Today's News and Commentary

About Covid-19

 Highly immune evasive omicron XBB.1.5 variant is quickly becoming dominant in U.S. as it doubles weekly “KEY POINTS
The Covid omicron XBB.1.5 variant has nearly doubled in prevalence over the past week and now represents about 41% of new cases in the U.S., according to CDC data.
XBB.1.5 is highly immune evasive and appears to bind better to cells than other members of the XBB omicron subvariant family.
Scientists at Columbia University have warned that the rise of subvariants such as the XBB family could ‘result in a surge of breakthrough infections as well as re-infections.’”

About health insurance/insurers

CMS cracks down on Medicare Advantage TV marketing “CMS is cracking down on deceptive marketing practices and will no longer allow Medicare Advantage or Part D prescription drug plans to advertise on television without agency approval first.
The new policy is effective Jan. 1, 2023 and was discussed in an Oct. 19, 2022 memo from CMS to MA and Part D providers. The agency said it issued the new policy after reviewing thousands of beneficiary complaints regarding confusing, misleading or inaccurate information from plans — plan sponsors are also responsible for all marketing activities from brokers and third-party agencies….
To ensure compliance during the ongoing open enrollment period, CMS will review all marketing materials received during the period and target its oversight toward organizations with high rates of complaints. It will also monitor broker calls with potential enrollees and continue to ‘secret shop.’”

Medical bills heading to dispute resolution far more often than anticipated “Insurers and providers are overwhelming an arbitration system Congress set up to resolve billing disputes as part of the law to prevent surprise medical bills, according to CMS data
Federal agencies estimated there would be 17,333 claims a year submitted to the independent dispute resolution process.
But, CMS data shows, there were more than 90,000 disputes initiated in less than six months.
Determining which disputes are eligible for review is taking longer than anticipated as well, CMS officials said in the report.”

Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Cigna-HealthSpring of Tennessee, Inc. (Contract H4454) Submitted to CMS “With respect to the 10 high-risk groups covered by our audit, most of the selected diagnosis codes that Cigna submitted to CMS for use in CMS’s risk adjustment program did not comply with Federal requirements. For 195 of the 279 sampled enrollee-years, the medical records that Cigna provided did not support the diagnosis codes and resulted in $509,194 in overpayments.
As demonstrated by the errors found in our sample, Cigna’s policies and procedures to prevent, detect, and correct noncompliance with CMS’s program requirements, as mandated by Federal regulations, could be improved. On the basis of our sample results, we estimated that Cigna received at least
$5.9 million in overpayments for 2016 and 2017.”
This review is part of the OIG’s program to review appropriateness of coding for all MA plans. Read the article for proposed remedies.

About pharma

 Novartis pays $245M to settle Exforge generic pay-for-delay lawsuit “Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements.
The Swiss pharma will pay altogether $245 million in separate settlements with direct purchasers, indirect purchases and retailers who had accused the company of colluding with Endo’s Par Pharmaceutical to push back the launch of a generic version of Novartis’ high blood pressure med Exforge.”

Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021 “Manufacturers of brand-name inhalers listed many more secondary patents than primary patents with the FDA from 2000 to 2021 and earned substantially more revenue on inhalers after active ingredients went off patent compared with revenue generated when the primary patents remained active…
The current patent and regulatory system rewards minor changes to the delivery systems of existing molecules, diverting incentives for investments in new therapeutic breakthroughs.2 Regulators and lawmakers have begun to scrutinize patenting practices relating to drug-device combinations.5,6 Without substantial reform, patients and payers may continue spending large sums on inhaled products with active ingredients developed decades ago.”

96 drugs lost exclusivity in 2022 FYI

2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37 FYI

About healthcare personnel

 The US doesn’t have enough infectious disease doctors — and the situation is about to get worse.  “According to Association of American Medical Colleges data and a 2017 IDSA survey, ID doctors who care for patients make around $175,000 to $215,000 annually — which doesn’t go as far as you’d think given most US doctors’ are hundreds of thousands of dollars in educational debt. It’s also less than half of what some other specialties earn.”

Today's News and Commentary

To all readers,

Thanks so much for your interest this past year.
I wish you all the best for a happy and healthy New Year.

Joel

About health insurance/insurers

 Medical Debt Is Being Erased in Ohio and Illinois. Is Your Town Next?  “Cook County, Ill., and Toledo, Ohio, are turning to the American Rescue Plan to wipe out residents’ medical debt. Experts caution it is a short-term solution….
More local governments are likely to follow as county executives and city councils embrace a new strategy to address the high cost of health care. They are partnering with RIP Medical Debt, a nonprofit that aims to abolish medical debt by buying it from hospitals, health systems and collections agencies at a steep discount.”

About pharma

 Insulin costs will be capped in 2023, but most people with diabetes won't benefit The article highlights the fact that Republicans blocked price controls for insulin that will become for Medicare beneficiaries in the new year.

AmerisourceBergen Hit With Federal Lawsuit Over Opioid Crisis “The Justice Department has sued AmerisourceBergen Corp., alleging the large drug distributor contributed to the prescription opioid epidemic by failing to report suspicious orders to law enforcement.
Associate Attorney General Vanita Gupta said during a news conference Thursday that AmerisourceBergen could face billions of dollars in civil penalties if found liable in the lawsuit, filed in federal court in Philadelphia.”
For readers who are physicians, this article, published earlier this month, should be of interest:The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

About the public’s health

 A Study Sounds a False Alarm About America’s Emergency Rooms This Wall Street Journal Op-ed article critiques the methodology that AHRQ used to project that 250,000 deaths occurred per year due to ER errors.
See, also: No, ER misdiagnoses are not killing 250,000 per year 

Today's News and Commentary

About Covid-19

 Wisconsin Supreme Court to hear ivermectin treatment case “The Wisconsin Supreme Court will determine whether a court can compel a hospital to provide ivermectin as treatment for COVID-19. 
A Dec. 23 article published on the AMA website detailed a lawsuit filed against a Wisconsin hospital. After a patient was forced to be intubated, the patient's nephew tried to compel physicians to give his uncle ivermectin, a treatment experts say is ineffective against COVID-19. His uncle has since recovered and was released from the hospital…
Wisconsin law does not require physicians to provide treatment that medical evidence suggests will not benefit patients and may cause harm, the brief said. Ivermectin is not approved or recommended by the CDC or FDA for treating COVID-19, and the National Institutes of Health, World Health Organization and the drug's manufacturer, Merck, say there is insufficient evidence to support using ivermectin to treat COVID-19.”
My non-legal opinion is that the court will dismiss the case outright in favor of physician judgement and federal approval of treatments. On the other hand it may sidestep the issue and dismiss the case, saying that it is moot because the patient recovered and does not need currently require treatment.
Imagine the consequences if the court rules for the plaintiff…bring in the leaches!

About health insurance/insurers

Cost-Sharing Reform for Chronic Disease Treatments as a Strategy to Improve Health Care Equity and Value in the US  The authors make the point that out-of-pocket expenses are not likely to reduce demand, since those with chronic diseases need the treatments. Further, cost sharing can only hurt- contributing to lower compliance due to high expenses.

Performance of Physician Groups and Hospitals Participating in Bundled Payments Among Medicare Beneficiaries Findings  This cohort study with a difference-in-differences analysis found that physician group practices participating in bundled payments had associated savings with surgical but not medical episodes, whereas participating hospitals had savings associated with both episode types.
Meaning  The findings of this cohort study suggest that policy makers should consider the comparative performance of participant type when designing and evaluating future bundled payment models.”

Beneficiary Switching Between Traditional Medicare and Medicare Advantage Between 2016 and 2020 “While switching rates from MA to TM exceeded those for TM to MA in 2016, this pattern was reversed from 2017 through 2020. In 2020, TM-to-MA switching rates were almost 4 and 2.5 times higher than switching rates from MA to TM for Medicare only and Medicare-Medicaid enrollees, respectively. As a result, switching accounted for a growing share of new MA enrollment growth, increasing from 49% in 2016 to 67% in 2020.
While switching rates were not substantively different by sex, they generally declined with age. Switching patterns by mortality status also changed materially. In 2016, beneficiaries in their last year of life were more than twice as likely to disenroll from MA than from TM (5.4% vs 2.6%). By 2020, the trend had reversed (3.1% vs 5.1%).
Black and Hispanic beneficiaries generally switched at greater rates than White beneficiaries, and these differences have become more pronounced and were associated with the shift from TM to MA. By 2020, Black and Hispanic beneficiaries were more than twice as likely to disenroll from TM as White beneficiaries (13.4% and 13.5%, respectively, vs 5.9%). These switching patterns also persisted for beneficiaries during the last year of life.”
As MA is expected to exceed 50% of national Medicare enrollment next year, these findings are somewhat reassuring.

About hospitals and healthcare systems

 INCREASE IN LENGTH OF STAY ADDS TO HOSPITALS' FINANCIAL STRAIN “To increase collections and build a stronger, more positive relationship with patients amid these struggles, revenue cycle leaders are putting the spotlight on the patient experience, but as staffing shortages hit organizations’ hard and patients’ length-of-stay grow, these goals seem more unattainable.
The average length-of-stay in hospitals has increased by about 19% for patients in 2022 compared to 2019, according to data from the healthcare consulting firm Strata Decision Technology.
These delays in hospitals’ ability to discharge patients, as well as the negative consequences on both patients and hospitals, was stressed in a recent report released by the American Hospital Association (AHA).” 

About pharma

 House investigation faults FDA, Biogen for Alzheimer’s drug approval A good summary of the Aduhelm fiasco: “ The biotechnology company Biogen and its regulator, the Food and Drug Administration, worked in concert, ignoring internal concerns from the company and skirting the agency’s own written guidance, to allow the Alzheimer’s treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year, according to a scathing report released Thursday by two House committees.”
Also, see: FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation  

About health technology

 Trade Commission Sides with AliveCor, Orders Halt in Imports of Certain Apple Watches “The U.S. International Trade Commission (ITC) has affirmed its June initial decision and has once again sided with AliveCor that Apple infringed on AliveCor’s wearable electrocardiogram (ECG) device patents, potentially halting importation of certain Apple watches.
The cease and desist order sets a bond of $2 per unit of infringing Apple watches imported or sold during the required 60-day period during which President Biden must review the decision. If President Biden takes no action, the ITC’s final ruling will stand.”

About healthcare finance

 10 biggest health funding rounds of 2022 FYI

10 largest hospital groups and their 2022 credit ratings  FYI

Biggest health deals of 2022 FYI
Biggest is not always wisest. let’s look at these over the next year.

Today's News and Commentary

About Covid-19

U.S. imposes Covid testing requirements on travelers from China “The United States will require all travelers from China to show a negative Covid-19 test before boarding flights to the U.S., federal health officials announced Wednesday, citing concerns about a surge of Covid infections in China and a lack of transparency from Chinese government officials about how widespread that country’s outbreak is…
The new rules apply to all travelers over two years old, including American citizens, and applies to all travelers regardless of vaccination status. It also applies to travelers who transit through China on their way to the U.S. The new requirements will take effect at 12:01 a.m. ET on Jan. 5, to give airlines time to implement them.”
Comment: Why did the US take so long to impose the requirement and, once policy is set, why delay implementation? It only takes one plane to come with a few travelers infected with a new strain to rekindle our pandemic. Further, given the unreliability of Chinese data, all such travelers should be required to have a negative test at the US entry point.
As has been said before: Science + Politics= Politics

About health insurance/insurers

 HealthCare.gov Sign Ups Outpace Previous Years At Key Milestone An update FYI: “…Affordable Care Act (ACA) Marketplace enrollment continues to outpace previous years, with nearly 11.5 million people selecting a health plan nationwide as of December 15, 2022 – a key milestone marking the deadline for coverage starting January 1, 2023. About 1.8 million more people have signed up for health insurance, or an 18% increase, from this time last year.”

These states tried an Obamacare public option. It hasn’t worked as planned. “The public option envisioned by liberals during the Obamacare debate was a government-run insurance plan that would compete in the private market. That’s not what Colorado, Nevada and Washington are doing. Instead, they are using their regulatory authority to influence what private insurance companies offer.
Democrats view this new public option concept as one tool among many — including reinsurance programs, state subsidies, rate review programs, and coverage expansions to undocumented immigrants — to expand health insurance access.
But costs have not come down enough yet to make a real dent in affordability or in the rates of uninsured and underinsured.”

About pharma

 50 drugs on Mark Cuban's pharmacy with biggest cost reductions When evaluating articles like this one, you have to make sure you are comparing the same dosing (number of pills per dose), pill strength and number of pills per prescription, e.g., 30 or 90 day supplies.
That said, I looked up some of these drugs on both the Mark Cuban website and GoodRx. Two advantages were apparent using the former site. First, the drugs were cheaper than on GoodRx. Second, some of the drugs (see 1. and 4. on the article’s list, for examples) are only available from specialty pharmacies, not the retail outlets GoodRx promotes. So only the Mark Cuban site is available for a discount.
One more caveat: It may be cheapest, if you have insurance, to go through their contracted retail/specialty pharmacy.
Considering high cost and chronic drugs, it’s worth the time to investigate.

 Misleading Ads Fueled Rapid Growth of Online Mental Health Companies An excellent piece of investigative journalism by The Wall Street Journal. Such ads aren’t limited to mental health, but span the healthcare field. Well worth reading, even if you have kept up with the Cerebral scandal, which goes back more than a year.

About the public’s health

 Weekly U.S. Influenza Surveillance Report From the CDC: “Key Points
Seasonal influenza activity remains high but is declining in most areas.
Of influenza A viruses detected and subtyped during week 50, 77.8% were influenza A(H3N2) and 22.2% were influenza A(H1N1).
Seventeen influenza-associated pediatric deaths were reported this week, for a total of 47 pediatric flu deaths reported so far this season.
CDC estimates that, so far this season, there have been at least 18 million illnesses, 190,000 hospitalizations, and 12,000 deaths from flu.
The cumulative hospitalization rate in the FluSurv-NET system was more than 6 times higher than the highest cumulative in-season hospitalization rate observed for week 50 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-11.”

FDA, Concerned About Safety, Explores Regulating CBD in Foods, Supplements “The Food and Drug Administration is studying whether legal cannabis is safe in food or supplements and plans to make recommendations for how to regulate the growing number of cannabis-derived products in the coming months, agency officials said.”

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About Covid-19

 52% of Americans think COVID-19 PHE still needed “Fifty-two percent of Americans think a public health emergency should still be in effect for COVID-19, according to a new survey from Morning Consult. 
Morning Consult conducted the survey from Dec. 14-19 with 2,210 adults, posting the question, "In your opinion, do you think a public health emergency should be in effect currently for COVID-19?" 
Responses broke down as follows: 

  • Yes, definitely: 23 percent 

  • Yes, probably: 29 percent 

  • No, probably not: 21 percent

  • No, definitely not: 17 percent 

  • Don't know or no opinion: 10 percent”

About health insurance/insurers

Trends in Reported Health Care Affordability for Men and Women With Employer-Sponsored Health Insurance [ESI] Coverage in the US, 2000 to 2020 “A higher proportion of women than men with ESI reported that they were unable to afford needed health care, although the proportion experiencing unaffordability was low except for dental care. Lower income and higher health care needs among women could be driving sex differences in reported affordability. For both women and men, the trends (for most services) changed from increasing unaffordability to decreasing and then to increasing again. Although the Affordable Care Act extended ESI coverage to uninsured young adults through its dependent coverage provision, eliminated cost sharing for preventive services, and implemented maternal care coverage, rising health care costs, growth in high-deductible plans, and increased out-of-pocket health care expenditures may have contributed to increased unaffordability in recent years.”

Humana, TriWest tapped for $136B Tricare managed care contracts “Humana Military and TriWest Healthcare Alliance have been awarded the Defense Department's Tricare managed care support contracts. 
Humana Military was awarded the $70.9 billion East Region contract, according to a Dec. 22 news release from the department. This is the sixth time Humana has been selected for a Tricare contract dating to 1996, according to a news release from the company. 
TriWest Healthcare Alliance was awarded the $65.1 billion West Region contract, according to the Defense Department release…
The new contracts begin in 2024, according to the Defense Department. The nine-year contracts are the longest in the program's history, according to Humana.”

About hospitals and healthcare systems

 Big Nonprofit Hospitals Expand in Wealthier Areas, Shun Poorer Ones  A really good investigative journalism piece from The Wall Street Journal.
"
Many of the nation’s largest nonprofit hospital systems, which give aid to poorer communities to earn tax breaks, have been leaving those areas and moving into wealthier ones as they have added and shed hospitals in the last two decades.
As nonprofits, these regional and national giants reap $8.8 billion from tax breaks annually, by one Johns Hopkins University researcher’s estimate. Among their obligations, they are expected to provide free medical care to those least able to afford it.
Many top nonprofits, however, avoid communities where more people are likely to need that aid, according to a Wall Street Journal analysis of nearly 470 transactions. As these systems grew, many were more likely to divest or close hospitals in low-income communities than to add them.”

About pharma

 FDA grants fast-track review for over-the-counter overdose drug “The nonprofit pharmaceutical company Harm Reduction Therapeutics on Monday said in a release the FDA had granted it priority review for a new drug application for RiVive, a naloxone nasal spray for emergency overdose treatment.” 

About healthcare IT

Philadelphia-area Company To Pay $45 Million Whistleblower Settlement For Outsourcing Heart Monitoring To India “A Philadelphia region company has agreed to pay $44.875 million to settle allegations that it defrauded U.S. taxpayers by outsourcing critical remote medical services to technicians in India who were not properly trained.
The fraud allegations against Malvern, Pa.-based BioTelemetry, Inc., now a Royal Philips company, emerged through a whistleblower lawsuit brought by Ross Feller Casey, LLP, of Philadelphia, on behalf of former company employees.”

About healthcare personnel

 Trends in Labor Unionization Among US Health Care Workers, 2009-2021 “In this cross-sectional study of 14 298 US health care workers, the prevalence of reported labor unionization was 13.2%, with no significant change from 2009 through 2021. Reported membership or coverage by a labor union was significantly associated with higher weekly earnings and better noncash benefits but greater number of weekly work hours.” 

Today's News and Commentary

The Senate passed the omnibus budget bill, which now goes to the House. The Washington Post has a really good summary of what’s in the legislation.  

About pharma

 Gilead scores FDA okay for twice-yearly HIV drug Sunlenca “Gilead Sciences said Thursday that the FDA has approved its long-acting HIV-1 capsid inhibitor Sunlenca (lenacapavir) for patients with multi-drug resistant HIV infection. The drug, which was cleared by EU regulators in August, ‘offers a new twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen,’ the company said.”

About the public’s health

 MITRE-Harris Poll: Many Patients Feel Ignored or Doubted When Seeking Medical Treatment “A new MITRE-Harris Poll Survey on Patient Experience finds 52 percent of individuals in the United States feel their symptoms are ‘ignored, dismissed, or not believed’ when seeking medical treatment. That number rises to 6-in-10 within the Hispanic community.  
The polling also revealed that more than half of Blacks and Hispanics feel the ‘healthcare provider is biased against me based on their attitude, words, or actions,’ contributing to a 4-in-10 average across all demographics. Fifty percent (50%) of respondents also reported “a healthcare provider assuming something about me without asking me.” 

Today's News and Commentary

Statistics to ponder:

The United States spent $4.1 trillion on healthcare in total in 2020, an increase of $500 million over the previous year.
The Omnibus Budget Bill that Congress is expected to pass will cost $1.7 trillion.

About Covid-19

 FDA approves Roche’s Actemra for the treatment of COVID-19 in hospitalised adults “Roche…announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalised adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.”

About health insurance/insurers

 Millions to lose Medicaid coverage under Congress’ plan “The legislation will sunset a requirement of the COVID-19 public health emergency that prohibited states from booting people off Medicaid. The Biden administration has been under mounting pressure to declare the public health emergency over, with 25 Republican governors asking the president to end it in a letter on Monday, which cited growing concerns about bloated Medicaid enrollment.” 

Blue Cross liable for employer's trans coverage exclusion, court rules “Blue Cross & Blue Shield of Illinois violated the anti-discrimination provisions of the Affordable Care Act by refusing to pay for a transgender teenager’s gender-affirming care through an employer plan it administers, a federal judge ruled Monday.
The health insurer, owned by Health Care Service Corp., is required to cover this care even though, as a third-party administrator, the company was carrying out its employer client's directives when it denied the lead plaintiff, Judge Robert Bryan of the U.S. District Court for the Western District of Washington decided in a summary judgment. The employer, Catholic Health Initiatives of Englewood, Colorado, objects to these services on religious grounds. The health system, which is part of Chicago-based CommonSpirit Health, is lawfully entitled to refuse to pay for medical care that doesn't accord with its religious beliefs and is not a party to the lawsuit.”
Comment: This ruling will have huge implications for third party administrators of ERISA plans.

About pharma

 Merck puts eye-popping $9.3B on the line in lopsided ADC deal with Kelun-Biotech “The exclusive licensing deal, announced Thursday, marks the third antibody-drug conjugate agreement between the two companies. Under the latest arrangement, the two companies will develop seven ADCs for cancer. Merck snagged the right to research, develop, manufacture and commercialize the ADCs and placed a hold on future candidates with an exclusive opt-in agreement. Kelun-Biotech, a subsidiary of Sichuan Kelun Pharmaceutical, will hang on to rights in mainland China, Hong Kong and Macau.
The small upfront fee [$175M] stands in stark contrast to the multibillion total offering should all go well with the ADCs. The $9.3 billion will be distributed based on future development…”
 

About the public’s health

 As flu rages, US releases medicine from national stockpile “States will be able to request doses of the prescription flu medication Tamiflu kept in the Strategic National Stockpile from HHS. The administration is not releasing how many doses will be made available.” 

U.S. life expectancy continued to fall in 2021 as covid, drug deaths surged “Even as some peer nations began to bounce back from the toll of the pandemic, life expectancy in the U.S. dropped to 76.4 years at birth, down from 77 in 2020, according to data from the National Center for Health Statistics. That means Americans can expect to live as long as they did in 1996 — a dismal benchmark for a reliable measure of health that should rise steadily in an affluent, developed nation. (In August, using preliminary data, the agency had pegged life expectancy in 2021 at 76.1 years.)
Notably, every age group in the U.S. — from young children to seniors85 and older — saw a rise in its death rate. Men, women and most racial groups lost ground. In some previous years, even when overall life expectancy declined, some groups advanced.”

About healthcare personnel

 Changes in Physician Work Hours and Implications for Workforce Capacity and Work-Life Balance, 2001-2021 “In this cross-sectional study of 87 297 monthly surveys of physicians from 17 599 unique households, average weekly hours worked by individual physicians declined by 7.6% from 2001 to 2021, driven by a decrease among men, particularly fathers, while mothers’ hours increased. Total weekly hours contributed by the physician workforce per capita grew at less than half the rate of US population growth, while advanced practice professional workforce hours rose considerably over the same period.”  

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About Covid-19

 COVID-19 Nursing Home Data From CMS (individual facility compliance is searchable):
National Percent of Residents Up to Date with Vaccines per Facility- 46.7%
National Percent of Staff Up to Date with Vaccines per Facility- 22.2%

Epidemiology society urges reduced COVID-19 screening at hospitals “Healthcare facilities should no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures, the Society for Healthcare Epidemiology of America said Dec. 21.
Research shows asymptomatic COVID-19 testing added 1.89 hours to patient stays and cost more than $12,500 to identify one asymptomatic COVID-19 patient…”

Drug price group slashes suggested price of Pfizer COVID treatment by 80% “The Institute for Clinical and Economic Review (ICER) said on Tuesday that its new suggested U.S. price based on the benefits and value to patients was in the range of $563 to $906 per treatment course. That compares with its previous assessment of $3,600 to $5,800 per course.”

About health insurance/insurers

 2023 forecast: Employers who self-insure face new responsibilities and opportunities “Self-insured employers will have to dig into the details of the health plans they offer their employees more so than they ever had to before thanks to provisions in the Consolidated Appropriations Act (CAA) that will go into effect in 2023.
These employers will now need to be fiduciaries of the healthcare plans they offer. Of course, at least on paper, self-insured employers have been fiduciaries of their healthcare benefits since the passage of the Employee Retirement Income Security Act in 1974, but the CAA means that they’ll have more data to work with and therefore more responsibility that their workers get the best coverage for a reasonable price.”

Fitch: Payers should withstand rising inflation, interest rates “Fitch said in its Dec. 20 report that payers are ‘somewhat protected from rapidly increasing healthcare costs,’ thanks to the typical three-year duration of contracts with hospitals and providers. These contracts — which include negotiated payment rates — give insurers time to incorporate higher costs into premium rates… 
Fitch said diversity of enrollment should benefit payers, as the expected decline in enrollment that is typically seen during recessions will likely be partially offset by increased Medicare and Medicaid enrollment.”

How health plans can use data to unlock better care The study asked: What do you consider the most important factors for having a positive experience in the healthcare system? “Top 5 responses
53% An insurance plan that fits my needs
48% Getting care from doctors with good bedside manner
38% Feeling better quickly
33% Securing an appointment quickly
31% Out-of-pocket cost”
Amazing that plan customization is first on the list.

About hospitals and healthcare systems

 Biden administration to publish hospital ownership data for first time “The Biden administration… [announced] it will release ownership data for all 7,000 hospitals that participate in Medicare in an effort to boost transparency.
The move comes amid a rapid increase in private equity investments in hospitals, resulting in an increasingly concentrated market. Private equity firms owned about 4 percent of hospitals as of last year.”

2023 forecast: Providers embrace start of new requirements on health equity Next year will be the start of a new payment model that calls for not just the collection of health equity data to determine social risk factors, but also the implementation of solutions to address these problems. Providers that have been working on equity for years are lauding the decisions to move beyond planning and collecting data and into action.  
The ACO REACH payment model contains the first of such requirements. The voluntary payment model offers fully or partially capitated payments to physicians for meeting spending and quality targets. 
In early 2023, participants will also have to submit to the Center for Medicare and Medicaid Innovation an equity plan, which is a totally new requirement for value-based care participants. The plan includes not only a requirement to collect data on social determinants of health for its patient population but also the development of measures to target these factors.”

Many Hospitals Get Big Drug Discounts. That Doesn’t Mean Markdowns for Patients. An excellent piece of investigative journalism about the 340B program.

Joint Commission makes major revisions to quality, safety standards The Joint Commission is retiring 14% of its quality standards during the first round of a review process that seeks to refocus hospital safety and quality goals and decrease administrative burden…
The Joint Commission is doing away with a variety of standards, including those related to discarding unlabeled medicine, monitoring safe opioid prescribing, establishing procedures and quality control checks for simple diagnostic tests, and adhering to behavioral management policies. Notably, the accrediting body is scrapping a measure based on healthcare facility smoking bans, which the Joint Commission deemed outdated because of widespread hospital policies and local laws that achieve the same result.
Most of the standards—such as a requirement that health systems provide incidence data to key stakeholders, including licensed practitioners, nursing staff and other clinicians—are addressed in other aspects of the accrediting process, according to the Joint Commission.

About pharma

 Drug Enforcement Administration Announces the Seizure of Over 379 million Deadly Doses of Fentanyl in 2022 “As 2022 comes to an end, the Drug Enforcement Administration is announcing the seizure of over 50.6 million fentanyl-laced, fake prescription pills and more than 10,000 pounds of fentanyl powder this calendar year. The DEA Laboratory estimates that these seizures represent more than 379 million potentially deadly doses of fentanyl.” 

About the public’s health

 WHO updates recommendations on HPV vaccination schedule “WHO now recommends
A one or two-dose schedule for girls aged 9-14 years
A one or two-dose schedule
for girls and women aged 15-20 years
Two doses with a 6-month interval for women older than 21 years

Trends and Disparities in Glycemic Control and Severe Hyperglycemia Among US Adults With Diabetes Using Insulin, 1988-2020 “From 1988-1994 to 2013-2020, there was no significant change in the percentage of adults using insulin or the prevalence of glycemic control and severe hyperglycemia among US adults with diabetes using insulin. Overall, less than 30% of patients with diabetes using insulin had an HbA1c level less than 7%, while approximately 15% had an HbA1c level greater than 10%.
Several factors may have contributed to the lack of improvement in glycemic control. First, the rising cost of insulin is likely leading to medication nonadherence. Approximately one-third of US adults using insulin report either rationing, dose skipping, or delaying prescription refills to save money. Second, only a small proportion of practitioners may be starting or intensifying insulin therapy in a timely manner. Third, acceptability of insulin remains low among patients, leading to reluctance to begin or continue using insulin therapy as recommended.
Trends in glycemic control varied considerably across race and ethnicity. While glycemic control was stable for non-Hispanic White adults using insulin, we found that control declined significantly among Mexican American adults.” 

About healthcare personnel

 Federal Employee Insurance Program to Reimburse Pharmacists as Providers for Patient Assessment and Prescribing of COVID-19 Therapy “The U.S. Office of Personnel Management (OPM), the federal agency that administers employer-sponsored health insurance for all civilian federal employees, announced that insurance carriers that provide coverage to federal employees through the Federal Employee Health Benefits Program must reimburse pharmacists for patient assessment and prescribing of nirmatrelvir and ritonavir.” 

Today's News and Commentary

Congress' last-minute $1.7 trillion omnibus package: 8 healthcare takeaways What makes reading the proposed bill difficult are the many subclauses that begin “Provided further…”
With that caveat, here are a few more provisions [the health content, except 1. below, start on page 989]:
1. There is hereby appropriated $2,000,000,  to remain available until expended, for the Secretary of Agriculture to carry out a pilot program that assists rural  hospitals to improve long-term operations and financial health by providing technical assistance through analysis of current hospital management practices.
2. $60,000,000 shall remain available until expended for grants to public institutions of higher education to expand or support graduate education for physicians. Preference will be given to areas with greatest need for primary care.
3. For carrying out titles III, XI, XII, and XIX of the  PHS Act with respect to maternal and child health and 24 title V of the Social Security Act, $1,171,430,000.
4.For carrying out the program under title X of the PHS Act to provide for voluntary family planning projects, $286,479,000: Provided, That amounts provided  to said projects under such title shall not be expended for abortions, that all pregnancy counseling shall be nondirective, and that such amounts shall not be expended for any activity (including the publication or distribution of literature) that in any way tends to promote public support or opposition to any legislative proposal or candidate for public office.
5. For payment to the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund, as provided under sections 217(g),  1844, and 1860D–16 of the Social Security Act, sections  103(c) and 111(d) of the Social Security Amendments of 1965, section 278(d)(3) of Public Law 97–248, and for administrative expenses incurred pursuant to section 201(g) of the Social Security Act, $548,130,000,000. [Medicare Parts A and B]
6. 1.     PUBLIC HEALTH PREPAREDNESS AND RESPONSE  For carrying out titles II, III, and XVII of the PHS Act with respect to public health preparedness and response, and for expenses necessary to support activities related to countering potential biological, nuclear, radiological, and chemical threats to civilian populations,  $883,200,000.  

About health insurance/insurers

Medicare Part B Spending on Lab Tests Increased in 2021, Driven By Higher Volume of COVID-19 Tests, Genetic Tests, and Chemistry Tests “Medicare Part B spending on laboratory (lab) tests increased by $1.3 billion in 2021, from $8.0 billion in 2020 to $9.3 billion in 2021. The 17-percent increase was the biggest change in spending since OIG began monitoring payments in 2014. The increase in spending in 2021 resulted from higher spending in three groups of tests: COVID-19 tests, genetic tests, and chemistry tests…”

New Poll of American Workers Reveals Tremendous Value Placed on Workplace Health Benefits “Ninety-three percent of respondents said they were satisfied with their insurance:  

  • 54% said they were “highly satisfied;”

  • 87% called their plans affordable; and,

  • More than 70% agree their health insurance is worth what they pay for it.

When provided with a list of words to describe their coverage, respondents’ top three choices were: 

  • Affordable,

  • High-quality, and

  • Comprehensive.” 

Providers Did Not Always Comply With Federal Requirements When Claiming Medicare Bad Debts “Providers sought reimbursement of nearly $10 billion for Medicare bad debts on their cost reports with cost reporting periods ending during Federal fiscal years 2016 through 2018. Federal regulations state that Medicare is to reimburse providers 65 percent of deductible and coinsurance amounts for Medicare beneficiaries that remain unpaid (1) after the provider has made a reasonable effort to collect, (2) the debt was uncollectible, and (3) there was no likelihood of future recovery based on sound business judgment (‘Medicare bad debts’)…
Providers did not always comply with Federal requirements when claiming Medicare reimbursement for Medicare bad debts. Of the 148 Medicare bad debts in our nonstatistical sample, 86 were associated with beneficiaries whom providers had deemed indigent and for whom, therefore, no reasonable collection efforts were required. Providers did not comply with Federal requirements when claiming 18 of the remaining 62 Medicare bad debts. We identified four additional bad debts for which the amounts that providers claimed did not reflect the amounts owed by the beneficiaries. These 22 bad debts resulted in a total of $29,787 in unallowable Medicare reimbursement. The Centers for Medicare & Medicaid Services (CMS) inappropriately reimbursed these amounts because the Medicare administrative contractors (MACs) did not concentrate on reviewing bad debts when performing audits of cost reports during our audit period.”

About pharma

 New compound shows promise in reversing dangerous fentanyl effects “…a lab at the University of Maryland has developed a new drug that shows early promise in reversing the effects not only of fentanyl, but methamphetamine as well—and potentially a whole host of other substances, too. The researchers described their findings in a study published Dec. 15 in Chem.”

CVS, Walgreens limit purchases of children’s pain-relief medicine “Increased demand has led CVS and Walgreens to limit purchases of children’s pain-relief medicine, the companies confirmed to CNN on Monday.
CVS is restricting both in-person and online purchases to two children’s pain relief products. Walgreens has limited online purchases to six over-the-counter fever reducers per transaction, but it does not have an in-store purchase limit.”

About the public’s health

Trends in Delivery Hospitalizations with Pregestational and Gestational Diabetes and Associated Outcomes: 2000-2019 “Pregestational diabetes increased over the study period, driven by a quadrupling in the prevalence of T2DM. Notably, the prevalence of chronic diabetes complications doubled concomitantly. Pregestational diabetes was associated with a range of adverse outcomes. These findings are further evidence that pregestational diabetes is an important contributor to maternal risk and that optimizing diabetes care in women of childbearing age will continue to be of major public health importance.” 

Biden administration doesn’t appeal Texas court loss on LGBTQ protections “The Biden administration did not appeal a recent court loss in Texas regarding federal LGBTQ protections, a decision Attorney General Ken Paxton is celebrating as a win.
On October 1, U.S. District Court Judge Matthew Kacsmaryk declared unlawful two pieces of federal guidance: one that said the Affordable Care Act protects transgender patients’ access to gender-affirming care; and another that said employment protections for gay and transgender workers extend to policies like dress code, as well as what pronouns and bathrooms they use.”

About healthcare IT

 Carta Healthcare Survey Reveals 83% of Patients Had to Provide the Same Health Information, or Duplicate Health Information, at a Doctor’s Office “Eighty-three percent of respondents reported they had to provide the same health information or duplicate forms with each appointment. Almost three-quarters of those surveyed reported completing more than two duplicate documents, and 42% said they spent 6 minutes or more recounting past medical history at every appointment. These results indicate that medical history is not shared between systems or displayed in a time-efficient manner. One in five respondents said having to repeat forms at a doctor’s office makes them less likely to return, which may impact healthcare costs since regular examinations and preventive care are less expensive than urgent care.” 

New HIPAA rule from CMS would streamline transactions with attachments, e-signatures “The Centers for Medicare and Medicaid Services on Monday put forth a new proposed rule that would modify HIPAA to better support both claims and prior authorization transactions – providing standards for electronic signatures to be used in conjunction with healthcare attachments transactions…
If finalized, it would promote standards adoption for transactions with attachments for prior authorizations, including medical charts, X-rays and provider notes that document physician referrals. The modifications to HIPAA would also include a standard for the referral certification and authorization transaction.
The proposed rule could save $454 million a year in administrative costs, according to CMS, and is another instance of the agency's efforts to reduce paperwork burdens and streamline provider and patient experience.”

About health technology

 FDA Approves First Gene Therapy for Specific Form of Bladder Cancer “The FDA has approved Ferring’s gene therapy Adstiladrin to treat adults with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer — the first gene therapy approved for this patient population...
Adstiladrin (nadofaragene firadenovec-vncg) is administered through a catheter into the bladder once every three months.”

Today's News and Commentary

National Health Spending Grew Slightly in 2021 “A decline in federal government spending led to more modest growth in health care expenditures last year, according to figures released today by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS). The 2021 National Health Expenditures (NHE) Report found that U.S. health care spending grew 2.7% to reach $4.3 trillion in 2021, slower than the increase of 10.3% in 2020. The slower growth in 2021 was driven by a 3.5% decline in federal government expenditures for health care that followed strong growth in 2020 due to the COVID-19 pandemic response. This decline more than offset the impact of greater use of health care goods and services and increased insurance coverage in 2021.”

About Covid-19

Get free at-⁠home COVID-⁠19 tests this winter The federal government is again supplying free Covid-19 tests.

Coronavirus boosters cut hospitalization risk by at least 50%, CDC data shows “Adults who received the updated coronavirus booster shots are better protected against severe disease than those who haven’t, cutting their risk of having to visit an emergency room or being hospitalized with covid-19 by 50 percent or more, according to new federal data.
Two reports released Friday by the Centers for Disease Control and Prevention give the first detailed look at how well the updated boosters from Pfizer and Moderna protect against serious illness. But uptake of the “bivalent” boosters rolled out in September has been low among vaccine-weary Americanswith only about 14 percent of those eligible — ages 5 and older — having received an updated shot.”

IDSA Guidelines on the Treatment and Management of Patients with COVID-19 A reminder of where to find the latest COVID-19 recommendations.

KFF COVID-19 Vaccine Monitor: December 2022 “The latest KFF COVID-19 Vaccine Monitor survey finds that about seven in ten adults (71%) say healthy children should be required to get vaccinated for MMR in order to attend public schools, down from 82% who said the same in an October 2019 Pew Research Center poll. Almost three in ten (28%) now say that parents should be able to decide not to vaccinate their school-age children, even if this creates health risks for others, up from 16% in 2019. Among Republicans and Republican-leaning independents, there has been a 24 percentage-point increase in the share who hold this view (from 20% to 44%).”

About health insurance/insurers

EMERGENCY: The high cost of ambulance surprise bills “In December 2020, Congress passed the No Surprises Act (NSA) to protect patients from many types of out-of-network balance bills…
It did not include protections from surprise billing by ground ambulances. 
Yet, Congress acknowledged important work was left undone, by including provisions in the NSA to establish the Advisory Committee on Ground Ambulance and Patient Billing. The committee is charged with reviewing options for protecting consumers from surprise ground ambulance billing.
Studies show about half of emergency ambulance patients with insurance are at risk of receiving a surprise medical bill which is an out-of-network charge for those transportation services. Those balance bills carry a median out-of-pocket charge of $450 but in some states, the average is more than $1000.”

Lab Owner Convicted in $463 Million Genetic Testing Scheme to Defraud Medicare “According to court documents and evidence presented at trial, Minal Patel, 44, of Atlanta, owned LabSolutions LLC (LabSolutions), a lab enrolled with Medicare that performed sophisticated genetic tests. Patel conspired with patient brokers, telemedicine companies, and call centers to target Medicare beneficiaries with telemarketing calls falsely stating that Medicare covered expensive cancer genetic tests. After the Medicare beneficiaries agreed to take a test, Patel paid kickbacks and bribes to patient brokers to obtain signed doctors’ orders authorizing the tests from telemedicine companies. To conceal the kickbacks, Patel required patient brokers to sign contracts that falsely stated that they were performing legitimate advertising services for LabSolutions.
The telemedicine doctors approved the expensive testing even though they were not treating the beneficiaries and often did not even speak with them.”

Trends in Medicare Part B Spending on Discarded Drugs, 2017-2020 “During the study period, 2.2% of administered drugs were reported as discarded, with an estimated cost of $3.0 billion. Chemotherapy accounted for the greatest percentage of discarded drugs and the greatest spending ($2.1 billion)…Among the 20 drugs with the highest percentage discarded, discarded drug amounts totaled $971 million…
Data reflect Medicare Part B fee-for-service claims and do not include Medicare Advantage beneficiaries.”
In an accompanying editorial: Stemming Medicare Spending on Discarded Drugs—Waste Not, Want Not? “Beginning next year, the 2021 Infrastructure Investment and Jobs Act requires manufacturers to pay rebates for spending on discarded drugs. Although the authors of the National Academies of Sciences, Engineering, and Medicine report on drug waste raised concerns that such an approach could be associated with manufacturers increasing prices, recent changes to Medicare mitigate this concern. Specifically, the Inflation Reduction Act limits the ability of industry to raise prices on therapies that are reimbursed by Medicare beyond the rate of inflation.”

Nonprofit Health Plans With $6.8 Billion in Projected Revenue Set to Combine “Two nonprofit health plans focused on government-backed coverage are planning to combine in a deal that aims to create a sizable new player in the rapidly growing business of managed Medicare and Medicaid.
SCAN Group, based in Long Beach, Calif., and CareOregon, of Portland, Ore., plan to join up under the new name HealthRight Group, they said. 
The planned combination, which the nonprofits are expected to announce Wednesday, would create an organization that they anticipate would have annual revenue next year of around $6.8 billion and membership of about 800,000 people.”

About healthcare quality

Diagnostic Errors in the Emergency Department: A Systematic Review  “Overall diagnostic accuracy in the emergency department (ED) is high, but some patients receive an incorrect diagnosis (~5.7%). Some of these patients suffer an adverse event because of the incorrect diagnosis (~2.0%), and some of these adverse events are serious (~0.3%). This translates to about 1 in 18 ED patients receiving an incorrect diagnosis, 1 in 50 suffering an adverse event, and 1 in 350 suffering permanent disability or death. These rates are comparable to those seen in primary care and hospital inpatient care.
We estimate that among 130 million emergency department (ED) visits per year in the United States that 7.4 million (5.7%) patients are misdiagnosed, 2.6 million (2.0%) suffer an adverse event as a result, and about 370,000 (0.3%) suffer serious harms from diagnostic error.”
For a more nuanced report on these findings, see this The NY Times article.

About hospitals and healthcare systems

Joint Commission surveys to include safety briefings in 2023 The Joint Commission will hold a safety briefing with healthcare organizations at the start of every accreditation survey starting in 2023…
Site surveyors and staff members preselected by the healthcare organization will conduct an informal, five-minute briefing to discuss any potential safety concerns — such as fires, an active shooter scenario or other emergencies — and how surveyors should react if safety plans are implemented while they are on site.”

Hospital systems are creating their own staffing agencies as a cheaper alternative to temp and travel nurses “An increasing number of hospital systems like Allegheny Health Network have created in-house staffing teams to cope with the pandemic-fueled nursing shortage—and try to beat private temp staffing agencies at their own game. Depending on the system, the nurses could work a weeklong stint or a multiple-week assignment at a hospital and then do a similar schedule at another facility. Some even work self-scheduled shifts in various locations, unlike regular staff nurses, who typically work in a single medical unit within one hospital. These workers differ from “float” nurses, who shift from unit to unit on an as-needed basis within a single hospital.
The goal of the in-house teams is to offer enough pay and flexibility to attract nurses to the jobs—and thus reduce the systems’ heavy dependence on more expensive RNs from outside agencies.”

 Mass General Brigham Reports Fiscal Year 2022 Financial Results “Mass General Brigham, a not-for-profit, integrated health care system, reported a loss from operations of $432 million (-2.6% operating margin) for the fiscal year ending September 30, 2022. The health care system’s financial performance continues to be impacted by external pressures that have intensified over the past year, including historic cost inflation, significant workforce shortages, and a worsening capacity crisis.”


About pharma

1st patient to receive base editing gene therapy in remission The world's first patient to be infused with base-edited T-cells is in remission for leukemia 28 days after receiving the gene therapy, according to the U.K.-based Great Ormond Street Hospital. 
Six months after being treated with base editing — a technique that modifies the genetic code to reduce side-effect risk — and a second bone marrow transplant, the 13-year-old patient, Alyssa, is still in remission and is doing well, according to a GOSH news release.”

DEA Serves Order to Show Cause on Truepill Pharmacy for its Involvement in the Unlawful Dispensing of Prescription Stimulants The “DEA served an Order to Show Cause on Truepill, a retail pharmacy that is alleged to have wrongfully filled thousands of prescriptions for stimulants used in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Truepill was the pharmacy for telehealth companies, including Cerebral, that marketed ADHD treatments, including Adderall ® and its generic forms, directly to consumers using Internet advertisements and social media. Cerebral arranged for patients to receive prescriptions for ADHD treatments through a telehealth visit, and for Truepill to fill those prescriptions.”

Eli Lilly says 4 new launches will help drive its 2023 revenue past $30B “Next year, Lilly plans to submit regulatory applications for five products plus initiate six phase 3 trials and present data from six other phase 3 trials, executives said in an investor presentation Tuesday. In all, several new approvals—plus market advances for diabetes launch Mounjaro—will help the company deliver more than $30 billion in sales next year, Lilly execs said.”

Biogen 19th drugmaker to shirk access in 340B program, nonprofit says “Biogen said two of its drugs that treat multiple sclerosis, Avonex and Plegridy, will not be discounted through 340B entities' partner pharmacies. 340B Health President and CEO Maureen Testoni said the decision, which Biogen said will take place Feb. 1, is ‘depriving safety-net hospitals of needed resources from mandated 340B discounts and keeping those dollars.’”

AbbVie leaves 2 pharmaceutical lobbies “North Chicago, Ill.-based AbbVie is cutting ties with the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, two leading pharmaceutical lobby groups. 
AbbVie, the fourth-largest drugmaker by revenue, will also leave the Business Roundtable, a lobby organization that's comprised of CEOs from healthcare companies…”
The company did not furnish a reason for this decision.

About the public’s health

Can politics kill you? Research says the answer increasingly is yes. “In one study, researchers concluded that people living in more-conservative parts of the United States disproportionately bore the burden of illness and death linked to covid-19. The other, which looked at health outcomes more broadly, found that the more conservative a state’s policies, the shorter the lives of working-age people.The reasons are many, but, increasingly, it is state — and not just federal — policies that have begun to shape the economic, family, environmental and behavioral circumstances that affect people’s well-being. Some states have expanded their social safety nets, raising minimum wages and offering earned income tax credits while using excise taxes to discourage behaviors — such as smoking — that have deleterious health consequences. Other states have moved in the opposite direction.”

The U.S. Maternal Health Divide: The Limited Maternal Health Services and Worse Outcomes of States Proposing New Abortion Restrictions “Compared to states where abortion is accessible, states that have banned, are planning to ban, or have otherwise restricted abortion have fewer maternity care providers; more maternity care “deserts”; higher rates of maternal mortality and infant death, especially among women of color; higher overall death rates for women of reproductive age; and greater racial inequities across their health care systems.”

Trajectories of ENDS and cigarette use among dual users: analysis of waves 1 to 5 of the PATH Study “Concurrent electronic nicotine delivery system (ENDS) and cigarette (dual) use is harmful. Identifying longitudinal trajectories of ENDS and cigarette use among dual users can help to determine the public health impact of ENDS and inform tobacco control policies and interventions…
Most dual users maintained long-term cigarette smoking or dual use, highlighting the need to address cessation of both products. Continued monitoring of trajectories and their predictors is needed, given ongoing changes to the ENDS marketplace.”

Only 14% of Cancers Are Detected Through a Preventive Screening Test  From the NORC, the headline is the story. The charts breaks down rates by type of cancer by state.

 USPSTF recommends clinicians prescribe PrEP to those at high risk for HIV “The U.S. Preventive Services Task Force has released a draft recommendation advocating for clinicians to prescribe preexposure prophylaxis to patients at increased risk for HIV.
The recommendation, an A grade, is consistent with the USPSTF’s 2019 ruling on preexposure prophylaxis (PrEP) use for reducing HIV infection in those who are at higher risk.”

About healthcare IT

 CMS Responding to Data Breach at Subcontractor “The Centers for Medicare & Medicaid Services (CMS) is responding to a data breach at Healthcare Management Solutions, LLC (HMS), a subcontractor of ASRC Federal Data Solutions, LLC (ASRC Federal), that may involve Medicare beneficiaries’ personally identifiable information (PII) and/or protected health information (PHI). No CMS systems were breached and no Medicare claims data were involved. Initial information indicates that HMS acted in violation of its obligations to CMS and that the incident involving HMS has the potential to impact up to 254,000 Medicare beneficiaries’ personally identifiable information out of the over 64 million beneficiaries that CMS serves. This week, CMS is mailing beneficiaries that have been potentially impacted a letter from CMS notifying them directly of the breach.  A copy of that letter can be found below.”

Google aims to translate hand-scribbled doctors' notes and prescriptions using AI “According to a report from TechCrunch, the future feature will be built into Google Lens—the search giant’s image recognition app. An early version of the tech was spotlighted at the company’s annual conference in India. 
Built with the help of pharmacists, the artificial intelligence program will start with a cellphone snapshot of a handwritten doctor’s note. The app will then highlight any medicines listed by attempting to decipher the physician’s quickly written shorthand.

About healthcare personnel

THE PRODUCTIVITY OF PROFESSIONS: EVIDENCE FROM THE EMERGENCY DEPARTMENT  From a NBER Working Paper: “Using data from the Veterans Health Administration and quasi- experimental variation in the patient probability of being treated by physicians versus NPs in the emergency department, we find that, compared to physicians, NPs significantly increase resource utilization but achieve worse patient outcomes.”

 U.S. medical schools grew more diverse in 2022, AAMC data shows “The number of Black, Hispanic, and women applicants and enrollees continued to increase at U.S. medical schools in the 2022-23 academic year, according to datareleased today by the Association of American Medical Colleges.” 

About healthcare finance

 Nine in 10 health care companies with financial stress are owned by private equity “Almost 90% of the health care companies deemed to be under financial stress by a leading credit rating agency are owned by private equity, a stark indicator of the toll financial investors have taken on a vital sector.
The striking finding is part of a new Moody’s Investors Service report released this week that shows broad turbulence throughout an industry weakened by private equity’s practice of loading companies with debt, making them less resilient to challenges like Covid-19, rising interest rates, litigation, or changes from a new federal law against surprise billing. Among the 193 North American health care companies Moody’s rates, the agency had placed almost 18% at or below its rating that indicates credit stress, B3 negative, as of Nov. 30. That’s compared with just 4% at the end of 2015.”

Today's News and Commentary

About Covid-19

 Covid-19 vaccines have saved more than 3 million lives in US, study says, but the fight isn’t over “The Covid-19 vaccines have kept more than 18.5 million people in the US out of the hospital and saved more than 3.2 million lives, a new study says – and that estimate is most likely a conservative one, the researchers say.”

About pharma

 Moderna says cancer vaccine reduces melanoma’s return by 44% “An experimental cancer vaccine being developed by the biotechnology firm Moderna and the drug giant Merck reduced the risk that melanoma would return after surgery or that patients would die by 44%, the company said.” 

About the public’s health

 Justices reject industry bid to block California’s ban on flavored tobacco “The Supreme Court on Monday turned down a request from a group of tobacco companies and retailers to block a California law that bans the sale of flavored tobacco. The state enacted the law in response to an increase in tobacco use by young people, but a group of tobacco companies argued that a 2009 federal law trumps state and local laws like California’s ban.
The justices did not provide any explanation for their decision, and there were no public dissents noted from Monday’s order.”

Judge rejects vaccine choice law in health care settings “A person's choice to decline vaccinations does not outweigh public health and safety requirements in medical settings, a federal judge ruled in a Montana case.
U.S. District Judge Donald Molloy last week permanently blocked a section of law the state said was meant to prevent employers — including many health care facilities — from discriminating against workers by requiring them to be vaccinated against communicable diseases, including COVID-19.”

About healthcare IT

‘Out of control’: Dozens of telehealth startups sent sensitive health information to big tech companies More and more information is coming out about hidden use of personal transactions and marketing. This article is the second excellent investigative report of this kind from STAT and The Markup.
”A joint investigation by STAT and The Markup of 50 direct-to-consumer telehealth companies like Workit found that quick, online access to medications often comes with a hidden cost for patients: Virtual care websites were leaking sensitive medical information they collect to the world’s largest advertising platforms…
On 13 of the 50 websites, STAT and The Markup documented at least one tracker — from Meta, Google, TikTok, Bing, Snap, Twitter, LinkedIn, or Pinterest — that collected patients’ answers to medical intake questions. Trackers on 25 sites, including those run by industry leaders Hims & Hers, Ro, and Thirty Madison, told at least one big tech platform that the user had added an item like a prescription medication to their cart, or checked out with a subscription for a treatment plan.”

 Longitudinal Associations Between Use of Mobile Devices for Calming and Emotional Reactivity and Executive Functioning in Children Aged 3 to 5 Years Findings  In this cohort study of 422 parents and 422 children, increased use of mobile devices for calming children aged 3 to 5 years was found to be associated with decreased executive functioning and increased emotional reactivity at baseline; however, only emotional reactivity had bidirectional, longitudinal associations with device use for calming at 3 and 6 months of follow-up. The associations were found to be increased in boys and children with higher temperamental surgency.
Meaning  The findings of this study suggest that, particularly in young boys or young children with higher surgency, the frequent use of devices for calming should be avoided.”

 8 largest healthcare data breaches of 2022 tied to vendors FYI

About health technology

 Plant power: Transplanted plant parts use photosynthesis to slow osteoarthritis progression  This discovery is one of the most fascinating I have ever seen. “…scientists at China’s Zhejiang University School of Medicine have harnessed plant power in mammalian cells to get them to produce energy when exposed to light. In a study published Dec. 7 in Nature, they described how they built tiny photosynthetic plant organelles called thylakoids and transplanted them into mammalian cells. They then demonstrated that the cells could stall disease progression in mouse models of osteoarthritis.”

100,000 newborn babies set to have their DNA fully decoded "One hundred thousand newborn babies in England will have their genomes sequenced, in a £105mn research programme that could pave the way for a full-scale neonatal screening plan to detect rare genetic conditions. Genomics England, a government-owned company, aims to read all the DNA carried by a representative national sample of babies shortly after they are born. The two-year project, to be carried out in partnership with the NHS, will begin late next year.”

Today's News and Commentary

About health insurance/insurers

11 states will offer health insurance for children without permanent legal status in 2023 “Eleven states will provide government health benefits to children without permanent legal status in 2023, Stateline reported Dec. 6. 
Connecticut and New Jersey will allow children without permanent legal status to enroll in Medicaid or the Children's Health Insurance Program in January, joining Maine, Rhode Island Vermont, Massachusetts, California, Illinois, New York, Oregon, Washington and the District of Columbia in extending these benefits.”

Oscar Health to stop accepting new members in Florida “Oscar Health will stop accepting new members through open enrollment on Dec. 13, the company said Dec. 12…
In third-quarter regulatory filings, published Nov. 9, Oscar Health said it had "proactively engaged" CMS to help the company keep its membership levels manageable following the exit of other carriers from certain markets.”

Unions suing Elevance Health for allegedly restricting access to claims data Labor unions contracted with Elevance Health for self-funded plans are suing the payer, alleging Elevance Health does not allow self-paid plans to access their own claims data and charged the self-pay plans higher rates than it had negotiated with hospitals. 
Law firm Berger Montague represents Bricklayers and Allied Craftworkers Local 1 Fund and Sheet Metal Workers Local 40 Fund, two unions who contracted with Elevance Health for access to the payer's network and negotiated rates.” 

About hospitals and healthcare systems

'We are in a crisis': Main Line anticipates 2nd straight $100M annual loss “Radnor Township, Pa.-based Main Line Health is anticipating its second consecutive $100 million annual loss as Philadelphia-area hospitals and health systems continue to face economic struggles, The Philadelphia Inquirer reported Dec. 12.
Through October, Main Line had already lost $62 million.”

About pharma

 Amoxicillin shortage worsens to 44 products, resupply dates pushed to 2023 “The number of amoxicillin products on back order has increased to 44 after months of the antibiotic being out of stock, according to the American Society of Health-System Pharmacists
Depending on the ASHP's website or the FDA's drug shortage database, between two dozen and three dozen oral presentations of amoxicillin have been in shortage because of high demand since late October. At the time, the shortage was expected to resolve by the end of 2022.”

Mark Cuban's drug company targets self-insured employer market “Mark Cuban Cost Plus Drug Company will offer prescription drug discounts to a coalition of 40 large private and public employers via a new platform called EmsanaRx Plus.
Cuban's drug company is partnering with pharmacy benefits manager EmsanaRx to expand access to lower-cost medicines to employers and employees. For Cost Plus Drugs, the partnership marks a strategic shift from operating exclusively in the direct-to-consumer market into the employer market.
EmsanaRx Plus is a supplemental drug discount product designed specifically for employers as a standalone pipeline for lower-cost medicines that have been contracted directly with drug manufacturers by Cost Plus Drugs, according to the company.”

About the public’s health

 Combo Vaccine Candidate for Influenza and COVID-19 Gets Fast Track Status “A phase 1 trial to investigate the immunogenicity and safety of the vaccine candidate has been initiated.
The Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer-BioNTech’s mRNA-based combination vaccine candidate for the prevention of influenza and COVID-19 with a single injection.
The vaccine candidate utilizes BioNTech’s mRNA technology to combine Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), and Pfizer-BioNTech’s authorized Omicron-adapted bivalent COVID-19 vaccine.”

Catholic healthcare providers can't be forced to do gender surgeries: U.S. court “The Biden administration cannot force a group of Catholic healthcare providers and professionals to perform gender transition surgeries under an Obama-era regulation barring sex discrimination in healthcare, a U.S. appeals court ruled on Friday.
A unanimous three-judge panel of the 8th U.S. Circuit Court of Appeals agreed with a North Dakota federal judge who said the U.S. Health and Human Services (HHS) rule infringes on the religious freedoms of the plaintiffs, including a group of nuns who run health clinics for the poor and an association of Catholic healthcare professionals.”

Merck escapes nearly 1,200 Zostavax shingles vaccine lawsuits as plaintiffs' testimony falls short “Tuesday, a Pennsylvania federal judge threw out exactly 1,189 cases against Merck in the four-year-long group of cases.
The plaintiffs in the now-dismissed clutch of lawsuits argued Zostavax caused their shingles. But the medical expert attempting to back up that claim failed to consider whether the plaintiffs’ disease occurred naturally because they’d had chickenpox as kids, according to court filings published this week.”

Juul to Pay $1.7 Billion in Legal Settlement “Juul Labs Inc. has agreed to pay $1.7 billion in a broad legal settlement covering more than 5,000 lawsuits, according to people familiar with the matter.
Many of the lawsuits accused the e-cigarette maker of marketing its addictive products to children and teens. Juul has said it never targeted young people and that it has been working to regain the public’s trust.”

About health technology

 Thermo Fisher Bacterial Test Recall Now Deemed Class I “The FDA issued an update on Remel’s Oct. 20 recall of Thermo Fisher Scientific Gram Negative IVD AST Sensititre Plates, deeming it a Class 1 recall because of the risk of serious injury or death from potential false results.
The in vitro diagnostic test assesses the susceptibility of Gram-negative organisms towards certain antibiotics, enabling physicians to select appropriate treatments for infected patients.”

About healthcare finance

 Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war “Amgen is offering around $28 billion in cash for its proposed takeover of Horizon, the company said Monday. The drugmaker is paying a premium of approximately $47.9% on the closing share price of $78.76 per Horizon share on Nov. 29, 2022, the company said in its release.
The deal is expected to close in the first half of 2023, Amgen executives said on a conference call Monday morning.” 

Walgreens sells off more AmerisourceBergen stock “For the second time in as many months, Walgreens Boots Alliance has sold off shares in Pennsylvania-based AmerisourceBergen, this time getting $1 billion that it says it will use, in part, to fund the VillageMD purchase of Summit Health-CityMD.
Deerfield-based Walgreens said in a statement Thursday night that it has sold common stock publicly for about $800 million and that AmerisourceBergen repurchased about $200 million of Walgreens' holdings in the company.”

Today's News and Commentary

About Covid-19

 China’s disappearing data stokes fears of hidden Covid wave  “China is under-reporting coronavirus cases and fatalities, obscuring the scale and severity of the health crisis just as the world’s most populous country enters its deadliest phase of the pandemic, analysts warn. Official statistics on Friday revealed no new deaths and only 16,363 locally transmitted coronavirus cases in China, less than half the peak caseload reported last month.”

About health insurance/insurers

Employers estimate health benefits costs will rise 5.4% next year: Mercer “Analysts at Mercer polled more than 2,000 employers representing 124 million full-time and part-time employees and found that they expect benefits costs to increase by 5.4% next year. And they're expecting faster cost growth to continue in the near future, according to the survey.”

Florida physician gets 40 months for kickbacks, bribes “The former owner of a Sarasota, Fla.-based pain management clinic was sentenced to 40 months in prison for his role in a $4.5 million fraud scheme involving the fentanyl spray Subsys.
Steven Chun, MD, 59, was sentenced after being found guilty on six counts related to receiving kickbacks, according to a Dec. 7 Justice Department news release. Dr. Chun was found guilty in May along with Insys Therapeutics sales representative Daniel Tondre. 
he Justice Department said Insys, through Mr. Tondre, marketed Subsys to Dr. Chun by holding sham speaker events, paying him between $2,400 to $3,000 per event in return for him writing prescriptions for greater quantities and higher doses of the spray than necessary.”

3 providers to pay $22.5M to settle Medicaid fraud allegations in California “Three providers will pay out $22.5 million across two separate settlements to resolve false claims allegations in California, the Department of Justice (DOJ) announced.
Dignity Health and two Tenet Healthcare subsidiaries will settle allegations that they violated both federal and state false claims laws by submitting fraudulent claims to California's Medicaid program, Medi-Cal. Dignity Health will pay $13.5 million to the U.S. government and $1.5 million to the state to resolve the allegations.

About hospitals and healthcare systems

Hospitals in the US are the fullest they’ve been throughout the pandemic – but it’s not just Covid
“Hospitals are more full than they’ve been throughout the Covid-19 pandemic, according to a CNN analysis of data from the US Department of Health and Human Services. But as respiratory virus season surges across the US, it’s much more than Covid that’s filling beds this year.
More than 80% of hospital beds are in use nationwide, jumping 8 percentage points in the past two weeks.”

 U of Michigan Health to acquire, invest $800M in 6-hospital system “The University of Michigan Health's board of regents on Dec. 8 approved a proposed agreement that would see it acquire Lansing, Mich.-based Sparrow Health System to become a $7 billion-health system with more than 200 sites of care.
Ann Arbor-based University of Michigan Health said it will inject $800 million into Sparrow, a six-hospital system, through facility projects, operations and strategic investments over eight years.”

About pharma

 Gov. Jared Polis submits proposal to import prescription drugs from Canada “Gov. Jared Polis is taking action to try to save Coloradans money on their prescription medications. He submitted a proposal to the FDA to import prescription drugs from Canada on Monday. 
This is the first step in getting approval to operate Colorado's ‘Canadian Drug Importation Program.’ The plan aims to save Coloradans an average of 65% on imported medication. 
That could result in $53 to $88 million saved each year.”

Complementary and Alternative Medicines in the Management of Heart Failure: A Scientific Statement From the American Heart Association An excellent review. Go to the end and look at the Figure.

Homeopathic Products The FDA just updated its guidance on these products. In short: “Products labeled as homeopathic and currently marketed in the U.S. have not been reviewed by the FDA for safety and effectiveness to diagnose, treat, cure, prevent or mitigate any diseases or conditions.”
"While products labeled as homeopathic are generally labeled as highly diluted, some of these products have been found to contain measurable amounts of active ingredients and therefore could cause significant patient harm. Additionally, FDA has tested products that were improperly manufactured, which can cause incorrect dilutions and increase the potential for contamination. Further, some products labeled as homeopathic are marketed to treat serious diseases or conditions.”

About the public’s health

Texas state court throws out lawsuit against doctor who violated abortion law “A judge in San Antonio has thrown out a lawsuit filed against a Texas abortion provider who intentionally violated a controversial state abortion law.
The law, known as Senate Bill 8, allows anyone to bring a lawsuit against someone who “aids or abets” in an abortion after about six weeks of pregnancy. On Thursday, state District Judge Aaron Haas in Bexar County said people who have no connection to the prohibited abortion and have not been harmed by it do not have standing to bring these lawsuits.
Thursday’s ruling sets an important precedent but does not overturn the law, said Marc Hearron, senior counsel for the Center for Reproductive Rights.”

 EU Approves Takeda’s Dengue Vaccine “The European Commission (EC) has approved Takeda’s dengue Qdenga vaccine for individuals four years and older in preventing dengue, a mosquito-borne disease that can cause severe bleeding and shock.
The approval was supported by results from multiple clinical trials in which the vaccine prevented 80 percent of symptomatic dengue cases at 12 months after vaccination.”

HHS, Providers Drop Trump Health Worker Conscience Rule Appeals “The Second Circuit Thursday ended a fight over a Trump administration rule that threatened to strip health-care entities of federal money if they disciplined workers for refusing to provide services that violate their moral or religious beliefs.
The federal appeals court certified the parties’ stipulation withdrawing their challenge of a decision that vacated the rule from its review. The rule was touted as a means of strengthening health-care workers’ conscience rights, but never took effect, due to litigation that resulted in its invalidation.”

About healthcare IT

A Twitter data tracker inhabits tens of thousands of websites “Tens of thousands of websites belonging to government agencies, Fortune 500 companies and other organizations host Twitter computer code that sends visitor information to the social media giant, according to research first reported by The Cybersecurity 202 [Washington Post]. And virtually none of them have used a Twitter feature to put restrictions on what the company can do with that data, said digital ad analysis firm Adalytics, which conducted the study.”
Read the study! Many healthcare organizations are affected, including HHS.

More than 620,000 patients' data breached in CommonSpirit ransomware attack, new report shows “More than 620,000 patients of Chicago-based CommonSpirit Health had their data breached in the recent ransomware attack on the nation's second-largest nonprofit health system, according to a report to the HHS Office of Civil Rights.
That cyberattack led to widespread IT outages and appointment disruptions across the health system's nationwide network of hospitals beginning in early October.”

About healthcare finance

Deal volume remains resilient despite headwinds From PwC: “For select sectors, M&A volume retreated when compared to the historic levels experienced in 2021; however, the health services sector continued an impressive display of volume level through the last 12 months (LTM) ending November 15.
While traditional buy-side activity comprised a portion of this volume, an upcoming PwC study has identified the role divestitures can play in creating value in the healthcare sector.
PwC anticipates increased divestitures activity within health services for 2023 based on a variety of economic, regulatory and overall strategic repositioning.” 

Today's News and Commentary

About Covid-19

 Children as young as 6 months can now receive an updated Covid-19 vaccine “The US Food and Drug Administration on Thursday authorized updated Covid-19 vaccines from Moderna and Pfizer/BioNTech for use in children from ages 6 months through 5 years.
The bivalent vaccines target the original strain as well as the BA.4/5 Omicron strains. Bivalent vaccines were previously authorized as a booster for people age 5 and older.”

Vaccine hesitancy prospectively predicts nocebo side-effects following COVID-19 vaccination “Results show that a quantifiable and meaningful portion of COVID-19 vaccine side-effects is predicted by vaccine hesitancy, demonstrating that side-effects comprise a psychosomatic nocebo component in vaccinated individuals. The data reveal distinct risk levels for future side-effects, suggesting the need to tailor public health messaging.”

New Receptor “Decoy” Drug Neutralizes COVID-19 Virus and Its Variants “Scientists at Dana-Farber Cancer Institute have developed a drug that potently neutralizes SARS-CoV-2, the COVID-19 coronavirus, and is equally effective against the Omicron variant and every other tested variant. The drug is designed in such a way that natural selection to maintain infectiousness of the virus should also maintain the drug’s activity against future variants.
The investigational drug, described in a report published today in Science Advances, is not an antibody, but a related molecule known as an ACE2 receptor decoy. Unlike antibodies, the ACE2 decoy is far more difficult for the SARS-CoV-2 virus to evade because mutations in the virus that would enable it to avoid the drug would also reduce the virus’s ability to infect cells.  The Dana-Farber scientists found a way to make this type of drug neutralize coronaviruses more potently in animals infected with COVID-19 and to make it safe to give to patients.”

Federal judge declines 14 states' challenge to CMS vaccine mandate “A federal judge in Louisiana on Dec. 2 declined a case brought by 14 states challenging the Biden administration's rule that requires COVID-19 vaccination for eligible staff at healthcare facilities participating in Medicare and Medicaid programs.”

About health insurance/insurers

 UnitedHealth's LHC Group acquisition delayed until 2023 “Previously expected to close by the end of 2022, United Health Group's acquisition of home-health firm LHC Group will now likely be finalized in the first quarter of 2023, according to an LHC filing with the Securities and Exchange Commission.
The agreement was extended until March 28, according to the filing. UnitedHealth and LHC also certified to the FTC their substantial compliance with a June 10 request for additional information and documentation regarding the proposed acquisition.”

Value-Based Payment As A Tool To Address Excess US Health Spending An excellent review.
A couple takeaways: More Than Half Of Health Care Payments Are Still Based On Fee-For-Service
Savings Attributable To ACOs Range From Just Under 1 Percent To Just Over 6 Percent

About pharma

 RCTs with prognostic digital twins overcome the limitations of external control arms Digital twins are being used for a variety of purposes, including expedited drug development. This article is a good review of what it is and how it is being used.

About the public’s health

 FDA expected to decide on Pfizer RSV vaccine for older adults by May 2023 “KEY POINTS:
Pfizer, in a statement Wednesday, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval process by four months.
The FDA is expected to make a final decision on whether to approve the vaccine by May 2023.
Between 60,000 and 120,000 older adults are hospitalized with RSV every year and 6,000 to 10,000 older adults die from the virus.
There currently is no vaccine.”
 About healthcare IT

Amazon shuts down support for Alexa HIPAA-compliant programs for hospitals, payers “Amazon will no longer support HIPAA compliance on its Alexa devices after launching a program three years ago for some hospitals and payers.
In April 2019, Amazon paved the way for Alexa to be used in healthcare when it announced its Amazon Alexa HIPAA-compliant skills kit for developers. The announcement paved the way for developers to build voice skills that can securely transmit private patient health information.”

Survey of Telehealth Use by Commercial Insurance Enrollees Highlights: 40% of respondents with commercial insurance used telehealth to access health services in the past year. 60% are satisfied with the care they received via telehealth.”
Obviously, convenience was the leading benefit users cites.

Digital Therapeutics Alliance and Curebase release publication setting the stage for a fit-for-purpose evidence standard for digital therapeutics (DTx) “The Digital Therapeutics Alliance (DTA), a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare, in collaboration with DTA Resource Partner, Curebase, a company committed to democratizing access to clinical studies, today released a publication to provide a fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance. 
The publication, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”, outlines foundational principles specific to the DTx category of medicine and baseline expectations for healthcare decision makers (HCDMs) related to the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.”

A new coalition aims to close AI’s credibility gap in medicine with testing and oversight “The group, billing itself as the Coalition for Health AI, called for the creation of independent testing bodies and a national registry of clinical algorithms to allow physicians and patients to assess their suitability and performance, and root out bias that so often skews their results…
Like the many documents of its kind, the coalition’s blueprint is merely a proclamation — a set of principles and recommendations that are eloquently articulated but easily ignored. The group is hoping that its broad membership will help stir a national conversation and concrete steps to start governing the use of AI in medicine. Its blueprint was built with input from Microsoft and Google, MITRE Corp, universities such as Stanford, Duke and Johns Hopkins, and government agencies including the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration, National Institutes of Health, and the Centers for Medicare & Medicaid Services.”

 Augmented Reality and Virtual Reality in Medical Devices A great review of the subject from the FDA.

Today's News and Commentary

About Covid-19

 Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1, and XBB.1 by parental mRNA vaccine or a BA.5-bivalent booster “The results showed that a BA.5-bivalent-booster elicited a high neutralizing titer against BA.4/5 measured at 14- to 32-day post-boost; however, the BA.5-bivalent-booster did not produce robust neutralization against the newly emerged BA.2.75.2, BQ.1.1, or XBB.1. Previous infection significantly enhanced the magnitude and breadth of BA.5-bivalent-booster-elicited neutralization. Our data support a vaccine update strategy that future boosters should match newly emerged circulating SARS-CoV-2 variants.”
In other words, the new bivalent vaccine does not work as well on the new, emerging variants.

CDC encourages people to wear masks to help prevent spread of Covid, flu and RSV over the holidays “KEY POINTS
CDC Director Dr. Rochelle Walensky said wearing a mask is an everyday precaution that people can take to reduce their chances of catching or spreading a respiratory virus.
Flu and respiratory syncytial virus are circulating at high levels at the same time Covid is picking up, straining hospital emergency departments.”

Pfizer countersues Moderna in COVID-19 vaccine patent infringement case “Pfizer and BioNTech filed a countersuit against Moderna Dec. 5 over their rival COVID-19 vaccines made from the same mRNA technology, court documents show. 
Moderna filed suit against Pfizer in late August and accused the drugmaker of infringing on patents and copying its mRNA technology ‘without ever requesting a license.’ 
About three months later, Pfizer submitted an 81-page document in the U.S. District Court in Massachusetts accusing the other pharmaceutical company of writing a ‘revisionist history not based on fact.’”

Paxlovid Has Been Free So Far. Next Year, Sticker Shock Awaits. “Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with covid-19 from being hospitalized or dying, and it may even reduce the risk of developing long covid. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug — the uninsured and seniors — may have to pay the full price.”

About health insurance/insurers

 FAQS ABOUT CONSOLIDATED APPROPRIATIONS ACT, 2021 IMPLEMENTATION - GOOD FAITH ESTIMATES (GFES) FOR UNINSURED (OR SELF-PAY) INDIVIDUALS Q1: Will CMS enforce the requirement that GFEs for uninsured (or self-pay) individuals include cost estimates from co-providers and co-facilities beginning on January 1, 2023?
A1:
No. HHS is extending enforcement discretion, pending future rulemaking, for situations where GFEs for uninsured (or self-pay) individuals do not include expected charges from co- providers or co-facilities.”

Trends In Treat-And-Release Emergency Care Visits With High-Intensity Billing In The US, 2006–19 “We performed an observational study of US treat-and-release ED visits using data from the Nationwide Emergency Department Sample. In 2006, 4.8 percent of treat-and-release ED visits exhibited high-intensity billing, and this figure rose to 19.2 percent by 2019. The proportion of visits for older patients, those with more comorbidities, and those with nonspecific but potentially serious diagnoses grew. Of the observed growth in high-intensity billing, 47 percent was expected, based on changes in administrative measures for patient case-mix and care services.”
The other conclusion is that 53% of the increase was not expected- in other words, overfilling using higher than warranted severity codes.

Trends in Episode-of-Care Spending for Cancer-Directed Surgery Among US Medicare Beneficiaries From 2011 to 2019 “This cross-sectional study revealed that 30-day episode spending for cancer-directed surgery decreased significantly among Medicare fee-for-service beneficiaries. This overall decrease was largely attributable to lower spending associated with inpatient procedures and a concomitant increase in the proportion of surgeries performed in the less-expensive outpatient setting.”

About hospitals and healthcare systems

Leapfrog Recognizes 2022 Top Hospital and Top ASC Recipients FYI

 Faced with costly discharge bottlenecks, hospitals want Congress to pay for patients' extended stays “The hospital lobby is looking to secure temporary per diem Medicare payments from Congress it says are needed to offset increased costs and missed revenues caused by patients who are ready to leave the hospital but have nowhere to go.
Per a new report (PDF) from the American Hospital Association (AHA), the average hospital length-of-stay has increased by 19.2% from 2019 to 2022 as well as by nearly 24% for patients being discharged to a post-acute care provider.
That increase isn’t just due to patients getting sicker during the course of the pandemic. When adjusting by case-mix index, average length-of-stay was still up 15.4% for discharges to post-acute care providers. Adjusted average stays were even higher when discharging to a skilled nursing facility (20.2%) or a psychiatric hospital (28.9%), according to data from Strata Decision Technology cited in AHA’s report.
Rather, acute care hospitals, long-term care hospitals and rehabilitation facilities alike are facing discharge logjams due to industrywide workforce shortages.”

About pharma

Unsubstantiated price hikes drove U.S. drug spending up $805 mln in 2021-report “Price increases spread among seven of the 10 drugs in 2021 behind an $805 million increase in U.S. spending from the prior year were not supported by clinical evidence, an influential U.S. pricing research firm said on Tuesday.
The Institute for Clinical and Economic Review (ICER) said the spending increase in 2021 was still less than the $1.67 billion rise in the previous year. This is the third year the group has looked at the top 250 drugs by spending and assessed if those driving U.S. spending increases were justified.”

 Drugmakers dodge US federal litigation over Zantac after judge tosses lawsuits “A judge in the US on Tuesday rejected the validity of scientific evidence used to back up claims that the withdrawn heartburn drug Zantac (ranitidine) causes a variety of cancers. The decision by US District Judge Robin Rosenberg in West Palm Beach, Florida, means companies such as GSK, Pfizer, Sanofi and Boehringer Ingelheim, which have all marketed the drug at different times, will not have to fight over 1700 lawsuits in federal court, although they still face tens of thousands of similar cases at the state level.”

About the public’s health

 Effects of Diet on 10-Year Atherosclerotic Cardiovascular Disease Risk (from the DASH Trial) “Using data from the original DASH (Dietary Approaches to Stop Hypertension) trial, we determined the effects of adopting the DASH diet on 10-year ASCVD risk compared with adopting a control or a fruits and vegetables (F/V) diet… In conclusion, compared with a typical American diet, the DASH and F/V diets reduced 10-year ASCVD risk scores by about 10% over 8 weeks. These findings are informative for counseling patients on both choices of diet and expectations for 10-year ASCVD risk reduction.”

UnitedHealth report: As mental health concerns rise, more providers are available to treat these needs “The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual "America's Health Rankings" report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%…
However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.”
Comment: The entire report is worth reading for its wealth of different kinds of information.

Cardiometabolic benefits of micronutrient supplements vary “Supplementation of certain micronutrients benefited cardiometabolic health, but others did not, according to a systematic review and meta-analysis.
Specifically, supplementation with omega-3 fatty acids, folic acid and coenzyme Q10 conferred certain benefits, supplementation with vitamin C, vitamin D, vitamin E and selenium had no effect on CVD risk and supplementation with beta-carotene was harmful…”

Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing Findings In this cluster randomized clinical trial of 4131 patients from 28 primary care practices, nudges to clinicians using electronic health record active choice prompts and monthly peer comparison feedback significantly increased statin prescribing by 5.5 percentage points relative to usual care. Nudges to patients by text message before the visit did not significantly increase statin prescribing, but the combination of nudges to clinicians and patients significantly increased statin prescribing by 7.2 percentage points relative to usual care.” [Emphasis added]

Deferral of primary care signals a troubled future for Americans’ health “Primary care visits are down 10.3% on average across U.S. cities relative to pre-pandemic levels. That, combined with more people with chronic diseases like diabetes, obesity, and cancer, and accelerating health care costs as inflation soars, signal a troubled future for the health of Americans…
Commercially insured women between the ages of 20 and 49 are the ones most likely to be resuming visits with their primary care providers. However, the demand is distributed unequally across various metro areas with demand greater in areas like Dallas and Miami compared to Los Angeles, New York City, Philadelphia, Houston, Seattle, and Washington, D.C.”

About healthcare IT

FDA Clears apoQlar’s Surgical Planning Software “The FDA has granted apoQlar 510(k) marketing clearance for its VSI HoloMedicine software device which helps surgeons plan complex procedures using 3D holograms created from flat imaging sources.
The software uses Microsoft’s HoloLens 2, a mixed-reality head-mounted display inside or outside the operating room. Computed tomography scans as well as magnetic resonance imaging and positive emission tomography scans can be used to create to the interactive 3D holograms.”

About health technology

 EU Tells Illumina How to Unwind Deal to Buy Cancer-Test Developer Grail “The European Union on Monday set out the details of a planned order requiring Illumina Inc. to unwind its $7.1 billion acquisition of cancer-test developer Grail Inc.
The European Commission, the bloc’s competition watchdog, said in a so-called statement of objections that it intends to require Illumina to swiftly return Grail to the same level of independence the company had before the acquisition. Grail must also be as competitive after the divestment as it was before the deal closed, the commission said.”

Today's News and Commentary

About Covid-19

 Pfizer asks FDA to clear updated COVID shot for kids under 5 “Pfizer is asking U.S. regulators to authorize its updated COVID-19 vaccine for children under age 5 — not as a booster but part of their initial shots.
Children ages 6 months through 4 years already are supposed to get three extra-small doses of the original Pfizer COVID-19 vaccine — each a tenth of the amount adults receive — as their primary series. If the Food and Drug Administration agrees, a dose of Pfizer’s bivalent omicron-targeting vaccine would be substituted for their third shot.”

US Won’t Back 2022 Patent Waivers for Covid Tests and Treatments “The US won’t agree to waive intellectual-property protections for Covid-19 treatments and tests this year -- aligning with developed-nation peers and delaying prospects for a World Trade Organization accord aimed at boosting global access to life-saving medicines. 
On Tuesday, US Trade Representative Katherine Tai said the agency needs more information about the market dynamics for Covid diagnostics and therapeutics, and plans to ask the US International Trade Commission to launch an investigation into the matter.”

About health insurance/insurers

Association of Medicare Advantage vs Traditional Medicare With 30-Day Mortality Among Patients With Acute Myocardial Infarction “Among Medicare beneficiaries with acute MI, enrollment in Medicare Advantage, compared with traditional Medicare, was significantly associated with modestly lower rates of 30-day mortality in 2009, and the difference was no longer statistically significant by 2018. These findings, considered with other outcomes, may provide insight into differences in treatment and outcomes by Medicare insurance type.”
And in a related editorial: How Much of an “Advantage” Is Medicare Advantage? This commentary provides a thoughtful analysis of differences between MA and FFS Medicare.

Association Between Individual Primary Care Physician Merit-based Incentive Payment System Score and Measures of Process and Patient Outcomes Question  Are higher scores for primary care physicians in the Medicare Merit-based Incentive Payment System (MIPS) associated with better performance on a broad range of clinical process and patient outcome measures?
Findings  In this cross-sectional observational study of 80 246 primary care physicians, MIPS scores were inconsistently related to performance on process and outcome measures, and physicians caring for more medically complex and socially vulnerable patients were more likely to receive low MIPS scores, even when they delivered relatively high-quality care.
Meaning  The MIPS program may not accurately capture the quality of care that primary care physicians provide.”
And in an accompanying editorial: Pay for PerformanceWhen Slogans Overtake Science in Health Policy: “In sum, theory and evidence tell us that quality of care is not as contractible through the payment system as the emphasis in policy would suggest. Talk of a fix that attaches stronger incentives to just the right measures—measures that somehow encompass what is valued and are impervious to the problems discussed above—is vague and fanciful. At some point, the slogans overtook the science, derailing a national conversation about quality improvement that will need to get back on track for progress to be made.”
The entire article is worth reading.

 9 Medicare Advantage plans audited for upcoding by OIG in the last 6 months FYI

The Impact of the COVID-19 Public Health Emergency Expiration on All Types of Health Coverage Key Findings
18 million people could lose Medicaid coverage when the COVID-19 public health emergency (PHE) ends, according to a new analysis.
While many who are currently enrolled in Medicaid will transition to other coverage options, nearly 4 million people (3.8M) will become completely uninsured.
19 states will see their uninsurance rates spike by more than 20 percent.
3.2 million children will transition from Medicaid to separate Children’s Health Insurance Program (CHIP) health plans.”

About hospitals and healthcare systems

Financial updates from 23 health systems: CommonSpirit, Tenet and more FYI

About pharma

Cigna’s PBM Express Scripts Latest To Put Less Pricey Biosimilars Of Abbvie’s Humira On Preferred Drug List “Cigna’s pharmacy benefit manager Express Scripts Monday said it will put ‘multiple’ biosimilar versions of Abbvie’s expensive rheumatoid arthritis drug Humira in the ‘same position as the brand’ on the PBM’s formulary in 2023.
Humira, approved by the U.S. Food and Drug Administration 20 years ago, has for years now been one of the nation’s most costly drugs generating more than $20 billion in sales for its maker, Abbvie in 2021 alone. Cigna and Express Scripts said Humira, which treats inflammatory and skin conditions, is one of the most widely used specialty medications.”

About the public’s health

Rising flu cases drive up U.S. hospitalizations, CDC says “The United States is experiencing the highest levels of hospitalizations from influenza that it has seen in a decade for this time of year, the head of the U.S. Centers for Disease Control and Prevention (CDC) said on Monday, adding that 14 children have died so far this flu season.
CDC Director Rochelle Walensky added that U.S. hospital systems also continue to be stressed with a high number of patients with other respiratory illnesses such as respiratory syncytial virus (RSV) and COVID-19.
There have been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu so far this season, according to CDC estimates. It urged people to get vaccinated.”

 mRNA vaccines take the sting out of malaria infection—and transmission “After nearly four decades of development, the world finally has a malaria vaccine. The first large-scale rollout of GlaxoSmithKline’s RTS,S, or Mosquirix, kicked off at the end of November.
And more are on the way. In September, Oxford researchers reported promising phase 2 results for R21/Matrix-M, which bumps up the efficacy rate against infection from Mosquinix’s 35% to as high as 80%. COVID-19 vaccine-maker BioNTech is working on its own version, too.”

About health technology

 Apple scores victory in dispute over heart monitoring technologies in Apple Watch “The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board, or PTAB, on Tuesday ruled that three AliveCor patents covering heart monitoring technologies for wearable devices were unpatentable. AliveCor alleged in federal court and before the International Trade Commission that Apple had copied the technologies with its Apple Watch, and over the summer an ITC judge found that Apple had infringed on two of three patents AliveCor asserted in its complaint.”

About healthcare finance

 Centene completes sale of Magellan Rx to Prime Therapeutics “Centene has completed its $1.35 billion divestiture of Magellan Rx to Prime Therapeutics.
The move adds Magellan's specialty drug management capabilities to Prime Therapeutics' suite of pharmacy benefit management tools, allowing it to enhance its collection of solutions. Prime is collectively owned by 19 Blues plans and affiliates.
Magellan Rx also brings 1.7 million new PBM members into the fold…”

Today's News and Commentary

About health insurance/insurers

Growth Of Value-Based Care And Accountable Care Organizations In 2022 An excellent update on the growth and types of these organizations.

Medicare Advantage Coverage is Rising for the Declining Share of Medicare Beneficiaries with Retiree Health Benefits From a KFF study: Based on the Survey, we find:

  • Half (50%) of large employers offering retiree health benefits to Medicare-age retirees offer coverage to at least some retirees through a contract with a Medicare Advantage plan, nearly double the share in 2017 (26%).

  • About 44% of large employers that offer Medicare Advantage coverage to their retirees do not give retirees a choice in coverage options.

  • Among larger employers with 1,000 or more workers that offer retiree health benefits through a Medicare Advantage plan, the most commonly cited reason they elected this option was the lower cost.

About hospitals and healthcare systems

Operating Margins Among the Largest For-Profit Health Systems Have Exceeded 2019 Levels for the Majority of the COVID-19 Pandemic The article covers HCA, Tenet and CHS.

About pharma

 Swiss Parliament Approves Motion to Allow FDA-Approved Medical Devices into Market “The Swiss Parliament has cleared the way for legislation to allow non-CE-marked medical devices — including those approved or cleared by the FDA — to be marketed in Switzerland, where only CE-marked medical devices are currently available.”
Comment: This action is a real breakthrough: it allows a device to be used in a European country with only FDA approval.

CVS, Walgreens, Walmart appeal Ohio $650M opioid ruling “Arguing in the U.S. Sixth Circuit Court of Appeals, lawyers for the three pharmacy chains said there was never any proof the companies had violated the federal Controlled Substances Act through dispensing the drugs. It was also unfair to target these companies and therefore allow other pharmacy chains not to contribute to any of the fines imposed, the report added.”

About healthcare IT

Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of the HIPAA Rules.For example, disclosures of PHI to tracking technology vendors for marketing purposes, without individuals’ HIPAA-compliant authorizations, would constitute impermissible disclosures.”[Emphasis in original].
These guidelines come after exposure that many hospitals have been using third-party tracking tools, such as Google Analytics or Meta Pixel, to perform analysis on their data.

About health technology

 Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics “The outdated framework has forced the agency to regulate a test based on where it is made — by a medical device manufacturer, for example, or in an academic or clinical laboratory — rather than its distinctive complexity or potential risks. The result is an obsolete and bifurcated approach that leaves patients and providers often overestimating the amount of oversight that’s been applied to tests that matter for increasingly important clinical decisions, and that leaves test developers facing both uncertainty and inefficient regulatory burdens.”
An excellent review of what is needed to correct this problem.

Today's News and Commentary

About Covid-19

 ‘The more you submit, the more we get paid’: How fintech fueled covid aid fraud A great piece of investigative journalism.

About health insurance/insurers

Assessment of Churn in Coverage Among California’s Health Insurance Marketplace Enrollees Findings  In this cross-sectional study of 5.4 million enrollees in California’s health insurance marketplace, from 2014 through 2021, many had short enrollment tenures, with a median tenure of 14 months. Survey data from 6474 members who terminated coverage in 2018, 2019, or 2021 indicated that most churn was associated with changes in eligibility; most disenrolled individuals took up other types of coverage (46% through an employer and 24% through Medicaid), with only 14% going uninsured.
Meaning  This study found that health insurance marketplace churn was largely the result of changes in eligibility to other sources of coverage rather than enrollees taking up coverage only when they needed care, suggesting that marketplaces should adopt policies to smooth the high volume of coverage transitions among its enrollees.”

Trends in and Factors Contributing to the Slowdown in Medicare Spending Growth, 2007-2018 Findings  In this analysis of individual-level Medicare spending data of more than 30 million beneficiaries, 44% of the decline in per-beneficiary spending growth from 2012 to 2015 and 63% from 2016 to 2018 could be attributed to lower increases in payment rates, sequestration measures, and shifts in beneficiary characteristics.
Meaning  Continued attention to Medicare payment policies and how to target them appropriately will be needed to maintain slow spending growth and extend the Medicare program’s sustainability.”

About hospitals and healthcare systems

 Trinity Health weathers $565M net loss, -2.9% operating margin to start its 2023 fiscal year “Revenue growth from Trinity Health’s recent MercyOne acquisition wasn’t enough to outpace volume struggles and rising expenses during the Catholic health giant’s first fiscal quarter of 2023.
Thursday, the 88-hospital system reported a $146.3 million operating loss (-2.9% operating margin) and a $565 million net loss for the quarter ended Sept. 30, 2022. The organization had notched a $106.3 million operating gain and a $378.8 million net profit at this time last year.”

About pharma

 Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland Findings  This cohort study found that fewer biosimilars entered the market in the US between 2011 and 2020 compared with Germany and Switzerland and on average, the biosimilar market share at launch was highest in Germany yet increased at the fastest rate in the US. Monthly treatment costs of biosimilars were substantially higher in the US compared with Germany and Switzerland.
Meaning  These findings suggest that policies aimed against anticompetitive practices could allow biosimilars to enter the US market more quickly and could result in overall lower costs and that awareness of biosimilars should be promoted to increase uptake of biosimilars globally.”

About the public’s health

Biden administration poised to lift monkeypox emergency declaration “The Biden administration plans to end the public health emergency for monkeypox, officials said Friday, as new cases of the viral disease plummet.
Officials at the Department of Health and Human Services issued a 60-day notice to lift the emergency declaration, which had gone into effect in August.”

On World AIDS Day, Biden administration releases new global strategy to end HIV/AIDS by 2030 “On World AIDS Day, the Biden administration renewed its focus on ending the HIV/AIDS epidemic by 2030, releasing a new five-year strategy for the United States’ global response.
The administration said Thursday it is accelerating its response to HIV/AIDS with new global goals including reaching key treatment targets across ages, genders and population groups; supporting UNAIDS targets to reduce new HIV infections; and closing equity gaps for certain groups, including adolescent girls, young women and children.

About healthcare IT

 Telehealth department dissolving, Marshfield Clinic Health System facing financial difficulties “Another department within the Marshfield Clinic Health System has been dissolved as of Thursday. The Telehealth team of 18 employees was told in a meeting Oct. 27 that their positions were being eliminated due to “business reasons,” effective Dec. 1.” 

Today's News and Commentary

About Covid-19

 Coronavirus in the U.S.: Latest Map and Case Count As of the week closed 11/30:
Cases:45,21914 +15%
Test positivity:10% +26%
Hospitalized: 32,445 +16%
In I.C.Us: 3,794 +16%
Deaths: 262 (-7%) 

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers This article has been quoted widely in the press with the conclusion that medical masks are just as good as N95 Respirators in preventing COVID-19. However, the results varied greatly among the countries where the study was carried out. N95s are still the safest choice for prevention.

Long Covid may be ‘the next public health disaster’ — with a $3.7 trillion economic impact rivaling the Great Recession “Long Covid has affected as many as 23 million Americans. It may cost the U.S. economy $3.7 trillion, roughly that of the Great Recession, according to one estimate.”

About health insurance/insurers

Highmark posts $268M loss across three quarters as investments, labor issues ding finances “Highmark Health posted a $268 million net loss through the first nine months of 2022 as multiple headwinds drag its finances.
Highmark reported $19.5 billion in revenue, up 22% year-over-year, and $594 million in operating gain. The performance of its equity investment portfolio is a key challenge facing the integrated system, as its financial report includes $670 million in unrealized investment impact driven by a decline in the portfolio…
Other major headwinds include ongoing supply chain issues, inflation and high labor costs, particularly at its Allegheny Health Network health system. Strong performance at its health plan arm is helping to bolster AHN as it weathers these challenges that providers nationwide are staring down.”

UnitedHealthcare loses to TeamHealth — again — over alleged underpayments “A three-judge arbitration panel in Florida ruled that UnitedHealthcare must award $10.8 million to a TeamHealth clinician group for underpayments from 2017 to 2020. 
The verdict is the latest in a contentious legal history between the payer and the Knoxville, Tenn.-based physician staffing company. A jury ruled in December 2021 that UnitedHealthcare must pay $60 million in punitive damages after losing a Nevada lawsuit against TeamHealth over thousands of provider underpayments for emergency services. TeamHealth medical groups have eight additional lawsuits pending across the country challenging the payer's alleged underpayment practices, according to a Nov. 30 TeamHealth news release.”

About hospitals and healthcare systems

 National Hospital Flash Report, November 2022 “Key Takeaways”

  1. Margins remain negative in October.
    October represented another month of negative operating margins for hospitals, with a slight downturn from September. As the year comes to a close, compounding months of poor performance could signal continued difficulties for hospitals in the near future.

  2. Expense pressures drive poor performance.
    Hospitals continue to face the significant weight of high expenses outpacing revenues, particularly when it comes to the cost of labor. Additionally, hospitals are turning to external sources for services like IT and human resources support, instead of keeping them in house at a lower cost. Finally, the high cost of materials due to inflation has not abated.

  3. Hospitals struggle to discharge patients.
    Hospitals struggled to discharge patients in October due to internal labor shortages and shortages in post-acute settings. The struggle to discharge patients led to a slight increase in length of stay. However, longer stays did not translate to additional revenue for hospitals.

  4. Emergency department visits and operating room minutes increase slightly.
    Hospitals experienced slight increases in both categories from September to October. However, the increase in emergency department (ED) visits put further strain on hospitals as many were unable to admit patients needing in-patient care due to staffing shortages. Many hospitals were forced to board patients in the ED leading to increased pressure on ED staff.” 

Mayo Clinic, Intermountain, HCA post quarterly incomes when many systems see losses “Labor challenges, rising costs, inflation and declining inpatient volumes are some of the key factors leading to many hospitals and health systems reporting third-quarter losses. However, Mayo Clinic, HCA Healthcare and Intermountain Healthcare are three systems that have bucked that trend.
While income did slip for these health systems, according to recent financial reports, the drops were not as significant as other healthcare organizations, with all three still reporting an income over a loss for the quarter.”

About the public’s health

 Drug Overdose Deaths in Adults Aged 65 and Over: United States, 2000–2020 

  • “Between 2000 and 2020, age-adjusted rates of drug overdose deaths for adults aged 65 and over increased from 2.4 to 8.8 deaths per 100,000 standard population.

  • For men aged 65–74 and 75 and over, rates of drug overdose deaths were higher among non-Hispanic Black men compared with Hispanic and non-Hispanic White men.

  • For women aged 65–74, drug overdose death rates were higher for non-Hispanic Black women compared with Hispanic and non-Hispanic White women, but for women aged 75 and over, non-Hispanic White women had the highest rates.

  • The age-adjusted rate of drug overdose deaths involving synthetic opioids other than methadone (such as fentanyl) for adults aged 65 and over increased by 53% between 2019 (1.9) and 2020 (2.9).”

 
CDC expands wastewater testing for polio to Michigan and Pennsylvania “The Centers for Disease Control and Prevention is expanding efforts to test wastewater to detect the polio virus in Philadelphia and the Detroit area, targeting communities at highest risk for the life-threatening and potentially disabling illness, officials said Wednesday.
The expansion of wastewater monitoring for polio comes amid pressure to increase efforts to fight the disease after the first U.S. polio case in nearly a decade was discovered in New York’s Rockland County in July.”

Is Spreading Medical Misinformation a Doctor’s Free Speech Right? “When Gov. Gavin Newsom signed into law a bill that would punish California doctors for spreading false information about Covid-19 vaccines and treatments, he pledged that it would apply only in the most “egregious instances” of misleading patients.
It may never have the chance.
|Even before the law, the nation’s first of its kind, takes effect on Jan. 1, it faces two legal challenges seeking to declare it an unconstitutional infringement of free speech. The plaintiffs include doctors who have spoken out against government and expert recommendations during the pandemic, as well as legal organizations from both sides of the political spectrum.”

About health technology

 U.S. FDA gives first-ever approval to fecal transplant therapy “The U.S. health regulator on Wednesday approved Switzerland-based Ferring Pharmaceuticals' fecal transplant-based therapy to reduce the recurrence of a bacterial infection, making it the first therapy of its kind to be cleared in the United States.
The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. In the United States, the infection is associated with 15,000-30,000 deaths annually.”

About healthcare finance

GE board approves GE healthcare spinoff “GE said Nov. 30 its board approved the planned spin-off of its healthcare business, GE Healthcare. 
GE announced June 26, 2018, that it would spin off its healthcare business into a standalone enterprise as part of its plan to split into three public companies. Under the spinoff, shareholders will receive one share of the new company for every three GE shares they hold on Dec. 16, according to a press release from GE. 
The new company is also expected to begin trading on Nasdaq Jan. 4, under the symbol GEHC.”

Today's News and Commentary

About Covid-19

 BB variant's arrival won't cause a new deadly COVID surge, officials hope “The Centers for Disease Control and Prevention revealed Friday it is now tracking a new COVID-19 variant of concern around the U.S. known as XBB, which has grown to make up an estimated 3.1% of new infections nationwide. 
The strain's prevalence has grown furthest so far in the Northeast, according to the agency's weekly estimates. More than 5% of infections in the regions spanning New Jersey through Maine are linked to XBB…”

Twitter ends its ban on covid misinformation “Twitter will no longer enforce its policy against coronavirus misinformation, worrying experts who say the move could have serious consequences in the midst of a still-deadly pandemic.”  

About health insurance/insurers

AHIP says Medicare Advantage audit reports 'fail to provide context' “AHIP is pushing back on claims that Medicare Advantage plans are overcharging the government. 
In a Nov. 28 press release, the trade association rebutted a Nov. 21 story from Kaiser Health News detailing CMS audits of Medicare Advantage plans conducted between 2011 and 2013. 
The audits showed some plans overbilled an average of more than $1,000 per patient per year…
In the release, AHIP said the CMS audit process relies on physician records and suggested the agency create an ‘open, transparent and collaborative’ process for oversight.”

Humana shuttering most SeniorBridge home care locations “SeniorBridge offers services at 23 centers in nine states. The facilities in Arizona, Connecticut, Florida, Massachusetts, New Jersey, Ohio, Texas and Virginia will close, while seven sites in New York will remain in operation ‘until further notice,’ the Humana spokesperson wrote in an email.”

About hospitals and healthcare systems

How Elevance Health is working with NCQA and Harvard to advance its health equity work “Elevance Health, formerly Anthem, announced that 21 of its affiliated Medicaid plans earned full three-year accreditation for health equity from NCQA. The health equity accreditation provides an actionable framework to guide and evaluate organizations' health equity work, according to the nonprofit organization.
The accreditation was earned by Elevance Health affiliates in 20 U.S. states.”
The Health Equity accreditation is a relatively new NCQA process.

Cleveland Clinic's net losses reach $1.5B so far in 2022 “Cleveland Clinic has reported a more than $1 billion loss for the first nine months of 2022 as salaries increase and inflationary pressures mount.
The 20-hospital health system reported $469.2 million in third quarter net losses, a significant drop from $422.2 million net income last year. Cleveland Clinic's investment returns were nearly $682 million lower for the third quarter this year than last due to ‘unfavorable financial markets,’ according to the health system's financial report.
For the nine month's end, Cleveland Clinic reported $1.5 billion net loss compared to nearly $1.7 billion net income over the same period last year.”

About the public’s health

 Meal Skipping and Shorter Meal Intervals Are Associated with Increased Risk of All-Cause and Cardiovascular Disease Mortality among US Adults “In this large, prospective study of US adults aged 40 years or older, eating one meal per day was associated with an increased risk of all-cause and CVD mortality. Skipping breakfast was associated with increased risk of CVD mortality, whereas skipping lunch or dinner was associated with increased risk of all-cause mortality. Among participant with three meals per day, a meal interval of ≤4.5 hours in two adjacent meals was associated with higher all-cause mortality.”

 CDC awards over $3 bln to strengthen U.S. public health infrastructure “The Centers for Disease Control and Prevention (CDC) said on Tuesday it is awarding more than $3 billion to help strengthen public health workforce and infrastructure across the United States after the COVID-19 pandemic put severe stress on them.
The public health agency's funding includes $3 billion from the American Rescue Plan announced by President Joe Biden's administration last year, and would cover all state, local and territorial health departments across the country.
It also includes $140 million from a new appropriation to those jurisdictions and an award of $65 million to three public health entities to help provide training and technical assistance.”

Trends and Disparities in Firearm Fatalities in the United States, 1990-2021 “In this cross-sectional study of 1 110 421 firearm fatalities, all-intent firearm fatality rates declined to a low in 2004, then increased 45.5% by 2021. Firearm homicides were highest among Black non-Hispanic males, and firearm suicide rates were highest among White non-Hispanic men ages 70 years and older.”

Weekly U.S. Influenza Surveillance Report “Five influenza-associated pediatric deaths were reported this week, for a total of 12 pediatric flu deaths reported so far this season.
CDC estimates that, so far this season, there have been at least 6.2 million illnesses, 53,000 hospitalizations, and 2,900 deaths from flu.
The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 46 during every previous season since 2010-2011.”

Trends in Stage I Lung Cancer “Highlights:
The percentage of patients diagnosed with stage I lung cancer is increasing
This trend is observed in non-small cell lung cancer but not in small cell lung cancer
The staging shift may be due to lung cancer screening and a higher detection of incidental lung nodules
There are significant imbalances in the percentages of stage I lung cancer according to demographic characteristic”

 About health technology

THE BEST INVENTIONS OF 2022 From Time magazine. Many of the inventions are healthcare relayed.