 2012, soon after Medicare began implementing value-based payment policies and increased antifraud enforcement after the ACA. Third, the types of services that accounted for the decrease in geographic variation were postacute care (which declined as a proportion of total expenditures), and most of the decline in geographic variation in postacute care was related to home health care. Notably, for both hospital and physician services, geographic variation was unchanged over the study period.”

About pharma

Utilization of Generic Cardiovascular Drugs in Medicare’s Part D Program: “Of ≈$22.9 billion spent on cardiovascular drugs in Medicare Part D prescription programs in 2017, ≈$11.0 billion was spent on medications with both brand-name and generic options. Although only 2.4% of medication fills were for the brand-name choice, they made up 21.2% of total spending. Accounting for estimated brand-name rebates, generic substitution for these medications would save $641 million, including $135 million in costs shouldered by patients. Furthermore, the minority of clinicians with the lowest generic utilization was responsible for a large proportion of the potential cost savings.”

House Democrats find in three-year investigation that drug prices are ‘unsustainable, unjustifiable and unfair’: “The findings, released Friday, show that companies studied by the committee raised prices of common brand-name drugs during the past five years by nearly four times the rate of inflation. The report seeks to debunk industry contentions that companies’ pricestrategy is needed to plow money back into researching and developing new medicines, finding that revenue is substantially greater than those investments….
In a counterpunch, the Oversight committee’s Republicans issued their own drug-industry report, based on a less exhaustive look at companies known as pharmacy benefit managers, which act as go-betweens to manage drug benefits on behalf of private insurers, Medicare drug plans and other payers. The pharmaceutical industry and other critics have contended for years that PBMs, as they are known, are a major reason for the growth of drug spending because they receive undisclosed payments — called rebates — based on a medicine’s list price, so the higher the price the greater the payment.”

Federal Jury Convicts Pharmacy Owner for Role in $174 Million Telemedicine Pharmacy Fraud Scheme: This case is a rare example of a multiyear scam that did not target federal programs. “According to court documents and evidence presented at trial, Bolos and his co-conspirators, Andrew Assad, Michael Palso, Maikel Bolos, Larry Smith, Scott Roix, HealthRight LLC, Mihir Taneja, Arun Kapoor, and Sterling Knight Pharmaceuticals, as well as various other companies owned by them, deceived pharmacy benefit managers (PBMs), such as Express Scripts and CVS Caremark, regarding tens of thousands of prescriptions. The PBMs processed and approved claims for prescription drugs on behalf of insurance companies. Bolos and his co-conspirators defrauded the PBMs into authorizing claims worth more than $174 million that private insurers such as Blue Cross Blue Shield of Tennessee, and public insurers such as Medicaid and TRICARE, paid to pharmacies controlled by the co-conspirators.”

About the public’s health

Becerra names incoming acting NIH director: “Lawrence Tabak, who currently serves as the principal deputy director at NIH, will take on the acting position starting on Dec. 20, while the administration searches for Collins’s permanent replacement, the HHS secretary said in an announcement.”

Association of Air Pollution and Physical Activity With Brain Volumes: “Physical activity is associated with beneficial brain outcomes, while AP is associated with detrimental brain outcomes. Vigorous physical activity may exacerbate associations of AP with white matter hyperintensity lesions, and AP may attenuate the beneficial associations of physical activity with these lesions.” Beneficial individual efforts are balanced out by public errors.

Supreme Court lets Texas abortion law continue but says providers can sue: “In this latest decision, court said in an 8-1 vote that abortion providers should be allowed to sue in federal court, with only Justice Clarence Thomas saying in a dissent that he would have thrown out the providers' case.
By a 5-4 vote, the Supreme Court's conservative majority said that the providers could not sue state court clerks, as clinics had sought to do in their efforts to short-circuit the private state court litigation that could be brought against them for violating the six-week ban. Chief Justice John Roberts said that the Court should have allowed lawsuits to proceed against those and other officials.”
In a related article: Judge says Texas abortion law’s enforcement mechanism unconstitutional: "The enforcement mechanism for Texas’s abortion ban, which is the most restrictive in the nation and effectively outlaws the procedure, violates the Texas constitution, a state judge ruled Thursday.
While a win for abortion rights advocates, the narrow decision by District Judge David Peeples of Austin does not include an injunction that would halt litigation against doctors or others who “aid or abet” an abortion.”

NHS waiting list in England hits record high in October: A cautionary note fro those advocating a national health scheme like the one in England: “The number waiting for non-emergency NHS hospital treatment has risen to 6m, the highest since records began almost 15 years ago, underlining the health service’s fragility as it braces for the consequences of the new Omicron coronavirus variant. Official data from NHS England published on Thursday showed a large jump in the backlog in October, with about 35 per cent of patients waiting more than 18 weeks to start treatment, against a target of just 8 per cent.”

IDF Diabetes Atlas 10th edition 2021: From the International Diabetes Federation: “Findings of the current 10th edition confirm that diabetes is one of the fastest growing global health emergencies of the 21st century (see Map 1). In 2021, it is estimated that 537 million people have diabetes, and this number is projected to reach 643 million by 2030, and 783 million by 2045. In addition, 541 million people are estimated to have impaired glucose tolerance in 2021. It is also estimated that over 6.7 million people aged 20–79 will die from diabetes-related causes in 2021. The number of children and adolescents (i.e. up to 19 years old) living with diabetes increases annually. In 2021, over 1.2 million children and adolescents have type 1 diabetes. Direct health expenditures due to diabetes are already close to one trillion USD and will exceed this figure by 2030.”

About Covid-19

US government has granted vaccine mandate exceptions to 165,000 workers: “8% of federal employees remain unvaccinated against Covid-19 despite November mandate.”

Austrians who refuse Covid jabs face fines of up to €3,600: “Government plans to make vaccination compulsory for everyone aged above 14 from February.”

Covax promised 2 billion vaccine doses to help the world’s neediest in 2021. It won’t even deliver even half that.: “The U.N.-led initiative is now racing to deliver 800 million doses by the end of the year, according to interviews with senior officials involved in Covax, which includes the World Health Organization and other groups. Even if that benchmark is met, it will be a far cry from the 2.3 billion doses hoped for in January by a program designed to counter a glut of vaccines in wealthy nations.
Covax lowered its estimate of doses delivered in 2021 to between 800 million and 1 billion doses late this year after a range of complications with supply and delivery.“

AstraZeneca’s COVID-19 Long-Acting Antibody Combo Snags EUA: “The FDA has granted AstraZeneca’s long-acting antibody combination Evusheld an Emergency Use Authorization (EUA) for preventing COVID-19 in adults and children 12 years of age and older with weak immune systems.
The combination tixagevimab/cilgavimab treatment is indicated for people with moderate-to-severe immunocompromise caused by a medical condition or immunosuppressive drugs who may be unable to mount a proper immune response to a COVID-19 vaccine, as well as those who shouldn’t receive a coronavirus vaccine at all.”

Today's News and Commentary

COVID cases spike even as US hits 200M vaccine milestone: “The number of Americans fully vaccinated against COVID-19 reached 200 million Wednesday amid a dispiriting holiday-season spike in cases and hospitalizations that has hit even New England, one of the most highly inoculated corners of the country.
New cases in the U.S. climbed from an average of nearly 95,000 a day on Nov. 22 to almost 119,000 a day this week, and hospitalizations are up 25% from a month ago. The increases are due almost entirely to the delta variant, though the omicron mutation has been detected in about 20 states and is sure to spread even more.
Deaths are running close to 1,600 a day on average, back up to where they were in October. And the overall U.S. death toll less than two years into the crisis could hit another heartbreaking milestone, 800,000, in a matter of days.”

Omicron may require fourth vaccine dose sooner than expected, Pfizer says: “Albert Bourla, Pfizer’s chief executive, had projected that a fourth dose might be needed 12 months after a third shot. But he said on CNBC’s ‘Squawk Box’ that the timeline might need to be moved up. One of the company’s top scientists recently said a fourth shot — possibly one targeting omicron — is likely to be necessary.”

U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail: “The U.S. Food and Drug Administration on Wednesday authorized the use of AstraZeneca's antibody cocktail to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.”

Senate votes to nix Biden's vaccine mandate for businesses: “The Senate on Wednesday voted to nix President Biden’s vaccine mandate for larger businesses, handing Republicans a symbolic win.
Senators voted 52-48 on the resolution, which needed a simple majority to be approved. Democratic Sens. Jon Tester (Mont.) and Joe Manchin (W.Va.) voted with Republicans, giving it enough support to be sent to the House. 
The resolution faces an uphill path in the House, where Republicans aren’t able to use a similar fast-track process to force a vote over the objections of Democratic leadership. Instead, Republicans are hoping to get the simple majority needed to force a vote through a discharge petition, which will require support from a handful of House Democrats.”

FDA authorizes Pfizer-BioNTech coronavirus vaccine booster shots for 16- and 17-year-olds amid omicron threat: “Federal regulators Thursday authorized booster shots of Pfizer-BioNTech’s coronavirus vaccine for 16- and 17-year-olds, a step that could bolster protection against delta, the dominant variant in the United States, and the emerging omicron version.”

Health Experts Worry CDC’s Covid Vaccination Rates Appear Inflated: “CDC as of Dec. 5 has recorded more seniors at least partly vaccinated — 55.4 million — than there are people in that age group — 54.1 million, according to the latest census data from 2019. The CDC’s vaccination rate for residents 65 and older is also significantly higher than the 89% vaccination rate found in a poll conducted in November by KFF.”
Other discrepancies are also reported.

The Coronavirus Attacks Fat Tissue, Scientists Find: “From the start of the pandemic, the coronavirus seemed to target people carrying extra pounds. Patients who were overweight or obese were more likely to develop severe Covid-19 and more likely to die.
Though these patients often have health conditions like diabetes that compound their risk, scientists have become increasingly convinced that their vulnerability has something to do with obesity itself.
Now researchers have found that the coronavirus infects both fat cells and certain immune cells within body fat, prompting a damaging defensive response in the body.”

About hospitals and health systems

City of Hope to acquire Cancer Treatment Centers of America for a reported $390M: “Hospital system City of Hope is acquiring Cancer Treatment Centers of America to build a national, integrated cancer research and treatment system.
Financial details of the acquisition were not disclosed, but Reuters reported the deal was valued at $390 million.”

About health insurers

Bright Health banks $750M investment from Cigna Ventures, New Enterprise Associates: “Insurtech startup Bright Health has secured a $750 million capital investment that includes funding from Cigna Ventures.
Cigna's investment arm is a new backer for the company. Bright Health's largest shareholder, New Enterprise Associates, will also participate as a co-investor. The funds will be used to help Bright Health continue to grow and enhance its differentiated alignment model.”
In a related article: Why Cigna Keeps Partnering With Its Competitors: “These partnerships with smaller insurers and tech companies help Cigna bridge blindspots in its insurance products and add new customers to its health services division, allowing it to better compete and mimic the strategy of larger insurers like UnitedHealth Group, said Rick Kes, a healthcare industry senior analyst at RSM.”

How ACA Marketplace Premiums Are Changing by County in 2022: “Premiums for ACA Marketplace benchmark silver plans are decreasing on average across the U.S. in 2022 for the fourth consecutive year. However, premium changes vary widely by location and by metal level, with premiums increasing in several cases. As most enrollees receive significant premium subsidies on the ACA Marketplaces, the net premium amount an exchange enrollee pays out-of-pocket depends on their income and the difference in the cost between the benchmark plan (second-lowest silver plan) and the premium for the plan they choose.”
The article has a helpful interactive U.S. map that gives changes for plans by county.

About pharma

In the Years before the COVID-19 Pandemic, Nearly 13 Million Adults Delayed or Did Not Get Needed Prescription Drugs Because of Costs: From Urban Institute research:
”We find the following:
—Nearly 13 million adults delayed getting or did not get needed prescription drugs in the past year because of the cost, including 2.3 million elderly Medicare beneficiaries and 3.8 million nonelderly adults with private insurance, 1.1 million with Medicaid, and 4.1 million who were uninsured at any point during the year.
—About 1 in 10 adults who were uninsured all year (9.5 percent) or part of the year (11.6 percent) reported unmet prescription drug needs, compared with 4.9 percent of Medicare beneficiaries, 3.0 percent of privately insured adults, and 5.6 percent of nonelderly adults with Medicaid.
—For both Medicare beneficiaries and privately insured adults, unmet prescription drug needs were most common among women, people with low incomes, and people with multiple chronic health conditions. Nearly all Medicare beneficiaries and more than 8 in 10 privately insured adults with unmet needs have been diagnosed with a chronic condition such as high blood pressure, high cholesterol, stroke, diabetes, arthritis, and respiratory illnesses.
—More than one-quarter of adults with Medicare (25.4 percent) and 5.3 percent of privately insured adults spent more than 1 percent of their family incomes on their individual out-of- pocket prescription drug costs. More than 3 percent of Medicare beneficiaries—and nearly 7 percent of beneficiaries with unmet prescription drug needs—spent more than 10 percent of their family incomes on prescription drugs.”

A pilot trial to evaluate the feasibility, acceptability, and accuracy of a digital pill system to measure PrEP adherence in men who have sex with men [MSM] who use substances: “Digital pill systems (DPS) comprise a radiofrequency emitter integrated into a gelatin capsule containing PrEP, which transmits data to a wearable Reader following ingestion, thereby enabling direct, real-time adherencemeasurement. This study evaluated the feasibility, acceptability, and accuracy of a DPS to measure PrEP adherence…
DPS are a feasible, acceptable, and accurate method of measuring PrEP adherence in MSM with substance use. Future investigations should incorporate DPS into behavioral interventions targeting nonadherence.”
In a related article from the CDC: PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES – 2021 UPDATE: “In anticipation of likely FDA approval of a PrEP indication for cabotegravir (CAB) in late 2021, we added a new section about prescribing PrEP with intramuscular injections of CAB every 2 months for sexually active men, women, and transgender persons with indications for PrEP use.”

$56K Alzheimer’s drug avoiding Biden’s cost curbs, for now: “The medication known as Aduhelm would be protected from Medicare price negotiations for more than a decade under the Democratic drug pricing compromise before Congress, part of Biden’s social agenda legislation. That’s because the bill doesn’t allow Medicare to negotiate over newly launched drugs, providing a window for drugmakers to recoup investments in research and development. Biologics such as Aduhelm get 13 years of protection.”

Drug Company Settles with N.Y. for $200 Million in Sprawling Opioid Case: “The settlement with Allergan, a company that has made opioids but whose most well-known product is Botox, is the latest agreement in a trial jointly argued by New York State and two counties that began in June.”

About healthcare IT

10 biggest patient data breaches in 2021: “In 2021, 578 healthcare organizations reported to HHS more than 41.45 million individuals being affected by data breaches.”

Interoperability and Patient Access for Medicare Advantage Organizations and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers: CMS is putting on hold enforcement of some interoperability requirements. “This notification is to inform the public that CMS is exercising its discretion in how it enforces the payer-to-payer data exchange provisions. As a matter of enforcement discretion, CMS does not expect to take action to enforce compliance with these specific provisions until we are able to address certain implementation challenges.”

About healthcare policy

Biden promised to reverse Trump's health policies. He's done that -- mostly.: A really good review of the headline’s topic. The major actions still needed are:

• ”The rule that got the most pushback from Democrats: Trump’s expansion of short-term health plans, which typically don’t cover pre-existing conditions.

• A regulation expanding so-called association health plans — which allows businesses to band together to buy health coverage — has been stalled in the courts. A federal judge still hasn’t ruled on the measure, despite hearing the case back in 2019, and the Biden administration told the court as recently as this week that the administration is still considering the matter.

• The last regulation allows for employers to provide subsidies for their workers to buy health coverage on the individual market.”

About the public’s health

New Zealand’s plan to end smoking: A lifetime ban for youth: “New Zealand has been at the front of social and public health initiatives. This one is the latest: New Zealand’s government believes it has come up with a unique plan to end tobacco smoking — a lifetime ban for those aged 14 or younger.
Under a new law the government announced Thursday and plans to pass next year, the minimum age to buy cigarettes would keep rising year after year.
That means, in theory at least, 65 years after the law takes effect, shoppers could still buy cigarettes — but only if they could prove they were at least 80 years old.” 
Unfortunately, this plan would not be politically feasible here ( less than 0.01% of agricultural land in NZ is devoted to tobacco cultivation). Further, it would impinge on our Constitutional right to abuse our bodies at the public’s expense.

Today's News and Commentary

About hospitals and health systems

2021 Healthcare Consumer Experience Study: Among the findings: “More than one-third (35%) of survey respondents say they have changed (or would change) healthcare providers to get a better digital patient administrative experience. And one-third (33%) have changed or would change payers to get a better digital member experience.”

CONSUMER EXPERIENCE TRENDS IN HEALTHCARE 2021: In a different study (this one by Press Ganey), below are some highlights:

“Digital drives choice: Patients rely on digital resources 2.2x more than provider referrals when choosing a healthcare provider.
Referral leakage: 84% would not see a referred provider if they were rated under 4 stars.
The rise of virtual health: Over 1/3 of patients have used telehealth in the past year—a 337.6% increase since 2019.
Patient as customer: Assuming quality care, patients rate “customer service” (70.8%) and “communication” (63.4%) as more important than even “bedside manner” when it comes to a 5-star experience.
Shopping for healthcare: On average, consumers use three different websites during their healthcare research process and read 51⁄2 reviews before making a decision.”

CMS to roll out 'birthing-friendly' hospital tag on Care Compare site: “The Biden administration wants to add a ‘birthing-friendly’ designation to facilities on the Centers for Medicare & Medicaid Services’ (CMS') Care Compare website.
The designation, announced Tuesday as part of a larger call to action from the White House to address maternal care, would apply to hospitals that provide perinatal care and participate in a maternity care quality improvement collaborative.
CMS is also encouraging states to take advantage of an option in the American Rescue Plan Act to provide a year of postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program.”

About Covid-19

Booster doses of Pfizer-BioNTech vaccine will be critical against omicron, companies’ study suggests: “The early data, which is not yet peer reviewed or published, suggests that two shots may not be sufficient to prevent infection from omicron and echoes a finding published Tuesday afternoonby leading scientists in South Africa.
Both studies suggest that higher levels of antibodies — whether triggered by a booster shot or a previous infection in addition to vaccination — may restore protection.”

If you are looking for reasons why we have not controlled the Covid-19 pandemic, the two articles below should help clarify the problem:
Losing your job because of vaccine mandates? You can collect unemployment benefits in these states: “At least three red states -- Iowa, Tennessee and Florida -- have recently passed laws extending eligibility to these folks as part of broader measures restricting employer vaccine mandates.
Kansas' GOP-led legislature approved a similar bill that Gov. Laura Kelly, a Democrat, recently signed. And in Arkansas, which is controlled by Republicans, a law curtailing vaccine mandates will take effect in January.
Other states, including Wyoming and Wisconsin, have looked into such provisions, and more are expected to consider similar legislation when lawmakers return to their capitols in January.”

Half of Americans Back Biden’s Vaccine-or-Test Mandate for Private Sector, WSJ Poll Finds: “Fifty percent of voters said they support Mr. Biden’s vaccine requirements for the private sector, which direct companies with 100 or more employees to require workers to either get vaccinated or tested weekly, while 47% oppose them. A slightly larger share of voters support state and local vaccine mandates for public safety workers, such as police officers, firefighters and first responders, with 55% in favor and 44% opposed.
Voters were also divided on whether the Covid-19 vaccine should be mandatory for school-aged children, with more people in favor of requiring vaccines for older children. Fifty-one percent of respondents said they would support schools requiring that children 12 and older get vaccinated, while 45% said they were opposed to the idea. Voters were evenly split, 48%-48%, on whether schools should mandate vaccines for children ages 5 to 11.”

6 states account for 60% of US COVID-19 hospitalizations: “Michigan, Ohio, Indiana, Pennsylvania, New York and Illinois are mostly driving this increase. These states make up 35 percent of the population among states with increasing hospitalizations, but comprise 60 percent of new hospital beds filled between Nov. 10 and Dec. 5, according to an NBC News analysis of HHS data.”

WHO Says ‘No’ to Convalescent Plasma for Nonsevere COVID-19: “A review of 16 different trials that included 16,236 COVID-19 patients with nonsevere, severe and critical COVID-19 infection found that the plasma did not improve survival or reduce the need for supplemental oxygen for nonsevere patients, a WHO panel found.”

About the public’s health

United Health Foundation report: U.S. deaths rose 17% between 2019 and 2020: “While overall U.S. deaths increased 17% from 2019 to 2020, people also reported a 13% increase in high health status during the same time.
The report examined more than 80 measures from 30 data sources, with the goal of illuminating the strengths and pitfalls of this country’s health. It offers a look into disparities by age, gender, race, ethnicity, geography, education and income level. The report is available at AmericasHealthRankings.org, as is an interactive breakdown of the data.”
The report also has rankings of states. Colorado is the healthiest, West Virginia the least healthy.

About health insurance

House passes bill that delays 6% in Medicare cuts, postpones radiation oncology model: “The House passed by a vote of 222 to 212 a bill that delays 6% in Medicare cuts set to go into effect Jan. 1 and reduce most of a 3.75% cut to physicians, handing providers a major win they have been fervently lobbying Congress for.”
The action was a delay that still needs to clear the Senate. Read the article for more details.

UnitedHealthcare Must Pay TeamHealth $62 Million For Shortchanging Clinicians, Jury Says: “UnitedHealthcare must pay $62.65 million in total damages for shortchanging TeamHealth clinicians, a Las Vegas jury decided Tuesday.
The jury unanimously found the nation’s largest insurer guilty of fraud and unjust enrichment, saying it had formed and violated an implied contract with TeamHealth and engaged in unjust and oppressive claims practices. The private equity-backed provider group initially demanded $100 million in punitive damages when it alleged the insurer reimbursed clinicians at unlawfully low rates. The jury awarded the plaintiff $60 million. With the $2.65 million TeamHealth won in compensatory damages last week, UnitedHealthcare’s total obligation reached $62.65 million. UnitedHealthcare will reportedly appeal the ruling.”

About pharma

Vyera Pharmaceuticals to pay $40M in price-gouging settlement: “As part of a drug-pricing inflation settlement, Vyera Pharmaceuticals will pay $40 million in relief to victims affected by its price-gouging scheme involving the lifesaving drug Daraprim, the Federal Trade Commission announced Dec. 7. 
The FTC and seven state co-plaintiffs filed the Dec. 7 court order after a January 2020 complaint alleging Vyera, former CEO Martin Shkreli and his associate Kevin Mulleady engaged in anticompetitive practices when they raised the price of the drug from $17.50 to $750 per tablet after acquiring it in 2015.”

About healthcare IT

Microsoft’s $19.7B Nuance buy hits a snag with EU antitrust probe: “The E.U.’s antitrust regulator began issuing the questionnaires after the companies submitted the acquisition for approval last month. It currently has until Dec. 21 to either officially widen the probe or give the all-clear.
Either way, the transaction is seemingly no longer on track to close by the end of the year, as Microsoft and Nuance initially planned when they announced their agreement in April.”

Amazon launches new elder care subscription service Alexa Together with emergency assistance, fall detection: “Amazon has officially launched Alexa Together, a subscription-based service helping caregivers provide remote support to elderly loved ones, the tech giant said Tuesday.
First announced in late September, the service uses Amazon’s range of Echo devices with new features like fall detection and 24/7 emergency assistance supporting the health and wellbeing of older users.
Family members can choose to receive notifications through the Alexa app when their loved one uses their device for the first time each day and will be contacted along with emergency services if the user calls for help.”

Today's News and Commentary

About health insurance

Latest Findings Indicate Payment Incentive for Providing Primary Care in the Home Has Not Had Desired Impacts: “The Independence at Home (IAH) Demonstration tests whether implementing a payment incentive and delivering home based primary care leads to reductions in overall spending and improvements in quality of care for chronically ill and disabled Medicare beneficiaries. Mathematica’s evaluation of the first six years of IAH provided no compelling evidence that the IAH payment incentive reduced Medicare spending or hospital use for high-need patients of practices participating in the demonstration. When examining dually eligible beneficiaries who received home-based primary care from any provider, Mathematica’s analysis found lower expenditures on institutional care and higher expenditures on home-based services—but no reduction in total Medicare or Medicaid spending.”

Provider groups urge feds to change dispute process, good faith estimates in surprise billing rule: “The No Surprises Act calls for the creation of an independent arbitration process in case payers and providers cannot come to terms on an out-of-network charge. Under the law, a third-party arbiter chooses between amounts offered by the payer and provider.
But providers claim that the Biden administration gravely misconstrues congressional intent in how the arbiter should choose which offer. They point to language in the rule that calls for the arbiter to primarily consider which amount is closest to the ‘qualifying payment amount’ that is the insurer’s median in-network rate for a specific region.”

Centene to pay Kansas $27.6M to settle drug overbilling allegations: “Centene reached a $27.6 million agreement with Kansas to settle allegations it overcharged the state for drugs, Kansas Attorney General Derek Schmidt said Dec. 6 in a news release.
Kansas began its investigation into Centene in 2019, after a similar effort in Ohio revealed pharmacy benefit managers were overbilling states. Kansas' investigation concluded that Centene artificially inflated dispensing fee amounts reported to state regulators and failed to report discounts it received from CVS-Caremark on certain retail pharmacy claims.”

CVS Health Contributes $9.2M to Address SDOH, Homelessness in DC: “The payer’s contributions will go toward building a 41-unit housing development in DC that aims to reduce homelessness and increase access to affordable housing.”

Underinsurance Among Children in the United States: “From 2016 to 2019, the proportion of US children experiencing underinsurance rose from 30.6% to 34.0% (+3.4%; 95% CI, +1.9% to +4.9%), an additional 2.4 million children. This trend was driven by rising insurance inadequacy (24.8% to 27.9% [+3.1%; 95% CI, +1.7% to +4.5%]), which was mainly experienced as unreasonable out-of-pocket medical expenses. Although the estimate of children lacking continuous insurance coverage rose from 8.1% to 8.7% (+0.6%), it was not significant at the 95% CI (−0.5% to +1.7%). We observed significant growth in underinsurance among White and multiracial children, children living in households with income ≥200% of the federal poverty limit, and those with private health insurance. Increased child health complexity and private insurance were significantly associated with experiencing underinsurance (adjusted odds ratio, 1.9 and 3.5, respectively).”

About Covid-19

Real-time alerting system for COVID-19 and other stress events using wearable data: “…analysis of smartwatch signals by an online detection algorithm provides advance warning of SARS-CoV-2 infection in a high percentage of cases. This study shows that a real-time alerting system can be used for early detection of infection and other stressors and employed on an open-source platform that is scalable to millions of users.”

Rise in Blood Pressure Observed Among US Adults During the COVID-19 Pandemic: “… annual BP increase was significantly higher in April to December 2020 than 2019 (P<0.0001 for systolic and diastolic BP). During the pandemic period, mean changes each month, compared with the previous year, ranged from 1.10 to 2.50 mmHg for systolic BP and 0.14 to 0.53 mmHg for diastolic BP; systolic and diastolic BP increases held true for men and women and across age groups; larger increases were seen in women for both systolic and diastolic BP, in older participants for systolic BP, and in younger participants for diastolic BP (all P<0.0001)…
Weight gain was not the apparent reason for the observed rise in BP during the pandemic…”

Gen Z most stressed by coronavirus, citing pandemic toll on careers, education and relationships, poll says: “Higher proportions of Americans between ages 13 and 24 say the pandemic has made their education, career goals and social lives more difficult, compared with millennials and Gen X.”

About pharma

Biden points to drug prices in call for Senate social spending vote: “Lowering drug prices is one of the most popular parts of Biden's sweeping climate and social spending measure, and Democrats are looking to tout the changes and hammer Republicans for opposing them. A Kaiser Family Foundation poll found that 83 percent of the public supports allowing the government to lower drug prices.”

The unraveling of Walgreens Boots Alliance: “Walgreens Boots Alliance is reportedly exploring the sale of its Boots pharmacy so that the Deerfield-based company can focus on plans to transform its U.S. stores into health care destinations…
Sky News, which first reported the potential deal, said the company could also spin off the chain into a separately listed company.
Analysts agree that offloading Boots makes sense for Walgreens. The company already sold the majority of distributor Alliance Healthcare to AmerisourceBergen earlier this year for $6.5 billion, including cash and stock.”

About hospitals and health systems

Nearly All States Have At Least 70% Of Hospital And ICU Beds Occupied: “Nearly all U.S. states have at least 70% of their hospital and intensive care unit beds occupied and could face hospital constraints if coronavirus cases continue to surge amid the spread of the delta variant and new omicron variant.
There are 611,917 (78.7%) hospital beds and 65,226 (79.3.%) intensive care units occupied in the U.S., with Covid-19 patients occupying 59,579 (7.75%) of hospital beds and 13,736 (17.53%) of ICU beds, according to the Department of Health and Human Services.”

Top Hospitals: From the Leapfrog Group. Note the absence of some of the top rated hospitals, e.g., Cleveland and Mayo Clinics, Children’s Hospital of Pennsylvania, etc.

Supreme Court won't hear antitrust suit against Atrium Health: “The justices won't review a March decision from the U.S. Court of Appeals for the 4th Circuit, which rejected a proposed class-action lawsuit that argued Atrium exploited its market dominance to prohibit insurers from directing patients toward lower-cost care options.”

About healthcare IT

Medicare Beneficiaries’ Use of Telehealth in 2020: Trends by Beneficiary Characteristics and Location: From CMS:
”KEY POINTS

• The number of Medicare fee-for-service (FFS) beneficiary telehealth visits increased 63-fold in 2020, from approximately 840,000 in 2019 to nearly 52.7 million in 2020.

• Despite the increase in telehealth visits during the pandemic, total utilization of all Medicare FFS Part B clinician visits declined about 11% in 2020 compared to levels in 2019.

• Most beneficiaries (92%) received telehealth visits from their homes, which was not permissible in Medicare prior to the pandemic.

• Prior to the pandemic, telehealth made up less than 1% of visits across all visit specialties but increased substantially in 2020. Telehealth increased to 8% of primary care visits, while specialty care had smallest shift towards telehealth (3% of specialist visits).

• Visits to behavioral health specialists showed the largest increase in telehealth in 2020. Telehealth comprised a third of total visits to behavioral health specialists. While data limitations preclude clear identification of audio-only telehealth services, up to 70% of these telehealth visits during 2020 were potentially reimbursable for audio-only services.

• Black and rural beneficiaries had lower use of telehealth compared with White and urban beneficiaries, respectively. Telehealth use varied by state, with higher use in the Northeast and West, and lower in the Midwest and South.”

Ascension, Johns Hopkins & 14 others launch campaign to protect telehealth access: “Sixteen leading healthcare organizations have partnered to launch Telehealth Access for America, a public education campaign to defend telehealth access.
The campaign, launched Dec. 2, is urging Congress to protect access to telehealth, arguing such services lead to better health outcomes, greater equity, more patient choice and lower costs.
The 16 members are: Adventist Health Policy Association, Alliance for Connected Care, AARP, American Heart Association, American Hospital Association, American Telemedicine Association, Ascension, Athenahealth, Consumer Technology Association, Executives for Health Innovation, Health Innovation Alliance, Healthcare Leadership Council, Included Health, Johns Hopkins Medicine, Partnership to Advance Virtual Care, and Teladoc Health.”
In a related article: Top 25 telehealth hospitals ranked by visit claims: “University of Michigan Hospitals and Health Centers in Ann Arbor topped the list of hospitals providing the most telehealth visits billed to Medicare during the first quarter of 2021, according to a Dec. 6 analysis from Hospital Pricing Specialists.”

About health care professionals

Female Physicians Earn An Estimated $2 Million Less Than Male Physicians Over A Simulated 40-Year Career: “Differences in income between male and female academic physicians are well known, but differences for community physicians and career differences in income have not been quantified. We used earnings data from 80,342 full-time US physicians to estimate career differences in income between men and women. The differences in annual income between male and female physicians that we observed in our simulations increased most rapidly during the initial years of practice. Over the course of a simulated forty-year career, male physicians earned an average adjusted gross income of $8,307,327 compared with an average of $6,263,446 for female physicians—an absolute adjusted difference of $2,043,881 and relative difference of 24.6 percent. Gender differences in career earnings were largest for surgical specialists ($2.5 million difference), followed by nonsurgical specialists ($1.6 million difference) and primary care physicians ($0.9 million difference). These findings imply that over the course of a career, female US physicians were estimated to earn, on average, more than $2 million less than male US physicians after adjustment for factors that may otherwise explain observed differences in income, such as hours worked, clinical revenue, practice type, and specialty.”

Today's News and Commentary

About Covid-19

Omicron may be less severe than delta, early reports suggest: “New data from South Africa suggests the omicron COVID-19 variant may cause less severe infections than delta, though more research is needed to confirm this finding.”

CMS suspends enforcement of COVID-19 vaccination mandate: “CMS has suspended implementation and enforcement of its COVID-19 vaccination mandate for healthcare workers pending developments in litigation, the agency said in a Dec. 2 memorandum.”

FDA authorizes Lilly antibody treatment for use in children, including newborns: “The treatment is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together through intravenous infusion. It was previously authorized for pediatric patients 12 years of age and older weighing at least 88 pounds.
The treatment is now authorized for all pediatric patients who have a positive COVID-19 test or who have been exposed to someone with COVID-19, who are at high risk for progression to severe COVID-19, including hospitalization or death. 

The US is averaging more than 100,000 new Covid-19 cases a day, the highest level in two months: “For the first time in two months, the US is averaging more than 100,000 new Covid-19 cases each day, shortly after millions of Americans traveled for the Thanksgiving holiday. 
The seven-day moving average of new cases was 121,437 as of Saturday, according to data from Johns Hopkins University (JHU). Prior to this week, the US last topped the 100,000-cases-a-day mark in early October.
Also on the rise is the number of Covid-19 deaths, with a seven-day average of 1,651 people dying from the virus each day as of Saturday, the JHU data showed. Average daily deaths haven't been this high in more than a month.”

Coronavirus vaccine demand grows in U.S. amid omicron variant concerns, booster eligibility expansion: “Health-care providers administered 2.18 million doses of coronavirus vaccines on Thursday, according to the Centers for Disease Control and Prevention — the ‘highest single-day total since May,’ the White House said. According to the latest CDC report, over the week ending on Thursday, the average number of daily administered vaccine doses reported to the agency was 22 percent higher than the previous week…
The increased demand for coronavirus vaccines is largely driven by demand for booster doses, CDC data shows.”

It Would Cost $50 Billion to Vaccinate the World, OECD Says: “That’s the amount needed to vaccinate the world, a measure that’s key to ending the pandemic and tackling the imbalances ‘plaguing the recovery,’ according to OECD Chief Economist Laurence Boone. 
‘When you balance things out, $10 trillion for supporting the economy going through the pandemic compared with a tiny $50 billion to bring the vaccine to the entire world population, that looks completely disproportionate,’ she told Bloomberg Television in an interview Wednesday. The first number is the amount spent by Group of 20 countries to mitigating the economic impact of Covid-19.”

New York City Announces Vaccine Mandate for Private Employers: “Mr. de Blasio said the aggressive measure, which takes effect Dec. 27 and which he described as the first of its kind in the nation, was needed as a ‘pre-emptive strike’ to stall another wave of coronavirus cases and help reduce transmission during the winter months and holiday gatherings.”

Novavax to Develop Omicron-Specific COVID-19 Shot: “Novavax is throwing two punches at Omicron, the new COVID-19 variant that’s sparking fresh waves of travel restrictions: evaluating how well its lead COVID-19 vaccine candidate NVX-CoV2373 targets the new variant and creating a new vaccine made specifically to target the highly mutated virus….
The current vaccine (known as Covavax outside the U.S.), which is yet to be authorized in the U.S…”

U.S. to not reimburse private health insurers for covering at-home COVID test costs: “‘The Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security Act require coverage of diagnostic testing for COVID-19 without any cost-sharing requirements during the public health emergency,’ the White House official said.
’The Departments of Health and Human Services, Labor and the Treasury will clarify that coverage of over-the-counter COVID-19 tests is generally subject to those provisions,’ the official added.”

Pfizer accused of funding anti-AstraZeneca information: “US drugmaker Pfizer, the world’s dominant Covid vaccine maker, has been accused of funding educational presentations that said its UK rival AstraZeneca was ineffective and even dangerous for some members of the population.”

About pharma

Express Scripts launches new prescription discount card solution: “Through the new Right Price offering, a member who is eligible for savings through a discount card will automatically see those savings applied at the pharmacy counter. Matt Perlberg, senior vice president of supply chain at Express Scripts, told Fierce Healthcare that the pharmacy benefit manager most often sees these discounts come into play for members who have yet to meet their deductible.
For about 2% of claims, members who are purchasing generic drugs but have not yet met the deductible may find these coupon cards lead to a lower price than their drug benefits, Perlberg said.”

Drug prices slashed over 60% on average to get on China's bulk-buying list: What happens when a country uses its purchasing power to buy pharmaceuticals?
“Chinese authorities said Friday that the National Reimbursement Drug List (NRDL) has been updated, with pharmaceutical firms agreeing to cut prices by an average of 62% for 67 branded medicines that have no generic equivalents in the country. Meanwhile, seven drugs that do have generic versions were also included, for a total of 74 additions to the centralised procurement scheme this time around, while 11 medicines of low clinical value were removed, according to the National Healthcare Security Administration (NHSA).
The latest average discount marks a record for the bulk-buying programme, which negotiated average cuts of 61% for 70 drugs in 2019, and of 51% on 119 drugs in 2020. For the 2021 edition, new listings include Eli Lilly's psoriasis treatment Taltz (ixekizumab) and Johnson & Johnson's multiple myeloma drug Darzalex (daratumumab), the latter of which saw its annual cost reduced from CNY1 million ($157,000) to under CNY300,000 ($47,000) per year under the scheme.”

Understanding the Evolving Business Models and Revenue of Pharmacy Benefit Managers:
“KEY FINDINGS:

• Overall, gross profit (defined as revenue minus the cost of goods sold) increased by 12%, from $25 billion in 2017 to $28 billion in 2019.

• Between 2017 and 2019, PBMs adapted their business model to rely more on revenue collected through fees assessed on manufacturers and payers and gross profit on prescriptions filled through affiliated mail order and specialty pharmacies, while shifting away from a dependence on retained rebates.”

An important caveat to the above research: “It is notable that available financial data proved insufficient to fully describe the source of nearly 40% of PBMs’ total gross profit. Exploration of all publicly available data, an extensive review of the literature and our survey of industry insiders cast little light
onto specific gross profit derived from a variety of PBM business practices that include, but may not
be limited to, spread pricing, pharmacy fees and clawbacks, fees collected from payers, and other non-administrative fees collected from manufacturers.” [Emphasis in the original.]

BD finalizes name and leadership for its billion-dollar diabetes spinoff: “BD has settled on a new name for its new company, the independent spinout that will house its billion-dollar diabetes care business. 
Embecta is set to launch as its own, publicly traded brand in the second quarter of 2022 after almost a century of supplying a portfolio of insulin pens and syringes under the BD banner. The diabetes division contributed about 6% of the company’s revenues in the 2020 fiscal year, or nearly $1.1 billion, by serving about 30 million users worldwide.”

About the public’s health

Immune system-stimulating nanoparticle could lead to more powerful vaccines: “Researchers from MIT, the La Jolla Institute for Immunology, and other institutions have now designed a new nanoparticle adjuvant that may be more potent than others now in use. Studies in mice showed that it significantly improved antibody production following vaccination against HIV, diphtheria, and influenza…
The researchers now hope to incorporate the adjuvant into an HIV vaccine that is currently being tested in clinical trials, in hopes of improving its performance.”

Association of Prenatal Care Services, Maternal Morbidity, and Perinatal Mortality With the Advanced Maternal Age Cutoff of 35 Years: “In this cross-sectional study, the AMA [advanced maternal age] designation at age 35 years was associated with an increase in receipt of prenatal monitoring and a small decrease in perinatal mortality, suggesting that the AMA designation may be associated with clinical decision-making, with individuals just older than 35 years receiving more prenatal monitoring. These results suggest that increases in prenatal care services stemming from the AMA designation may have important benefits for fetal and infant survival for patients in this age range.”

About health insurance

CMS Provides Guidance on Good Faith Estimates for No Surprises Act: “CMS has released 11 documents to help providers comply with the No Surprises Act’s requirement that providers give patients a ‘good faith estimate’ of expected charges.
The No Surprises Act was passed as part of the Consolidated Appropriations Act, 2021. The Act will prohibit surprise medical billing in most healthcare situations starting Jan. 1, 2022. As part of No Surprises Act compliance, providers and facilities will need to be able to inform patients, both orally and in writing, of a cost estimate if they are not enrolled in a plan or are covered by a federal healthcare program, or who are not seeking to file a claim with their insurance for care. This ‘good faith estimate,’ as the Act calls it, must be given upon request or at the time of scheduling.
Included in the documents released by CMS is a template for providers and healthcare facilities to use to deliver good faith estimates under the No Surprises Act.“

An Analysis of Medicare Accountable Care Organization Expense Reports: The objective of the study was to ” understand the investments that Medicare Shared Savings Program accountable care organizations (ACOs) in the ACO Investment Model (AIM) made to participate in the program and the costs that they incurred as a result of their efforts to lower spending and improve quality…
AIM ACOs reported expenses of $264.8 million over the 3 performance years (2016-2018). The majority of the $264.8 million in expenditures was incurred for personnel (55.5%), followed by infrastructure (22.3%), management firm expenses (15.3%), and internal programs and systems (6.9%). The dominant identifiable ACO strategy was care coordination and management, accounting for 52.9% of related ACO expenses…
Efforts to change clinician practice patterns, alter the way patients access the health care system, and institute other practice redesigns were not primary targets for investment.”

The Medicare Advantage Quality Bonus Program Has Not Improved Plan Quality: “In 2012 Medicare introduced the quality bonus program, linking financial bonuses to commercial insurers’ quality performance in Medicare Advantage (MA). Despite large investments in the program, evidence of its effectiveness is limited…
We observed no consistent differential improvement in quality for MA versus commercial enrollees under the quality bonus program. Program participation was associated with significant quality improvements among MA beneficiaries on four measures, significant declines on four other measures, and no significant change in overall quality performance (+0.6 percentage points). Together, these results suggest that the quality bonus program did not produce the intended improvement in overall quality performance of MA plans.”

About hospitals and health systems

Physician Compensation In Physician-Owned And Hospital-Owned Practices: “Among physician practices overall, vertical integration with hospitals or health systems was associated with, on average, 0.8 percent lower income compared with independent physicians after multivariable adjustment. In analyses by physician specialty, vertical integration of physician practices with hospitals or health systems was associated with lower income for nonsurgical specialists, no difference in income for primary care physicians, and slightly higher income for surgical specialists. Although vertical integration of physician practices is a rapidly growing trend, physicians might not directly benefit financially.”

Trinity Health's operating income doubles: “Trinity Health reported higher revenue and operating income in the three months ending Sept. 30 than in the same period a year earlier, according to financial documents released Dec. 3….
Trinity also reported higher expenses…
After factoring in investments and other nonoperating items totaling $164.87 million, Trinity posted a net income of $378.83 million in the first quarter of fiscal year 2022, down from $771.87 million a year earlier.”

Today's News and Commentary

About Covid-19

Early data shows past infection does not ward off Omicron, but vaccines effective: “People infected with earlier variants of COVID do not appear to be protected against Omicron, although vaccination does prevent serious illness, a top South African scientist said on Thursday.
‘We believe that previous infection does not provide protection from Omicron,’ said Anne von Gottberg, an expert at the National Institute for Communicable Diseases.
Outlining early research into the newly emerged variant, she said doctors were seeing ‘an increase for Omicron reinfections.’”

Immunogenicity of Extended mRNA SARS-CoV-2 Vaccine Dosing Intervals: “Longer mRNA vaccine dosing intervals demonstrated improved immunogenicity, which was consistent when responses were measured based on timing of the first or second dose. These data suggest that extending dosing intervals may be particularly advantageous against the Delta variant.”

FDA asks for 55 years to complete FOIA request on Pfizer's COVID-19 vaccine: “Hungry for details on Pfizer's COVID-19 vaccine? Just file a Freedom of Information Act (FOIA) request and wait until the U.S. tricentennial in 2076. That's the schedule the FDA proposed in documents filed in a U.S. District Court this week.
According to the documents filed in a U.S. District Court for the Northern District of Texas, the FDA asked a federal judge for 55 years to complete a FOIA request for data and information on the approval of Pfizer-BioNTech's COVID-19 vaccine, Comirnaty.”

Biden seeks to require private health plans to pay for at-home Covid tests: “However, the requirement will not take effect immediately. Three federal departments — Health and Human Services, Labor and the Treasury — must still issue official guidance on the reimbursement requirement, language that may not be published until Jan. 15.
The forthcoming policy change will also not be retroactive, meaning people will not be able to obtain reimbursement for at-home tests they already purchased, the senior administration official said. It is also unclear if limitations will be placed on the number of at-home tests individuals can submit for reimbursement.”
Insurance companies are worried that such a policy will result in price gouging, which has occurred in the past. Eventually, such behavior will cause increased premiums- no such thing as a free lunch.

Biden pledges to fight new variant ‘with science and speed,’ as omicron cases multiply and winter outlook worsens: Reinforcing yesterday’s report on the summary of measures the federal government is proposing.
The article has videos of Biden and Fauci. “The president’s plan includes campaigns to increase vaccinations and booster shots, more stringent testing for international travelers and plans to make rapid at-home coronavirus testing free for more people. While some of the measures are new — notably a plan to launch ‘family mobile vaccination clinics,’ where all eligible members of a family could simultaneously get shots and boosters — others build on existing tactics, such as rallying businesses to impose vaccination-or-testing mandates for employees.”

Omicron COVID-19 variant found in five U.S. states: “New York has confirmed five cases of the Omicron coronavirus variant, its governor said on Thursday, bringing to five the number of U.S. states having detected the variant, with 10 reported infections nationwide.
California, Colorado and Minnesota have found cases of the coronavirus variant among patients who were fully vaccinated and developed mild symptoms, while Hawaii reported a case with an unvaccinated person, who had moderate symptoms.”

Walmart extends COVID leave policy, brings back vaccination incentives: “Walmart, the nation’s largest retailer, is responding to the threat of the new Omicron variant of COVID-19 by extending its COVID leave policy for associates through March 31, 2022, as well as reintroducing its vaccine incentive for frontline associates to provide $150 after an associate becomes fully vaccinated.
The COVID leave policy, which was implemented in March 2020 during the initial surge of the pandemic, provides up to two weeks of paid time off if an associate contracts COVID-19, if a facility is part of a mandated quarantine or if an associate is required to quarantine by a health care provider, government agency or Walmart.”

About pharma

In the Years before the COVID-19 Pandemic, Nearly 13 Million Adults Delayed or Did Not Get Needed Prescription Drugs Because of Costs: From the Urban Institute:
”In this brief, we explore prescription drug affordability challenges using pooled 2018 and 2019 data from the Medical Expenditure Panel Survey. We primarily focus on the extent to which elderly adults ages 65 and older with Medicare and nonelderly adults ages 19 to 64 with year-round private insurance delay or forgo needed prescription drugs because of the cost and their out-of-pocket spending burdens. We find the following:

• Nearly 13 million adults delayed or did not get needed prescription drugs in the past year because of the cost, including 2.3 million elderly Medicare beneficiaries and 3.8 million nonelderly adults with private insurance, 1.1 million with Medicaid, and 4.1 million who were uninsured at any point during the year.

• About 1 in 10 adults who were uninsured all year (9.5 percent) or part of the year (11.6 percent) reported unmet prescription drug needs, compared with 4.9 percent of Medicare beneficiaries, 3.0 percent of privately insured adults, and 5.6 percent of adults with Medicaid.

• For both Medicare beneficiaries and privately insured adults, unmet prescription drug needs were most common among women, people with low incomes, and people with multiple chronic health conditions. Nearly all Medicare beneficiaries and more than 8 in 10 privately insured adults with unmet needs have been diagnosed with a chronic condition such as high blood pressure, high cholesterol, stroke, diabetes, arthritis, and respiratory illnesses.

• More than one-quarter of adults with Medicare (25.4 percent) and 5.3 percent of privately insured adults spent more than 1 percent of their family incomes on their individual out-of-pocket prescription drug costs. More than 3 percent of Medicare beneficiaries—and nearly 7 percent of beneficiaries with unmet prescription drug needs—spent more than 10 percent of their family incomes on prescription drugs.”

PCMA pulls lawsuit over rebate disclosure rule after reaching deal with Biden admin: “The Pharmaceutical Care Management Association (PCMA) pulled its lawsuit, filed back in August in the U.S. District Court for the District of Columbia, after having engaged with the Biden administration on a resolution. The administration issued a final rule last month that still required PBMs to disclose rebate prices to the federal government but won't be released publicly.
The lawsuit centered on a rule passed near the end of the Trump administration that required PBMs to publicly post the rebate amounts they negotiate with drugmakers.”

Sanofi to Progress 10 New Candidates in Vaccine Pipeline: “Six of those candidates will leverage the mRNA Center of Excellence that the company established in June, into which it pledged to pump $500 million a year…
A giant in the vaccine industry that hasn’t yet had success in the COVID-19 space, the company said sustained growth will be driven by its four core franchises: influenza, meningitis, PPH3 and boosters, as well as the planned launch of nirsevimab, a first-in-class monoclonal antibody for all infant protection against respiratory syncytial virus (RSV).

About the public’s health

Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial: “Financial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.”
The success of using financial incentives to motivate behavior is situationally dependent— which is why these specific studies need to be performed.

HHS seeks comment on efforts to improve organ transplant equity, dialysis care: “The U.S. Department of Health and Human Services, through the Centers for Medicare and Medicaid Services, is soliciting public feedback on potential changes to rulemaking it's considering to improve both the organ transplantation system and dialysis care -- part of a broader effort to introduce more equity into the healthcare system.
The formal Request for Information issued by the agency stems from a Biden Administration goal of improving health outcomes for the roughly 106,000 people who are living with organ failure and are awaiting a transplant.”

FDA approves trivalent hepatitis B vaccine for adults: “According to VBI Vaccines, PreHevbrio contains the S, pre-S2 and pre-S1 HBV surface antigens and is the only approved three-antigen HBV vaccine for adults…
The approval of PreHevbrio was based on the results of two phase 3 studies that compared the vaccine with a monovalent HBV vaccine. Adults aged 18 years and older who received PreHevbrio elicited higher rates of seroprotection (91.4% vs. 76.5%). This included adults aged 45 years and older (89.4% vs. 73.1%).
PreHevbrio is expected to be available in the U.S. in the first quarter of 2022, VBI Vaccines said.”

About healthcare IT

Assessment of Patient Preferences for Telehealth in Post–COVID-19 Pandemic Health Care: “In this survey study of 2080 adults, most respondents were willing to use video visits in the future but, when presented with the choice between an in-person or a video visit for nonemergency care, most preferred in-person care. Willingness to pay for preferred visit modality was higher for those who preferred in-person care, and those who preferred video visits were more sensitive to out-of-pocket cost.”

Google rolls out new search tools for health information on Medicare services, languages spoken by providers: “Announced Thursday in a blog post by Hema Budaraju, director of Google Search's social impact division, the additions make it easier for patients to seek out doctors near them that fulfill their individual needs, addressing questions like whether a provider accepts Medicare or what languages that provider speaks.”

The Digital Experience is the Key Driver of Growth and Patient Retention, According to Press Ganey’s 2021 Consumer Report: From a Press Ganey survey:

• “All generations are increasingly shopping online for healthcare. 44% of baby boomers and 60% of millennials and Gen Z prefer researching healthcare providers on their smartphone or tablet, representing a 27% and 13% increase from 2019, respectively.

• Digital drives patient choice. In fact, they rely on digital resources more than twice as much as provider referrals when choosing a healthcare provider. [Emphasis added]On average, consumers use three different websites during their healthcare research process and five reviews before making a decision.

• Search engines are just the start. Among the top five websites used, consumers rely on a brand’s website, WebMD, Healthgrades and Facebook the most to research a provider.

• Online reviews prevent referral leakage. 83% of patients go online to read reviews about a provider after they receive a referral. 84% would not see their referred provider if they had less than a four-star rating.

• Customer service is the new bedside manner. Assuming quality care is received, patients rate “customer service” (71%) and “communication” (64%) as more important than even “bedside manner” when it comes to rating a five-star experience.

• Telehealth isn’t going anywhere anytime soon. More than one-third of patients have used telehealth in the past year—a 38% increase since 2019—and usage surged among baby boomers during the same period.

About health insurance

Providers slam House for not delaying nearly 10% Medicare payment cuts in must-pass spending deal: “Major provider groups were livid that a continuing resolution to fund the federal government also doesn’t stave off nearly 10% in cuts to Medicare payments set to go into effect on Jan. 1.
The Federation of American Hospitals and American Medical Association were upset that legislative language to fund the government through Feb. 18 does not delay cuts from several sources including the Sequester and PAYGO law. Other providers have been lobbying Congress fervently on the cuts.”

Unum: Workers to pay more attention during open enrollment this year:

• “Two-thirds of workers surveyed by employee benefits provider Unum said they plan to pay more attention and spend more time reviewing their choices during open enrollment this year. Unum polled 1,500 full-time U.S. workers in August.

• Fifty-seven percent of respondents said they will enroll in benefits they did not have last year. The uptick may be due to greater awareness; two-thirds of workers said they are more interested or aware of the choices their employers provide.

• Concern over finances and mental health will drive workers' choices, Unum's findings indicated.”

About hospitals and health systems

State-by-state breakdown of 73 hospital closures: About 60 million people — nearly 1 in 5 Americans — live in rural areas and depend on their local hospitals for care. More than 70 of those hospitals have ended all services since 2011, according to the Cecil G. Sheps Center for Health Services Research.”

Texas hospital will pay $18.2M to settle false claims case: “The settlement resolves allegations that Flower Mound Hospital, a partially physician-owned facility, violated the Anti-Kickback Statute and Stark Law when it repurchased shares from physician-owners aged 63 or older and then resold those shares to younger physicians. Prosecutors allege that hospital leaders took into account the volume or value of physicians' referrals when selecting which physicians to resell the shares to and determining the number of shares each physician would receive.”

About medical devices

Device Recalls Soar in Recent Months: “Medical device recalls increased by more than 35 percent to 235 incidents in the third quarter of 2021, up from just 173 in the second quarter, reversing a year-long trend of declining numbers, a new analysis suggests.” See this FDA website for specific products.

Today's News and Commentary

About Covid-19

Survey: Many employers rolling out vaccine mandates despite ongoing legal challenges: “Willis Towers Watson surveyed nearly 550 employers in mid-November and found that 57% either currently require workers to be vaccinated or are planning to roll out such requirements. Eighteen percent of those surveyed currently require employees to be vaccinated against COVID-19.
In addition, 32% said they were planning to roll out requirements if the Occupational Safety and Health Administration (OSHA) emergency standard takes effect. The remaining 7% said they plan to require vaccinations regardless of what happens to the OSHA standard.”

Myocardial Infarction, Stroke, and Pulmonary Embolism After BNT162b2 mRNA COVID-19 Vaccine in People Aged 75 Years or Older: “In this nationwide study involving persons aged 75 years or older in France, no increase in the incidence of acute myocardial infarction, stroke, and pulmonary embolism was detected 14 days following each BNT162b2 mRNA vaccine dose.”

The White House's plan to combat winter COVID-19 surges: 8 things to know: A good summary of the recent federal activities geared to pandemic control.

Moderna loses appeal in standoff over Arbutus vaccine patents: “Moderna could face a patent infringement lawsuit over its COVID-19 vaccine Spikevax after the US Court of Appeals for the Federal Circuit on Wednesday affirmed decisions by an administrative panel regarding patents that belong to Arbutus Biopharma. Specifically, the federal appeals court let stand findings by the Patent Trial and Appeals Board (PTAB) regarding two Arbutus patents dealing with liquid nanoparticle (LNP) technology, which can be used to deliver mRNA to cells.
The news sent Moderna stock sliding 9%, while shares in Arbutus jumped as much as 57%. The latter company was ‘heavily favoured’ to win the appeals, according to Jefferies analysts Kelechi Chikere and Michael Yee. In court filings, Moderna has indicated that Arbutus could bring a lawsuit demanding royalties from its COVID-19 vaccine if the patents are upheld. The company is expecting that Spikevax will generate a total of between $15 billion and $18 billion in 2021, and up to $22 billion next year.”

5 health systems suspending vaccination mandates: Includes Intermountain and HCA.

COVID-19 Still Widely Named as Biggest U.S. Health Problem: “In a Gallup poll conducted Nov. 1-16, 47% of U.S. adults named viruses as the country's top health problem, with the vast majority of these (45%) mentioning COVID-19 or the coronavirus, specifically. In November 2020, 69% saw viruses as the top threat, including 67% citing COVID-19.” Access was named by 11%. Quality was not mentioned.

GSK says early data suggest its Covid drug is effective against Omicron: “The UK drugmaker and its partner, Vir Biotechnology, said on Thursday that initial tests suggested their antibody treatment, called sotrovimab, was effective against Omicron’s mutations. The research has not been peer-reviewed and lab tests of sotrovimab are still to be completed but the UK health regulator on Thursday approved its use for high-risk patients. The companies said they would provide updated data by the end of this year.”

About pharma

CVS expands 'talking' prescription labels to all locations to support visually impaired patients: “CVS Pharmacy is expanding an in-app feature for visually impaired patients, which reads prescription information out loud, to all of its nearly 10,000 U.S. locations.
The solution, called Spoken Rx, was designed in collaboration with the American Council of the Blind. Patients enrolled in the program can scan the labels on their prescription containers and have their information, including the medication’s name and directions for use, read out loud to them in either English or Spanish.”

About healthcare IT

HHS launches website for healthcare cybersecurity resources: “HHS unveiled a website Dec. 1 for its 405(d) Aligning Health Care Industry Security Approaches Program that offers healthcare providers and public health officials cybersecurity and patient safety resources and best practices. 
The 405(d) program was established as a congressional mandate under the Cybersecurity Act of 2015; under section 405(d), HHS created the Cybersecurity Act Task Group to strengthen cybersecurity efforts within the healthcare and public health sectors.”

VA revises timeline for $16B Cerner EHR rollout, taps new project leaders: “The Department of Veterans Affairs is planning to pick up deployment of its $16 billion Cerner EHR system in early 2022 after the project was paused earlier this year because of inadequate training and safety concerns.”

Assessment of Patient Preferences for Telehealth in Post–COVID-19 Pandemic Health Care: “This survey study found that participants were generally willing to use video visits but preferred in-person care, and those who preferred video visits were more sensitive to paying out-of-pocket cost. These results suggest that understanding patient preferences will help identify telehealth’s role in future health care delivery.”

TransUnion acquires IT services company for $3.1B: “TransUnion finalized its acquisition of information services and tech company Neustar for $3.1 billion, the credit reporting agency said Dec. 1”

Telehealth take-up: the risks and opportunities: In this Kaspersky survey:
“Half (52%) of remote telehealth providers have experienced cases where patients, not trusting the technology, have refused to have a video call with staff – citing concerns about privacy and data safety. Clinicians have also voiced their own reservations, with eight in ten (81%) raising concerns over conducting remote telehealth sessions. These include concerns about how patient data will be used and shared from these sessions, as well as the security of data and any personal penalties that might arise in the case of a leakage from a remote consultation…
Worryingly, three in ten (34%) remote telehealth providers agree that one or more clinicians in their organization have made a wrong diagnosis because of poor video or photo quality.
When it comes to the safety afforded by operating system upgrades, seven in ten (73%) healthcare providers currently use medical equipment with a legacy OS. Reasons for this include the cost of upgrades being too high (37%), compatibility issues (29%), not having the internal knowledge on how to upgrade (17%), and other reasons (18%).”

About the public’s health

Rhythm Biosciences Gets CE Mark for Colorectal Cancer Test: “The immunoassay measures the presence of multiple protein biomarkers for colorectal cancer that were identified by Australia's Commonwealth Scientific and Industrial Research Organization.
Rhythm Biosciences says the simple blood test ‘has the potential to become the new first-step screening test’ for people who choose not to participate in the existing screening programs for colorectal cancer.”

Mumps in Vaccinated Children and Adolescents: 2007–2019: “Since 2007, one-third of US reported mumps cases occurred in children and adolescents, the majority of whom were vaccinated. Clinicians should suspect mumps in patients with parotitis or mumps complications, regardless of age, travel history, and vaccination status.”

HPV Vaccine Is Reducing Cervical Cancers in Teens, Young Women: “Since the vaccine went on the market, cervical cancer deaths have declined by 43% and cases by 38% in females between 15 and 24 years of age, researchers found.
By comparison, cervical cancer deaths actually increased on average about 4% in women between 25 and 29 and declined by about 5% in women in their 30s.
Cases fell by 16% for those between 25 and 29 and by 8% for those in their 30s.”

What abortion laws would look like if Roe v. Wade were overturned: An excellent overview of the headline’s subject.

About health insurance

Democrats’ Bill Would Go Far Toward ‘Patching the Holes’ in Health Coverage: A really good summary of the proposal by three of The NY Times’ top health reporters.