Today's News and Commentary

CVS plans to expand HealthHubs to 1,500 stores by 2021: As previously reported, CVS has rolled out HealthHubs in select markets to try a concept that is different from a traditional drug store. A HealthHub is a place where patients can not only fill their prescriptions, but do supervised exercise, receive acute care and even buy Aetna insurance. But don’t expect a wide selection of greeting cards or alcoholic beverages; the space for those items has been cut back for health programs. As the headline says, CVS announced it is expanding HealthHubs to 1500 stores by 2021.

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PwC’s 22nd Annual Global CEO Survey: Lots to read in this CEO survey but the overall takeaway is that “Optimism for global economic growth has plummeted over the past year.”

Read the survey

About the public’s health

Low-Value Diagnostic Imaging Use in the Pediatric Emergency Department [ED] in the United States and Canada: Canadian EDs order fewer pediatric diagnostic imagining tests than their US counterparts; the outcomes are no different. Time to look at adherence to guidelines and tying compliance to liability protection.

Read the research

FDA confirms PFAS chemicals are in the US food supply: “PFAS is a family of nearly 5,000 synthetic chemicals that are extremely persistent in the environment and in our bodies… sometimes called forever chemicals. These chemicals all share signature elemental bonds of fluorine and carbon, which are extremely strong and difficult to break down in the environment or in our bodies.” A disturbing report because it is very hard to avoid these substances.

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Taking Stock of Dietary Supplements' Harmful Effects on Children, Adolescents, and Young Adults: This story was very popular with the news media today. The research concluded: “Consumption of dietary supplements sold for weight loss, muscle building, and energy involved increased risks for severe medical events compared with vitamins. Proactive enforcement of regulations is needed to reduce access and consumption among children, adolescents, and young adults.”

Read the research

Coffee not as bad for heart and circulatory system as previously thought: And now, another conflicting piece of research about coffee consumption. Yesterday I reported a study that 6 cups of coffee per day seemed to be the cutoff for deleterious cardiovascular effects. This British study indicates that even much larger amounts have no lasting effects on blood vessels. Now the rest is up to your judgment.

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Survey: Housing, food, isolation major barriers to health: Another survey that emphasizes the importances of social factors to health. For example:

—”Americans view social needs as equally important to their health as medical care, with 89% of respondents saying safe and stable housing is very or extremely important to health and 80% saying reliable transportation is very or extremely important.”
—”The vast majority of Americans want their medical providers to ask about social needs, with 97% of respondents saying their providers should ask about social needs during medical visits. “

—”…68% of Americans surveyed reported they experienced at least one unmet social need in the past year. More than a quarter of those surveyed said that an unmet social need was a barrier to health, with 21% prioritizing paying for food or rent over seeing a doctor or getting a medication.”

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'It’s a miracle': Helsinki's radical solution to homelessness: A response to the above article might be that the costs of addressing such problems are prohibitive. This program in Helsinki provides housing for all who need it when they need it. It is communal living and each tenant “has a contract, pays rent and (if they need to) applies for housing benefit.” This policy has “made Finland the only EU country where homelessness is falling.” And the cost? “ Finland has spent €250m creating new homes and hiring 300 extra support workers. But a recent study showed the savings in emergency healthcare, social services and the justice system totalled as much as €15,000 a year for every homeless person in properly supported housing.”

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Trump administration imposes new restrictions on fetal tissue research: Breaking news: “The administration is discontinuing funding of all ‘intramural’ fetal tissue research within the National Institutes of Health.” Further, “The Department of Health and Human Services terminated the years-long contract to a laboratory at the University of California at San Francisco, ending its only source of funding. Officials said in a statement they were ‘not sufficiently assured that contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.’” These changes will impede progress on such diseases as AIDS and Zika infections.

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7 complex words you shouldn’t include on your consent form: Given the low level of health literacy, this article provides recommendations for simpler language on consent forms.

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Effects of red meat, white meat, and nonmeat protein sources on atherogenic lipoprotein measures in the context of low compared with high saturated fat intake: a randomized controlled trial: Bottom line- doesn’t matter if you eat red or “white” meat, the effect on your lipid (fat) profile is the same.

Read the research


About insurance

Newsom Proposes Penalty To Fund Health Insurance Subsidies: California’s governor is proposing a penalty on those who do not have health insurance in order to help those who make too much to qualify for Medicaid or ACA plan premium subsidies.

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10 Years[2008-2017] of Emergency Room Spending for the Commercially Insured: This study was presented by Health Care Cost Institute researchers on Monday at AcademyHealth's 2019 Annual Research Meeting. The analysis revealed that: “Overall ER Use did not change over the 10 years, but the mix of CPT codes billed did.” The higher intensity codes grew much faster than the lower intensity ones. Prices also went up disproportionately. USA Today also picked up this story with the headline: “Average cost of hospital ER visit surges 176% in a decade…”

Read the research summary (It has great graphics)

Hospitals can't challenge Medicare payment methodology, court rules: As previously reported, the Supreme Court ruled the federal government cannot cut Disproportionate Share Hospital (DSH) payments because there was no comment period as the law requires. In a separate ruling, the U.S. Court of Appeals for the D.C. Circuit just ruled that hospitals cannot challenge the methodology of the payments. In other related news, there seems to be bipartisan support for some changes in the formula for these payments. Attention to the issue is also important because the savings from eliminating the DSH payments was going to fund other federally sponsored health programs.

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About healthcare IT

2018 Data Breach Investigations Report: This article is the annual Verizon report that covers many industries, including healthcare (see page 33). Some of the highlights:

—Ransomware accounts for 85% of all malware in Healthcare.

— Most threats (56%) come from inside the organization

—Most motives are financial (75%)

—Most of the compromised data is medical (79%) not payment (4%)

Read the report

Quest, LabCorp report billing data breach compromising nearly 20M patients: Speaking of breaches, these were huge.

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Here's what former national coordinators, health IT groups had to say on ONC's information blocking rules: Six former national coordinators for health IT support the ONC’s rules for information blocking and timeline for implementation. Their joint letter is in contrast with strong opposition by user groups that have argued the guidelines are vague and the timeline is too short.

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About pharma

Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?: This article is a good case study on the workings of the pharma industry. At the heart of the answer to the headline’s question may be that Enbrel (the drug in question) is going generic soon and the research costs of a study to prove the drug’s effectiveness will never be recouped.

Read the article (Washington Post but appears to be open access)

ASCO19: Round-up for day four and five… 

Read the summary

Today's News and Commentary

About health insurance

In a blow to HHS, Supreme Court sides with hospitals in legal battle over DSH payments: Prior to the ACA’s insurance and Medicaid expansions in 2014, certain hospitals received extra federal payments to care for the uninsured and low-paying Medicaid patients. Those facilities were called disproportionate share hospitals (DSH). After 2014, the federal government anticipated more patients would be insured, and thus it proposed cutting the DSH payments after a period of time. Now the Supreme Court has ruled that HHS cannot cut payments. The reason: “Because the government has not identified a lawful excuse for neglecting its statutory notice-and-comment obligations, its policy must be vacated.” In other words, HHS did not institute a comment period for the payment change- which law requires it to do.

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Toward 2020: A Survey of ACA Market Insurers: Among the survey results for this eHealth study:

Nearly two thirds of insurers said the lack of a tax penalty for 2019 led to reduced ACA plan sales

—Two thirds of insurers say elimination of the ACA tax penalty has had no impact on member retention to date

—60 percent said they intend to broaden their market participation next year, compared to 53 percent the year before

—42 percent of respondents said they expect to raise premiums between 5 and 10 percent over 2019 rates.

Read the survey

Obamacare rate hikes appear modest for 2020: This article corroborates the one above about modest rate hikes for ACA plans in 2020. Those kinds of pronouncements, however, always come with the caveat that actual rates vary widely among states.

Read the article

About the public’s health

Are industry-funded charities promoting “advocacy-led studies” or “evidence-based science”?: a case study of the International Life Sciences Institute [ISLI]: The results of this research are disturbing. “Between June 2015 and February 2018, U.S. Right to Know, a non-profit consumer and public health group, submitted five U.S. state Freedom of Information requests (FOIs) to explore ILSI engagement with industry, policy makers, and/or researchers, which garnered a total of 17,163 pages for analysis…” Researchers found that “ILSI seeks to influence individuals, positions, and policy, both nationally and internationally, and its corporate members deploy it as a tool to promote their interests globally. Our analysis of ILSI serves as a caution to those involved in global health governance to be wary of putatively independent research groups, and to practice due diligence before relying upon their funded studies and/or engaging in relationship with such groups.” The research cites some very worrisome emails.
I cannot find a list of contributors to the ISLI on its website . The ISLI Research Foundation Annual Report lists sources for funding (2018 Financial Contributors, Collaborators, and Partners) and states 40% come from the private sector.

Read the research and draw your own conclusions

About pharma

US aims to help more cancer patients try experimental drugs: A physician can seek FDA approval for compassionate use of a drug if it has not yet been approved. But the application process is very cumbersome and time consuming. At this week’s ASCO meeting (see yesterday’s blog), the FDA announced that it will provide assistance to physicians by assigning a caseworker to help fill out the paperwork and expedite the compassionate use process.

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FDA wins groundbreaking case against for-profit stem cell company: Some for-profit companies have sought to exploit possible loopholes in regulations to treat patients with unproven stem cell therapies. In a groundbreaking decision, the FDA has succeeded in a lawsuit that accused a company of “openly violating the law and endangering patients by manufacturing an unapproved, experimental drug.” In other words, the FDA can regulate stem cell treatments as drugs.

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Today's News and Commentary

About pharma

ASCO19: Round-up for day one, two and three…": The American Society of Clinical Oncology’s annual meeting is this week. It is a huge gathering where many pharma companies promote their products. This article provides a summary of the first few days’ product presentations.

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The top 10 pharma R&D budgets in 2018: This article provides a great summary of the top R&D spenders and the productivity of that spending. A few take-aways:

—”Last year, and for the first time, the top 15 largest companies (by sales) funneled more than $100 billion into research, and we also saw the FDA approve more drugs than ever before.”

—The most spent on R&D was Roche’s almost $11billion. The largest R&D as percent of revenue (by a large company) was 27% by AstraZeneca. A decade ago such companies were spending about 30% of revenue on R&D.

—Despite these large amounts, "emerging biopharma companies (those spending less than $200 million annually on R&D and having less than $500 million in sales) account for 72% of all late-stage pipeline activity, up from 61% a decade ago.”

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Eli Lilly to pay Atomwise $1M for each AI-discovered drug: The headline speaks for itself and highlights the growing partnerships between pharma companies and Artificial Intelligence firms that help identify promising molecules.

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OptumRx Drug Pipeline Insights Report-Q2 2019: OptumRx publishes this quarterly report of top drugs expected to have the greatest impact on “payers, patients, and the general population, in terms of adoption, effectiveness, and anticipated cost.”

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Trends in Prices of Popular Brand-Name Prescription Drugs in the United States: The authors of this research conclude: “In this economic evaluation of 49 common top-selling brand-name drugs, 78% of the drugs that have been available since 2012 have seen an increase in insurer and out-of-pocket costs by more than 50%, and 44% have more than doubled in price.” They do not see any end in site for these increases and call for greater price transparency.

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Disclosure of oncologists' ties with industry did little to stymie them: study: The federal government hoped that creating an public website, the Open Payments Database, would curtail physician acceptance of non-research funds from pharma and medical product companies. Research reported at the ASCO meeting revealed that the public database is not meaningfully changing behavior. The number of oncologists receiving industry payments fell from about 67% in 2014 to about 60% in 2017; however, “the value and number of payments has not significantly changed.There were 1.4 million industry payments totaling $330.6 million during that time period.

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About health insurance

Utah proposes new cap on Medicaid spending: Utah is seeking a federal waiver to put a cap on the amount the state would spend on individuals who rely on Medicaid benefits to pay for their healthcare. This measure is the first time I have seen this kind of cost control measure. Usually states put numerical or dollar limits on visits for certain services (like physician care or hospital days).

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ACA linked to reduced racial disparities, earlier diagnosis and treatment in cancer care: This article highlights more benefits to the increased coverage under the ACA.

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Many Adults Targeted by Medicaid Work Requirements Face Barriers to Sustained Employment: The headline is self-explanatory. As this Urban Institute study shows, states that have work requirements for Medicaid eligibility put many at risk for losing benefits because they are unable to put in enough hours.

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Mired In Medical Debt? Federal Plan Would Update Overdue-Bill Collection Methods: Five years ago, the federal Consumer Financial Protection Bureau (CFPB) estimated 44 million Americans had overdue medical debt on their credit reports. This article looks into that issue and highlights some federal and state initiatives to put restrictions on bill collection methods.

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About the public’s health

13 Years After the HPV Vaccine Was Introduced, US Uptake Remains Low: This article came from a talk at the ASCO meeting this week. Among its messages is that the top reported reasons parents decide not to have their children vaccinated agains HPV are: “ safety concerns and side effects, lack of knowledge about the vaccine, not believing it was necessary, no provider recommendation, and… their child was not sexually active, so they did not need it.” Social factors are the biggest obstacles and will require enhanced public education programs to overcome them.

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“Liquid biopsies” are blood tests that can detect cancers much earlier than waiting for signs or symptoms to develop. They can also help oncologists monitor a patient for recurrences of their cancers. Here are two articles that offer insight into this emerging methodology.

With $110M and Johns Hopkins tech, Thrive aims to make early cancer screening routine
Grail's blood test identifies 12 cancers before they can spread in early study results

How Much Coffee Is Too Much?: The answer is “drinking six or more cups of coffee a day can increase your risk of heart disease by up to 22%…”

Read the report

Blueberries improve biomarkers of cardiometabolic function in participants with metabolic syndrome—results from a 6-month, double-blind, randomized controlled trial: On the other hand, some things that you enjoy may be good for you. 1 cup of blueberries per day for 6 mo resulted in improved blood vessel function and helped cholesterol profiles enough to lower cardiovascular disease about 12-15%. The effects seem to be due to anthocyanin in the fruit. One caveat- the study received support from the United States Highbush Blueberry Council.

Read the research

About healthcare IT

Local Investment in Training Drives Electronic Health Record [EHR] User Satisfaction: It is well-known that physicians are unhappy with EHRs because of their time consuming requirements. This research claims that the fault is inadequate training; better training will improve satisfaction.

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Today's News and Commentary

About pharma

Global Oncology Trends 2019 -Therapeutics, Clinical Development and Health System Implications: The summary findings of this annual !QVIA report is that a “record 15 new oncology therapeutic drugs were launched in 2018 for 17 indications. Over half of the new therapies are delivered as an oral formulation, have an orphan indication or include a predictive biomarker on their label.” Other details include costs and a breakdown of therapeutic areas.

Read the report

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval: Speaking of oncology drugs, this research reviewed 93 drugs that received accelerated approval and found only about 20% had confirmed increased survival rates or other benefits. The authors recommend: “Reassessment of the requirements for confirmatory trials may be necessary to obtain more clinically meaningful information.”

Read the research

Estimates of all cause mortality and cause specific mortality associated with proton pump inhibitors [PPIs] among US veterans: cohort study: This research revealed that taking “PPIs is associated with a small excess of cause specific mortality including death due to cardiovascular disease, chronic kidney disease, and upper gastrointestinal cancer. The burden was also observed in patients without an indication for PPI use. Heightened vigilance in the use of PPI may be warranted.” The association is related to the duration of exposure.

Read the research

About the public’s health

How the Microbiome Might Predict Diabetes, Premature Birth and Gut Diseases: The term microbiome describes the bacteria throughout her body, but usually focuses on the gastrointestinal tract. Research over a number of years has found an association between a disturbed microbiome and certain diseases, like diabetes. Such disturbances can be due to such events as infection with disease-causing organisms or antibiotic use. This article is a nice summary of the current status of this important and emerging topic.

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Annual Report to the Nation on the Status of Cancer, 1999–2015, Featuring Cancer in Men and Women ages 20–49: This report is published annually by The American Cancer Society, Centers for Disease Control and Prevention, National Cancer Institute, and North American Association of Central Cancer Registries (NAACCR). While mortality trends were favorable overall, as expected, statistics varied by sex and type of malignancy.

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New U.S. Measles Cases Break 25-Year-Old Record, Health Officials Say: While measles has not been at the top of the news, the problem is still not over. As the headline says, we broke a 25-year-old record.

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About health insurance

Healthcare Costs Top Financial Problem for U.S. Families: A Gallup poll issued yesterday found that “Americans are more likely to name healthcare costs than any other issue when asked to say what is the most important financial problem facing their family. Seventeen percent name healthcare, followed by lack of money or low wages, named by 11%. A year ago, those two issues and personal debt essentially tied for first; healthcare was also the clear leader in 2017…Gallup has asked the ‘most important family financial problem’ question on 48 separate occasions since 2005. During that time, only three issues -- healthcare costs, energy costs/oil and gas prices and lack of money/low wages -- have topped the list in any single poll.”

Read the results

Medicare Index Report:Annual Enrollment Period for 2019 Coverage: This report from eHealth found that the “average premium for Medicare Advantage Prescription Drug plans selected by eHealth customers [emphasis added] decreased 42 percent between the enrollment periods for 2018 and 2019 coverage… Average deductibles decreased 13 percent… Average out-of-pocket limits decreased
3 percent … The average monthly premium for Medigap plans selected by eHealth customers increased 8 percent.” Maybe Medicare advantage is a good deal after all.

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Early Release of Selected Estimates Based on Data From the 2018 National Health Interview Survey: This study has a wealth of information ranging from where people get their medical care to how they spend their leisure time. The one item from this survey (released yesterday) that made the news was: ”For 2018, the percentage of the population that failed to obtain needed medical care due to cost at some time during the past 12 months was 4.8% … which was not significantly different from the 2017 estimate of 4.5%.” Curiously, that figure is much smaller than the percent of uninsured at the time of the study in 2018, 13.3% among adults aged 18–64.

Read the report

About safety

More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database: As previously reported, up until recently the FDA had an alternative reporting mechanism for products that experienced adverse results. Those reports were not available to the public. This article highlights the problem looking specifically at surgical stapler malfunctions.

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About healthcare IT

How four promising trends could aid patient matching: Since patients do not have unique identifiers, healthcare providers need a way to match patients across different IT systems. The article provides a good look at some trends to solve this problem.

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Health IT stakeholders calling for ONC, CMS to 'go back to the drawing board' on interoperability rules: The 21st Century Cures Act has IT provisions that include prohibition on “data blocking,” that is, blocking transmission of data to enhance interoperability. The Health Innovation Alliance  (which includes such members as Aetna, IBM, Athenahealth and Teladoc) is now asking the ONC to rewrite its interoperability rules. Among the reasons for this stance is that the rules are so vague that they may impede innovation. As one person commented: ” the language around…information blocking is too ambiguous and allows too much room for discretion, and that makes it problematic for affected stakeholders who potentially face penalties of as much as $1 million per infraction.” ONC and CMS have yet to reply.

Read the article

Today's News and Commentary

About pharma

Pharmacogenomics testing: What the FDA says: Pharmacogenomics is using genetic data to guide medication choices and dosing. This article is a bit technical but it highlights the fact that many of these genetic tests are laboratory-specific and, thus, not subject to FDA review. (They are covered by the Clinical Laboratory Improvement Act- CLIA.) The results and how they should be used are controversial.

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Pediatric Patients Wait an Average of 6.5 Years Longer Than Adults to Access New Oncology Drugs: This research quantifies the delay in providing pediatric oncology drugs. What it does not get is the reason for it. Pharma companies get more product protection if they delay a pediatric indication for any drug. Time to change this law?

Read the study

About health insurance

At packed hearing, NY lawmakers weigh single-payer health care: This article is a good example of the issues being debated when a state is considering adopting a single payer system. One issue is affordability for all. Another issue is coverage for all. If the latter were the only concern, would it make sense to re-do the entire system for 5% of the population without insurance?

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Public option hits rocks, key components stripped from bill: In nearby Connecticut, a public option plan has encountered some problems when certain measures were stripped from the proposed bill. The argument is over whether or not Cigna threatened to pull out of the state if the bill is passed.

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Leveraging Data-Driven Insights to Support Development of Targeted Supplemental Benefits Under Newly Expanded Flexibilities in Medicare Advantage to Improve Outcomes in High-Cost, High-Need Beneficiaries: This report was based on a presentation by Avalere consulting at a conference last week. It reviews the characteristics and social support service needs of dual eligibles in Medicare Advantage plans. The conclusions are self explanatory in the article. One problem is that conclusions are based on 2015 data. Research based on such old findings is common in healthcare. Chances are in this case the conclusions would not be different with more recent data. But that is not always the case.

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Medicaid Expansion Fills Gaps in Maternal Health Coverage Leading to Healthier Mothers and Babies: This study provides further evidence “that states that expand Medicaid improve the health of women of childbearing age: increasing access to preventive care, reducing adverse health outcomes before, during and after pregnancies, and reducing maternal mortality rates.”

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Blue Cross Blue Shield consortium picks Cricket Health as preferred kidney care provider: A consortium of Blue plans decided to contract with a startup renal company (Cricket Health) instead of giants Fresenius or DaVita.

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About the public’s health

Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial: The bottom line in this technical article is that drinking energy drinks (which have a lot of caffeine in them) can cause EKG changes and raise blood pressure. The authors also conclude: Further investigation is warranted on whether an individual ingredient or a unique combination leads to the observed electrophysiological and hemodynamic changes. The impact of long‐term energy drinks consumption remains unknown.” Obviously you should be very careful if you are consuming these products.

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Your Bottled Water Probably Has Plastic In It. Should You Worry? To answer the headline’s title directly, we don’t know. One thing is certain, water bottled in plastic is not always better than tap water. Also, plastic is, unfortunately, ubiquitous.

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Association of Nonfasting vs Fasting Lipid Levels With Risk of Major Coronary Events in the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid Lowering Arm: The conclusion of this study is that non fasting lipids levels (like cholesterol) can be used to screen for abnormalities and also to follow treatment responses. This finding will help patients more conveniently get their followup tests and also aid “health fairs” in detecting problems in those who attend them not-fasting.

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First diagnostic test for Zika virus gets FDA's OK to market: The title speaks for itself.

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About healthcare quality

Maternity Care Report 2019: The Leapfrog Group just issued its annual maternity care report and the results are not good. Surveying for early elective deliveries, C-sections and episiotomies, they found only 20% of hospitals met criteria in all three areas. There is a lot of detail about each measure in the report and also a map of compliance by state. Now the question is what we can do to improve the performance.

Read the study

AND FINALLY…

Healthcare CEOs again lead the way in pay: “.For the third time in four years, chief executives in the healthcare field led the S&P 500 in terms of total compensation. The typical CEO in the industry made $16.1 million last year…”

Read the story (Modern Healthcare but appears to be open access)

Today's News and Commentary

About the public’s health

Estimating the Attributable Cost of Physician Burnout in the United States: Physician burnout has been discussed as an availability problem. This research puts a price on it: “On a national scale, the conservative base-case model estimates that approximately $4.6 billion in costs related to physician turnover and reduced clinical hours is attributable to burnout each year in the United States.”

Read the research summary(Full article requires subscription)

World's rivers 'awash with dangerous levels of antibiotics': Antibiotic resistance is one of the world’s biggest health problems. Fixes have been directed at physicians to decrease unnecessary prescriptions and at patients to lessen their demands when treatments will not help. This article highlights a potentially bigger problem--”Hundreds of sites in rivers around the world from the Thames to the Tigris are awash with dangerously high levels of antibiotics.” The worst area is Africa, where 35% of tested rivers contain unsafe levels of antibiotics. (North America is at 15%). Clearly we need to address this source in our effort to combat drug resistance.

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New directions in incidence and prevalence of diagnosed diabetes in the USA: Finally some “good news.” According to the CDC: “ After an almost 20-year increase in the national prevalence and incidence of diagnosed diabetes, an 8-year period of stable prevalence and a decrease in incidence has occurred. Causes of the plateauing and decrease are unclear but the overall burden of diabetes remains high and deserves continued monitoring and intervention.” The reason the cause is particularly unclear is that obesity and overweight incidences are still rising.

Read the research

Why smelling good could come with a cost to health: “Fragrances” are found in dozens of products we use every day. But they are not regulated by the FDA and their exact chemical compositions are trade secrets. Many of these fragrances have been found to contain harmful substances. Read this article before you use any of these products.

Read the article

About healthcare IT

Babylon’s GP at Hand app raises questions over NHS tech tie-ups: This British app collects a patients’ symptoms and enables them to talk to an NHS physician at one of two sites. However, a recent study calls into question whether the technology is medically accurate or if it saves money for the NHS. One big problem is that NHS sites are funded to care for their local populations. But only 10% of the app’s subscribers are in the catchment areas of the two participating providers.

Read the story(Subscription may be required)

Using Health IT for Care Coordination: Insights from Six Medicare Accountable Care Organizations: This report from the HHS Inspector General’s office revealed some insights into problems ACOs face in using IT for care coordination. While organizations that share a single electronic health record (EHR) show promise in enhanced coordination of care, ACOs that use multiple systems “faced challenges from physician burnout due to the workload of managing EHRs. Most of the ACOs had access to HIEs [Health Information Exchanges] with little or incomplete data, making it difficult to coordinate care when patients saw providers outside the ACOs' networks. Few of the ACOs use analytics to customize care to an individual patient's needs.”

Read the study

Two Years In and WannaCry is Still Unmanageable: 40% of healthcare organizations suffered an attack by this malware in the last 6 months. One issue (as previously reported) is that many organizations use Windows 7 and older versions- 70% in healthcare compared to less than 30 % in the tech sector. The article has some suggestions on protection.

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About healthcare systems

UCSF ends affiliation talks with Dignity Health following protests: Several months ago, San Francisco-based Dignity Health and Denver-based CHI (formerly Catholic Health Initiatives) merged to form a 21 state $29 billion system. The new entity is called CommonSpirit Health and in headquartered in Chicago. UCSF (part of the public University of California system) had been in affiliation talks with Dignity. However, the plan prompted protests by those concerned that an affiliation "with a healthcare system that has certain limits on women’s reproductive services, LGBTQ care, and end-of-life options.” The deal is now off.

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About pharma

Specialty Drug Pricing and Out-of-Pocket Spending on Orally Administered Anticancer Drugs in Medicare Part D, 2010 to 2019: After spending a certain amount on drugs, seniors are responsible for all costs up to a maximum. This responsibility has been called the doughnut hole because it is between two corridors of coverage. The cost has decreased from 100% in the gap in 2010 to 25% this year. However: “Despite efforts to close the coverage gap between 2010 and 2019, mean expected out-of-pocket spending in 2019 benefit designs increased for 12 of 13 orally administered anticancer drugs available in both years (mean 12-month out-of-pocket spending in 2010 was $8794 and in 2019 is expected to be $10 470; mean increase, $1676).” In other words, the increases in costs are outpacing the decreased financial responsibility.

Read the article (Summary only may be available without subscription)

As Trump Battles Congress, U.S. Drug Spending To Eclipse $370B: The bottom line is “U.S. drug spending is projected to grow this year by 2.5% to more than $370 billion, boosting overall healthcare spending past $3.3 trillion for 2019.” By 2023, the pharma is expected to be 9.7% of total spending; but it has been in the 9.5-10% range for many years.

Read the story 

Today's News and Commentary

About the public’s health

Modeling Cardiovascular Risks of E-Cigarettes With Human-Induced Pluripotent Stem Cell–Derived Endothelial Cells: This research article concludes that using e-cigarettes causes damage to the lining of arteries, which can lead to such complications as a heart attack and stroke.

Read the research summary (Full article requires subscription)

Atlas of group A streptococcal vaccine candidates compiled using large-scale comparative genomics: Group A strep (GAS) is well-known to parents for causing such illnesses as “strep throat” and skin infections (impetigo). With all the vaccines available why isn’t there one for GAS? The reason is the large genetic variations of this microbe: the researchers found “more than 290 clinically associated genomic phylogroups across 22 countries, highlighting challenges in designing vaccines of global utility.” But they developed techniques to narrow down candidates for vaccines. Maybe strep throat will be rare sometime in the future- if parents get their children immunized.

Read the research summary (Full article by subscription)


The drug
About healthcare quality

Deadly errors, infections: When hospital ratings don't align what should patients believe?: This article from USA Today points out what healthcare quality specialists have long known- ratings not only don’t often agree, but they can vary significantly. Who to believe? There is no right answer.

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About pharma

WHO agrees watered-down resolution on transparency in drug costs: Bowing to industry pressure, today the WHO said it would recommend clearer information about drug pricing instead of insisting on publication of development costs that companies use to justify those prices.

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Novartis to charge $2.1 million for Zolgensma following its US approval as first gene therapy for paediatric SMA patients: This story has been the #1 health report for the past several days. The drug is the most expensive single treatment- others cost less but must be given on a regular basis for life. Given its cost, Novartis is considering creative payment methods- like financing a car?

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B.C. becomes first province to force change to 'biosimilar' drugs: The province will require publicly funded patients to switch to biosimilar drugs by this November to continue their coverage. This measure is the most far reaching I have seen to control costs in this sector.

Read the story

About health insurance

Network Matching: An Attractive Solution To Surprise Billing: While there is nothing new in this article, it is a nice summary of the topic of surprise billing and potential solutions. I found the relative charges for different non-contracted specialties particularly interesting. At the top were anesthesiologists and ER physicians.

Read the article

About healthcare IT

IT applications and healthcare: Here are two related articles on this topic. The first is a nice overview of some of the ways smartphones are being used as medical devices. The other article is a review from the Office of the National Coordinator (ONC) about the growth in the public’s use of healthcare IT, such as remote medical record access.

About health insurance

Reduced Pricing of Diagnostic Health Tests Could Save Consumers More Than $18 Billion a Year: This United HealthGroup study looked at some common diagnostic tests, including imaging, and found that if all tests priced above the 40th percentile could be lowered to that level, consumers would save $18 Billion per year.

Read the study

Today's News and Commentary

About health insurance

Appeals court sets July hearing in ObamaCare case: Recall that in December U.S. District Court Judge Reed O'Connor said the ACA could not stand if the individual mandate no longer has a penalty for non compliance. The 5th U.S. Circuit Court of Appeals in New Orleans will hear the appeal on July 9.

Read the story

Public Health Insurance Legislation Announced in Connecticut: Connecticut is poised to join a trend to create a state-based public health insurance option.

Read the story(Wall Street Journal, subscription required)

More than Half of All OCM Providers Could Owe CMS Money if Required to Join in 2-Sided Risk Model: As part of CMS’s bundled payment programs, oncologists can participate in the Oncology Care Model. Analysis by Avalere indicates that under a new risk program 48% of participants would end up paying CMS. The good news is that under the old system it was about 70%.

Read the research

Moody's: Health insurers off to strong financial start in 2019—but political uncertainties loom: Bond-rating firm Moody’s found that:  “Of the eight insurers included in the analysis—Aetna, Anthem, Centene, Cigna, Humana, Molina, UnitedHealth and WellCare—none were given a negative credit implication rating for their performance…” Medicare Advantage growth was a significant contributor to their financial health. The report pointed out, however, that political instability (such as Medicare for All proposals) may make the financial future more volatile for these companies and others.

Read the story

About the public’s health

Scientists spy on superbugs to see how they outsmart our antibiotics: This is a fascinating explanation of how bacteria can persist even if they face antibiotics to which they should be sensitive. It could open up a whole new mechanism for designing antibacterial medications.

Read the story

“Best if used by." The FDA renders its decision on food expiration date labels: When is food no longer safe to eat? Because there were so many term used on labels, “after a two-year effort by industry, the FDA on Thursday came out with its own guidance on labels, saying it favored a single designation to guide consumers when they opened the cupboard or fridge door: ‘Best if used by.’”

Read the story (Washington Post- may require subscription)

Association of Black Race With Prostate Cancer–Specific and Other-Cause Mortality: Physicians assumed that worse outcomes in African American men who have prostate cancer were because of biologic factors. This research shows the differences are due to “nonbiological differences, notably access to care and standardized treatment.” Other cause mortality was also higher in black men.

Read the research (Abstract is accessible; full article requires subscription)

New Trump administration rule would weaken protections for transgender people in health care: The Trump administration said it would interpret the civil rights term of nondiscrimination “on the basis of sex” to mean the biological state at birth; it changes the Obama administration’s inclusion of transgender people in the law’s protection.

Read the story (Washington Post, may require subscription)

About pharma

Colorado becomes first state in the nation to cap price of insulin: Diabetics will pay a maximum of $100 per month under the new law.

Read the story (Denver Post, requires subscription)

House Bill: To amend title XVIII of the Social Security Act to reduce the Medicare part D reinsurance subsidies, eliminate beneficiary out-of-pocket costs above the Medicare part D catastrophic threshold, and for other purposes: This as-yet unnumbered Medicare Part D bill was proposed yesterday with bipartisan support by House health care leaders. Among its major provisions are setting an out of pocket cap for beneficiaries and reducing the catastrophic subsidy the federal government will pay when limits are reached from the current 80% to 20% (four years after passage).

Read the proposed bill

‘‘Lower Health Care Costs Act’’: This proposed bipartisan bill came from the Senate and is much more complex than the one from the House described above. It addresses: ending surprise medical bills (including independent dispute resolution); reducing the price of prescription drugs; improving transparency in healthcare; improving public health (including grants to address vaccine-preventable diseases); and improving the exchange of health information.

Read the proposed bill
Read a summary

About healthcare IT

Healthcare breach of 1.5M records made worse by notifications sent to wrong addresses: Unfortunately, data breaches are so frequent they are not really newsworthy. This one deserves attention for two reasons. First, 1.56 million records were involved. Second, the company ,Inmediata Health Group, is a healthcare clearinghouse rather than a provider organization or payer.

Read the story

HealthcareInsights.MD will resume on May 28 after Memorial Day

Today's News and Commentary

About the public’s health

Moderators of real‐world effectiveness of smoking cessation aids: a population study: This English research highlights that there is no single best strategy for getting people to quit smoking. Other than increasing taxes (which works for everyone), market segmentation provides a guide to best methods. The study found that the best overall measure was e‐cigarettes, followed by varenicline (Chantix). Nicotine replacement treatment was only effective for those over 45 years old. “Use of websites was associated with increased abstinence in smokers from lower … but not higher social grades... There was little evidence of benefits of using other cessation aids.”

Read the research

One-minute survey tool can help providers prioritize patients' social needs: A brief questionnaire handed out in the ER at Virginia Commonwealth University produced some interesting findings: “…more than 60% of patients reported at least one unmet social need within the past 30 days. Almost 8% of inpatients and ED patients reported two needs and 18.4% of inpatients and 15.5% of ED patients reported three or more unmet needs.” While specific results are characteristic of the local population, the ease of use and 100% return rate make the tool worth considering by other facilities.

Read about the research

About health insurance

CBO: Medicare for All gives 'many more' coverage but 'potentially disruptive': Further Congressional testimony on this topic yesterday revealed a couple issues. First, “Medicare for All” still means different things to different people. Second, the Congressional Budget Office deputy director Mark Hadley said that such a program would be very disruptive to the country. For example, he predicted the possibility of “increased wait times and problems with access to care.” How much would it cost? Depends on the specific proposal and who is doing the analysis; in other words, we don’t know.

Read the story

About pharma

Verma: CMS mulling outcomes-based ways to address expensive specialty drugs: In an interview yesterday, CMS Administrator Verma opined about how the federal government could lower costs for specialty pharmaceuticals. One method that has been discussed is paying only if the drug works. But that definition may be difficult— what if a “partial cure” is all that can be expected? She gave some other potential obstacles as well. “For example, patients rarely stick with one insurer indefinitely, which could make it hard to track mortality or other outcomes to establish payment. In addition, outcomes-based pricing could lead to higher list prices at launch, as pharmaceutical companies would be expected to pay rebates or discounts if the drug is less effective.”

Read the story

Today's News and Commentary

About healthcare IT

Google’s cancer-spotting AI outperforms radiologists in reading lung CT scans: Using the Google AI application, “researchers were able to detect 5% more cancer cases while reducing false-positives by more than 11% compared to the findings of unassisted radiologists.” I assume the final report will be available quicker as well.

Read the story

About pharma

Baltimore sues J&J for spinning up a 'sham' Zytiga patent to fend off generics: Pharma manufacturers employ a variety of techniques to extend their patent protection. Congress and states have looked at ways to attack these processes and others that keep prices high. This case is unusual because a city is suing.

Read the story

Lilly to insulin pricing critics: Check out our 50%-off Humalog copy instead: In response the the rapidly rising costs of insulin, Lilly had promised a generic to its Humalog. It is now available. At 50% off the branded version it lists for $137.35 per vial or $265.20 for a five-pack of pens.

Read the story

How Does Prescription Drug Spending and Use Compare Across Large Employer Plans, Medicare Part D, and Medicaid?: This study from the Kaiser Family Foundation analyzes drug spending for 2017 (its most recent year). Among the the findings:
—Private health insurance, Medicare, and Medicaid accounted for 82% of total retail prescription drug spending in the U.S. in 2017, while patients paid 14% of the total as out-of-pocket payments.
—For spending on specific drug products, the top five drug products with the highest total spending alone account for at least 10% of total prescription drug spending in large employer plans, Medicare Part D, and Medicaid.
—Antidiabetic agents, antivirals and psychotherapeutics are among the top therapeutic classes by total spending in large employer plans, Medicare Part D, and Medicaid.

Lots more to read there.

Read the report

Hearing on “Improving Drug Price Transparency and Lowering Prices for American Consumers”—House Committee on Energy & Commerce:You can view the testimony delivered yesterday on a number of bills to enhance transparency and lower costs of drugs. One of those testifying was Kristin Bass, the chief policy and external affairs officer for the Pharmaceutical Care Management Association (PCMA). She opined that drug rebate amounts should be reported in aggregate rather than by individual company. The reason for her statement is that in categories with few drugs, such firm-specific information might signal price increases rather than decreases. In other words, imagine two companies with products in a therapeutic class. If one finds out the other has lower rebates it will lower its own, leading to higher consumer prices.

View the testimony

About health insurance

Medicare Advantage Plans Outperforms Fee-For-Service Medicare Plans in Caring for Dual-Eligible Beneficiaries with Chronic Conditions: Dual eligibles have both Medicare and Medicaid coverage. They are usually both older and sicker than other population segments. To assess whether Medicare Advantage (MA) plans or traditional Medicare fee for service (FFS) provides better care for this population, Avalere sampled files of 2.7 million beneficiaries. The research found that: “ MA outperformed FFS Medicare on overall cost of care (16.7% higher in FFS), quality measure outcomes, and utilization of high cost health services such as inpatient and emergency room visits when it came to caring for dual eligible beneficiaries with chronic conditions. Dual eligible beneficiaries experienced significantly lower rates of complications, avoidable hospitalizations and readmissions, and received more preventative care services compared to dual eligible FFS Medicare beneficiaries. These findings suggest that MA plan flexibility to provide additional benefits and coordinate care results in better outcomes and lower costs for Medicare.”

For more details, read the report

Providers, insurers parse what they could support—and what they won't—in surprise billing solution: The House Ways and Means Committee held hearings yesterday from a variety of stakeholders on protections for patients from surprise billing, e.g., when a patient goes to a hospital with an emergency and gets a large bill from a physician who is not contracted with his or her insurance plan. All agreed the practice should be addressed so that patients are removed from the middle. But solutions were all over the map. Someone needs to sit down and propose a bill, like what is being done with drug prices and transparency. It can then be voted up or down.

Read the article
View the hearing (About 2 hours)

About the public’s health

Thermal Stabilization of Viral Vaccines in Low-Cost Sugar Films: This research should be the health story of the week (or maybe longer). Often vaccines need refrigeration or at least a very stable, moderate temperature, to be transported without loss of effectiveness. But delivery to such countries as those in sub-Saharan Africa pose a special problem. The technique explained in the article provides a low-cost answer to this issue, allowing vaccines to be transported without refrigeration or loss of potency even for 2-3 months at 40 degrees C (depending on the vaccine).

Read the research

U.S. states, cities sue to block Trump 'conscience' rule for healthcare workers: Today’s most reported story across media is the lawsuit led by NY Attorney General Letitia James on behalf of two dozen U.S. states and municipalities. These governments are suing the Trump administration over the previously reported “conscience rule” that would allow providers to refuse care based on their religious and other beliefs.

Read the article

United States Government Global Health Security Strategy 2019: This document was published last week and is far-reaching in its desire to link this country with the global health environment. Its stated Vision is: “The United States, in close cooperation with its international partners, prevents, detects, and responds to infectious disease threats at home and abroad, whether naturally occur- ring, unintentional, or deliberate.”

Read the document

Natural compound found in broccoli reawakens the function of potent tumor suppressor: Yes, eating broccoli is good for you. “A new study demonstrates that targeting the gene, known as WWP1, with the ingredient found in broccoli suppressed tumor growth in cancer-prone lab animals.”

Read the story

Millennial Healthcare Preferences Are A Departure From The Status Quo: This study from Transamerica is an interesting look at different generational preferences and attitudes regarding healthcare, with a focus on millennials. For example: “One in five Millennials (21 percent) are not satisfied with the quality of the healthcare system they have access to—a dissatisfaction that has increased each year since 2016. “

Read the study

Today's News and Commentary

About health insurance

McConnell and Kaine want to raise the federal smoking age to 21: Finally, some rational bipartisan cooperation: “Senate Majority Leader Mitch McConnell (R-Ky.) and Sen. Tim Kaine (D-Va.) introduced a bill Monday to raise the federal minimum age to purchase tobacco from 18 to 21, a measure they say is aimed at reducing teen use of e-cigarettes.”

Read the story

California eyes health care for immigrants in US illegally: France covers illegal immigrants as a matter of public health. But this measure may be “no good deed goes unpunished.” These illegal immigrants may not be eligible for legal status if they are receiving public welfare benefits.

Read the story

‘Medicare for All’s’ rich benefits ‘leapfrog’ other nations: This article is a nice summary pointing out that “Medicare for All” not only provides more benefits than does other countries’ public systems, but also eliminates the private sector, on which other countries rely to relieve excessive waiting times.

Read the story

Variation Among Primary Care Physicians in 30-Day Readmissions: Medicare is continuing to look at the quality pf physician performance and linking it to payment. One measure is 30-day readmission rates. This study looked at primary care physicians in Texas and found that for their fee for service Medicare patients, the variation in readmission rates is very low. If the findings are found to be more generalizable, this metric will need to be reassessed for certain physician groups.

Read the research (Full article is by subscription but this summary makes the point)

About the public’s health

Provider and Staff Feedback on Screening for Social and Behavioral Determinants of Health for Pediatric Patients: This research highlights that gathering social determinants of healthcare is important, but the information also needs to be customized to the local patient population.

Read the research

Contributions of Health Care to Longevity: A Review of 4 Estimation Methods: How much does medical care contribute to increased longevity? The exact figure depends on study methodology, but it is clear any benefit is dwarfed by the contribution of public health measures. The authors conclude: “The results converge to suggest that restricted access to medical care accounts for about 10% of premature death or other undesirable health outcomes. Health care has modest effects on the extension of US life expectancy, while behavioral and social determinants may have larger effects.“ It is interesting that today’s NY Times also has a story on this subject.

Read the research
Read the NY Times article

Freestanding emergency departments in Texas do not alleviate congestion in hospital-based emergency departments: To expand access to care and relieve overcrowed ERs, many communities and hospitals have opened up free standing ERs or urgent care centers (FrEds). Have they accomplished their mission? At least in Texas, the answer is they “did not help relieve congestion in nearby hospitals in major metropolitan areas in Texas. By offering more treatment options to patients, FrEDs are associated with increased usage of emergency services.” The same increase in service delivery has been found in some telemedicine programs.

Read the research

About pharma

IBD [Inflammatory Bowel Disease]Rx Tied to Pharma Payments to Docs: Many healthcare systems do not allow its physicians to receive anything of value from pharma companies. The results of this study are one reason. “The researchers accounted for patient volume, and the associated prescription cost was still significantly related to the value of industry payments, with every $1,000 in industry payments associated with a $3,846 increase in prescription claims (P<0.001, R2=7.64%, 95% CI $3,285 to $4,407)…”

Read about the results

About medical technology

The top 11 medtech approvals of 2018: The online publication Fierce Biotech has just issued its top 11 medtech approvals of 2018.

Read the article and list

About healthcare law

Supreme Court Refuses to Hear Case on Doctrine Preventing Military Medical Malpractice Lawsuits: “The lawsuit had failed from succeeding in the lower courts due to a 1950 Supreme Court case, Feres v. United States, which established the controversial legal precedent known as the Feres doctrine. The doctrine prevents service members on active duty from leveraging medical malpractice lawsuits against the armed forces under the Federal Tort Claims Act for injuries and negligence.” Read the article for the whole story. To show how controversial this issue is, Justices Ginsburg and Thomas joined in the dissenting opinion.

Read the story

Today's News and Commentary

About health insurance
Deductible Relief Day: How rising deductibles are affecting people with employer coverage: Yesterday was “Deductible Relief Day” – the day when “enrollees have, on average, incurred enough health spending to hit the average deductible in an employer plan.” Ten years ago, Deductible Relief Day fell two months earlier in the year, on March 18, 2009, when the average deductible was $533 for a single person; in 2018 the figure was 2018.

Read the story

Health Plan Customer Satisfaction Challenged by New Era of Empowered Healthcare Consumers, J.D. Power Finds: While out of pocket costs are dragging down customer satisfaction, this survey concludes that increased health plan satisfaction is driven by coverage and benefits: “Overall health plan member satisfaction is 713 (on a 1,000-point scale), up 7 points over the previous three years. The increase, in part, is driven by improved satisfaction with the coverage and benefits offered. Coverage and benefits—not cost—is the most important driver of customer satisfaction, now accounting for 25% of total health plan member satisfaction.”

Read the survey

CMS announces delay of CAR T-cell national coverage determination: The title speaks for itself. No reason was given for the delay.

Read the announcement

JP Morgan buys health-care payments firm InstaMed in the bank’s biggest acquisition since the financial crisis: This story was the biggest business news of the day. JP Morgan will pay more than $500 million for this business that processes healthcare transactions.

Read the announcement

About healthcare IT

Microsoft warns flaw in Windows legacy systems 'likely to be exploited' similar to WannaCry: As previously reported, systems with some Microsoft legacy products will not be supported in the future. Now “Microsoft has taken the rare step of releasing a patch for a handful of legacy operating systems it no longer services after finding a critical vulnerability. The company is warning users to patch their systems quickly to avoid another WannaCry ransomware attack.”

Read the announcement

Social Determinants of Health Data Deemed Most Difficult to Share: As previously reported, social determinants are difficult to capture in EMRs. Part of the problem has been lack of codes. A recent survey shows that even if social determinants are captured, they are very difficult to share among systems.

Read the story

Health plans back Solera’s SDOH program with $42 million:A consortium of health plans is financing Solera, which “uses data science to consolidate highly fragmented programs and services into a single marketplace for health plans and employers, which helps them proactively identify what will best fit an individual’s needs.”

Read the story

CHIME urges CMS, ONC to give providers 3 years to comply with interoperability rules: CMS has been pushing providers to comply with its interoperability and data blocking rules. As previously reported, provider organizations have been pushing back, saying the requirements don’t leave them enough time to comply. Now, the “College of Healthcare Information Management Executives, representing healthcare CIOs, is urging federal healthcare policy officials to go slow with dual interoperability and information blocking rules by first publishing interim final rules rather than final rules.”

Read the story

About the public’s health

Bloomberg expands gender-neutral paid parental leave: Bloomberg is expanding parental leave for the primary caregiver from 18 to 26 weeks.

Read the announcement (May require subscription)

About healthcare quality

Centers of Excellence Designations, Clinical Outcomes, and Characteristics of Hospitals Performing Percutaneous Coronary Interventions: Centers of excellence (COE) are providers who demonstrate higher quality care. In this study, criteria for inclusion in the COE designations were obtained from publicly accessible directories of three payers. The bottom line: the research  “found a lack of correlation between COE designation and lower mortality or readmission rates.” Readers should be cautioned, however that if this study is further validated, it may only apply to this procedure.

Read the research

About pharma

AbbVie's discounting Humira to aid Skyrizi's launch—and a price war could follow: analyst: AbbVie has a strategy for making sure its new immunomodulator drugs, Skyrizi and upadacitinib, get on drug formularies. The plan is to discount the price of its blockbuster drug Humira. Will the strategy lead to a price war in the category?

Read the announcement

Today's News and Commentary

About the public’s health

Liver transplant rules spark open conflict among transplant centers: As previously reported, federally sponsored allocation methods for organ transplants have been changing. Undersupplied, populated areas complained that they don’t have enough organs. Relatively underpopulated areas (which are better-supplied) say they will be discriminated against if their available organs go elsewhere. Atlanta federal court judge Amy Totenberg said she will allow a lawsuit to go forward by those claiming to be adversely affected by the new rules.

Read the story (Washington Post but appears to be open access)

Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake: This research explains the science of why junk food is bad for you. Subjects were presented with identical diets were with respect to calories, sugar, fat, fiber, and macronutrients. One diet was “ultra processed” and the other was a healthier offering. In addition to the presented diets, subjects were free to eat other foods without caloric restriction. Results showed the ultra processed diet (junk food) led to about 500 calories more per day than the healthier diet, with a significant increase in weight gain. The healthier diet also led to weight loss.
Reasons for these findings? The glucose tolerance between groups was not changed but “the appetite-suppressing hormone PYY increased during the unprocessed diet as compared with both the ultra-processed diet and baseline. Also, the hunger hormone ghrelin was decreased during the unprocessed diet compared to baseline.” Other researchers have been investigating obesity treatments using PYY and ghrelin. This study may lend some scientific credence to those investigations.

Read the research

Fostering Productive Health Care Cost Conversations: Sharing Lessons Learned and Best Practices: This themed issue of the Annals of Internal Medicine has articles about how physicians can conduct cost of care conversations with patients.

Link to the articles (Open access)

About pharma

Trump administration backs off Medicare drug pricing rule: “Under current law, private Medicare health plans are required to cover all or ‘substantially all’ drugs in six ‘protected”’classes, such as HIV treatments, antidepressants, drugs to treat epileptic seizures, and cancer drugs, regardless of cost.
Last fall, the administration proposed allowing health plans to exclude protected drugs with price increases that are greater than inflation, as well as certain new drug formulations that were not a ‘significant innovation’ over the original product.” Yesterday, CMS Administrator Seema Verma said that, based on feedback, the agency is withdrawing the proposal.

Read the story

White House, Congress considering killing Part D rebate rule, creating spending cap: In a related story about Medicare drug costs, the White House and Congress are considering abandoning a policy of rebates going to patients in favor of a spending cap.

Read the story

Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses: CMS issued final rules to address lowering drug costs. Among the rules are: the requirement to include “negotiated drug pricing information and lower cost alternatives in the Part D Explanation of Benefits beginning on 01/01/2021”; the requirement that Part D plans provide access to a Real Time Benefit Tool to be integrated into clinicians’ electronic prescribing or electronic health records systems no later than 01/01/21; and “certain new requirements for when MA [Medicare Advantage] plans may apply step therapy as a utilization management tool for Part B drugs.”

Read the rule:

Are pharmaceutical companies making progress when it comes to global health?: The Access to Medicine Foundation issued this report looking at how pharma companies are responding to the healthcare needs of developing countries. Among the findings: “…several pharmaceutical companies are now doing business in new, inclusive ways that aim to reach people on very low incomes. Seven companies are running a total of ten inclusive business models, eight of which are being expanded. Plus, 17 companies now set measurable targets related to access to medicine, up from eight in 2010. Yet, only some companies (9) are tackling the risks of unethical sales behaviour by changing sales bonuses. Fewer companies (4) have consistently supported international trade agreements designed to ensure the poorest people can benefit from medical innovation.” 

Read the report

AAM Rejects FDA’s Updated Biosimilar Naming Policy: As recently reported, manufacturers of branded biological drugs want the FDA to come up with a suffix for the product’s name that will identify it as the “original.” Predictably, “the Association for Accessible Medicines (AAM) and its Biosimilars Council is urging the FDA to scrap its proposed suffix-based naming policy for biological products because it would act as ‘a barrier to biosimilars access.’”

Read the story

Gilead schemed with J&J, Bristol-Myers to keep their HIV combo monopoly, lawsuit claims: It seems there is an epidemic of anticompetitive behaviors among pharma companies. On the heels of the recently reported Teva case, Gilead and others have been charged with monopolistic practices regarding a key component in an HIV treatment combination.

Read the story

Dems push bill on health care, drug prices through House: Along with five Republican votes, House Democrats passed a bill to address high drug prices. However, the bill also has provisions to rescind Executive Orders intended to dismantle the ACA, like allowing short-term plans to compete with those on the exchanges. Because of that addition, senate Republicans say it is DOA.

Read the story

Today's News and Commentary

Yesterday was the 100th issue of this blog.
Thanks to those whose encouragement and interest have kept it going.

About antitrust

FTC commissioner: Panel outmatched by healthcare's merger mania: This article summarizes comments by FTC Commissioner Rebecca Kelly about current antitrust prosecution problems. She says the Commission is understaffed and underfunded. Further, the McCarran-Ferguson Act is impeding investigation of insurance company mergers, since the data gathering in that sector requires Congressional action.

Read the article

DOJ sides with Oscar Health in ongoing spat with Florida Blue over broker agreements: Last November, Oscar health sued the Florida Blues plan, claiming that the latter’s broker agreements prevented competitors from expanding into the local ACA exchanges. The presiding judge, citing the McCarran-Ferguson Act, was not convinced of Oscar’s argument. Now the DOJ has stepped in to encourage the trial to proceed.

Read the story

Novartis may be close to settling a kickback case on the eve of a trial: After six years of sparring with the DOJ over charges that it offered lavish gifts to physicians to encourage prescription of its products, Novartis is rumored to be settling this whistleblower suit for $1 billion.

Read the story

Civica Rx and Xellia Pharmaceuticals Join Forces to Reduce Chronic Drug Shortages: Civica Rx, the hospital consortium formed to combat drug shortages for its owners, signed a contract with Xellia Pharmaceuticals of Denmark to “manufacture essential antibiotics, including Vancomycin and Daptomycin…” This contract is the first definitive agreement the organizations has made.

Read the announcement

The Death of Antibiotics: We’re Running Out of Effective Drugs to Fight Off an Army of Superbugs: This article is a good summary of the problem of antibiotic resistance. One startling statistic: The World Health Organization predicts that worldwide death rates from drug-resistant microbes will climb from the current 700,000 per year to 10 million by 2050. At that point, they will have surpassed cancer, heart disease and diabetes to become the main cause of death in the human race.”

Read the article 

CMS cracks down on spread pricing by pharmacy benefit managers [PBMs]: As part of its continuing scrutiny of PBMs, CMS is now looking into their practice of “spread pricing.”

Spread pricing occurs when health plans contract with a pharmacy benefit manager to manage their prescription drug benefits, and PBMs keep a portion of the amount paid to them by the health plans for prescription drugs, instead of passing the full payments on to pharmacies. 

The spread is the amount between what the health plan pays the PBM and the amount the PBM reimburses the pharmacy for a beneficiary's prescription.”

The reason CMS is involved is that spread pricing is especially of concern for Medicaid and CHIP plans.

Read the story

About healthcare IT

Express Scripts Simplifies Digital Health Technology Marketplace for Consumers and Payers: “The new formulary will help payers ensure the safety, effectiveness and usability of digital health technology tools made available to their members. Available in 2020, the digital health formulary will be a curated list of technology- and software-enabled applications and devices that help patients prevent, manage or treat a medical condition.”

Read the announcement

Forescout Releases Inaugural Device Cloud Research Based on Leading Device Intelligence: Among the findings of this report is that “71 percent of Windows devices within these healthcare deployments are running Windows 7, Windows 2008 or Windows Mobile, with Microsoft support planned to expire on January 14, 2020. Running unsupported operating systems poses a risk that may expose vulnerabilities and has the potential to impact regulatory compliance.”

Read the report

Erasing the Affordable Care Act: Using Government Web Censorship to Undermine the Law: This report from the Sunlight Foundation documents the federal actions to delete web content regarding the ACA. “The Web Integrity Project has documented 26 instances of ACA censorship — including excised words, removed links, altered paragraphs, and removed pages — on HHS websites.” If you want to get an idea of what was done, check Table 1 starting on page 15. For example, authorities removed HealthCare.gov from the header of CMS.gov.

Read the report

About the public’s health

Alabama governor invokes God in banning nearly all abortions: If left standing, this new Alabama law would outlaw abortion except in cases the mother’s life is in danger. Rape and incest are not exceptions. A woman who obtains an abortions would not be prosecuted but physicians performing the procedure could get up to 99 years in prison. The expectation is that the law will be challenged in court. Supporters of the law hope the case will be taken to the Supreme Court where Roe v. Wade will be overturned.

Read the story

States with the worst anti-abortion laws also have the worst infant mortality rates: The article’s title speaks for itself.

Read the story

North Carolina sues Juul, setting up a fresh legal fight for the embattled e-cigarette company: In the first state action against e-cigarettes, the North Carolina Attorney General filed a lawsuit against Juul Labs, alleging that the company caused consumer addiction by “deceptively downplaying the potency and danger of the nicotine” and employed advertising campaigns that targeted people under the legal smoking age. In addition to the FDA prohibition on the sale of fruit or candy flavors in stores, North Carolina’s would also remove mint. Further, the state seeks to prohibit online sales that are not tobacco or menthol flavors.

Read the story

Federal judge orders FDA to start regulating e-cigarettes: In a related story, a federal judge in Maryland ordered the Food and Drug Administration (FDA) to “speed up its reviews of thousands of electronic cigarettes currently on the market…" The order was given as a result of a lawsuit filed last year by the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and other public health groups.

Read the story

About healthcare quality

Walmart Charts New Course By Steering Workers To High-Quality Imaging Centers: Walmart will financially incentivize its employees to use one of 800 high quality imaging centers when CT or MRI scans are needed. The company said that because of incorrect diagnoses from those studies “about half of the company’s workers who went to the Mayo Clinic and other specialized hospitals for back surgery in the past few years turned out not to need those operations. They were either misdiagnosed by their doctor or needed only non-surgical treatment.”

Read the story

About health insurance

White House Wants Patients to Know Health-Care Prices Up Front: In February the White House floated a proposal that would make providers’ negotiated fees public. Now it also wants payers to publish these proprietary figures. Patients would still have to know what their plan’s terms are with respect to out of pocket costs.

Read the story (Wall Street Journal but appears to be open access)

Today's News and Commentary

About pharma

Pfizer Recommends Suffixes for Biosimilar Reference Products: Suffixes on biologicals indicate the type of molecule. The most well known is “-mab” which stands for monoclonal antibody. Pfizer is now asking the FDA to add a new class of suffixes for reference compounds for biosimilars. Such a change may give the “original” product a marketing edge the manufacturer can use to exploit. Imagine a direct to consumer campaign that asks patients to “look for ‘xyz’ at the end of your drug name to make sure you are getting an original product.”

Read the article

AbbVie wraps up all Humira-related patent litigation in US after reaching deal with Boehringer Ingelheim over biosimilar: Speaking of biologics, in 2017 Boehringer Ingelheim got FDA approval for a generic version of AbbVie’s blockbuster Humira. However, litigation has prevented its launch. The companies just settled— the biosimilar will not be available until 2023. Remember this story when you read about Congressional action to lower drug prices.

Read the story

About the public’s health

UK turns to Asia for nurses to cover staff shortages: What does Brexit have to do with American healthcare? The UK has heavily depended on other EU countries to supply physicians and nurses to staff its National Health Service. With Brexit’s visa uncertainties, the country is relying more and more on recruiting nurses from Asia- particularly the Philippines and India. The problem is the US also relies on Philippine nurses. Such diversions of potential staff have not been figured into our needs projections. We will need to see what these global issues do to our nursing capabilities.

Read the story (Financial Times requires subscription)

This doctor posted online in favor of immunization. Then vaccine opponents targeted her: This story is about an internist who posted her encouragement for immunization and was blasted on social media with negative personal reviews ( by people who were not her patients). The anti-vexers have now gotten mean. Let’s hope violence is not next.

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Twitter launches tool to combat vaccine misinformation: On the same theme, Twitter has now provided a pop-up link when someone enters a term like “vaccine.” It directs the searcher to credible sources of information like the Department of Health and Human Services's (HHS) website about vaccines.

Read the story

Why the Government Pays Billions to People Who Claim Injury by Vaccines: The federal Vaccine Injury Compensation Program was established in 1986 to compensate persons who were harmed from vaccinations. The harm payments were designed to indemnify against manufacturing problems and very rare side effects caused by the vaccines. The story of this program is very interesting and has public health implications.

Read the story

Association of a Beverage Tax on Sugar-Sweetened and Artificially Sweetened Beverages With Changes in Beverage Prices and Sales at Chain Retailers in a Large Urban Setting: Philadelphia imposed an excise tax of 1.5 cents per ounce on sugar-sweetened and artificially sweetened beverages in 2017. Over the next year, “volume sales of taxed beverages in Philadelphia decreased by 1.3 billion ounces after tax implementation (51%), but sales in Pennsylvania border zip codes increased by 308.2 million ounces, partially offsetting the decrease in Philadelphia’s volume sales by 24.4%…In contrast to Mexico and Berkeley findings [two other places that imposed such taxes],  there were no statistically significant increases in nontaxed beverage sales, suggesting consumers were not substituting with these drinks in Philadelphia.” This study is additional proof that increased taxes on unhealthy products reduce consumption.

Read the research

Births: Provisional Data for 2018: CDC’s National Center for Vital Statistics just released birth data for 2018. The trend of lower numbers and rates continues (with few exceptions) since 1991. This demographic information has a profound effect on funding for Medicare and Social Security, which are paid by current workers for current beneficiaries. We will need to look for sources other than population growth for relief of these rapidly depleting funds.

Read the report

About healthcare quality

The Leapfrog Group announced results of its 2018 hospital comparisons: This announcement was picked up by many media- even non-healthcare ones. People can look up the quality scores (A to F) of the 2600 surveyed hospitals. Among the findings:
”Patients at “D” and “F” hospitals face a 92% greater risk of avoidable death
Patients at “C” hospitals on average face an 88% greater risk of avoidable death
Patients at “B” hospitals on average face a 35% greater risk of avoidable death…
If all hospitals had an avoidable death rate equivalent to ‘A’ hospitals, 50,000 lives would have been saved…”

Read the report and look for a hospital close to you

The Joint Commission enters next generation of quality measurement, offers accredited hospitals real-time quality metrics: Over the last two years, The Joint Commission has implemented electronic clinical quality measure (eCQM) reporting with a Direct Data Submission Platform (DDSP). The DSSP is now continuously available, i.e., not just for periodic reporting purposes. This connectivity allows “providers to measure and improve performance in near realtime without additional outside vendors.”

Read the announcement

Today's News and Commentary

About health insurance

U.S. judge calls hearing on merger of CVS and Aetna: court filing: The CVS-Aetna deal has closed, but Judge Richard Leon of the U.S. District Court for the District of Columbia scheduled June 3 to hear arguments that the merger is anticompetitive. The hearing, which is to last a maximum of three days, is not expected to undo the merger.

Read the announcement

Maryland Gov. Larry Hogan Signs 1st-In-Nation Measure To Help Uninsured: “The new law will create a box for people to check on state income tax returns. If a taxpayer checks the box, the state’s health care exchange will see if the person qualifies, based on information in the tax return. Those who qualify for Medicaid will be enrolled automatically. The exchange will reach out to people who qualify for private coverage.” The government is proactively helping those in need? How unusual!

Read the story
New York’s 2014 Law to Protect Consumers from Surprise Out-of-Network Bills Mostly Working as Intended: Results of a Case Study:
Surprise medical bills have gotten the attention of Congress and the White House. In March 2014, the New York legislature passed the Emergency Services and Balance Billing Law (“Surprise Billing” law), which went into effect in March 2015. With this law, the state has come up with a successful program that may be a model for national initiatives. In its baseball-style arbitration: “Each party to the dispute (the payer and the physician) must submit to the arbiter their best offer. The arbiter must choose one of the two offers without compromising between the two sides. This encourages the parties to submit reasonable bids.” While not a panacea, the results are encouraging: a 34 percent drop in out-of-network billing since the law was in effect, with 57 percent of cases resolved. Decisions have been roughly evenly split between providers and payers.

Read the report

About the public’s health

How Public Health Outreach Ended A 1990s Measles Outbreak And What's Different Now: The measles epidemic is not over and is expected to spread. This article is a reminder that the past outbreak is very different than the current one. From 1989-1991 there was a funding problem causing low income children not to be immunized. With attention to funding and fundamental public health measures in a cooperative community, the problem was successfully addressed. The current problem is due to uncooperative parents who are misinformed about immunizations. Perhaps what we need is more PR/persuasive advertising than classical public health measures.

Read the story

The fate of rural and inner city hospitals: Two recent articles highlight the problems of rural and inner city hospitals. Both were local stories that provide lessons for similar institutions across the country.

Who’s going to take care of these people? As emergencies rise across rural America, a hospital fights for its life (From the Washington Post but appears to be open access)
Medical center's traumas illustrate struggle of all Medicaid-dependent hospitals (From Crain’s Chicago Business but appears to be open access)

About healthcare technology

Stem Cell Treatments Flourish With Little Evidence That They Work: Stem cell therapies have the potential to treat many illnesses. But their use in orthopedic conditions has not been shown to be definitively effective. Since infusions of stem cells (and platelets) into joints is not FDA regulated, these treatments are being administered without regulatory review of efficacy or safety. Caveat emptor.

Read the story

Health Canada Aligns with FDA Guidance for 3D printed Medical Devices: This article is a reminder of the medical uses of 3D printing and some of the companies in this sector.

Read the article
Read what the FDA says about 3D printed devices

Today's News and Commentary

About pharma

U.S. states accuse Teva, other drugmakers, of price-fixing: Today’s top story is in all news media: Teva apparently led a conspiracy (with 19 other drug manufacturers) “to divide up the market for drugs to avoid competing and, in some cases, conspire to either prevent prices from dropping or to raise them…” 44 states filed a lawsuit on Friday in the U.S. District Court in Connecticut.

Read the story

Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry: Biosimilars are the equivalent of generic drugs for biological compounds. Definition and handling of generic drugs are straightforward; but because biologicals are more complex, their evaluation has not been clear. The FDA issued this document (called a “nonbonding recommendation”) for evaluating these drugs. The guidance is expected to help biosimilar manufacturers gain easier approvals.

Read the document

CBO Says Bill to Curb Pay-for-Delay Would Cut the Deficit by $613 Million Over 10 Years: On a related note, Senators Amy Klobuchar, D-Minnesota, and Chuck Grassley, R-Iowa. are cosponsoring a bill that would prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time (a practice called pay-for-delay). If the bill passes, the Congressional Budget Office (CBO) says because of cheaper drugs and higher fees it will reduce the deficit by $613 million by 2029.

Read the story

Delivery Might Be Key to Gene Therapy’s Orphan Status, CBER Official Says: The FDA says it is open to granting orphan drug status to an established genetic therapy if the mode of delivery is different than the other treatment.

Read the story

Lessons from UnitedHealthcare's [UHC] stalled plan to get oncologists to prescribe generics: In an attempt to encourage oncologists to use generic medications, UHC offered a voluntary program to pay these physicians a higher rate for these drugs. Bottom line: it did not have any notable impacts on prescribing rates or spending. Two possibilities for this failure: 1) the extra payment was still not enough to compensate for gains from using more expensive medications and 2) this payer was one of many, so overall habits did not change from a focused, voluntary program. The solution would be for the insurer to buy the drugs from the manufacturer or wholesaler and supply them to the oncologist. As usual, this process is not new— just waiting for someone to “rediscover it.”

Read the story (The research is in Health Affairs but it only available by subscription)


About health insurance

Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2018: This governmental study provides a wealth of information about health insurance coverage. Among the findings:

“In 2018, 30.4 million persons of all ages (9.4%) were uninsured at the time of interview—not significantly different from 2017, but 18.2 million fewer persons than in 2010…

Among adults aged 18–64, 68.9% (136.6 million) were covered by private health insurance plans at the time of interview in 2018. This includes 4.2% (8.4 million) covered by private health insurance plans obtained through the Health Insurance Marketplace or state- based exchanges.

The percentage of persons under age 65 with private health insurance enrolled in a high-deductible health plan increased from 43.7% in 2017 to 45.8% in 2018.”

Read the report

DOJ asks Supreme Court to toss payers' suits seeking $12B in risk corridor payments: The federal government enticed insurance plans to participate in ACA exchanges by providing some time-limited financial guarantees. One of the guarantees was implementation of risk corridors: If a plan made more than a certain profit it would  pay the government; if the plan lost more than a target, the government would subsidize that loss. This scheme was designed to be budget neutral. What happened was there were not a lot of profitable plans to subsidize the ones who lost money. (Recall the problems signing up healthy people and erroneous actuarial assumptions about the covered populations.) Insurers appealed earlier court decisions, claiming they are owed $12 billion in risk corridor payments. The Justice Department is asking the Supreme Court to deny the appeals.

Read the story

Washington to offer first ‘public option’ insurance in US: “Washington is set to become the first state to enter the private health insurance market with a universally available public option.

A set of tiered public plans will cover standard services and are expected to be up to 10% cheaper than comparable private insurance, thanks in part to savings from a cap on rates paid to providers. But unlike existing government-managed plans, Washington’s public plans are set to be available to all residents regardless of income by 2021.”

Read the story

Bob Menendez proposes bill to help NJ save Obamacare insurance gains: Other states, like NJ, Pennsylvania, New Mexico, Nevada, Oregon and Minnesota are also considering public exchanges.

Read the article

Today's News and Commentary

IN MEMORIUM
NY Times reporter Robert Pear was an insightful investigator and commentator about health issues.
His death was announced in a number of outlets but, fittingly, here is what the NY Times had to say:
Robert Pear, Authoritative Times Reporter on Health Care, Dies at 69

About the public’s health

Juul’s ‘switch’ campaign for smokers draws new scrutiny: Vaping company Juul has been under attack for marketing to teenagers. In a strategic shift, it is now encouraging current cigarette smokers to switch to its product.

Read the story

It’s time to stop murder by counterfeit medicine: This article reviews a very serious global problem- counterfeit medication. WHO estimates that about 10% of medications world-wide are fake. Other estimates put the figure in some countries at 50%. As some in this country are promoting importation from abroad to lower our pharma costs, we should keep this problem in mind.

Read the story

Inactivated polio vaccine now introduced worldwide: This article is really an announcement. With the addition of Zimbabwe and Mongolia, every country has and endorses this polio vaccine. The problem now is getting it to all those who need it and preventing violence against those who administer it.

Read the announcement

Is Conference Room Air Making You Dumber?: Finally, some scientific evidence that those long meetings will not help make better decisions. As the meeting goes on and on, the accumulated carbon dioxide in the room reduces decision-making capabilities. I suppose you could open the windows, but it would be better to be more efficient in the first place.

Read the article

Coca-Cola gained control over health research in return for funding, health journal says:According to this report in Politico: “"Using Freedom of Information Act requests, researchers at the University of Cambridge identified more than 87,000 pages of documents that included five agreements between Coca-Cola and universities in the U.S. and Canada. The provisions gave Coca-Cola the right to review research in advance of the publications. It also was allowed to have control over data and disclosure of any study results.

The universities involved were Louisiana State University, University of South Carolina, University of Toronto and University of Washington.

Despite having the power to prevent publication, the researchers of the study didn’t find any hard evidence Coca-Cola exercised that right. However, the FOIA documents collected included several redactions, making a final conclusion difficult.” Do you still wonder how proposals for taxes on sugar drinks are defeated?

Read the article
Read the original research

Increase in Hepatitis A Virus Infections — United States, 2013–2018: With all the recent focus on measles, we often forget that other preventable viral infections are also on the rise. This article from the CDC calls on greater attention to immunizations for vulnerable populations.

Read the report


About pharma

Pharma companies, PBMs play blame game over drug prices at hearing: The arguing continues as Congressional committees try to get to the bottom of why drug prices are so high. At the House Energy and Commerce Committee’s Subcommittee on Health, PBMs claimed that eliminating rebates would raise premiums for individuals while drug companies said it would help them lower their prices. The article is a nice update on this ongoing issue.

Read the story or
Watch the testimony (WARNING- it’s more than 6 hours)

Most European Academic Centers Fail to Report Trials, Study Finds:The reason this story is important US news is that our regulators are considering accepting European studies for drug approvals here. If many trials are not reported, it raises concerns about that proposal.

Read the story

Medicine Use and Spending in the U.S.: This study from IQVIA found: “Spending on all U.S. medicines increased 4.5% to $344 billion on a net price basis, despite lower price growth, due to higher patient use of new and protected brands…There were 5.8 billion prescriptions dispensed in 2018, up 2.7% from 2017 when adjusted for prescription duration. More than two-thirds of total prescriptions last year were for chronic conditions, which are increasingly filled with 90-day prescriptions…”

Read the report

Drugmakers Urge FDA to Add PBPK Modeling to Food Effects Guidance:”Leading drugmakers are calling on the FDA to include the use of physiologically-based pharmacokinetic (PBPK) modeling in its draft guidance on assessing the effects of food on drugs...” The reason this story is “news” is that rules are usually imposed on industries, not originated with requests from those being regulated.

Read the story

About health insurance

Democrats launch health-care law rescue in face of Trump’s threat of repeal: Yesterday the House Democrats passed a bill that would block HHS state waivers for insurance plans meant to skirt the ACA’s regulations.

Read the story (Washington Post but appears to be open access)

About quality

Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial: This article highlights that we need to constantly reevaluate the evidence about accepted treatments. The research looks at a well-established procedure (gall bladder removal) and compares usual care with surgery only after certain more restricted criteria are used. While the clinical outcomes were the same in both groups, the latter had many fewer operations.

Read the research

About healthcare IT

2019 Data Breach Investigations Report (DBIR): Verizon just published its annual report on data breaches by industry. For healthcare, the main threat was from internal sources. However: “This is the second straight year that ransomware incidents were over 70 percent of all malware outbreaks” in this sector.

Read the report (Healthcare starts on page 44)

To Philips, the future means selling more than a better MRI machine: It might seem strange that this story is listed under IT. Phillips has announced its intention to expand from just a medical equipment company into artificial intelligence to integrate care across a continuum of services. According to its CEO, Jeroen Tas: “The whole theme around precision diagnosis is no longer about building the best MRI or CT scanner—it’s really about fusing the information you get from these modalities, and creating profiles or models of the disease that allows for a very precise selection of the right-fit therapy.”

Read the story

About health insurance

Prices Paid to Hospitals by Private Health Plans Are High Relative to Medicare and Vary Widely: This research from RAND was reported in many news outlets today. Among its findings:

“On average, case mix–adjusted hospital prices were 241 percent of Medicare prices in 2017…Relative prices for hospital outpatient services were 293 percent of Medicare rates on average…”

“Reducing hospital prices to Medicare rates over the 2015–2017 period would have reduced health care spending by approximately $7.7 billion for the employers included in this study.”

It is common knowledge that private insurance payments subsidize public programs. This study provides the amount of that subsidy. and also how much hospitals would lose if Medicare for All is implemented and adopts Medicare payment methods.

Read the report

Today's News and Commentary

About the public’s health

Assessment of Use, Specificity, and Readability of Written Clinical Informed Consent Forms for Patients With Cancer Undergoing Radiotherapy: “This nationwide study of informed consent practices for cancer treatment with radiotherapy demonstrates that while all US academic radiotherapy departments use written consent forms, it is rare for templates to meet the recommended readability levels for patient materials.” This article is a reminder about communication with patients at the appropriate level of education and literacy.

Read the abstract

Walmart, Sam's Club raise age to buy tobacco to 21; won't sell flavored nicotine to minors: The title is self-explanatory. Walgreens also recently raised its tobacco purchase age to 21. But they still do not match CVS, which stopped selling tobacco products because of health concerns.

Read the story

About healthcare technology

Natera Earns Breakthrough Device Designation for Tumor DNA Test: This technology uses genetic markers from the patient’s tumor to check for recurrence by detecting those markers in serial blood samples after treatment. It is a real breakthrough technology because it can detect the recurrence much sooner than other methods.

Read the announcement
Read about the test

Genetically Modified Viruses Help Save A Patient With A 'Superbug' Infection: Knowledge about bacteriophages antedates the antibiotic era. These organisms are viruses with special affinity for bacteria (as opposed to, for example, human cells). Once infected with the phage, the bacteria dies. By administration of special phages, a 17 year old woman has been successfully treated for a drug resistant infection after lung transplant. Until better antibiotics are found, this therapy may be the only hope for such patients.

Read the story

About quality

Physician groups voice frustrations with Quality Payment Program: Yesterday, representatives from the American College of Surgeons, American Academy of Family Practice and the American Medical Association testified before a Senate committee hearing their feed back about the MACRA quality programs. The organizations criticized the relevance of criteria and cumbersome reporting process. As well, they wanted an update on meaningful use IT criteria in the face of increasing interoperability requirements.

Read the article

MACRA, 2 years later: 9 ways to make it better: Following in the above article, this one summarizes the testimony of AMA president Barbara McAneny, MD about measures to improve MACRA.

Read the article

How Johns Hopkins researchers found a way to curb excessive skin cancer surgery: One way to treat skin cancer is to shave off the growth level by level- called Mohs micrographic surgery (MMS). Researchers noted that surgeons “are paid based on the number of stages performed per tumor, ‘creating a perverse incentive… to use an excessive number of staged resections to remove a lesion.’ …In other words, they may cut too much during surgery, quite possibly, because they'll get paid more to do it.” If physicians were provided data on their relative performance, however, 83% of surgeons who were identified as outliers improved their MMS behavior- a sustainable change. The study extrapolated Medicare savings from such an intervention at $11million per year. This research is another case of the benefit of peer data dissemination.

Read the story 

About pharma

Americans' Prescription Med Use Is Declining:This just-released study from the National Center for Health Statistics (part of the CDC) showed, among other findings, that:

  • In 2015–2016, 45.8% of the U.S. population used prescription drugs in the past 30 days.

  • Prescription drug use increased with age, from 18.0% of children under age 12 years to 85.0% of adults aged 60 and over.

  • Prescription drug use was highest among non-Hispanic white persons followed by non-Hispanic black persons, and lowest among non-Hispanic Asian and Hispanic persons.

  • The most commonly used types of drugs included bronchodilators for ages 0–11 years, central nervous system stimulants for ages 12–19, antidepressants for ages 20–59, and lipid-lowering drugs for ages 60 and over.

  • The percentage of the U.S. population that used prescription drugs decreased over the preceding decade. This finding reversed an previously upward trend.

Read the study results

Covance: Why biosimilars could be large piece of the drug price puzzle: This article is an interesting review of biosilmilar drugs (biologic generics). One factor impeding their adoption is that the branded versions provide such large rebates that in order to save money from these discounted versions, a health plan will have to drive large volumes to them.

Read the article

Today's News and Commentary

About pharma

In a crafty move, FDA may have found a way to dampen controversy over a $375,000 rare-disease drug: Here’s what competition can do. Earlier this year the FDA approved Firdapse, a drug manufactured by Catalyst to treat adult Lambert-Eaton myasthenic syndrome ( a muscle weakness disease). Since it was an orphan drug, it was also granted 7 years of market exclusivity. Because of its unique status, the company announced a $375,000 price tag. However, the FDA just approved the same drug, this one made by Jacobus Pharmaceuticals, called Ruzurgi. The difference is the latter approval was for children with the same condition. Once approved, either drug can be used to treat people of all ages. While Ruzurgi’s price has yet to be announced, Catalyst stock dropped 44% in anticipation of price competition.

Read the story

Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency:The final rules about advertising drug prices on television have been issued. If the wholesale acquisition cost is $35 or more per month, the advertisement must contain the statement: “ “The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.” The terms take effect 60 days after publication in The Federal Register.

Read the rule

Alphabet's GV leads funding in gene editing company Verve Therapeutics: Continuing a trend to cross-sector involvement, Alphabet Inc’s venture capital arm (GV) “led a $58.5 million investment to launch Verve Therapeutics, a new biotech focused on developing therapies that edit the human genome to treat heart diseases…Verve plans to target adults at risk of coronary artery disease, the leading cause of death worldwide, by editing their genes to mirror those of people whose naturally occurring genes have been associated with a lower risk of heart disease and heart attacks.” How much would you pay for such a treatment?

Read the announcement

Judge tells HHS to revisit 340B after ruling cuts 'unlawful': The 340B program allows certain hospitals and other healthcare providers to buy discount drugs from the manufacturers in order to provide them to Medicaid or free-care patients. These providers could then charge Medicare and Medicaid up to 6% over the average national sales price of drugs. Recently, CMS cut rates to to 22.5% less than the average sales price— a change that would result in a $1.6 billion payment reduction. In a lawsuit by multiple hospital entities challenging this reduction, DC District Court Judge Rudolph Contreras ruled it was unlawful. This decision was a truly big win for eligible providers. Now we will have to wait for the appeal.

Read the story

Study: Payers, PBMs hinder drug access for autoimmune patients: Researchers at Emory University graded insurance companies for their coverage of autoimmune drugs to treat Crohn’s disease, multiple sclerosis, psoriasis, psoriatic arthritis and rheumatoid arthritis. They found that: “86% of Medicare Advantage plans received an F for coverage of autoimmune drugs and 48% of private insurers received an F. Within private insurers, another 50% of companies rated a C and not one received an A.” Since these drugs are very expensive treatments, it is reasonable to recommend step therapy if all medicines in a class are equally effective but vary in price. However, imposing high out of pocket payments for patients as a cost reduction strategy makes no sense, since these drugs are not discretionary purchases.

Read about the study

About healthcare IT

Feds Want To Show Health Care Costs On Your Phone, But That Could Take Years: In a related story to the tv advertising rule above, HHS is proposing regulations in anticipation of consumers’ ability to price compare healthcare services on the phone. For example, such comparisons will likely have disclaimers about variance by insurance.

Read the article

Lawmakers call for delay in implementing interoperability rules: CMS has been pushing for IT interoperability implementation. But yesterday, Sen. Lamar Alexander, R-Tenn. (chair of the Senate Health, Education, Labor and Pensions ((HELP)) Committee) called for a delay of two new rules. He cited provider and payer costs and and the ability to comply with the rules in a relatively short amount of time.

Read the article

FDA clears first AI-powered mobile app to catch heart murmurs: Prior artificial intelligence healthcare apps have been geared to voice recognition, input of lab data, or recording patient information (like pulse or EKG readings). This one listens for heart murmurs. Is the stethoscope on its way out?

Read the story

Allscripts' Practice Fusion receives grand jury subpoena related to EHR certification, anti-kickback concerns: Allscripts recently bought Practice Fusion, knowing it had engaged in some questionable practices. In return for a deeply discounted price of $100million, as opposed to more than $1billion, Allscripts said it would assume all future liabilities. Now that contingency has come. In its latest SEC filing, Allscripts reported: “ In March 2019, Practice Fusion received a grand jury subpoena in connection with a related criminal investigation. The document and information requests received by Practice Fusion relate to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services’ Electronic Health Record Incentive Program and Practice Fusion’s compliance with the Anti-Kickback Statute and HIPAA as it relates to certain business practices engaged in by Practice Fusion.” The article also mentions past problems at Greenway and eClinicalworks.

Read the story

About the public’s health

Prediabetes puts your health at risk, but reversing it is "very doable," experts say: The main message is not new (diet and exercise can help stave off diabetes for those on the cusp of the disease). However, the statistics are very disturbing: “According to the Centers for Disease Control and Prevention, more than 1 out of 3 adults in the United States — approximately 84 million people — have prediabetes . Yet, 90 percent of those affected do not know they have it.” How many people would change their behavior if they knew they were prediabetic?

Read the article

Vital Signs: Pregnancy-Related Deaths, United States, 2011–2015, and Strategies for Prevention, 13 States, 2013–2017:Speaking of prevention, the CDC found that 60% of pregnancy-related deaths are preventable. Causes vary by when the death occurred after delivery.

Read the article for details

Strengthening national health security and preparedness helps build a culture of health: The 2019 Robert Wood Johnson Foundation health preparedness index shows continued improvement, but overall the U.S. scores only 6.7/10. Domain scores range from a high of 8.3 for Health Security Surveillance to a low of 4.9 for Healthcare Delivery. (The latter measure has not statistically improved in the past few years.)

Read the report

U.S. Library of Medicine Digital Collections: This new website has 906 video presentations on health-related topics. It is a fascinating historical archive. For example, on the first page is an audio recording with accompanying photos of President Roosevelt’s speech dedicating the National Institute {not Institutes at that time] of Health on October 31, 1940.

Connect to the site

About health insurance

Kaiser Permanente building infrastructure to 'connect the dots' for social determinants: This article is a nice review of what Kaiser Permanente is doing to address social determinants of healthcare for its members.

Read the story

Do People Who Sign Up for Medicare Advantage Plans Have Lower Medicare Spending? This research from the Kaiser Family Foundation showed that Medicare Advantage (MA) plan members had lower costs than traditional Medicare beneficiaries the year before they switched to a MA plan. The conclusion was that CMS payments to MA plans may be too high.
The better health of HMO members (Medicare or commercial plans) is not a new finding. What has been shown in the past is that for patients matched by health status, the HMO plan provided the same quality of care at a lower price. Further, MA payments are health status adjusted. Recently, CMS allowed MA plans to offer enhanced services that traditional Medicare does not cover.
More analysis needs to be done on this issue before making any payment policy changes.

Read the research

Individual Insurance Market Performance in 2018: Insurance company performance under the ACA was very rocky over the first few years. This research shows that finances are now on a stronger footing. Specifically, “individual market insurers saw better financial performance in 2018 than in all the earlier years of the ACA and returned to, or even exceeded, pre-ACA levels of profitability.” The Medical Loss Ratio has declined from a peak of 103% in 2015 to 70% last year. It is expected plans will need to rebate $800 million to subscribers for going under the 80% individual/small group target.

Read the report