Today's News and Commentary

About healthcare IT

DirectTrust hits milestone of 1B messages exchanged; developing instant messaging standard: “DirectTrust is a collaborative non-profit association of 121 health IT and health care provider organizations to support secure, interoperable health information exchange via the Direct message protocols. DirectTrust has created a ‘trust framework’ that extends use of Direct exchange to over 106,000 health care organizations and 1,582,373 Direct addresses/accounts. This trust framework supports both provider-to-provider Direct exchange and bi-directional exchange between consumers/patients and their providers.” Messages over this secure interchange just passed the 1 billion mark. [See Chapter 8 of the text for a fuller explanation of Direct Trust.]

32M patient records breached in 2019: The number of patient record breaches this year has already doubled the number that occurred infall of 2018. The article gives some examples of large offenders.

Industry Voices—Removing ban on nationwide unique patient identifier would save lives, money: The reason patients do not have unique identifiers (as do all other healthcare stakeholders) is concern over privacy/threat of breaches. Despite the number of breaches, IT experts claim that the unique identifier will aid interoperability and reduce “wrong patient” errors.

About healthcare insurance

What Explains Support for or Opposition to Medicare for All? This recent Urban Institute survey demonstrates how complex opinions are about “Medicare for All.” Support (or opposition) varies by such factors as political party membership, age and which version of the program is presented (such as single payer or option for enrollment).

Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration: CMS announced that: “After careful consideration, the Centers for Medicare & Medicaid Services (CMS) is discontinuing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration because of the rates of low participation. CMS will not be accepting applications for MAQI for 2019.” This option would have exempted qualified providers from being subject to the Merit-Based Incentive Payment System (“MIPS”) if they participated “to a sufficient degree in certain payment arrangements with Medicare Advantage Organizations…” [See Chapter 9 of the text for a fuller explanation of these programs.]

About healthcare quality and patients safety

UI Hospitals has 'healthy appetite' for improving low marks from patients: The article’s point is that the University of Iowa Hospitals and Clinics (UIHC) was working to improve its patient satisfaction scores. The other message is that patient satisfaction does not always correlate with measures of care quality. “UIHC fell below the state average on all but one of 10 patient satisfaction measures… It fell below the national averages in all but three categories.But despite low scores elsewhere, UIHC ranked above the state and national averages in the percentage of patients who said they’d recommends it to family and friends. UIHC earned four stars in that.” Most marketers would take the latter measure as a sign of organizational success.

Why Are These Medical Instruments So Tough to Sterilize?: Duodenoscopes are used to look at the upper gastrointestinal tract. But they are very hard to sterilize and have caused a large number of infections when reused.

About pharma

U.S. judge expresses support for novel opioid settlement talks framework: When the tobacco settlements were paid, states got all the money and rarely shared it with counties or municipalities. This time, the latter entities want some of the compensation. To that end, U.S. District Judge Dan Polster in Cleveland will allow a proposal that “calls for creating a class of up to 3,000 counties and 30,000 cities, towns and villages that could vote on whether to accept any settlement the plaintiffs reach with defendants in the opioid litigation.”

Today's News and Commentary

About pharma

FDA ready to crack down as Novartis reveals manipulated Zolgensma data: BREAKING NEWS Today, Novartis revealed that it manipulated data in its drug application for the gene therapy drug  Zolgensma. You will recall that, at $2.125million, it is the most expensive treatment on the market for any condition. The FDA is still deciding what to do with its already-granted approval.

Drug industry urges Canada to act early on U.S. import plan: Innovative Medicines Canada (IMC), their equivalent of our PhRMA, has issued recommendations to the Canadian government to prevent shortages in that country that would result from American importation of pharmaceuticals.

Pentagon eyeing Chinese production of tainted 'sartan' API as trade war grows: Active Pharmaceutical Ingredients (APIs) are the basic materials that make up pharmaceuticals. Most of these agents, as well as the raw materials that go into their manufacture, are produced abroad- particularly in China. A Chinese manufacturer of “sartan” drugs, used in antihypertensives, has been found to be supplying contaminated ingredients. The Pentagon has gotten involved because many active duty military are taking these medications. The situation may get worse (even without such tainting) if the trade war between our countries heats up even further.

Drug Price Forecast : This report is Vizient’s annual research on drug prices. Out of many findings is that their client’s pharma costs will continue to rise (by about 5%) and 90% of the top drugs (by spending) will be biologics. The obvious importance of development of more biosimilars is highlighted.

About the public’s health

Screening for Pancreatic Cancer US Preventive Services Task Force Reaffirmation Recommendation Statement: “The USPSTF found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves disease-specific morbidity or mortality, or all-cause mortality.” Early detection of this disease should be a top priority of cancer research.

2019’s Best & Worst States for Health Care: The annual WalletHub state rankings are out and Minnesota is on top. Composite scores are comprised of cost, access and outcome scores. Read the article to find out where your state ranks. Is there consistency among the three metrics?

About healthcare IT

Telemedicine May Boost Unnecessary Antibiotic Prescribing in Kids: One reason for this finding is that: “Getting an antibiotic prescription… was the strongest single predictor of satisfaction, and a physician's antibiotic prescribing rate was highly correlated with their overall satisfaction ratings…” Should we measure patient satisfaction for those visits if it leads to worse clinical behavior?

About health insurance

TRICARE families report worse access to care than commercially insured, uninsured: study: This article summarizes a report in Health Affairs (which is available only by subscription). The research compares access for beneficiaries covered by TRICARE (insurance for families of active military) with private and other public insurance plans. The headline tells the story.

Patients’ preferences over care settings for minor illnesses and injuries (Be patient, the site loads slowly): How do patients make choices about where to obtain care? Do financial considerations play a part? This research found that:

“Out‐of‐pocket costs and wait time had minimal impact on patient's preference for site of care. Choices were driven primarily by the clinical scenario and patient characteristics. For chronic conditions and children's well‐visits, the doctor's office was the preferred choice by a strong majority, but for most acute conditions, either the ER (for high severity) or urgent care clinics (for lower severity) were preferred to the office setting, particularly among younger patients and those with less education.” The authors concluded that the “low impact of out‐of‐pocket costs suggests that insurers interested in encouraging increased utilization of alternatives would need to consider substantial changes to benefit structure.”

Today's News and Commentary

About medical devices

3D bioprinting of collagen to rebuild components of the human heart: This article is a fascinating look at the use of collagen in 3D bio printing. It raises many possibilities for replacements of body parts other than for the heart.

About healthcare IT

NIST guidance aims to help providers secure IoT tools: As previously reported, peripheral devices (“Internet of Things” or IoT) have major security concerns. The National Institute of Standards and Technology has issued guidance aims to address these potential problems. This article summarizes the suggestions. For more information, check the NIST/IoT website.

Anthem, Humana along with Apple and Google testing API for patient access to claims data: As previously reported, CMS is launching a new version of its Blue Button link that will enable beneficiaries to check on their claims. The private equivalent also announced this functionality; it comes from the CARIN Alliance, “led by distinguished risk-bearing providers, payers, consumers, pharmaceutical companies, consumer platform companies, health IT companies, and consumer-advocates who are working collaboratively with other stakeholders in government to overcome barriers in advancing consumer-directed exchange across the U.S.” The lead management is from Leavitt Partners.

About the public’s health

Teens Are Getting Hooked on Leftover Prescription Meds: This article summarizes two studies published in the Journal of the American Academy of Child and Adolescent Psychiatry. “…the first one involved more than 18,000 high school seniors. It found that about 11% of them said they misused prescription drugs in the past year, and of those, 44% had multiple sources for the drugs.More than 70% of teens who got prescription drugs from multiple sources had a substance use disorder -- prescription medications, other drugs and alcohol -- within the previous year.”

“The second study, involving nearly 104,000 12- to 17-year-olds, found that the most common sources of prescription drugs were: getting them free from friends and relatives, physician prescriptions for opioids, and buying stimulants and tranquilizers illegally.”

Natural American Spirit's pro-environment packaging and perceptions of reduced-harm cigarettes: Public perception about two brands of cigarettes (both manufactured by Reynolds American) were assessed. Natural American Spirit [NAS] has pro-environmental packaging and Pall Mall does not. “Consistently on all measures, NAS cigarettes were rated as less harmful for oneself, others, and the environment relative to Pall Mall (p's < .001). Though Reynolds American manufactures both brands, participants rated the company behind NAS as more socially responsible than the company behind Pall Mall.” Authors concluded: “Stricter government regulations on the use of pro-environment terms in marketing that imply modified risk is needed.”

De Blasio Administration Launches NYC Care in the Bronx, Key Component of Mayor's Guaranteed Health Care Commitment: As previously reported, NY City announced it would provide “quality and affordable health care for hundreds of thousands of New Yorkers who are not eligible for insurance or who cannot afford it.” Last week, the first program was launched in the Bronx and will offer residents “access to a dedicated primary care provider, …preventive care and routine screenings, …access to specialty care services, [the ability to] make appointments and navigate their health care needs through a new 24/7 customer service center. New Yorkers will also get access to affordable medications day or night.”

About health insurance

Cigna Plans Big Medicare Advantage Expansion: This article is another example of how Medicare Advantage is continuing to expand. “…the insurer plans to enter 37 new counties with such HMO offerings for what executives said will be a 14% increase in the company’s Medicare Advantage footprint, pending regulatory approvals.”

Financial Costs and Burden Related to Decisions for Breast Cancer Surgery: We often think that the costs of care mainly affect poor, minority and uninsured patients. In this study, most of the subjects “were white (90%), were insured privately (70%) or by Medicare (25%), were college educated (78%), and reported household incomes of more than $74,000 (56%).” Researchers found that among “the highest incomes, 65% of women were fiscally unprepared, reporting higher-than-expected (26%) treatment costs.”
The costs of care need to be discussed with all patients regardless of their perceived ability to afford treatment.

Charity becomes a lifeline even for Americans with health insurance as deductibles soar: Continuing the theme of costs of care, this article is a great summary of how families are coping with these expenses by seeking charitable subsidies from a variety of sources. The problem is often that they are underinsured and need help meeting the rising annual out-or-pocket expenses, particularly deductibles.

The Use Of Vendors In Medicare Part B Drug Payment: The Medicare Part B drug benefit pays physicians 6% over average national sales price. Thus, revenue can be maximized by administering the most expensive effective medications. The pricing scheme is the only mechanism Medicare has for controlling Part B expenditures. Part D, on the other hand, is handled by private companies which have a variety of non-price mechanisms for controlling costs, e.g., step therapy, prior authorization, etc. This article is a nice summary of how the federal government is looking at adopting Part D procedures to control Part B expenses.

Military Health Systems: This topic is the subject of a special issue of Health Affairs (Most articles require a subscription).

About pharma

Johnson & Johnson scores latest talc trial win as case count reaches 15,500: This article is the latest update in legal proceedings against J&J for damages alleged to have occurred from asbestos in its talc-based baby powder.

Drugmakers master rolling out their own generics to stifle competition: This story provides another example of how pharma brands can effectively extend their patents by producing their own generics.

Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers [ARBs]: ACE inhibitors (ACEIs) and ARBs are equally effective, for example, to lower blood pressure. Because ACEIs were on the market first, they are all generic. These authors found that by “maximizing generic substitution and therapeutic interchange, Medicare could have saved approximately $676 million (89.6%) in 2016 and 2017 of the total $754 million spent on these brand-name ACEIs and ARBs during those 2 years ($537 million in 2016 and $203 million in 2017),excluding possible manufacturer rebates.” Imagine what such a program could save for other classes of medications.

About healthcare quality and patient safety

CMS delays funding renewal for quality improvement organizations: “The 13 quality improvement organizations that are part of CMS' Quality Innovation Network are halting operations and laying off staff as they wait for the agency to renew their multimillion-dollar contract. The $960 million contract, which ended in mid-July, wasn't renewed and won't be until sometime between September and November, according to a CMS memo to the organizations last month.”

Today's News and Commentary

About the public’s health

Binge Drinking Among Older Adults in the United States, 2015 to 2017: Binge drinking is defined as five or more drinks on the same occasion for men and four or more drinks on the same occasion for women. In this research sample of 10 927 respondents over age 65, 10.6% “were estimated to be current binge drinkers. Binge drinkers were more likely to be male, have a higher prevalence of current tobacco and/or cannabis use, and have a lower prevalence of two or more chronic diseases compared to nonbinge drinkers… the prevalence of binge drinking was higher among non‐Hispanic African Americans than whites…, tobacco users…, cannabis users …, and those who visited the ED in the past year.” The importance of this research is that the prevalence is larger than expected and interventions can be directed at certain populations.

Iceland cuts teen drinking with curfews, youth centers: At the other end of the population age group, teen drinking and drug use were huge problems in Iceland. “In 1999, when thousands of teenagers would gather in downtown Reykjavik every weekend, surveys showed 56% of Icelandic 16-year-olds drank alcohol and about as many had tried smoking. Years later, Iceland has the lowest rates for drinking and smoking among the 35 countries measured in the 2015 European School Survey Project on Alcohol and Other Drugs.” The Icelandic Centre for Social Research and Analysis accomplished this improvement by developing town-financed venues where teens can meet, instituting curfews and keeping “young people busy and parents engaged without talking much about drugs or alcohol. That stands in sharp contrast to other anti-abuse programs, which try to sway teenagers with school lectures and scary, disgusting ads showing smokers’ rotten lungs or eggs in a frying pan to represent an intoxicated brain.” The program has been successfully copied in many other countries ranging from Finland to Chile.

Association of Region and Hospital and Patient Characteristics With Use of High-Intensity Statins After Myocardial Infarction Among Medicare Beneficiaries: This research is a good example of geographic disparities in healthcare. The authors studied use of statins as secondary prevention for cardiovascular disease and found: “In models considering region and beneficiary and hospital characteristics, region was the strongest correlate of high-intensity statin use, with 66% higher use in New England than in the West South Central region.”

Whole genome sequencing revealed new molecular characteristics in multidrug resistant staphylococci recovered from high frequency touched surfaces in London: The headline speaks for itself and highlights the importance of hand handwashing.

Scientists are making human-monkey hybrids in China: “The Spanish-born biologist Juan Carlos Izpisúa Belmonte, who operates a lab at the Salk Institute in California, has been working working with monkey researchers in China to perform the disturbing research. Their objective is to create ‘human-animal chimeras,’ in this case monkey embryos to which human cells are added…The idea behind the research is to fashion animals that possess organs, like a kidney or liver, made up entirely of human cells. Such animals could be used as sources of organs for transplantation.” In addition to technical issues, a discussion of the ethics of this process is important. Additionally, will such engineered organs be allowed in this country if the process that produces them is illegal?

Performing different kinds of physical exercise differentially attenuates the genetic effects on obesity measures: Evidence from 18,424 Taiwan Biobank participants: This article is fascinating. The authors split the cause of obesity between individual behavior (overeating and sedentary) and genetically induced. Treatment of the former is straightforward. But will the same measures work on the genetic variety? The answer is a bit complex. “Regular jogging blunted the genetic effects on BMI [body mass index], BFP [body fat percentage], and HC [hip circumference]. Mountain climbing, walking, exercise walking, international standard dancing, and a longer practice of yoga also attenuated the genetic effects on BMI…Exercises such as cycling, stretching exercise, swimming, dance dance revolution, and qigong were not found to modify the genetic effects on any obesity measure.” Overall, jogging was best. One caveat: this study was done on a population of Han Chinese.

About pharma

Mylan reaches $30 million settlement in SEC's EpiPen probe: Mylan classified its branded EpiPen as a generic product so it could minimize government rebates. In 2017, the company finalized a $465 million settlement with the Justice Department. This latest, related settlement was with the SEC. I wonder how much Mylan thought it would make by misclassifying the EpiPen and if it was, a priori, worth a business risk of about half a billion dollars.

FDA drug approvals are up 11%: “The FDA accepted 137 new drug approvals (NDAs) and biologics license applications (BLAs) in 2018, up 11% from 2017 and 36% from 2012 to 2017, according to a new report. In 2017, the FDA approved 122 drugs, compared to 101 over the previous five-year period.”

GlaxoSmithKline, Pfizer complete formation of consumer healthcare joint venture: This joint venture is the latest variation on business unit restructuring in the pharma industry.

About healthcare quality/safety

Analysis of Human Performance Deficiencies Associated With Surgical Adverse Events: While perfection in any endeavor is impossible, continuing improvements require knowledge of the sources of error. Some errors are in the design of systems and require work flow or technical changes. Others are due to human error. This study found that human performance deficiencies “were identified in more than half of adverse events, most commonly associated with cognitive error in the execution of care.” Use of these findings are discussed with respect to frameworks for change.

Association of US News and World Report Top Ranking for Gastroenterology and Gastrointestinal Operation With Patient Outcomes in Abdominal Procedures: “In this administrative database study of 51 869 abdominal operations, the annual case volume was 397 at top-ranked hospitals compared with 114 at nonranked hospitals. No statistically significant differences in serious morbidity or in-hospital mortality were found between these cohorts.” This article is a comment on the volume-quality relationship. In the past it was found that hospital and/or physician volume could determine the quality of the outcome. One unstated interpretation of this research could be that physician volumes were more important than hospital volumes. Volumes per surgeon at these facilities was not studied.

About health insurance

Medicare proposes outpatient hip replacements: Medicare already pays for knee replacements on a same-day basis (that is, no hospital admission). Now it is proposing the same coverage for hip replacements. This proposal is a great opportunity to think about the financial impact on independent physicians and hospitals. Although hospitals have been moving to same-day surgeries and investments in surgicenters for years, this procedure has been mostly done as an inpatient.

Today's News and Commentary

About pharma

Would Trump's new drug-imports plan do much to prices—or to pharma?: Yesterday, CMS announced two pathways that would allow drug importation with the aim of lowering costs. On further reflection, it may not have such a large impact. First, “…many of pharma's most costly products—biologics such as AbbVie's Humira; IV drugs, a category that would include many pricey cancer treatments; and inhaled products, such as respiratory therapies from GlaxoSmithKline and AstraZeneca, are all excluded. So are meds that require Risk Evaluation and Mitigation Strategies at the FDA—a group that comprises many expensive and newer drugs, such as multiple sclerosis treatments.” Next, the second pathway that allows drug manufacturers to import medications does not compel them to do so- particularly if it is not in their best interest. Finally, we need to realize that not all drugs are cheaper abroad. Certainly, generics are much cheaper in the US than in the countries from which we would import drugs. We will need to see how much these pathways are used and whether it is worth the effort for interested stakeholders.

About healthcare IT

Unbounded—Parent-Physician Communication in the Era of Portal Messaging: While patient portals can increase accessibility of care, for physicians it can represent another “time sink” for uncompensated care. In addition to phone calls, this pediatric study states that “the average pediatrician currently answers approximately 10 patient portal messages a day, and this number is expected to grow.” The authors opine that one reason the number of messages will grow is that the bar is much lower for messaging than phone calls. This article is a balanced presentation of this issue.

About healthcare insurance

Health Plans Are Riding The Medicare Wave:This survey of insurance executives shows how bullish they are about growing their Medicare Advantage businesses. 92% say they plan to grow that product faster that their traditional Medicare offerings. The survey cites the growth of the Medicare-eligible population and value-based results as reasons for this growth.

HHS approves Colorado's waiver to set up ACA reinsurance program: Colorado became the eighth state to get a waiver that “enables the federal government to use ‘pass-through’ money that it would have spent on ACA tax credits to help fund the reinsurance program.” By offering health plans reinsurance for claims above $30,000 (with a cap of $400,000), premiums can be lowered. According to CMS, “the waiver is expected to lower premiums in the state by 16% in 2020, and enrollment could increase by nearly 3% because of the lower premiums…”

Democrat’s Proposals: Here are a couple good articles summarizing last night’s “round 2” of Democratic debates: The messy health care discussion at the second Democratic debate, explained and Biden and Harris put health care plans to test on Democratic debate stage. Bottom line is that the debate focuses mainly on two candidates. Harris has her version of “Medicare for All” and Biden wants to make the ACA better.

About the public’s health

Poorer U.S. patients less likely to get blood pressure controlled: A reminder that economic disparities are an independent factor in receipt of appropriate care. The headline speaks for itself.

Trump administration tightens opioid prescriptions for feds: The Federal Employee Health Benefits Program will change its coverage of opioids in view of widespread abuses. “Under the new policy, the initial prescription will be for a 7-day supply, instead of up to 30 days.”

Nutrient deficiencies in rice grown under higher carbon dioxide could elevate health risks for tens of millions: This article raises a “new” concern about global warming due to rising CO2 levels. “In the past decade both laboratory and free-air studies have shown that crops of many dietary staples, including wheat, barley, rice, potatoes, and soybeans, develop lower concentrations of iron, zinc, protein, and other nutrients crucial to human health when they are grown under elevated levels of carbon dioxide… Now a recent study in the AGU journal GeoHealth finds declines in B-vitamin concentrations in rice grown under elevated CO2 concentrations may increase the future health risks of large numbers of people around the globe.”

Today's News and Commentary

About health insurance

Democratic debate was a boxing match over Medicare-for-all: This review of last night’s Democratic debates (round 1 of 2) did not have any real policy surprises. The differences among candidates became more focused. This article from the Washington Post is the best summary I have read.

Fiscal Year 2020 Payment and Policy changes for Medicare Skilled Nursing Facilities: This announcement was part of a number of payment and policy changes CMS issued yesterday, This one concerns funding and revised quality measures for skilled nursing facilities. The good news is that:” CMS projects aggregate payments to SNFs will increase by $851 million, or 2.4 percent, for FY 2020 compared to FY 2019.”

Humana raises 2019 guidance as Medicare Advantage enrollment grows: This article is not so much about Humana as the prospects for continued growth for Medicare Advantage plans.

Trump Administration Drives Down Drug Costs for Seniors: The announcement is blatantly self-serving, but the message is good: “Over the past three years, average Part D basic premiums have decreased by 13.5 percent, from $34.70 in 2017 to a projected $30 in 2020, saving beneficiaries about $1.9 billion in premium costs over that time.” The announcement, however, does not include information about trends in out-of-pocket expenses.

About healthcare IT

Rite Aid launches telehealth service through in-store kiosks:”In partnership with telehealth company InTouch Health, Rite Aid will begin offering a virtual service that connects customers with clinicians via its RediClinic Express kiosks located in retail stores.” Awareness about telehealth options is a major reason for its low usage. Perhaps this opportunity will also publicize what telehealth is.

In ongoing feud with PillPack, Surescripts bars ReMy Health from using its patient data: Amazon owns PillPack and Surescripts (which manages about 80% of U.S. prescriptions) is owned by CVS Health and pharmacy benefit manager Express Scripts. By Surescripts withholding patient data from its competitor, the latter’s business model can be severely impeded. This action raises a continuing concern about antitrust activity that the FTC is currently investigating.

CMS pilot taps FHIR to give clinicians access to claims data: The more generic story in many outlets was the capability by clinicians to access claims data. This article looks into the technology a bit deeper than others do.

About pharma

Exclusive: Two powerful Canadian provinces argued against federal drug price crackdown: American pharma companies claim that controlling their prices will impede their ability to research and develop new products. At the same time, policy makers correctly claim we have the highest branded drug prices in the world and point to Canada as an example we should emulate. Well…”Ontario and Quebec, have privately expressed concerns with a federal government plan to slash the price of patented drugs, arguing that such regulatory changes could hurt investment in life sciences.”

Congress seeks briefing on potential threat to U.S. heparin supply: The specifics of the article are less important than the illustration of how fragile our pharma supply chain can be. The “blood thinner” heparin is made from ingredients originating in pig intestines. “…60 percent of the crude heparin used to make finished heparin in the United states is sourced from China,” where there is an outbreak of African swine fever.

A Massive U.S. Drug Price-Fixing Probe Has Hit Major Roadblocks (from Bloomberg, limited free access): Federal and state actions against generic manufacturers’ alleged price-fixing collusion began in September 2016 with an FBI raid on Mylan. Since then, the investigations have faced a number of roadblocks. This article is a comprehensive update on this story.

How a Big Pharma Lawsuit Could Succeed Where Big Tobacco Failed: This article provides some history behind the $246 billion settlement from Big Tobacco in the ’90s and how many states misused the payouts for purposes other than public health. The message is how settlements from the opioid lawsuits can be put to better use.

HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs: HHS announced plans for two pathways to allow states to import drugs. According to the government statement released today:
The first pathway would be through a notice of proposed rulemaking (NPRM) whereby HHS and FDA would rely on the authority under current federal law “to authorize pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval.”

The second mechanism is through guidance, whereby the “FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries…. To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the U.S.”

About the public’s health

Lyme disease: Lyme disease may be 3 times higher than previous estimates in the UK (perhaps also in the US). It is timely that the FDA has just approved four diagnostic tests with new indications for diagnosing Lyme disease.

For Mortality, Busting the Myth of 10 000 Steps per Day: You should exercise; but you may not need to do 10,000 steps a day. This research on women found that benefits start at 4400 steps, increasing with further activity and leveling off at 7500 steps.

Today's News and Commentary

About healthcare quality and patient safety

The Best Hospitals 2019-20 Honor Roll: This year’s US News rankings have just been published.

Medical-device reprocessing saved providers $470 million last year: Usually reprocessing single- use devices is a red flag for quality/safety concerns. This article explains how they can be safely reused at a substantial cost savings.

About pharma

Drug companies to pay $70 million for delaying cheaper generics, California attorney general says: The FTC has been challenging branded drug manufacturers who pay generic companies to withhold their products during the period when the latter have marketing exclusivity. This case is unusual because a state is taking action against such a practice.

In A 1st, Doctors In U.S. Use CRISPR Tool To Treat Patient With Genetic Disorder: A patient received cells that were genetically altered using the CRISPER tool. The treatment was to correct her sickle cell disease.

About health insurance

CMS proposes hospitals post online negotiated rates with payers: CMS has issued a proposed rule to require hospitals to post online their list prices and a payer-specific negotiated prices for 300 common shoppable services, such as lab tests or certain clinical services. After accepting comments, the measure is set to start January 1, 2020. Failure to comply will result in penalties of $300 per day.
Comments: Will patients who go to a facility dictated by their insurance bother to look at the prices? Will patients who need emergency care look up the prices? Will this measure have any impact on “surprise billing?” Is $300 per day a sufficient penalty for not revealing confidential negotiated fees? What if payers offer to compensate hospitals for the penalty to keep the prices confidential?

Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2020: CMS has issued its proposed policies for comment that concern next year’s Medicare physician payments and quality provisions.

Trump Administration’s Patients over Paperwork Delivers for Doctors: In a related publication, CMS published measures '‘aimed at reducing burden, recognizing clinicians for the time they spend with patients, removing unnecessary measures and making it easier for them to be on the path towards value-based care.” The administration claims these new regulations will save 2.3 million hours per year.

Hurry up and wait: Docs say insurers increasingly interfere: This article highlights how utilization reviewers determine what tests/treatments are done by withholding payments.
Comment: If providers assumed financial risk for services would we have this problem?

About healthcare IT

Google Translate accurate enough to convert medical research into English: Review articles in the US are usually limited to studies published in English. This research showed that Google Translate is accurate enough to expand these reviews to other languages.

Today's News and Commentary

About health insurance

Governors weigh health care plans as they await court ruling: The headline is self explanatory. Governors gathered in Salt Lake city and discussed what would happen if the courts find the ACA is invalid.

2019 Wellness & Wealth Report: This inaugural report from Lively, Inc. found that healthcare benefits are the most important factor for employees- surpassing competitive salaries and 401 (k) plans.

Despite calls to start over, US health system covers 90%: This story was in a number of media today. Some spun it positively and others said “only 90%” of the population is covered. This article also points out that the adequacy of coverage is also important, as American face higher out of pocket costs.

Trump administration rejects Utah request for partial Medicaid funding: As previously reported, Utah and some other states were considering a partial expansion of Medicaid- more than current limits but not quite up to ACA expansion requirements. The Trump administration turned down the state’s request, setting this option aside.

Judge strikes down New Hampshire Medicaid work requirements program: Some states have tried to add work requirements to receive Medicaid benefits. This court decision is the latest (after Kentucky and Arkansas) striking down this condition for participation.

Aetna enlists AI to settle health insurance claims: Claims payments can get very complicated. This article explains how “Aetna allocates 50 employees to read notes about payment, deductible, and extraneous fee explanations in each contract, calculate pricing and update the claim. And with Aetna handling 2.4 million contracts per year, the process takes weeks to months, and often results in incorrect payment for claims.” The solution to this complex, often personnel-intensive process is use of artificial intelligence. This article is a nice summary of this use for AI.

HHS' OIG: CMS must review how MSSP overhaul is affecting ACO care: The HHS’ Office of the Inspector General interviewed 20 high performing Accountable Care Organizations to find out their secrets for success. Among the findings were the presence of care coordinators. But the one shortcoming was lack of a mechanism to share best practices with other ACOs.

Legislation introduced to back state Medicaid programs in addressing social determinants: Addressing social determinants of disease can reduce overall costs. But until legislation is passed, theses measures are not part of Medicaid funding. The model for expansion is what CMS allows Medicare Advantage plans to provide to their members.

About pharma

Restrictions on $2 Million Drug Highlight Challenge for Gene Therapies (Wall Street Journal, subscription may be required): The article deals with the specifics of Novartis’ gene therapy Zolgensma, which costs $2.1 million. The principles apply to other extremely expensive, life-saving or life-altering therapies.

Pfizer close to merging off-patent drug business with Mylan: report: This story was the top healthcare “business news” today and is the latest in the pharma sector’s ongoing restructuring.

NIH issues strict new requirements for fetal tissue research funding(Washington Post, subscription may be required) “In a notice spelling out the rule changes, NIH says that all grant applications and renewals for research relying on tissue collected from elective abortions must provide a detailed justification, documenting why no alternative methods could accomplish the same research goals. This and other changes for scientists at universities and other institutions take effect in two months.”

About healthcare IT

VA to spend $4.9B maintaining EHR over next decade as it rolls out Cerner replacement: This article is the latest on the VA EHR fiasco which is way over budget and time projections. The VA estimates that while it is rolling out its $10 billion Cerner system over the next 10 years, it will need $4.9 billion to maintain its legacy system, which has “130 versions or instances…across 1,500 sites.”

VUMC pilot to use voice commands to retrieve EHR data: It is often cumbersome to navigate an EHR. This pilot study at Vanderbilt will use voice commands to expedite searches.

HHS Awards Nearly $42 Million to Expand Health Information Technology In Health Centers Nationwide: “HHS, through the Health Resources and Services Administration (HRSA) awarded almost $42 million in funding to 49 Health Center Controlled Networks (HCCNs). These awards will enable the HCCNs to support 1,183 federally-funded health centers across all 50 states, the District of Columbia and Puerto Rico to expand the use of health information technology (health IT)…HCCNs are groups of health centers collaborating to improve operational and clinical practices by making technology easier for providers and patients to use, increasing the security of patient information and using data to improve patient care.”

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Association of Racial Bias With Burnout Among Resident Physicians: Physician burnout has been blamed for clinical errors and personnel shortages due to early retirement. This article explains another problem resulting from burnout- racial bias among resident physicians. The authors speculate that burnout may thus be contributing to healthcare disparities.

Juul went into a ninth-grade classroom and called its device 'totally safe,' teens testify:This story was reported in a number of media outlets. At the same time Juul has been promoting its programs to restrict its products to potential underage users, according to these stories it paid schools to do presentations on the safety of vaping. The stories are really disturbing.

Yale Employees Test Their Workplace Wellness Program In The Courts: Yale instituted a workplace wellness program to reduce healthcare costs. Participation is “voluntary,” but non compliance will trigger a financial penalty deducted from paychecks. Employees have filed a class action lawsuit against this program. Perhaps Yale should have increased costs for health benefits for all and provided reductions for those who participated in healthy activities?

About healthcare quality and safety

Modernizing the HCAHPS Survey: The Federation of American Hospitals conducted a survey about the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) that is administered to Medicare patients after hospital care. The organization points out a number of problems with the current version: Response rates are falling; the survey could do better to provide patients with comparable data; the topics need to be updated (for example to include questions related to efficiency and team-work of the care team); more research is needed on additional factors that influence patient experience; and  health literacy level needs to be made more appropriate for the surveyed population.

The top recommendations were: Add a digital mode of delivery to patients; shorten the survey; make revisions “in light of today’s shift to value-based care, changes in health care delivery, improvements in technology, and evolving patient priorities; reframe the care transitions and discharge planning sections of the HCAHPS survey; and periodically re-evaluate the HCAHPS survey.”

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Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies (From the Journal of General Internal Medicine- subscription required): Unlike other countries, the US does not have a central technology evaluation entity that looks at cost-effectiveness. This research compares FDA-approved drugs with those from Australia, Canada, and England, which do have cost-effectiveness review. Medicare spending from 2011-2016 was then calculated for the drugs that were used in this country but not approved in the other three. The results were: “Medicare spending totaled $3.7B, $17.8B, and $2.1B on drugs and biologics not recommended nor covered in only Australia, Canada, and England, respectively… $2.8B on those not recommended nor covered by any two countries, and $0 by all three countries. Between 2011 and 2015, Medicare beneficiaries filled 43.4M prescriptions for the not recommended nor covered drugs and biologics, spending $2.8B out-of-pocket …” The recommendation to apply cost-benefit standards seems obvious but it is currently illegal here.

Trump gives boost to state drug import plans: As previously reported, several states (Vermont, Florida, Colorado and Maine) passed laws allowing foreign drug importation to lower costs. But this action is illegal unless it gets federal approval. Now HHS Secretary Azar has changed his stance on this issue and will support ordering drugs, mainly from Canada.

FDA Agrees to Accept Inspections for All 28 EU Member States: One of the objections to drug importation is the spotty oversight of manufacturing in other countries. The US has been working with other nations to deem their supervisory authorities acceptable for imported drugs. Now, the “FDA has agreed to recognize inspections by all 28 EU member states under the U.S.-EU's mutual recognition agreement (MRA) for GMP [Good Manufacturing Practices] inspections.”

Senate panel advances bipartisan bill to lower drug prices amid GOP blowback: This bipartisan bill is the one Senators Grassley and Widen have been crafting. One of the controversial parts of the bill is provision that limits drug price increases for Medicare Part D; drug companies would have to repay revenue if their prices rise faster than inflation. Many Republicans see this measure as a free market constraint. Democrats are crafting their own bills which may go even further than this one. Further, the industry trade group, Pharmaceutical Research and Manufacturers of America (PhRMA), has continued to lobby against this Senate bill. In any case, nothing further will be done before the August recess.

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A look at people who have persistently high spending on health care: This study from Kaiser draws on three year’s experience with its membership. There are many good lessons from this research, but, in summary, the conclusion was: “Those with persistently high spending, while few in number, are some of the most expensive users of care – the 1.3% of enrollees with high spending in each of three consecutive years (2015-2017) had an average spending in 2017 of almost $88,000, accounting for 19.5% of overall spending that year. The predictability and extent of their spending suggest that any efforts to reduce the total costs of care and improve health system quality must focus heavily on this group of people.” High cost patients had significantly increased expenses for inpatient, outpatient and pharmaceuticals, so case management looking at the entire episodes of care need to be implemented. HIV infection, cystic fibrosis and multiple sclerosis were, by far, the three costliest conditions.

Senate will not vote on bipartisan health costs bill before leaving for August: The headline says it all.

About the public’s health

Births in the United States, 2018:This annual report from the CDC reveals that birth rates fell to an all-time low in the US. The rates declined for non-Hispanic white, non-Hispanic black, and Hispanic women. The teen birth rate also declined ( by 7%) from 2017 to 2018.

New Texas anti-abortion group vies for family planning funds: In a new twist on federal withholding of Title X funds: “A new faith-based, anti-abortion health group in Texas is suing HHS for the right to receive federal family planning funds — another sign such groups are moving aggressively to win some of the backing that long went to organizations like Planned Parenthood.”

About healthcare IT

Fitbits and other wearables may not accurately track heart rates in people of color: “In short: Skin with more melanin blocks green light [used by the sensors in the wearables], making it harder to get an accurate reading. The darker your skin is, the harder it gets.”

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Sanofi grabs nonprescription rights to Roche's Tamiflu, aiming for Rx-to-OTC switch: The title explains the article’s contents. Sanofi seeks to get FDA approval to make the influenza drug Tamiflu available over the counter.

Senators announce bipartisan proposal to lower drug prices: There is bipartisan support in the Senate Finance Committee for a proposal to keep drug prices down “by forcing pharmaceutical companies to pay rebates to Medicare if they raise prices of drugs more than the rate of inflation. Those rebates would be equal to the difference between the price increases and the inflation rate.The proposal also includes a cap on out-of-pocket costs for drugs covered under Medicare’s Part D, which is for self-administered prescription drugs, as well as changes to the program’s Part B, which covers physician-administered drugs….The senators said the proposal would save taxpayers $100 billion from the Medicare and Medicaid programs. Beneficiaries would save $27 billion in out-of-pocket costs.” The proposal has White House support but still has a long way to go before becoming law.

Drugmakers shell out record amount lobbying Congress(Financial Times subscription required): The industry lobbying group Pharmaceutical Research and Manufacturers of America spent a record $16.1 million in lobbying in the first half of 2019. The article cites the above proposed legislation as one reason for the stepped up activity.

More biosimilar drugs are coming to market. Yesterday the FDA approved the second biosimilar for Rituxan. Also approved was a biosimilar for Humira.

Implanted drug could someday prevent HIV infection: A number of news outlets reported on a matchstick-sized implant that could offer continuous protection against HIV infection for at least a year. While apparently effective, running randomized controlled trials could prove to be ethically difficult.

Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes: What happens when insurers deny coverage for very expensive medication? In the case of these costly cholesterol-lowing agents: “Individuals in the rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort. Rejection, abandonment, and disparities related to PCSK9i prescriptions are related to higher cardiovascular outcome rates.” Perhaps the payers need to change criteria for coverage.

Latest generic drug deal puts hospital-owned Civica Rx ahead of schedule: This article is an update on Civica, a generic pharma company formed last year by hospitals who wanted to lower their pharma costs and relieve some of their drug shortages. “More than 30 health systems are Civica members, representing 900 U.S. hospitals and 30% of U.S. licensed beds.”

About the public’s health

Trump proposal would push 3 million Americans off food stamps: The title tells it all. Obviously there are healthcare implications to this action.

Worldwide recall launched for textured breast implants linked to rare cancer: This morning Allergan announced a breast implant recall.

About healthcare IT

IBM Watson Health's new manager talks about returning to basics, doubling down: There are a number of uses for artificial intelligence (AI) in healthcare settings (see below). IBM’s Watson has realized it cannot be all things to all stakeholders. Instead, it has decided to focus on clinical care. In the past year it gave up the healthcare management sector and is not enrolling new pharma clients.

Hand hygiene compliance surveillance with time series anomaly detection: Use of Artificial Intelligence-aided time series methods provided “more interpretable views of anomalous data compared to traditional statistical process control charts.” As well, individual patterns could be detected for more focused interventions.

Deep Learning to Assess Long-term Mortality From Chest Radiographs: Using AI in this study, “the deep learning CXR-risk score stratified the risk of long-term mortality based on a single chest radiograph. Individuals at high risk of mortality may benefit from prevention, screening, and lifestyle interventions.”

AmeriHealth Caritas' Inclusion of Community Health-Based Services Reduces Emergency Room Utilization: “An analysis of data compiled by AmeriHealth Caritas' clinical and health care analytics teams indicates that high-risk Medicaid members who receive community-based services, with an emphasis on screening for and addressing the social determinants of health, experience a reduction in hospitalization rates.” The program resulted in decreases of : 26.3% in inpatient admissions; 27.2% in inpatient days; 9.7 % in emergency department visits; 22% in potentially preventable admissions; and 12% in potentially preventable emergency department visits.

Wellness culture's obsession with Fitbits, 23andMe and data isn't necessarily making us healthier: Is more data always better when one desires to improve health? Not always, as this article explains.

Cost of a Data Breach Report 2019: (Registration is free for the full report) This annual report comes from IBM Security. The average cost of all data breaches is $3.9 million; but healthcare breaches are the most expensive at an average of $6.45 million. All breaches cost an average of $150 per record; healthcare breaches average $429.

DataSpii: The catastrophic data leak via browser extensions: On a related note, this report explains the data leaks that can occur from using browser extensions.

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The High Cost of Avoidable Hospital Emergency Department Visits: This study by United Health Group found that “the average cost of treating common primary care treatable conditions at a hospital ED is $2,032…, 12 times higher than visiting a physician office ($167) and 10 times higher than traveling to an urgent care center ($193) to treat those same conditions. In other words, visiting either a physician’s office or an urgent care facility instead of a hospital would save an average of more than $1,800 per visit – creating a $32 billion annual savings opportunity systemwide.” The main extra cost is the hospitals’ facility charge.

Politicians Tackle Surprise Bills, but Not the Biggest Source of Them: Ambulances: 51% of out-of- network surprise bills are from ambulance services; yet these charges are not addressed by current legislative proposals.

About the public’s health

U.S. Global Health Legislation Tracker: “This tracker provides a listing of global health-related legislation introduced in the 116th Congress. Currently, there are more than 30 pieces of legislation related to global health. They address topics ranging from global health security to neglected tropical diseases (NTDs) and reproductive health.” This site is a great source for keeping up with public policy proposals in Congress.

Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004‐2015: “The proportion of persons diagnosed with CRC at an age younger than 50 years in the United States has continued to increase over the past decade, and younger adults present with more advanced disease. These data should be considered in the ongoing discussion of screening guidelines.” Should guidelines be revised to lower the first age of screening?

Use of Antibiotics Without a Prescription in the U.S. Population: A Scoping Review: One of the causes of bacterial resistance is use of unprescribed antibiotics. These drugs can be obtained over the counter in some foreign countries, “saving pills” from a previous prescription, or “borrowing” from others. This article reviews this often overlooked problem.

Firearm Ownership and Domestic Versus Nondomestic Homicide in the U.S.: The anti-gun lobby wants more controls on firearms in order to reduce homicides. But is such ownership correlated with these deaths? Yes and no. According to these researchers: “State-level firearm ownership rates are related to rates of domestic but not nondomestic firearm homicide.”

Mortality Trends by Race and Ethnicity Among Adults Aged 25 and over: United States, 2000–2017: The CDC released this report today. Hispanics fared best in all age categories (see the charts for quick information). The over-65 age group had declining mortality rates. From 2012-2017, the 25-44 age group had increasing mortality rates. In all categories, the rates were highest for non-Hispanic blacks.

A Unified Welfare Analysis of Government Policies: This paper is from two Harvard economists working with the National Bureaus of Economic Research and is to be presented at a conference there on Thursday. The authors looked at which public policies paid back their investments. No surprise that the answer was childhood-related programs; the reason is the time over which to recoup the spending is longer than in older persons. For example, for every dollar spent on children’s health programs, the system recoups about $1.47. For adult health programs every dollar spent loses an additional sixty cents. Obviously the issues of equity are not considered.

About healthcare quality and safety

Adverse Events in Long-term Care Residents Transitioning From Hospital Back to Nursing Home: Transitions in processes create frequent opportunities for errors. In transition from hospital back to long term care facilities patients in this study experienced a 40% chance of an adverse event. “…pressure ulcers, skin tears, and falls with injury representing the most common types of events in this category. Health care–acquired infections… and adverse drug events… were the next most common…Most were preventable or ameliorable.” The authors call for better information transmission between sites. But person-to-person communication, and even provider continuity, would be better.

About healthcare IT

Groups host congressional briefing to support lifting patient ID ban: As almost every other country has discovered, you cannot have completely useful interoperability of medical information without the ability to link individual patient data. That linkage requires unique patient identifiers. The identifiers were part of the original HIPAA legislation but, subsequently, Section 510 of a Labor-HHS Appropriations bill prohibited federal spending to set up them up. Professional IT groups are now lobbying to reinstate this unique designation.

Health system boards don't do enough IT oversight, report shows: A new study by Black Book Research finds some significant problems with health system boards' knowledge about healthcare IT. For example: “4% of survey respondents said they have direct technology experience relevant to the healthcare industry, and nearly eight in 10 said they don’t get enough feedback or actual data regarding the technology challenges their health system faces… 88% said they had no knowledge of healthcare cybersecurity risks, with just 7% claiming they were ‘somewhat knowledgeable’ of the risks.” Clearly some education and/or board recruiting improvements need to be made immediately.

Anthem launching new app offering personalized health information, texting with doctors: Usually patient-physician communication is driven by the software at the provider site. This app is interesting because it is payer- sponsored. The platform is from K Health, a company that “built its platform by using anonymized electronic health records of over 2 million patients from Maccabi Health Services in Israel from the past 20 years. That data, which includes 2 billion health events, was used to train artificial intelligence algorithms to recognize symptoms and diagnoses…” Humana announced a communication app with primary care physicians in April.

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Federal judge upholds Trump's expansion of non-ObamaCare plans: Washington U.S. District Judge Richard Leon ruled that expansion health plans (that is, non-ACA compliant health insurance) can be offered. They do not have to meet the coverage requirements of ACA plans so they can be sold at a cheaper price. To what extent these offerings will further fragment the healthcare insurance market remains to be seen. If experience is any guide, healthier people will flock to them, making the exchange offerings more expensive. The federal government will end up picking up the tab for the higher costs through premium subsidies.

Colorado’s reinsurance bill drops marketplace health insurance: The Colorado legislature passed a law last session that set up a reinsurance scheme for ACA health plans operating in the state. The money comes from the federal government that would go to financial assistance. Since insurance companies have limits on their liability, the premiums have decreased. Other states have also looked at this program, which requires HHS approval. Depending on the individual states, this financial arrangement could be cheaper for the federal government and individuals than straight premium subsidies.

With lessons from hospitality and tech, Forward expands primary care footprint on East Coast: This article looks at the “latest” in concierge medicine, a high tech approach to primary care. While physician and lab fees are part of the monthly charge, patients will need traditional insurance if they really get sick.

About pharma

Incenting Competition to Reduce Drug Spending:The Biosimilar Opportunity : This in-depth report looks at potential cost-savings from current and expanded use of biosimilars: “… the current biosimilar market share is annually creating $253.8 million in savings… Greater savings are possible if the share of biosimilars were higher. Should biosimilars grow to 25 percent, 50 percent, or 75 percent of the market, annual total health care spending would be $2.5 billion, $4.8 billion, and $7.2 billion lower respectively than the baseline scenario. Over 10 years, these savings would become $24.7 billion, $48.0 billion, and $71.7 billion respectively. It should be noted that these savings only count the nine biologic drug classes where approved biosimilars already exist. Even greater savings will be realized if biosimilars were approved for more drug classes.”

Biosimilars were supposed to save us. Can they even save themselves?: On the same theme as the above study, this article keys on patent protections preventing biosimilars from getting to market. Also, discounts in this country start at about 15% below reference drugs- a figure the latter can easily match. In Europe, biologics have shorter patents and can be discounted as much as 80%. The savings outside the U.S. are therefore more substantial. Time to reexamine the regulations for this market?

Lyrica generics roll: Pfizer blockbuster finally hits patent cliff: On Friday, the FDA approved 10 generics for Pfizer’s blockbuster drug Lyrica. With that many competitors, prices are expected to drop by about 75%.

Mounting battle between Amazon's PillPack and Surescripts over access to patient data: Amazon’s PillPack has been cut off from patient medication histories by Surescripts, which is owned by competitors CVS Health and pharmacy benefit manager (PBM) Express Scripts. This action comes, as previously reported, during an FTC investigation of Surescripts for alleged antitrust. PillPack is suing so the fight is not yet over.

About healthcare IT

Anti-extremism software to be used to tackle vaccine disinformation: “Technology used to counter violent messages online from Islamic State and the far right is being adapted to counter the spread of ‘anti-vax’ conspiracy theories.”

Philips Future Health Index 2019 finds US among leaders in EMR use and AI spend, but overall digital health technology adoption mixed: The title is a bit misleading. Much of this wide-ranging report covers American healthcare IT issues such as interoperability, desire for privacy and telemedicine. One part of the report compares the U.S. with other countries. In comparing the percentage of U.S. healthcare professionals who currently use digital health technology or mobile health apps (76%) against many other countries, we do not do so well; for example, Russia is at 81%, Saudi Arabia is at 85% and China tops out at 94%. Clearly we have a long way to go.

Do protections for people with disabilities apply online? Domino’s asks high court: This article is not, strictly speaking about healthcare but the implications for the field are obvious. Domino’s Pizza is being sued by a blind customer because the website does not offer ordering options for his disability. The overall question being raised is in the article’s title.

About the public’s health

Oral health: This link is for a special issue of The Lancet on important trends in oral health- a topic that is often ignored in public health.

Trump administration pauses new rule limiting abortion referrals: The rule prohibiting abortion referrals for all organizations receiving Title X funds has been paused. Affected groups now have up to 2 months to comply.

About healthcare quality and safety: The American College of Surgeons, along with 50 stakeholder organizations (the ACS Coalition for Quality in Geriatric Surgery Project) launched The American College of Surgeons (ACS) Geriatric Surgery Verification (GSV) Program. The GSV consists of “30 new surgical standards designed to systematically improve surgical care and outcomes for the aging adult population.” Included are assessments of social issues, such as a patient’s caregiver situation.

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Calories Purchased by Hospital Employees After Implementation of a Cafeteria Traffic Light–Labeling and Choice Architecture Program: In their main cafeteria, the Massachusetts General Hospital installed “‘traffic light’ food labels (in which green indicates healthy, yellow indicates less healthy, and red indicates least healthy) and choice architecture (product placement)…” These signals resulted in a reduction of 47 kcal per day and estimated a 2.0-kg weight loss over 3 years. This reduction was sustained and assumes no other dietary or activity changes. This program is really simple and much easier (and faster) than having people read labels.

Natural environments and craving: The mediating role of negative affect: This small, but intriguing study from the UK’s University of Plymouth shows that exposure to nature (fields, tress, etc.) reduces cravings for such items as unhealthful snacks, alcohol, or tobacco.

Association between coffee consumption and overall risk of being diagnosed with or dying from cancer among >300 000 UK Biobank participants in a large-scale Mendelian randomization study: Breath easier when you have that cup of coffee. Based on observational data as well as literature review (through a meta-analysis) the researchers found that “summary data on various cancers do not support a strong causal relationship between coffee and risk of breast, ovarian, lung or prostate cancer, upon correction for multiple testing.”

About healthcare professionals

Investing in Primary Care: A State-Level Analysis: All studies from around the world show the advantages of a primary care system; yet the US has had a very specialty-focus. This difference is highlighted by the facts that on average, “the United States spends 5%-7% on primary care as a percentage of total health care spending. By comparison, Organisation for Economic Co-operation and Development (OECD) countries average 14% spending on primary care.” This research study of primary care investment by state found an association “between increased primary care spend and fewer emergency department visits, total hospitalizations, and hospitalizations for ambulatory care-sensitive conditions.” While a causal relationship was not asserted, the results were consistent with other research studies about primary care’s benefits.

About healthcare quality and safety

Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis: Clinical protocols usually come from medical organizations or accreditation groups. In 2013 New York State mandated the use of protocols for sepsis recognition and treatment. “By the 10th quarter after implementation of the regulations, the adjusted absolute mortality was 3.2% lower than expected in New York State relative to the control states.” The authors caution about applying the program to other states.

CMS updates Medicaid and CHIP Scorecard with new data: For the second year, CMS released scorecards for Medicaid and CHIP, this time with new data. This article provides an overview of the scorecard while the CMS site provides more details. Unfortunately, like much health data, the findings are a bit old.

Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis: “Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).”

About pharma

Canada warns U.S. against drug import plans, citing shortage concerns: It might not be so easy to get medications from Canada. To save money on prescription drugs, some states (like Florida) have passed laws enabling their purchase from Canada. Canada has warned the US that if the volume is large enough to affect Canadian supplies, the exports will be cut.

Roche doomsday is here: Long-feared Herceptin, Avastin biosims bust into U.S. market: Good news for consumers, bad news for Roche. “Amgen and Allergan Thursday launched U.S. biosimilars of both HER2-positive breast cancer med Herceptin and colorectal cancer treatment Avastin, threatening a combined $5.9 billion in U.S. sales in 2018.” The prices will be 15% lower than the reference biologics, which is consistent for biosimilars.

Novartis, aiming to clean up its rep, sets aside $700M for kickback settlement: This amount should settle a decade-long federal bribery charge from a whistleblower suit. Novartis was accused of bribing physicians to prescribe their medications. “Among some of the most eyepopping claims in the suit were Novartis sales execs treating doctors to $10,000 dinners at expensive New York seafood restaurants and wild nights out at Hooters. In one instance, Novartis held one of its speaker events aboard a fishing boat, allegedly without any educational material in tow.”

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Aetna-CVS merger to go back before judge; 5 states support approval: In a continuation of scrutiny of this merger, next Wednesday “lawyers from California, Florida, Hawaii, Mississippi, and Washington will appear before U.S. District Judge Richard J. Leon in Washington, D.C., … to defend a Justice Department-brokered settlement as an ‘effective and appropriate remedy’ for potentially anti-competitive effects stemming from the tie-up.”

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House votes to get rid of ACA's controversial 'Cadillac' tax on high-cost plans: As predicted a few days ago, the House voted to repeal the tax on costly health plans. Now large firms will be able to provide rich health benefits that are fully tax deductible for them and tax exempt for employees. I expect the Senate to vote to pass the measure.

House lawmakers add arbitration to surprise billing measure: The House Energy and Commerce Committee “unanimously advanced the No Surprises Act as part of a major package that reauthorizes funding for community health centers and delays implementation of cuts to disproportionate share hospitals. The legislation, which now heads to the full House, bans balance billing and requires insurers to pay the median in-network rate for out-of-network surprise bills.” A last minute addition was an arbitration provision if the provider does not accept the insurance company payment.

Health Care Spending, Utilization, and Quality 8 Years into Global Payment: A pilot project of Blue Cross in Massachusetts set spending goals for physicians through population-based global budgets and . quality payments. “During the first 8 years after its introduction, the BCBS population-based payment model was associated with slower growth in medical spending on claims, resulting in savings that over time began to exceed incentive payments. Unadjusted measures of quality under this model were higher than or similar to average regional and national quality measures.” While these results were just published today, the trial ended in 2016. Further, there is nothing new in these findings, as similar results have long been known for capitated arrangements.

About healthcare quality and safety

Today, the Leapfrog Group released: Safety In Numbers: The Leapfrog Group’s Report on High-Risk Surgeries Performed at American Hospitals. Of the eight high-risk procedures assessed, “open abdominal aortic aneurysm repair and esophageal resection for cancer are the two procedures where the fewest hospitals met the volume standard for patient safety (less than 3% fully meeting for each). The procedure for which hospitals were most likely to meet the safety standard was bariatric surgery for weight loss (38%).”

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Medscape Residents Salary & Debt Report 2019: Some major findings:
—Over the past 2 years, average resident salaries have increase 3% to $61,200.
—Medical genetics topped the list at $67,500 and at the bottom was family medicine ($10,000 lower). Of course salaries increase each year and are greatest in the longest residencies.
—41% of residents said future earnings were extremely or very important to their specialty choice, while only 8% said it had no influence.
—22% had no debt while 24% had more than $300,000 in debt.

About healthcare IT

Exploring the Digital Divide: Age and Race Disparities in Use of an Inpatient Portal: This research found that there was “lower use of the inpatient portal among African American and older patients, relative to White and younger patients, respectively.” Authors concluded the “findings suggest that the availability of the technology alone may be insufficient to overcome barriers to use and that additional intervention may be needed to close the digital divide.”

About the public’s health

Disease X: Which Plague Is Coming Next?: Ebola, SARS, MERS, Zika…These are infections diseases which have sprung up relatively recently. What is next? This article is a nice summary of the answer to this question.

Association of Genetic and Environmental Factors With Autism in a 5-Country Cohort: Many environmental causes (including, erroneously, vaccinations) have been hypothesized as the cause of autism. This multi-country study shows that the heritability of autism is 80%, “indicating that the variation…is mostly owing to inherited genetic influences…”

Provisional Drug Overdose Death Counts: According to CDC provisional data, about 68,500 Americans died of a drug overdose in 2018, a 5% drop from the previous year. The decrease is the first time the number has fallen since 1999.

Latin America’s war on obesity could be a model for U.S.: Obesity is a major problem in Latin America. Countries in the region face the same obstacles as the U.S. in addressing this problem- including hard lobbying by business groups that would be affected by public health laws. This article is a nice summary of their successful efforts. For example, in" “July 2012, the Chilean Senate approved the law of food labeling and advertising, which went into effect in 2016 with comprehensive food-regulation policy in three, increasingly stringent phases. Spearheaded by Guido Girardi, a physician and senator, the law included front-of-package warnings, restrictions on marketing unhealthful foods directly to children, and limits on what foods could be sold in schools and day-care facilities.”

About healthcare technology

CVS Health Announces Start of Clinical Trial for New Home Hemodialysis Device: CVS announced it will initiate a clinical trial on up to 70 patients to test the safety and effectiveness of the at-home HemoCare Hemodialysis System. Because typical hemodialysis is accomplished during regular, scheduled hours in a facility, times are limited. CVS hopes that this home system will not only make treatment more convenient for patients but also allow them to have longer (or more frequent) sessions- thus improving clearance of blood toxins.

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CBO: Senate surprise billing legislation would save feds $7B over next decade: The Senate Health, Education, Labor and Pensions Committee asked the Congressional Budget Office for estimates on the financial impact of its proposal to address surprise medical bills and high pharmaceutical costs. The CBO reported that the law would lower federal expenses by $7 billion over the next decade. A closer look (Table 1) reveals that that savings do not start until 2025. By 2028 the net federal budget savings reaches about $4.5 billion.

Democratic chair: Medicare negotiating drug prices not moving before August: On the House side, it appears that drug price legislation will not happen before the August recess.

New CMS resources help states waive ACA requirements: The ACA has provisions to grant states waivers (Section 1332) to adopt alternative schemes to provide health insurance. “Most states have gotten or are seeking the Section 1332 waivers to establish a reinsurance program to fully or partially reimburse insurers that are covering claims for high-risk beneficiaires. This reduces the price of premiums in those states.” CMS has just issued guidelines to make the waiver process easier. The question that arises is what happens to insurance markets as the number of products increase and enrollees segment themselves among these plans by financial and health status criteria?

Trump Administration Moves to Shift Patients’ Chronic Illness Costs to Insurers: In order to have a Health Savings Accounts (HSAs), participants must also have a high deductible health plan. These plans require large out of pocket payments before the insurance becomes responsible. The Internal Revenue Service and the Treasury Department just issued a guidance for high-deductible health plans that allows insurance companies to pay for such chronic disease items as glucose monitors and blood pressure cuffs without first satisfying the deductible. This type of allowance has been discussed before with respect to total coverage of chronic medications to ensure compliance.

Insurers Running Medicare Advantage Plans Overbill Taxpayers By Billions As Feds Struggle To Stop It: Payments to Medicare Advantage plans include adjustments for the severity of illnesses of covered persons. CMS clams that over the past three years these plans have overbilled Medicare $30 billion. The controversy over this issue is whether plans are documenting better or exaggerating patient findings. We will see which is true when the government seeks to recoup the money it claims plans owe.

Early Effects of an Accountable Care Organization Model for Underserved Areas: In its first year, the Accountable Care Organization Investment Model "was associated with a differential reduction in total Medicare spending of $28.21 per beneficiary per month relative to the comparison group, which amounted to an aggregate decrease of $131.0 million…” After accounting for “$82.4 million in CMS spending, the aggregate net reduction was $48.6 million, which corresponded to a net reduction of $10.46 per beneficiary per month. Decreases in the number of hospitalizations and use of institutional post-acute care contributed to the observed reduction in overall spending.”

Health Insurance Index Report for the 2019 Open Enrollment Period: This report from eHealth found that, for unsubsidized enrollees in exchange plans, the average premiums for two-person families broke $1,000 per month for the first time and the total “combined annual premiums plus deductible for a four-person family now tops $25,000.” The good news is that for 2019 the “average individual deductible decreased 6%…” and the “average family deductible decreased 8%…”

About the public’s health

Unintentional Injury Death Rates in Rural and Urban Areas: United States, 1999–2017: We pay much attention to diagnosis and treatment of diseases such as cancers and heart attacks; however, according to the CDC, unintentional injury is a leading cause of death in the United States. In this category are traffic accidents, unintentional drug overdoses, and falls. In this July report, the CDC says that from” 1999 through 2017, the age-adjusted unintentional injury death rate increased 40%.” Clearly more attention needs to be directed at this category of deaths.

Planned Parenthood ousts leader after less than a year: Normally a job change is not big news. However, this ouster was caused by the Monday start of the rule prohibiting federally funded family planning clinics from providing referrals for abortions. Apparently former president Leana Wen, MD wanted to approach the issue as a medical one while the organization saw it as a political fight. In related stories, two Planned Parenthood clinics (in Illinois and Maine) said they would refuse federal funding so they could continue to provide abortion services.

76 billion opioid pills: Newly released federal data unmasks the epidemic: This Washington Post story details the magnitude of opioids that have been flooding the market and the role played by pharma companies and the manufacturers which supply them. This information comes from the public release of data from the Drug Enforcement Administration. The question now is not about who produced and promoted what drugs, but why the DEA was sitting on data that clearly showed an epidemic in the making.

Trump to order drive for improved flu vaccine: Now some good news. After years of questioning the safety of vaccines, President Trump “is readying an executive order that would direct HHS to overhaul the development of flu vaccine and encourage more Americans to get vaccinated.”

Incentives for smoking cessation: The best way to get people to stop smoking is to raise cigarette taxes. But does paying them to stop also work? This Cochrane Collaborative article concludes that: “Six months or more after the beginning of the trial, people receiving rewards were more likely to have stopped smoking than those in the control groups.” The amount did not matter.

New York City Hopes to Ease Strain on Its Emergency Rooms: NY City has announced an expanded primary care system called NYC Care. It is expected to serve 300,000 patients and reduce ER usage by providing a regular source of care.

About pharma

Johnson & Johnson lifts annual revenue guidance as Q2 drugs sales top estimates, led by Darzalex, Imbruvica, Tremfya: Despite the pending liability suits over opioids and asbestos in baby powder, and pressures from generics, J&J continues to be profitable. This is article provides a good look at the importance of a diversified product line.

Today's News and Commentary

About health insurance

A look at how providers could fare in CMS' new primary care payment models: As previously reported, starting in January 2020 CMS will start a demonstration project to incentivize primary care physicians to accept risk arrangements with quality bonuses. This scheme is separate from the ACO program. This article is a nice summary of what the primary care payment models will look like.

Problems Remain for Ensuring That All High Risk Medicaid Providers Undergo Criminal Background Checks: The Office of the Inspector General of HHS surveyed states’ compliance with measures to assure “high risk” individuals were appropriately screened before being allowed to participate in the Medicaid program. The OIG “found flaws with States' implementation of fingerprint based criminal background checks for high risk Medicaid providers. Eighteen States missed the deadline for implementation that CMS had set, and 13 of those 18 States had still not implemented these checks as of January 1, 2019.” Recommendations are included in the report.

About healthcare IT

Surescripts files motion to dismiss FTC's antitrust case: Recall that in April the FTC filed suit against Surescripts for monopolizing the e-prescribing market. This article provides an update on that story.

About pharma

Advocates frustrated over pace of drug price reform: Despite all the talk in Congress (by both parties) about addressing high drug prices, nothing has been done; and the August recess is fast approaching. This article is a nice summary of what is (or is not) happening.

How pharma, under attack from all sides, keeps winning in Washington: This article provides a different spin than the one above by focusing on the role of the pharma lobby.

Limited Information Exists on the Effects of Synchronizing Medication Refills: “Medication synchronization is a process whereby a pharmacist aligns the refill dates of two or more of a patient’s medications to a single day.” The GAO was mandated to do a survey about this issue and found scant data. Some findings support increased drug adherence. But there are problems with this process. A major one is that patients stagger their filling of prescriptions because they need to spread out the costs. Perhaps the problem could be solved with a utility-like payment method that “smooths” payments rather than requiring a periodic lump sum. For example, instead of paying the out-of-pocket costs of several 90-day supplies of medications all at once, the patient could be billed equal amounts each month for 3 months.

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About health insurance

1 in 5 employers may face the ACA's 'Cadillac' tax on high-cost health plans: Health benefits are deductible expenses for employers and tax free benefits for employees. If these benefits expand in place of higher salaries (which are taxable), the government loses more money. Further, such a system discourages prudent purchasing of insurance. In this setting, the ACA mandated a so-called “Cadillac tax” ( a 40% excise tax) on an employer health plan when its cost surpasses $11,200 for an individual and $30,100 for a family. Both major political parties do not like this provision. One reason is it was not indexed to inflation or even geared to rising healthcare costs, thus causing the burden to fall on the middle class. The start date for this tax has been delayed but is now set to go into effect in 2022. If it proceeds as planned, this new study estimates that about 21% of “employers offering health plans will have at least one plan affected.” The House is expected to vote this week on a full repeal of this tax.

Biden reveals healthcare plan piggybacking on ACA: Add one more variation…Biden proposes that a Medicare-like system be offered with Medicaid benefits. This option would be offered for those who would qualify for Medicaid if their states had signed on for the expansion.

CMS Proposing Bundled Payment Model for Radiation Oncology: The title speaks for itself. This proposal has been months in the making. "Participation would be mandatory for certain geographic areas during the model's projected five-year timeline…” and prospective payments will be linked to quality metrics.

U.S. appeals court blocks Trump administration birth control exemptions: “A federal appeals court on Friday blocked the Trump administration from enforcing new rules allowing employers to obtain exemptions from an Obamacare requirement they provide health insurance that covers women’s birth control.”

About healthcare quality

Quality Payment Program Releases 2017 Physician Compare Data and Sees Increases in Clinician Participation Rates and Success for 2018: CMS Administrator Seema Verma announced that the number of Qualified Practitioners participating in the Advanced APM programs for quality reporting “nearly doubled in 2018 from the previous year, increasing from 99,076 to 183,306 clinicians…Additionally, nearly 90% of clinicians in small practices participated in 2018, which was an increase from 81% in 2017.” Any recent economic and clinical benefits still need to be assessed.

CMS to delay star ratings update pending expert panel review: This February, CMS started to look at changes in the quality assessment methodology that underpins the star reports for hospitals. After receiving more than 800 comments from a solicitation, CMS decided to delay its summer report and instead look at revisions in the program.

Serious misdiagnosis-related harms in malpractice claims: The “Big Three” – vascular events, infections, and cancers: The authors of this study looked at malpractice claims and found that '“ vascular events, infections, and cancers… account for about three-fourths of serious misdiagnosis-related harms.” They concluded that initial programs to improve diagnoses should be targeted at these conditions.

Today's News and Commentary

About the public’s health

Court rules Trump administration can go ahead with Title X 'gag rule':By a 7-4 vote, the U.S. Court of Appeals for the 9th Circuit upheld the June 20 ruling by a three-judge panel that allows the government to withhold Title X funds from clinics that provide abortion referrals.

Trends in prevalence of protective levels of hepatitis B surface antibody among adults aged 18–49 years with risk factors for hepatitis B virus infection—United States, 2003–2014: Fewer than a third of high risk adults had been immunized for hepatitis B by 2014. Clearly more needs to be done to increase this coverage. (The number today is perhaps higher given the requirement for vaccine coverage under the ACA. Recall the insurance exchanges started in 2014.) This problem is the perfect example for the need for more social marketing.

Health plans ramp up new IT efforts:This article is not just about IT. The main theme is how Social Determinants of Health are being addressed by insurers. The lead example is a food market in a bus that brings healthy food into a “food desert” in Minneapolis-St. Paul.

About pharma

Failure to Launch: Patent Abuse Blocks Access to Biosimilars for America’s Patients: This Whitepaper from the trade group “Biosimilars Council” details the impediments to biosimilars getting to market. The study claims that these obstacles, including patent abuse by branded products, have cost the public $7.6 billion.

Speaking of generics, the FDA tentatively approved Mylan's generic Eliquis. As this class of drugs goes generic, prices will come down; however the number of indications have increased.

About healthcare quality

Association of residency work hour reform with long term quality and costs of care of US physicians: observational study: Work hour reforms for residents started in 2003 because of problems in care attributed to fatigue. Since then the question has been raised about the quality of care these physicians will deliver after training, viz., will the reduced hours produce less qualified practitioners? The answer, at least for internists, is “no difference.” The bottom line: “ Exposure of internists to work hour reforms during their residency was not associated with post-training differences in patient mortality, readmissions, or costs of care.”

About health insurance

CMS Proposes Elimination of RAPs, $250 Million Medicare Payment Increase: CMS is proposing a number of changes in home care payments, including a new home infusion benefit. Overall, these changes “would increase Medicare payments to home health agencies by 1.3% — or about $250 million.”

CMS proposes new approach to monitoring protections for Medicaid beneficiaries: Current Medicaid rules require states to report data on access to that program every three years. But the rule only applies to fee for service Medicaid. Since the majority of Medicaid recipients are enrolled in managed care plans. the rules need to be changed. Further, CMS plans to change the type of evaluation to more of an outcomes-driven approach.

About healthcare IT

GE anesthesia/respiratory devices have cyber vulnerabilities: This story highlights another recent example of the vulnerability of healthcare “peripherals” too hacking.

Today's News and Commentary

About pharma

White House kills major drug pricing proposal: Remember the President’s proposals to lower individuals’ drug costs by re-channeling rebates? Nevermind. Now Congressional focus will be on prices pharma companies charge.

About healthcare IT

FCC approves $100M rural telehealth program: “The proposed pilot program would offer an 85 percent discount on connectivity for telehealth services powered by broadband internet access. The virtual care services would connect patients directly to their physicians through audio and video technology.” The question is whether there is adequate connectivity in places that need it.

Amazon's Alexa will now give Brits health advice: Want to ask Alexa about your symptoms or how to treat your illness? You can in the UK. It appears the concerns there are only about privacy. In this country we would also have liability concerns.

About healthcare quality

Changes in hospital safety following penalties in the US Hospital Acquired Condition Reduction Program: retrospective cohort study: Does the threat of penalties improve care? The answer with respect to hospital acquired conditions is: “No.” In fact financially penalizing hospitals could make it more difficult to deliver care to needy populations. The research concluded: “Penalization was not associated with significant changes in rates of hospital acquired conditions, 30 day readmission, or 30 day mortality, and does not appear to drive meaningful clinical improvements.”

About the public’s health

Sugary drink consumption and risk of cancer: results from NutriNet-Santé prospective cohort:  “In this large prospective study, the consumption of sugary drinks was positively associated with the risk of overall cancer and breast cancer. 100% fruit juices were also positively associated with the risk of overall cancer. These results need replication in other large scale prospective studies. They suggest that sugary drinks, which are widely consumed in Western countries, might represent a modifiable risk factor for cancer prevention.”

About health insurance

Appeals court appears likely to call for lower court to settle unanswered questions on ACA lawsuit, experts say: More legal experts have weighed in on what might happen as the appeals court rules on the ACA. The most recent comments are that the court will send the suit back to a lower court to decide which parts of the law can exist without the individual mandate.

Rifts Emerge Over Congressional Move to Curb Surprise Medical Bills: While bipartisan support for addressing surprise medical bills still exists, the implementation details are causing some disagreements. For example, if you take the patient out of the equation, who is responsible for the difference between what the insurance company pays and what the provider is asking?

California gov signs health care bill extending coverage to some undocumented residents: “Democratic Gov. Gavin Newsom on Tuesday signed SB-104, which extends health care benefits to individuals 19 to 25 years of age, regardless of their immigration status.”