Today's News and Commentary

About the public’s health

Suicide Rates by Industry and Occupation — National Violent Death Reporting System, 32 States, 2016: The CDC issued this report today. It is a good resource for those dealing with potential patient suicides. As an example, men working in construction and mining trades have a much higher risk of suicide than the average population.

US Surgeon General: Not enough smokers are being told they should quit: This story was in many media outlets today. The basic message is in the headline with details in the Surgeon General’s report.

About healthcare quality

CMS tool to help consumers make informed care decisions: “Administrator Seema Verma announced on Thursday that the agency is planning to combine and standardize its eight separate Compare tools on Medicare.gov—Hospital, Nursing Home, Home Health, Dialysis Facility, Long-term Care Hospital, Inpatient Rehabilitation Facility, Physician and Hospice)—to enable consumers to better differentiate providers.” The revised tool is scheduled to be available later this year.

About healthcare IT

FDA issues cybersecurity warning on GE medical equipment that monitors patients: “The Food and Drug Administration released a warning on Thursday to health-care providers, facilities and consumers about a vulnerability in certain electronic health-care data equipment made by General Electric.
The flaw could allow a person to tamper with the devices in order to “silence alarms, generate false alarms and interfere with alarms of patient monitors connected to these devices,” the release says.” This instance is yet another example of the hack-ability of medical peripherals.

Epic releases software update to help identify coronavirus infections: The update revises Epic’s standard travel screening questionnaire “to remind clinicians and other front-line staff to ask patients about recent international travel. If the patient has traveled from China or has symptoms of Wuhan novel coronavirus, the provider is advised to start isolation precautions to contain potential infection.”

About pharma

Want to know how contentious drug pricing is in Washington? Check the receipts: “Pfizer, Johnson & Johnson, Merck, and the 31 other major drug makers that belong to the trade group PhRMA together spent more than $120 million lobbying Congress in 2019, according to recently released federal disclosures.
That helped pay for an army of over 450 lobbyists who helped the drug makers and their trade group vehemently oppose the sweeping proposals lawmakers and the Trump administration put forth in their efforts to lower prescription drug prices.
PhRMA also broke its all-time annual lobbying record this year. It spent $28.9 million in 2019, surpassing its previous record of $27.5 million, set last year.”
Read the article for more details of this massive lobbying campaign.

About medical devices

FDA approves Medtronic's tiny, wireless, minimally invasive pacemaker implant: This technology is a real breakthrough: a pacemaker that does not require the wiring of separate electrodes between the implant and the heart.
“Less than one-tenth the size of traditional pacemakers and described as one of the world’s smallest, the Micra AV device is designed to be placed entirely within the heart’s right ventricle and attach itself to the muscle wall using small tines.
It is implanted via a catheter and a minimally invasive procedure…”

About health insurance

The answer to America’s health care cost problem might be in Maryland: Maryland is different from other states in how its hospitals are paid.
”Since the 1970s, the state has set the prices hospitals can charge for medical care, known as all-payer rate setting.” Even Medicare regs dovetail with this system. Further, since 2014, “it’s also capped how much health spending can grow overall, including how much revenue each hospital can take in.”
This Vox article is a good summary of this system and how controls cost.

Today's News and Commentary

About pharma

Blues plans invest in new generic drug company: “Eighteen Blue Cross Blue Shield insurers are investing a combined $55 million to build a new generic drug company as a subsidiary of the nonprofit Civica Rx. The firm will focus on manufacturing generics people get at the pharmacy.” In addition to providers, payers are now getting into the pharma space.

Interesting science

Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study: This promising study shows the efficacy of an oral influenza vaccine. Such technology could revolutionize public health by eliminating temperature restrictions and enhancing portability and ease of administration.

About health insurance

Medicare Surgical Payments Should Be Updated to Reflect Postoperative Care That Is Actually Provided: This research from the RAND corporation and published in the New England Journal of Medicine looks at Medicare payments for post operative services. Post-op care (usually for the first 90 days) is bundled into the payments for the surgical procedure itself. However, many of those visits do not take place. If Medicare (Part B) accounted for those reduced services, it would have saved $2.6 billion in 2018. Recall that the work component of these payments is determined by the AMA committee that sets the RBRVS weights.

Critics: consumers should be wary of short-term health plans: A reminder of the severe pitfalls of choosing a short-term health plan.

Trump 'going to look' at Medicare cuts: This short article summarizes Trump’s statements about Medicare during a wide-ranging interview at Davos with CNBC’s Joe Kernen. No specifics, but entitlement programs were on the budget-cutting table.

About healthcare IT

Humana to allow members to connect hundreds of wearables to Go365 wellness program: “Humana is teaming up with health data company Validic to allow its members to connect a slew of wearable devices to the insurer’s Go365 wellness program.” The article does raise the issue of whether such programs improve health but does not address the security issues when such interoperable software is connected.

2020-2025: Federal Health IT Strategic Plan: This plan from the Office of the National Coordinator lists four overall goals (each with subsections on objectives and strategies):
—Promote Health and Wellness
—Enhance the Delivery and Experience of Care
—Build a Secure, Data-Driven Ecosystem to Accelerate Research and Innovation
—Connect Healthcare and Health Data through an Interoperable Health IT Infrastructure
With regard to the last goal, Epic’s CEO sent a letter to large hospital clients claiming the interoperability requirements would give app makers unauthorized access to patient data. Consumer groups want more interoperability, so one wonders how much of the concern is really over protecting her business.

2019 CAQH INDEX®: Conducting Electronic Business Transactions: Why Greater Harmonization Across the Industry is Needed: CAQH is a consortium of large payers whose mission is: “To accelerate the transformation of business processes in healthcare through collaboration, innovation and a commitment to ensuring value across stakeholders.” This monograph looks at the potential savings of electronic business transactions over manual processes. From a percent improvement standpoint, the greatest potential is in prior authorizations, of which only 13% are being conducted electronically.

About the public’s health

A couple insightful articles about the Chinese corona virus:

Appetite for 'warm meat' drives risk of disease in Hong Kong and China: “For various reasons, the Chinese prefer freshly slaughtered pig, chicken and beef over chilled or frozen meat that has been slaughtered before being shipped.
That desire is at the heart of why diseases such as avian flu in poultry and ASF [African swine fever] been so difficult to eradicate, with huge movements of live animals from all over the country – from farm to slaughterhouse to market – on a daily basis making controlling the spread of disease incredibly difficult.”
The coronavirus outbreak is linked to a market in Wuhan, eastern China where the meat was freshly slaughtered. “Like other respiratory illnesses, the disease was initially transmitted from animal to human, but is now being passed from human to human.” For deep cultural reasons, this habit may be hard to control without strict governmental intervention, not only now (as was quickly done) but in the future.

How China’s slow response aided coronavirus outbreak: This article is a good summary of how the Chinese government reacted to initial cases of the virus. One metric was holding hospital administrators to a “zero infections” target among staff; failure to comply could result in loss of their jobs. Obviously the policy slowed reporting of infections among nurses. This article is from the Financial Times (available by subscription only), so if you can get a copy it is well worth it.

Today's News and Commentary

About the public’s health

7 things to know about the coronavirus outbreak: Good summary to-date of the outbreak.

A self-aggregating peptide: implications for the development of thermostable vaccine candidates: Vaccines delivered to warm areas without refrigeration will quickly degrade. This animal research shows great promise for thermostabile vaccines that will retain their potency for at least a year.

About healthcare quality and safety

ISMP Publishes Top 10 List of Medication Errors and Hazards Covered in Newsletter: The Institute for Safe Medication Practices published its annual errors and hazards list. Among the items is selecting the wrong medication after entering the first few letters of the drug name in the EMR.

About health insurance

UnitedHealth: MA plan holders save nearly 40% more compared to fee-for-service Medicare beneficiaries: “UnitedHealth’s analysis, which was conducted by consulting firm Milliman, found that the average annual healthcare costs for a 72-year-old MA beneficiary were $3,632 and $5,960 for beneficiaries on fee-for-service…The analysis also found that a typical MA beneficiary who also has Part D prescription drug coverage spends $1,477 less than beneficiaries on fee-for-service with Part D coverage.”

340B has minimal effect on health spending, study finds: MedPAC “found that for 340B hospitals, spending on cancer drugs was 2 percent to 5 percent higher than hospitals that don't participate in the program and 1 percent to 7 percent higher than physician offices, a modest increase in overall healthcare spending since 2018.
The spending also depends on the type of cancer. MedPAC found that spending on cancer drugs was only higher among 340B hospitals for prostate and lung cancer. These increases couldn't be definitively linked to incentives from the 340B program and could be due to other factors…”

Today's News and Commentary

About pharma

Prices cut by an average of 53% under China's latest update to centralised procurement programme for generic drugs: What happens when a government starts negotiating pharma prices?

Study finds fewer than half of US clinical trials complied with new regulations on reporting results : “…compliance with US regulations requiring clinical trials to report results within one year of completion remains poor, with about one in three trials remaining unreported. The findings also indicate that studies backed by non-industry sponsors such as universities, hospitals and governments are more likely to breach the rules than those sponsored by industry, with US government-backed trials least likely to post results on time at the ClinicalTrials.gov registry.”

How the 8 biggest U.S. pharmas enriched their shareholders in 2019: These companies did well by taking advantage of new tax laws and buying back shares. The eight companies are profiled in more detail.

How Civica Rx became a force in the generic drug industry: A timeline: I have been reporting on CivicaRx since inception. This article provides a timeline of its development.

10 most expensive drugs for Medicare Part B and
10 most expensive drugs for Medicare Part D: The headlines speak for themselves.

About healthcare policy

Envisioning a Better U.S. Health Care System for All: Coverage and Cost of Care: This comprehensive policy paper from the American College of Physicians is well worth the read. “Part 1 of this paper discusses why the United States needs to do better in addressing coverage and cost. Part 2 presents 2 potential approaches to achieve universal coverage. Part 3 describes how an emphasis on value-based care can reduce costs.”

About healthcare IT

Hospitals Give Tech Giants Access to Detailed Medical Records: “Deals with Microsoft, IBM and Google reveal the power medical providers have in deciding how patients’ sensitive health data is shared.” This article from today’s print edition of the Wall Street Journal is a good summary of how our health data is being shared.

About health insurance

Supreme Court declines to hear case challenging legality of ACA: “The Supreme Court will wait for a federal appeals court to decide on the constitutionality of the Affordable Care Act, meaning that a final decision on the law won’t come before the 2020 election.”

Supreme Court to hear Trump appeal in Obamacare contraception fight: “At issue is a challenge by the states of Pennsylvania and New Jersey to the administration’s 2018 rule that permits broad religious and moral exemptions to the Affordable Care Act’s contraception mandate and expands accommodations already allowed under the 2010 law dubbed Obamacare. The administration has asked the Supreme Court to reverse a nationwide injunction issued by a lower court blocking the rule from taking effect.”

Predicting Hospitalizations From Electronic Health Record Data: Insurance companies want to be able to predict hospitalizations to gauge future costs and hopefully prevent those events. Where can they find data for such predictions? “Prediction models using EHR-only, claims-only, and combined data had similar predictive value and demonstrated strong discrimination for which patients will be hospitalized in the ensuing 6 months.” Combined data was no better than either source alone.

Trump Administration to Soon Issue Guidance on Medicaid Block Grants: “The Trump administration plans to release guidance as soon as this month for granting states waivers to convert Medicaid funding to block grants.”

CMS-specified shoppable services accounted for 12% of 2017 health care spending among individuals with employer-sponsored insurance: This analysis for CMS by the Health Care Cost Containment Institute drew the same conclusions as a previous commercial insurance study. Only a small portion of healthcare expenses are shoppable and can, therefore, be controlled by patients making better decisions: “Our analysis shows that the 70 CMS-specified shoppable services totaled 12 percent of 2017 medical spending (excluding prescription drug spending from the denominator) among individuals with employer-sponsored insurance. These services made up 16 percent of out-of-pocket medical spending.”

About the public’s health

First U.S. case of potentially deadly coronavirus confirmed in Washington state: Since last month, public health authorities have been closely following the spread of this virus (in the same class as SARS) from its origin in the central Chinese city of Wuhan. Now it has reached the U.S. Screening is staring at such major airports as San Francisco (SFO), New York (JFK), Los Angeles (LAX) and Chicago (ORD). The difference between SARS and this viral outbreak is that this time there has been more transparency by the Chinese government.

About promising technology

Discovery of new T-cell raises prospect of ‘universal’ cancer therapy: “Cardiff [University] researchers have now discovered T-cells equipped with a new type of T-cell receptor (TCR) which recognises and kills most human cancer types, while ignoring healthy cells.
This TCR recognises a molecule present on the surface of a wide range of cancer cells as well as in many of the body’s normal cells but, remarkably, is able to distinguish between healthy cells and cancerous ones, killing only the latter.”

Today's News and Commentary

About pharma

Think JPM seemed slow this year? You're not alone—and here's why: Here is a rundown of the annual JP Morgan Healthcare Conference. Slower than usual. Here are some thoughtful questions from hospitals CEOs.

FDA says ’no’ to another new opioid: “For the third time this week, a joint FDA advisory committee rejected a new opioid drug, highlighting a growing conviction among experts that abuse-deterrent formulations can do little to slow the opioid epidemic.”

About health insurance

Urban Institute: Premiums for cheapest ACA silver plan fell across 31 states in 2020: The headline is the “bottom line” for the story. This finding is significant because of the “silver loading” of plan premiums (so insurers can get maximum governmental subsidies). Keep in mind, though, rates vary greatly among states and there are some where premiums increased.

MedPAC recommends 3.3% payment boost for hospitals in 2021: The Medicare Payment Advisory Commission is recommending a 3.3 percent raise in Medicare payments for hospitals in 2021; CMS planned on a 2.8% increase. The 3.3% would be divided between a 2% overall increase and a 1.3% quality performance bonus.
”MedPAC said it is recommending the payment boost to reduce the disparity in payments at different care sites and is part of a larger effort to introduce site-neutral payments.”
Congress has the final word on the funding.

About healthcare professionals

29 physician specialties ranked by burnout rates: Physician burnout has been a big topic over the past year. Causes such as stress due to EMR use have been discussed. This article provides a ranking of which specialties are stressed the most and least.

About the public’s health

Millennials least likely to get a flu shot, and anti-vax beliefs may play a role: 55 percent of “people in their 20s and 30s said they did not get the flu vaccine this year. Their reasoning, usually, was that they didn't have time or simply forgot.
But the poll also uncovered another potential reason for forgoing the flu shot: 61 percent of millennials familiar with the anti-vaccination movement said they agreed with at least some of those beliefs.”

About diagnostics

Foxconn backs digital X-ray startup Nanox’s $26M round: The technology explained in this article is interesting but perhaps more so is the business model— pay per scan by the radiologists.

Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study: This article explains how Fitbit can be used as an epidemiologic tool to isolate early cases of the flu: Pulse goes up with fever as activity decreases.

Today's News and Commentary

About the public’s health

Global reach of ageism on older persons’ health: A systematic review: “Ageism led to significantly worse health outcomes in 95.5% of the studies and 74.0% of the 1,159 ageism-health associations examined. The studies reported ageism effects in all 45 countries, 11 health domains, and 25 years studied, with the prevalence of significant findings increasing over time (p < .0001). A greater prevalence of significant ageism-health findings was found in less-developed countries than more-developed countries (p = .0002). Older persons who were less educated were particularly likely to experience adverse health effects of ageism. Evidence of ageism was found across the age, sex, and race/ethnicity of the targeters (i.e., persons perpetrating ageism).” As the global population ages, we clearly need to address this type of discrimination.

How Anti-Vaccine Activists Doomed a Bill in New Jersey: The headline is the story. It is a fascinating (and sad) tale of how lobbying killed a law that would improve the public’s health.

Sex Differences in Blood Pressure Trajectories Over the Life Course: This sex difference is new clinical information. When we construct Artificial Intelligence algorithms for treatment, it must be flexible enough to incorporate such new information.
“In contrast with the notion that important vascular disease processes in women lag behind men by 10 to 20 years, sex-specific analyses indicate that BP measures actually progress more rapidly in women than in men, beginning early in life. This early-onset sexual dimorphism may set the stage for later-life cardiovascular diseases that tend to present differently, not simply later, in women compared with men.”

About pharma

Pharmacy Owners Express Concern Over Amazon’s PillPack Prescription Transfer Requests: “Independent pharmacists are expressing concern over a growing practice involving Amazon’s Pillpack, describing what some believe is the company sending unsolicited phone calls to their patients as a way of requesting transfers of prescriptions.”

Civica Rx Partners with Thermo Fisher Scientific to Develop and Manufacture Drugs with a History of Drug Shortages: Civica announced “it has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications with Civica as the owner of the regulatory pathway. By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug shortages in the future.”

About healthcare professionals

Half of doctors would take a pay cut for less hours, more work-life balance: “Half of physicians said they would take a salary reduction of up to $20,000 per year in exchange for working less hours and achieving a better work-life balance, according to a new survey…Millennials (52%), Generation Xers (48%) and baby boomers (49%) all said they would take a salary cut in exchange for more personal time. That was true even among millennials, who typically earn less than their more established peers. Some 53% of women said they would take a pay cut, versus 47% of men.”

How brands can inspire doctors to take more action: “Our qualitative research, validated though quantitative research, identified four major motivators for physicians, one rational and three emotional.” Key on pages five and six of the report. Think about how you would market products and services to physicians given this decision-making information.

Interesting science

Intratumoral expression of IL-7 and IL-12 using an oncolytic virus increases systemic sensitivity to immune checkpoint blockade: In mouse models, injecting a viral fragment encoded with inflammatory genes resulted in complete tumor regression, even in distant tumor deposits. “Mice achieving complete tumor regression resisted rechallenge with the same tumor cells, suggesting establishment of long-term tumor-specific immune memory. Combining this virotherapy with anti–programmed cell death-1 (PD-1) or anti–cytotoxic T lymphocyte antigen 4 (CTLA4) antibody further increased the antitumor activity as compared to virotherapy alone, in tumor models unresponsive to either of the checkpoint inhibitor monotherapies.” Benefits were seen for melanoma and, to a lesser extent, colon cancer.

About health insurance

Projected costs of single-payer healthcare financing in the United States: A systematic review of economic analyses: This study will undoubtedly be in the news in the coming days. “To achieve net savings, single-payer plans rely on simplified billing and negotiated drug price reductions, as well as global budgets to control spending growth over time.”
Not included in administrative costs for Medicare are all the fraudulent activities the program incurs because of weak oversight compared to private plans. Further, private plans offer a large variety of benefits and payment methods because the public wants such choice; that choice adds to administrative costs of plans.
One further caution, the administrative cost difference between Medicare and private plans is not as great as first appears. One reason Medicare administrative costs are “lower” is healthcare expenses are much higher than commercial populations, i.e., as the denominator increases, the percent decreases.

Repeal of Obamacare taxes stirs questions on durability of offsets: The 2019 Congressional budget resulted in repeal of three health care taxes — a 2.3 percent levy on medical devices, a fee on health insurers and a 40 percent excise tax on high-cost health plans (also known as the Cadillac tax). Despite estimates that these taxes would have produced $373 billion over a decade, the liberal Center on Budget and Policy Priorities found the health care law would still reduce the deficit by between $55 billion and $75 billion in 2025.

Avalere: CMMI will not generate as much savings for Medicare as CBO projected:

“Avalere Health estimates that CMMI’s payment demonstrations will save Medicare $18 billion from 2017 through 2026, compared to $34 billion projected by CBO back in 2016.”

How the Affordable Care Act Has Narrowed Racial and Ethnic Disparities in Access to Health Care: The headline gives the “bottom line” in the study. One example: “The gap between black and white adult uninsured rates dropped by 4.1 percentage points, while the difference between Hispanic and white uninsured rates fell 9.4 points.”

About healthcare quality

Checking in on the checklist: This monograph is a good review of the benefits of surgical checklists in the past 10 years. What is fascinating is the global view of its adoption (see pages 21 and 22). 90% of highly developed countries use checklists while only 33% of lower developed countries do so. Reasons for this huge disparity are given.

Today's News and Commentary

NEW CATEGORY OF NEWS TODAY: INTERESTING SCIENCE.
These postings will have articles about basic science that has potential to make significant inroads in treating disease and improving health

Interesting science

Bacteria shredding tech to fight drug-resistant superbugs: Innovative use of metal nanotech to treat/prevent drug resistant bacteria (and perhaps other organisms).

Study finds potential new treatment for preventing Post Traumatic Stress Disorder (PTSD): University of Toronto scientists discovered a protein complex [Glucocorticoid Receptor-FKBP51] that is elevated in PTSD patients. “The researchers also developed a peptide to target and disrupt the protein complex. They found that the peptide prevented recall or encoding of fear memories in early tests. This suggests that the peptide could treat PTSD symptoms or prevent them entirely.”

About the public’s health

Fewer in U.S. Continue to See Vaccines as Important: From Gallup:

84% in U.S. say vaccinating children is important, down from 94% in 2001
86% say vaccines are not more dangerous than the diseases they prevent
45% of Americans say vaccines do not cause autism in children [46% are unsure]
There is clearly a need for a social marketing campaign to change these dangerous perceptions.

Americans drink about 2.3 gallons of alcohol a year: study: The consumption is rising and is greater than it was before the start of Prohibition.

Spain cracks down on influencers who are bad for your health: “The Health Ministry is working to eliminate videos on social networks such as Instagram that promote drugs and treatments that should only be available on prescription,” such as antibiotics. What about anti-vaxers?

Urgent health challenges for the next decade: This list and explanations are from the WHO. (Go to the photos and then click right arrow for the next item and explanation below.) Items range from the climate crisis to personnel issues. Interesting topics for discussion and term papers.

There's a mismatch in the flu shot -- and it's not good news for children: Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says the current flu vaccine is a 58% match for B/Victoria. As matches generally go its not bad; people should still be immunized with the current vaccine.

More Studies Link Vaping to Asthma, COPD: E-cigarettes were fist touted as safer than regular cigarettes. But the evidence keeps mounting that they have the same health hazards.

More than 100 billion pain pills saturated the nation over nine years: “Newly disclosed federal drug data shows that more than 100 billion doses of oxycodone and hydrocodone were shipped nationwide from 2006 through 2014 — 24 billion more doses of the highly addictive pain pills than previously known to the public.” The issue here is that the government knew there was a big problem sooner than we thought— and did nothing.

About health insurance

Warren and Klobuchar Say They Can Lower Drug Prices Without Congress’ Help: No major news about healthcare insurance in last night’s Democratic debate. Klobuchar raised the issue of long term care. This article is a nice summary of the health issues in the debate.

New York, Rhode Island Spend Highest Percentages of Budgets on Medicaid: The top 7 states now spend about a fifth of their budgets on Medicaid. What has to give to pay these expenses? Education, infrastructure…

CVS to add 600 HealthHUBs, link them to lower Aetna copays: “CVS Health plans to add 600 HealthHUB locations by the end of the year and offer low to zero copayments for Aetna members.” This action continues the company’s efforts to integrate its system.

UnitedHealth raked in $13.8B in profit for 2019: “Much of the company's 2019 performance and its projected 2020 growth is attributable to strong performance of its diverse Optum subsidiary, which posted $3 billion in earnings from operations in the fourth quarter and $9.4 billion in 2019.”

About pharma

FDA Approval and Regulation of Pharmaceuticals, 1983-2018: Here are the major findings of this study:
“Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period.” In other words, “The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.” The question is what about the safety of the faster-approved drugs?

Eli Lilly to offer half-priced versions of two more insulin products: Continuing a trend for insulin manufactures to sell lower price products, “Lilly will sell new versions of Humalog Junior KwikPen and Humalog Mix75/25, which contains a mix of fast- and intermediate-acting insulin, at a list price of $265.20 for a pack of five KwikPens. They will be available at that price by mid-April, the company said.” Recall last year Lilly said it would sell a half price version of Humalog.

To Generic Drug Manufacturers Considering Retiring or Withdrawing ANDAs for Essential Medicines: Civica Rx Is Interested: CivicaRx announced that “it is interested in talking to generic drug manufacturers who are considering retiring or withdrawing their Abbreviated New Drug Applications (ANDAs) for essential medicines that are at risk of being in short supply.
Periodically, the FDA withdraws approvals of ANDAs due to manufacturer inactivity. According to published reports, the FDA is considering withdrawing close to 250 ANDAs for these reasons.” Recall the company is a consortium of hospitals/systems that contract for the manufacture of generic drugs in short supply.

Gene Therapy: Keeping Costs from Negating Its Unprecedented Potential: This informative white paper from CVS Health explains how gene therapy works and gives examples of pending treatments and their costs. Totals for the next 4 years estimated at $15 to 45 billion.

Today's News and Commentary

About healthcare IT

Physician Time Spent Using the Electronic Health Record During Outpatient Encounters: A Descriptive Study: “Physicians spent an average of 16 minutes and 14 seconds per encounter using EHRs, with chart review (33%), documentation (24%), and ordering (17%) functions accounting for most of the time. The distribution of time spent by providers using EHRs varies greatly within specialty. The proportion of time spent on various clinically focused functions was similar across specialties.” Clearly there is much more opportunity for streamlining EHR interaction.

Too many providers are failing to meaningfully integrate data analytics: “Healthcare providers are failing to integrate digital data platforms into their IT infrastructure, and analytics into their clinical and operational workflows. This despite widespread availability of the technology – and a definite need for it, given the demands of value-based reimbursement…
84% of the C-suite execs and board members polled said their health systems only used analytics to a  ‘limited or minimal extent to generate commercial or outcome insights,’ according to the survey.”

About pharma

Hospitals are getting into the biopharma sector. Last month I reported that NYU Langone Health opened a 50,000-square-foot biotech incubator space in Manhattan to host startups. The past couple days, two other hospitals have announced their entry in this space. Nationwide Children's Hospital will build a biofactory to produce gene therapy material while “University of Pittsburgh Medical Center's venture capital arm is committing $1billion in investments toward developing new drugs, diagnostics and devices by 2024.”

Drugmakers Test New Ways to Pay for Six-Figure Treatments [Wall Street Journal, requires subscription]: This excellent article provides a useful video explaining all the stakeholders in the pharma transaction chain and some of the creative arrangements manufacturers of very costly drugs have structured with payers- like pay for success and installment payments.

Supreme Court Declines to Consider Medical Diagnostic Patents: “The U.S. Supreme Court stayed out of the debate over what types of medical diagnostic tests can be patented, leaving in legal limbo companies that discover ways to diagnose and treat diseases based on patients’ unique characteristics.
The justices rejected an appeal by Quest Diagnostics’s Athena unit that sought to restore its patent for a test to detect the presence of an autoimmune disease. A lower court had ruled in favor of the nonprofit Mayo Clinic that the test wasn’t eligible for a patent because it merely covered a natural law—the correlation between the presence of an antibody and the disease.” "Laws of nature, natural phenomena, and abstract ideas" cannot be patented under Section 101 of the Patent Act.

FDA and NIH let clinical trial sponsors keep results secret and break the law: “For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.” The article has a graphic of different prominent stakeholders and their reporting (un)timelines. As the FDA is moving to incorporate more real world evidence for drug evaluations, it needs to be stricter about reporting.

Today's News and Commentary

About health insurance

What's an Individual Coverage Health Reimbursement Arrangement (HRA)? Last June 13, the U.S. departments of Health and Human Services, Labor and the Treasury issued a final rule allowing employers that do not offer a group coverage plan to fund a new kind of health reimbursement arrangement (HRA), known as an individual coverage HRA (ICHRA).
Starting Jan. 1, 2020, employees can these new HRAs to buy individual-market insurance, including ACA exchanges. Previously, employers were forbidden to set up such accounts.

DIFFERENT EMPHASIS ON ACOs DATA IN THE FOLLOWING TWO ARTICLES

Number Of ACOs Taking Downside Risk Doubles Under ‘Pathways To Success’: This information is from CMS administrator Verma: "For the January 1, 2020 start date, CMS approved 53 applications for new ACOs and 100 applications for renewing ACOs. The total number of Medicare beneficiaries served by health care providers in ACOs is now 11.2 million, up from 10.4 million at the start of 2019. Nearly 30 percent of all beneficiaries in fee-for-service Medicare are now served by a health care provider in a Shared Savings Program ACO.
I’m especially proud to report that the number of ACOs taking on risk for cost increases has grown significantly—from 93 ACOs at the start of 2019 to 192 at the start of 2020.” 

Participants continue to drop out of Medicare ACO program: "Just 53 new accountable care organizations joined the Medicare Shared Savings program for the Jan. 1 start date, which is significantly less new entrants compared to previous years. 
There are now 517 ACOs in the Medicare program versus in 2018 when there were 561 ACOs. The drop in new participants follows a recent trend from six months ago when only 66 new ACOs joined. By comparison, in 2018, 124 new ACOs entered the program and in 2017, 99 new ACOs joined. 
The National Association of ACOs blames the changes to the Medicare ACO program for the recent drops in participation. In late 2018, the CMS finalized an overhaul of the program that requires ACOs to take on downside financial risk sooner after years where most organizations were risk averse.”

About pharma

FDA Makes Real-World Data Available on Google Cloud Platform: The FDA has been promoting “real world” data to improve drug evaluations.The FDA’s MyStudies platform is now available on Google Cloud Platform.

Supreme Court to Rule on States’ Right to Regulate Pharmacy Benefit Managers: In what could have profound effects on the way drugs are handled by insurers, the “US Supreme Court has announced it will hear a case in the coming months that could determine whether states have the right to regulate pharmacy benefit managers (PBMs).
The US Court of Appeals for the Eighth Circuit, covering Arkansas and 6 other states, previously ruled on Rutledge v. Pharmaceutical Care Management Association. The Eighth Circuit decision favored the Pharmaceutical Care Management Association (PCMA), ruling that the Employee Retirement Income Security Act of 1974 (ERISA), a federal law that sets minimum standards for voluntarily established retirement and health plans in private industry, superseded an Arkansas law that sought to regulate PBMs.
Passed in 2015, Arkansas Act 900 required PBMs to raise reimbursement rates for drugs if they fell below the pharmacy’s wholesale costs and created an appeal process for pharmacies to challenge PBM reimbursement rates. This effectively prohibited PBMs from reimbursing pharmacies below the pharmacies’ cost of acquisition.
In his brief to the US Supreme Court, Solicitor General Noel Francisco disagreed with the Eighth Circuit decision, stating that the ruling was contrary to higher court’s precedent and should be reviewed and corrected. He urged the court to take up the case, siding with attorney generals from 31 states and the District of Columbia that want the US Supreme Court to reverse the Eighth Circuit’s ruling.”

A ‘radical proposition’: A health care veteran tries to upend the system and bring drug prices down: This story appeared in several news media today. It is about a new company that plans to make “me-too” drugs (those medicines that have a unique composition, but are, perhaps, the 4th or 5th in their chemical class) at lower prices than existing treatments. It is not know which medications the company will initially target; but even these me-too products need to go through the FDA approval process since they are not generics. We will need to wait and see if they can get approval at a fraction of the cost of other drugs, since that is where they hope to achieve the savings to offer the lower prices.

Two Big Drug Flops Show How Health-Care Economics Have Changed: “For years, drug companies have enjoyed the freedom to charge high prices for their latest products. But when Sanofi and Amgen Inc. each marketed a powerful new cholesterol-lowering medicine, something surprising happened: High prices hurt sales. Sanofi’s experience has been especially painful. The French company spent more than five years developing Praluent with Regeneron Pharmaceuticals Inc. before its launch in 2015. But Praluent never caught on. Now Sanofi is cutting its losses, getting out of the U.S. market for the drug, and halting its heart disease research altogether in favor of more lucrative medicines for cancer and other diseases…Praluent’s disappointing sales are the result of insurance giants’ reluctance to pay for expensive new pharmaceuticals that treat chronic disease when far cheaper drugs can often get the job done.” The days of charging whatever the market is thought to bear may be limited.  

CMS Addresses Duplicate Discounts, State Medicaid Rebate Requests: States are submitting requests to the federal government for rebates for 340B drugs- which already carry steep manufacturers’ discounts. New guidance rules are addressing this double dipping.

23andMe licenses 1st drug: Genetic testing company 23andMe licensed a drug to Spanish drugmaker Almirall which is designed to treat autoimmune and inflammatory conditions, such as lupus and Crohn's disease.

About health devices

FDA clears 3D-printed airway stents tailored to patient anatomy: Just a reminder about how 3D printing is making its way into clinical use.

About healthcare IT

A billion medical images are exposed online, as doctors ignore warnings: “Hundreds of hospitals, medical offices and imaging centers are running insecure storage systems, allowing anyone with an internet connection and free-to-download software to access over 1 billion medical images of patients across the world.
About half of all the exposed images, which include X-rays, ultrasounds and CT scans, belong to patients in the United States.”

The Sneaky Genius of Facebook's New Preventive Health Tool: Interesting investigative piece about how the social media company gathers available information and uses it for a preventive health tool.

Today's News and Commentary

About healthcare personnel

Kaiser Permanente, union announce $130M initiative aimed at healthcare workforce shortage: This type of alliance is a new way for a health system to address a worker shortage. Kaiser and
the “Service Employees International Union-United Healthcare Workers West (SEIU-UHW) are launching the $130 million organization, called Futuro Health, as part of the labor agreement reached by the two parties last year. 
Futuro’s goal is to graduate 10,000 new licensed and credentialed allied health workers in California in the next four years. Estimates suggest California alone will face a demand of nearly 500,000 healthcare workers by 2024, Kaiser Permanente said.”

Employment Situation Summary: From the US Bureau of Labor Statistics: “Employment in health care increased by 28,000 in December. Ambulatory health care services and hospitals added jobs over the month (+23,000 and +9,000, respectively). Health care added 399,000 jobs in 2019, compared with an increase of 350,000 in 2018. “

About health insurance

DOJ boasts $2.6B in healthcare fraud settlements, judgments in 2019: “The recoveries involved all sectors of the industry including drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories and physicians. It is the tenth consecutive year the department's civil healthcare fraud settlements and judgments have exceeded $2 billion.”

Today's News and Commentary

About health insurance

HealtHcare affordabililty State Policy Scorecard: Take a look at how Altarum evaluates affordability of healthcare and then ranks states based on the criteria. For example, “The highest ranked state, Massachusetts, performed well on many policy measuresbut should enact stronger protections against surprise medical bills and pursuemore strategies to reduce the cost of high-value care. Massachusetts is a state with relatively high healthcare spending per person, but a comparatively low percentage of residents report affordability problems.”

Blackstone-KKR Hidden Hand in Ad Blitz Unleashes Washington Fury: “Confronted with the rare prospect of defeat on Capitol Hill, private equity titans Blackstone Group Inc. and KKR & Co.unleashed a national advertising blitz last year against legislation that threatened their investments in health-care companies valued at $16 billion.
The $53.8 million campaign sought to derail a crackdown on surprise medical billing, in which patients are unexpectedly hit with exorbitant charges, often following visits to emergency rooms.”

New York State Investigates Christian Health Cost-Sharing Affiliate: “More than one million Americans have joined such groups, attracted by prices that are far lower than the cost of traditional insurance policies that must meet strict requirements established by the Affordable Care Act, like guaranteed coverage for pre-existing conditions. 
These Christian nonprofit groups offer low rates because they are not classified as insurance and are under no legal obligation to pay medical claims. But state regulators are questioning some of the ministries’ aggressive marketing tactics, saying some consumers were misled or did not grasp the lack of comprehensive coverage in the case of a catastrophic illness.”

'Gold rush': Race is on for health data in East Europe's frontier market: This article explains what happens to public systems all around the world.
”Growing numbers of people in Eastern European states, from Hungary and Poland to Romania, are turning to private health. The shift is being driven by rising wages, coupled with low public health spending which has often led to staff shortages and long waiting times for tests and surgery.”
Private insurers are gathering data so they can offer insurance to these populations.

2020 Federal Health Insurance Exchange Enrollment Period Final Weekly Enrollment Snapshot: CMS released the final enrollment numbers yesterday. “Approximately 8.3 million people selected or were automatically re-enrolled in plans using the HealthCare.gov platform during the 2020 open enrollment period,” down slightly from the previous year. The announcement has a breakdown by state and enrollee activity.

Reduce Health Costs By Nurturing The Sickest? A Much-Touted Idea Disappoints: “Researchers tested whether pairing frequently hospitalized patients in Camden, N.J., with nurses and social workers could stop that costly cycle of readmissions. The study found no effect: Patients receiving extra support were just as likely to return to the hospital within 180 days as those not receiving that help.”

About the public’s health

Appeals court refuses to lift injunction on immigrant 'public charge' rule: “A panel of federal judges in New York on Wednesday denied the Trump administration’s request to begin a program aimed at cutting back benefits for immigrants while a lawsuit over the plan plays out in court.
The ruling by a three-judge panel of the U.S. Court of Appeals for the 2nd Circuit keeps in place a nationwide halt on President Trump’s ‘public charge’ rule that links immigrants’ legal status to their use of public benefits.”

.2020’s Best & Worst Cities for an Active Lifestyle: Honolulu and Chicago top the list.

About pharma

Gov. Gavin Newsom announces state-run prescription drug label to lower prices: “California Gov. Gavin Newsom is slated to announce Thursday a plan to create a state-run generic drug label, and also negotiate with prescription drugmakers to set uniform prices for Californians, including those on private insurance.
Under the generic-drug proposal, the state would not make its own medicines, but instead contract with manufacturers to produce certain drugs in an effort to spur competition and hence lower prices.”

Researchers Investigate the Novelty of Costly Drugs: “A new study from Harvard Medical School researchers found that of the 27 active ingredients in 25 brand-name drugs with the highest Medicare spend in 2017, 11 (41%) of the ingredients had previously been approved by the US Food and Drug Administration (FDA) in other formulations or products.
Of these 11, the median time between the first FDA approval and the end of 2017 was more than 19 years, they added.”In other words, according to the original research article, “the novelty of active ingredients in the 25 brand-name drugs with the highest Medicare Part D spending” did not justify the prices.

 Why price of Humira keeps rising despite FDA approval of generic competition: This article is a nice review about tactics branded manufacturers use to keep generic competitors off the market.

About healthcare professionals

HCA buys majority stake in multistate nursing school: “The for-profit hospital operator is now the majority owner of Galen College of Nursing, which has locations in Texas, Ohio, Kentucky and Florida.
The partnership aims to improve access to nursing education and career development opportunities to address the nation's nursing workforce needs.”

About hospitals

U.S. hospitals see first decline in outpatient visits since 1983: T”he American Hospital Association’s newly released 2020 Hospital Statistics report shows the 6,146 hospitals in the U.S. delivered a cumulative 879.6 million outpatient visits in 2018, 0.9% less than in 2017, when they delivered 880.5 million outpatient visits. The data, which covers health system-owned ambulatory surgery centers, outpatient clinics and urgent care clinics, is the first year-over-year decline since 1983, and comes even as health systems work to expand their outpatient offerings beyond hospital campuses.”

About healthcare IT

At CES, Humana offers a glimpse inside its new digital tech hub 'Studio H': More from the Consumer Electronics Show: Humana is leveraging remote monitoring and patient interactions to provide information about health needs of its members.

Healthcare Data Breaches Predicted to Cost Industry $4 Billion in 2020:”The healthcare data breach figures for 2019 have yet to be finalized, but so far 494 data breaches of more than 500 records have been reported to the HHS’ Office for Civil Rights and more than 41.11 million records were exposed, stolen, or impermissibly disclosed in 2019. That makes 2019 the worst ever year for healthcare data breaches and the second worst in terms of the number of breached healthcare records.
The healthcare industry now accounts for around four out of every five data breaches and 2020 looks set to be another record-breaking year. The cost to the healthcare industry from those breaches is expected to reach $4 billion in 2020.”

Today's News and Commentary

For your amusement and disgust

Lown Institute’s 3rd annual Shkreli Awards: Top ten list of reprehensible behavior in healthcare.

About the public’s health

Cancer death rate posts biggest one-year drop ever: Good news! The trend was driven by the decrease in lung cancer deaths, which in turn was due to two factors- better treatments and decline in smoking rates.

Sex differences in cardiometabolic disorders [Nature Medicine-subscription required] If you can get access to this article it is worthwhile. It presents a comprehensive review of the title’s subject. Particularly, it reviews differences in risk factors (such as hypertension, diabetes, obesity and socioeconomic factors) diagnosis and disease manifestations. For example, women “with IHD [ischemic heart disease] are characterized by a higher prevalence of angina, a higher burden of cardiometabolic risk factors, and a higher prevalence of non-obstructive CAD [coronary artery disease] on angiography compared to men (10–25% in women vs. 6–10% in men).” The molecular mechanisms of sex differences in cardiometabolic disorders is also explained.
With more Artificial Intelligence applications being used, it is critical that sex differences are understood and built into algorithms for diagnosis and treatment.

CVS, Walgreens sue Ohio physicians, claim they share blame for opioid crisis: The last shoe has fallen. Physicians have largely been spared from blame for the opioid crisis. Now the major pharmacy chains are sharing the responsibility.

About healthcare IT

Inside the Billion-Dollar Battle Over .Org: This article is not strictly about healthcare but, since many healthcare organizations are non profit, it can have a significant impact on the field. Two months ago, Ethos Capital, a private equity firm, announced that it planned to buy the rights to the “.org” domain for more than $1 billion. The article explains how this purchase could happen and the push-back by non profits.

About pharma

A new biotechnology and pharmaceutical industry commitment to patients and the public: A long list of biotech companies have issued a statement pledging to restrain pricing on their products. But the principles are broad and no numbers (like percent increases or limits) are mentioned. We will need to wait and see how the promise plays out.

The Effect Of Veterans Health Administration [VHA] Coverage On Cost-Related Medication Nonadherence: “Although people with VHA coverage were older and in worse health and had lower incomes than those with other coverage, VHA patients had lower rates of cost-related medication nonadherence: 6.1 percent versus 10.9 percent for non-VHA patients.” The authors say the reason is lower out-of-pocket expenses for veterans who fill their prescriptions at VA facilities.

Allergan settles pay-for-delay lawsuit for $300M: “The lawsuit, filed in 2013, claimed Warner Chilcott entered into agreements with Watson and generic drugmaker Lupin Pharmaceuticals to delay a generic version of Loestrin 24 FE from coming to market…” The FTC continues to prosecute such behavior.

About healthcare IT

A look at the most interesting health tech at CES 2020: Here are some of the most interesting health-related items at the Consumer Electronics Show, including a multipurpose robot.

About health insurance

Report to Congress on Oversight of Institutions for Mental Diseases [IMDs]: This report is from MACPAC (Medicaid and CHIP Payment and Access Commission) and fulfills a statutory requirement for a report on IMDs, which are defined as: a “hospital, nursing facility, or other institution of more than 16 beds that is primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases, including medical attention, nursing care, and related services.” Medicaid payments to IMDs has been prohibited since Title IX was passed in 1965. The services themselves are covered benefits, but not if provided in these institutions. “Even so, nearly all states are making payments for services provided in IMD settings via various exemptions and authorities, including: statutory exemptions related to older adults and children and youth; demonstration waivers under Section 1115 of the Act; a state plan option; and managed care arrangements under certain conditions.” This report looks at seven states and how they are handling this issue.

Today's News and Commentary

About healthcare quality

2018 Quality Payment Program (QPP) Performance Results: This statement is from CMS. In summary, 84 percent of eligible clinicians will receive an additional adjustment for exceptional performance, 13 percent will receive a positive payment adjustment and 2 percent will receive a negative payment adjustment.

Association of Powder Use in the Genital Area With Risk of Ovarian Cancer: “Among women from 4 prospective cohorts, there was not a statistically significant association between use of powder in the genital area and ovarian cancer, but the study may have been underpowered to identify a small increase in risk.” It is not certain what impact this study will have on the pending lawsuits against Johnson & Johnson.

Roughly 10% of U.S. children get unneeded medical care: “…11 percent of publicly insured children and 9 percent of privately insured children received "low-value" care, or care that offered little benefit to their health, at least once. In addition, 4 percent and 3 percent of each group received similar low-value care at least twice during the same period.” Studies show that evidence-based medicine that suggests underutilization results in physicians doing more; however studies like this one that show unnecessary care do not get as much traction. Think it has to do with reimbursements?

Spending And Quality After Three Years Of Medicare’s Voluntary Bundled Payment For Joint Replacement Surgery: We found that over three years, compared to no participation, participation in BPCI [Bundled Payments for Care Improvement] associated with a 1.6 percent differential decrease in average LEJR [lower extremity joint replacement] spending with no differential changes in quality, driven by early participants. Patient selection accounted for 27 percent of episode savings.”

The Impact Of Bundled Payment On Health Care Spending, Utilization, And Quality: A Systematic Review: Do not generalize from the above research. These researchers “performed a systematic review of the impact of three CMS bundled payment programs on spending, utilization, and quality outcomes. The three programs were the Acute Care Episode Demonstration, the voluntary Bundled Payments for Care Improvement initiative, and the mandatory Comprehensive Care for Joint Replacement model. Twenty studies that we identified through search and screening processes showed that bundled payment maintains or improves quality while lowering costs for lower extremity joint replacement, but not for other conditions or procedures [emphasis added].”

Seniors Still Wary of Online Reviews When Picking Doctors: “ Most older Americans don't fully rely on or trust online ratings of doctors, a new study finds. 
Among men and women between the ages of 50 and 80, only 43% have looked online to see how patients rated a doctor…”

About health insurance

CMS wants to use more encounter data for Medicare Advantage payments: “The CMS on Monday proposed changes to Medicare Advantage payments for 2021, including an increase in the percentage of patient ‘encounter data’ used to calculate payments.” Insurers say the data is inaccurate and incomplete, but they are the ones using that data to submit higher intensity payment requests to CMS.

Supreme Court sets Friday deadline for responses in ObamaCare case: ”The Supreme Court on Monday told the Trump administration and a group of [red] states to respond by the end of the week to an effort by Democrats to expedite a challenge to a lower court ruling that struck down a key tenet of ObamaCare.”

Combining medical, pharmacy and behavioral benefits delivers annual savings of more than $850 per customer with an identified health improvement opportunity: Benefits are often fragmented because of expertise in individual functional areas. But this study shows their integration for patients with chronic conditions can save money.

New Fast PATH Initiative Aims to Improve Prior Authorization for Patients and Doctors:”America’s Health Insurance Plans (AHIP), along with several of our member insurance providers, is launching the Fast Prior Authorization Technology Highway (Fast PATH) initiative to improve the prior authorization process…This new initiative will rely upon the proven automated technologies of both Availity and Surescripts to speed prior authorization requests, responses, and information exchange.”

Individual Insurance Market Performance in Late 2019: The main fear this year was that elimination of the penalty for not having insurance would cause healthy people to drop coverage and result in increased insurance premiums. This study found that: “Going into 2019, insurers reported that the reduction of the penalty to $0 drove premiums up by about 5 percentage points. Nonetheless, premiums were largely steady in 2019, on average, in part because insurers had priced too high in 2018. Despite concerns about the continuing impact of the loss of the mandate penalty, the individual market has remained fairly stable through 2019. Enrollment among those not eligible for subsidies declined by 10% in early 2019, but individual market enrollment overall appears to be stabilizing, with total market enrollment falling by just 5%.”

About the public’s health

The downstream air pollution impacts of the transition from coal to natural gas in the United States: Does reducing coal emissions really help improve health? Yes! And crop production as well.
“Between 2005 and 2016 in the continental United States, decommissioning of a coal-fired unit was associated with reduced nearby pollution concentrations and subsequent reductions in mortality and increases in crop yield. In total during this period, the shutdown of coal-fired units saved an estimated 26,610 (5%–95% confidence intervals (CI), 2,725–49,680) lives and 570 million (249–878 million) bushels of corn, soybeans and wheat in their immediate vicinities; these estimates increase when pollution transport-related spillovers are included.”

About healthcare professionals

Nurses Continue to Rate Highest in Honesty, Ethics: “For the 18th year in a row, Americans rate the honesty and ethics of nurses highest among a list of professions that Gallup asks U.S. adults to assess annually. Currently, 85% of Americans say nurses' honesty and ethical standards are ‘very high’ or ‘high’…” Engineers are in second with 66% and physicians are third with 65%.

Best Paying Jobs: The U.S. News report says that the top 11 highest paying jobs are in healthcare professions. #1 is anesthesiology.

Today's News and Commentary

About pharma

The medications that are thrown away: “Last year, Medicare paid for $725 million worth of expensive medications administered in outpatient clinics — things like chemotherapy drugs — that ended up being discarded, according to new data released by the federal government.” See the chart for the most costly wasted drugs.

Internal Deadlines, Drug Approvals, and Safety Problems: Quicker drug approvals have always been a doubled edged sword- the ability to get medications to those in need versus potential harm from overlooked side effects. This important research article quantifies this issue.
“ In the United States, the number of December drug approvals is roughly 80% larger than in any other month…Similar approval spikes occur at the end of each calendar month. Additionally, approvals spike before holidays, such as before Thanksgiving in the United States and the Chinese New Year in China (but not vice versa). Drugs approved in December and at month-ends are associated with significantly more adverse effects, including more hospitalizations, life-threatening incidents, and deaths. This pattern is consistent with a model in which regulators rush to meet internal production benchmarks associated with salient calendar periods: this type of ‘desk-clearing’ behavior results in more lax review, which leads both to increased output and increased safety issues.”

FDA Approves First-of-its-Kind Migraine Treatment: “Allergan’s Ubrelvy (ubrogepant) tablets received the FDA’s approval for the immediate treatment of migraine with or without aura, a visual disturbance or sensory phenomenon caused by the condition.
The novel drug, which is not indicated for preventive treatment, is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists the FDA has approved for acute migraine treatment.”

Lawsuit accuses Pfizer of concealing cancer-causing chemical in Zantac: It was bound to happen: “A proposed class-action lawsuit was filed Jan. 2 accusing Pfizer of hiding the fact that Zantac, which it made from 2000 to 2006…Pfizer never listed N-nitrosodimethylamine, or NDMA, a human carcinogen, as an ingredient in Zantac, the lawsuit alleges.”

About health insurance

House, blue states ask Supreme Court to immediately review ObamaCare case: Rather than wait for the slow wheels of justice, the House and blue state attorneys general asked the Supreme Court to decide the fate of the ACA before the election. Recall where things now stand: the Appellate Court said the insurance mandate was now unconstitutional because there was no longer a penalty (oops…tax) for non compliance. That Court sent the case back to the lower court to decide if the whole ACA is now invalid.

About the public’s health

US on track for one of the worst flu seasons in decades: “Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, said while it's impossible to predict how the flu will play out, the season so far is on track to be as severe as the 2017-2018 flu season, which was the deadliest in more than four decades, according to the US Centers for Disease Control and Prevention.”

Best and worst diets for 2020, ranked by experts, with a popular one near last: Bottom line: Mediterranean diet is best. But read the article for where the others weigh in.

Social inequalities in multimorbidity, frailty, disability, and transitions to mortality: a 24-year follow-up of the Whitehall II cohort study: Read the article for the particulars of the study population and data gathering. The indicators of socioeconomic status considered were education, occupational position, and literacy. The findings showed that: “Socioeconomic status affects the risk of multimorbidity, frailty, and disability, but does not affect the risk of mortality after the onset of these adverse health conditions. Therefore, primary prevention is key to reducing social inequalities in mortality. Of the three adverse health conditions, multimorbidity had the strongest association with mortality, making it a central target for improving population health.”

FDA clears PhotoniCare's handheld OCT scanner for checking ear infections: This article is under The public’s health section because of the high prevalence of ear infections in children. ”PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to check for fluids deep behind the eardrum—one of the main signs of childhood ear infections, According to PhotoniCare, middle ear infections affect more than 80% of children, though they can be misdiagnosed up to half of the time following examination with a traditional otoscope.” If this device proves a better diagnostic tool, it will replace otoscopic assessment of middle ear infections and hopefully reduce prescription of unneeded antibiotics.

About healthcare quality and safety

Psychological safety and infection prevention practices: Results from a national survey: “High psychological safety was reported in approximately 38% of responding hospitals, and was associated with increased odds of regularly using urinary catheter reminders or stop-orders and/or nurse-initiated urinary catheter discontinuation (odds ratio, 2.37; P = .002) for catheter-associated urinary tract infection prevention, and regularly using sedation vacation (odds ratio, 1.93; P = .04) for ventilator-associated pneumonia prevention…A culture of psychological safety should be considered an integral part of HAI [hospital acquired infection] prevention efforts.”

Prevalence of Potentially Unnecessary Bimanual Pelvic Examinations and Papanicolaou Tests Among Adolescent Girls and Young Women Aged 15-20 Years in the United States: “In this population-based, cross-sectional study using data from 2011 to 2017, an estimated 2.6 million women aged 15 to 20 years in the United States (22.9%) received a bimanual pelvic examination in the past year, and 54.4% of these examinations were potentially unnecessary. An estimated 2.2 million young women (19.2%) received a Papanicolaou test in the past year, and 71.9% of these tests were potentially unnecessary.”

An accompanying editorial comments and rebuts reasons usually given for these unnecessary exams: “Some have suggested that the benefit of requiring an annual pelvic examination is that it prompts women to visit a clinician for their annual examination. There is no evidence to support this hypothesis.”

Today's News and Commentary

About the publics’ health

U-Haul will no longer hire smokers in 21 states: Yes, it is legal to discriminate against smokers. Actually the new company policy includes “nicotine products.”

Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either: “Researchers found only 47% of pharmacies gave correct instructions on how to dispose of antibiotics and 34% provided correct information about opioid disposal. On weekends, only 15% correctly directed customers about safe antibiotic disposal and 7% gave the correct information about disposing of opioids.” The FDA has specific instructions on how to dispose of these medications.

About health insurance

Health insurance mandate takes effect in Rhode Island: Even as Republicans try to dismantle the ACA, some states are creating their own mandates for health insurance.

Judge shoots down California law on how kidney dialysis is paid for: “A federal judge has blocked a California law that would limit insurance payment rates at life-saving kidney dialysis clinics and prohibit the clinics from steering patients to private insurers.” Of note is that it is illegal for physicians to steer Medicare patients into a particular Medicare Advantage plan or recommend they drop such a plan to go back to traditional Medicare.

About healthcare IT

Global Healthcare Cloud Computing Market to Reach $51.9B by 2024: “The global healthcare cloud computing market is expected to reach $51.9 billion by 2024, according to a recent Research&Markets report.
The market is projected to increase from $23.4 billion in 2019 at a compound annual growth rate (CAGR) of 17.2 percent during the period, researchers reported. The main growth factors through 2024 will include the increasing adoption of big data analytics, wearable devices, and internet of things (IoT) in healthcare. The market is also slated to grow due to the advantages of cloud usage, such as improved storage, flexibility, and the scalability of data.”

About pharma

First generics to Bristol-Myers and Pfizer's Eliquis are here. But can they launch before 2026?: This story is a perfect example of defending a brand against generic competitors.

“The FDA approved the first two copycats to Eliquis, made by Mylan and Micro Labs, on Christmas Eve. But despite the agency's announcement, which touted its efforts to get generics to market, the Eliquis copies will not get there anytime soon…
In 2017, 25 generics companies told Bristol that they had filed for FDA approval of their copycats. The pair soon erected a patent wall, launching lawsuits against all those drugmakers.
That August, the U.S. Patent and Trademark Office granted Eliquis a key composition of matter patent, extending it from February 2023 to November 2026. Bristol and Pfizer have argued that’s when Eliquis generics can enter.”

Today's News and Commentary

HAPPY NEW YEAR!

About pharma

5 worst pharma deals of the decade: Some cautionary examples for the near future.

Provision in Spending Bill Paves Way for Follow-On Insulins: Sometimes it takes a while for news to “percolate.” Buried in more than 1,500 pages of the fiscal 2020 spending bill is an expanded definition of a biological product that now includes chemically synthesized polypeptides, such as insulin. The change makes it easier for competitors to introduce biosimilar insulins so prices can be lowered.

More drugmakers hike U.S. prices as new year begins: “Reuters reported on Tuesday that drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi SA were planning to increase prices on more than 200 drugs in the United States on Jan. 1. Nearly all of the price increases are below 10% and the median price increase is around 5%…”

Novo Nordisk's new insulin affordability offerings now available in the US: Novo Nordisk launched its “My$99Insulin” program for its authorized generics. “All patients can purchase up to three vials or two packs of FlexPen®/FlexTouch®/Penfill® pens of any combination of insulins from Novo Nordisk Inc. for $99.”

Standard of Evidence Expanded in New FDA Guidance: “In its first updated guidance in more than 20 years on acceptable trial design, the FDA said substantial evidence from a trial proving effectiveness could be gained from one trial instead of two, one adequate well-controlled trial plus confirmatory evidence or reliance on a previous finding of effectiveness from an approved drug. 

The FDA has decided that in some cases the traditional two-trial model can be replaced by other types of trial designs more suited to the study of rare diseases... five types of control are mentioned in the draft guidance: placebo, dose comparison, no treatment, active treatment and historical control.”

Comments on the draft guidance are due Feb. 21, 2020.

About the public’s health

Prevention of tuberculosis in macaques after intravenous BCG immunization: Tuberculosis kills more people than any other infectious agent. To prevent the illness, a vaccine, BCG, has been used for about 100 years, but with widely variable success. This research article shows promise in greatly enhanced effectiveness by administering the vaccine intravenously instead of into the skin, as has been the practice.

About healthcare IT

International evaluation of an AI system for breast cancer screening: This article is highlighted in most major media today. For example: Google’s DeepMind A.I. beats doctors in breast cancer screening trial. This study compares the AI system to a single radiologist reading. But a standard procedure is to have two radiologists read a mammogram. With this double reading, the AI system performs similarly. Further, some of the radiologists had not received special further training in mammography. The AI system is getting really good; if it continues to improve, it may be able to substitute for radiologists in the near future.

Trump administration’s compromise vape ban provokes public health outcry: Public health groups are angry that the president backtracked on part of his promise to curtail vaping. Yesterday the White House announced that fruity and minty cartridges would be banned, but not menthol, as previously promised. Further, e-liquids for “open tank” products that typically are sold by vape shops will now be allowed. An administration “official said the outcome was a compromise between administration officials pushing a comprehensive ban promised by Trump in September and others worried about the political fallout stemming from potential job losses in thousands of vape shops across the country.”

About health insurance

Tenth Circuit Upholds HHS Risk Adjustment Methodology: A number of ACA health plans, particularly the consumer-sponsored startups (COOPs) have sued the federal governments over methodologies it used to pay (or, in this case, not pay) them back for losses that started in 2014. One challenge was to the risk adjustment formula. In this ruling, “the Tenth Circuit upheld HHS’ risk adjustment methodology, concluding that HHS’ use of a statewide average premium and the adoption of a budget-neutral program were not arbitrary and capricious. HHS acted reasonably in explaining why it used the statewide average premium in the risk adjustment methodology for 2014 through 2016. Because HHS subsequently issued new rules covering the 2017 and 2018 methodologies, the challenges over the rules for those years are moot.” If upheld, HHS would not owe these plans any payments (almost all COOPs went bankrupt).

About healthcare quality

Changes in Quality of Care after Hospital Mergers and Acquisitions: Hospital combinations result in increased charges. The participants argue, however, that quality improvement justifies the expense. However, this research shows that: “Hospital mergers and acquisitions were associated with modest deterioration in patient experiences, small and nonsignificant changes in readmission and mortality rates, and inconclusive effects on performance on clinical-process measures. These findings challenge arguments that hospital consolidation, which is known to increase prices, also improves quality.”

Adding Patient-Reported Outcomes to Medicare’s Oncology Value-Based Payment Model: At the end of 2020, CMS will roll out its Oncology Care First (OCF) model, replacing the previous Oncology Care Model (OCM). Reflecting the evolution of payment and evaluation systems, this new model will have two new features: capitation and patient-reported outcomes. Similar changes in other advanced payment models cannot be far behind.

Today's News and Commentary

About pharma

Astellas Enters into Definitive Agreement to Acquire Audentes Therapeutics: The trend of large pharma buying biotech companies continues. In this $3billion deal, Audentes will operate as an independent subsidiary.

Chinese Researcher Who Created Gene-Edited Babies Sentenced To 3 Years In Prison: The headline speaks for itself.

About the public’s health

Prevalence of Human Papillomavirus Infection by Number of Vaccine Doses Among US Women: “Our study suggests that US women who received 1 dose of the HPV vaccine may have gained similar protection against vaccine-type infections compared with those who received additional doses. These findings support previous observational studies and post hoc analyses of vaccine trials that demonstrated comparable effectiveness of 1 dose to 2 or 3 doses.” If this study’s findings prove themselves it could greatly simplify this vaccination- and lower the cost.
Merck (maker of Gardasil) closed at 91.03 USD −0.47 (0.51%).

About health insurance

Governor Cuomo Unveils 14th Proposal of 2020 State of the State: Increasing Transparency in Healthcare Costs: “Under this proposal, Governor Cuomo will direct the Department of Health, the Department of Financial Services and the New York State Digital and Media Services Center - a joint enterprise of the Office of Information Technology Services and Office of General Services - to create a consumer-friendly website, called NYHealthcareCompare, where New Yorkers can easily compare the cost and quality of healthcare procedures at hospitals around the state. The platform will also provide consumers with educational resources designed to help consumers know their rights including financial assistance options, what to do about a surprise bill and more.” Pending federal action on these issues, seems like states are taking the lead. However, sites like Hospital Compare already provide such quality data.

About healthcare devices

FDA Reclassifies Electrotherapies for Anxiety and Insomnia: The reclassification from Class III to Class II for this specific device is not the issue- it is the general way the FDA looks at classifying newer technology.

Today's News and Commentary

About the public’s health

Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk: Risks for several types of cancer can be lowered with regular exercise- or at least the association suggests.

Patient Views on Religious Institutional Health Care: “In a population-based survey study of 1446 US adults, only 6.4% reported that they considered religious affiliation when selecting a health care facility. Most patients (71.4%), particularly women, believed that their personal choices about their health should take priority over a facility’s religious values…Given the growth in ownership of health care facilities by religious entities in the United States and increasing attention to conscientious objections, these findings point to a need for advocacy and legislation that effectively balances protections for religious institutions with protections for patients.”

About pharma

New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices: A recent study by the FDA quantifies how much additional generic entrants lower prices. Compared to the market before generic introduction, one generic product will lower prices by 39%; by the time there are six competitors, the price declines by at least 95%.

Today's News and Commentary

About the pubic’s health

Manipulating the Human Microbiome to Manage Disease: This article is a fascinating summary about how manipulation of our bacterial flora can be used to improve health and treat disease.

About healthcare IT

9 HIPAA settlements of 2019: Chronological listing ranging from $100,000 to $45 million.

Today's News and Commentary

About healthcare quality and safety

Outcomes Before and After the Recall of a Heart Failure Pacemaker: “This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.”

Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221): Patients do not always ask their physicians about use of dietary supplements; and physicians do not always bring up the subject. This research shows a very significant increase in recurrence for breast cancer patients who took certain supplements both before and during chemotherapy. On the list is any antioxidant supplement (vitamins A, C, and E; carotenoids; coenzyme Q10), B12 and iron.