Today's News and Commentary

About pharma

Inside the Drug Industry’s Plan to Defeat the DEA: This in-depth investigative piece in the Washington Post exposes newly released documents revealing how some pharma companies knew about the opioid crisis for years. “The industry enlisted members of Congress to limit the powers of the Drug Enforcement Administration. It devised “tactics” to push back against the agency. And it commissioned a ‘Crisis Playbook’ to burnish its image and blame the federal government for not doing enough to stop the epidemic.” Great investigative reporting.

Zantac and some OTC meds found to contain suspected carcinogen first discovered in blood pressure drugs: Recently, the drug Valsartan was found to be contaminated with N-nitrosodimethylamine (NDMA), which, in sufficient concentrations, is carcinogenic. Now the FDA has found small amounts of the substance in Zantac and some other over-the-counter heartburn drugs. Sources of the contaminant are still not certain.

About the public’s health

U.S. Obesity Rates Reach Historic Highs – Racial, Ethnic, Gender and Geographic Discrepancies Continue to Persist: Obesity is still a huge public health problem and this study provides an in-depth look at the statistics. Of note is that:
”Obesity rates vary considerably between states with Mississippi and West Virginia having the highest level of adult obesity in the nation at 39.5 percent and Colorado having the lowest rate at 23.0 percent.

As recently as 2012, no state had an adult obesity rate over 35 percent and within the last five years (2013 and 2018) 33 states had statistically significant increases in their rates of adult obesity.”

Revealed: Public Health England 'hot on the trail' of Disease X: While the examples are from England the approach is universal: How do you approach identifying and understanding the next, new infectious agent?

The switch’ was supposed to be a major step toward eradicating polio. Now it’s a quandary: Oral polio vaccine contains different strains of live, attenuated viruses. Type 2 poliovirus was declared eradicated in 2015, so recently it was eliminated from the oral vaccine. But the residual attenuated strain from vaccines still exists. The quandary is this: Is it unethical to give new vaccinations with Type 2 poliovirus if it has been wiped out or should it still be in vaccines in case the type emerges again from those who are vaccinated. Read this fascinating article. It’s as much ethics as science.

Gluten Does Not Induce Gastrointestinal Symptoms in Healthy Volunteers: A Double-Blind Randomized Placebo Trial: The title says it all.

About health insurance

Who Are the Remaining Uninsured, and Why Do They Lack Coverage?: In answering this question, the Commonwealth foundation looked at 2018 data. The whole article is interesting, but the highlights are:

“…uninsured working-age adults in the United States were disproportionately low income, Latino, and under age 35.

Nearly half of uninsured adults may have been eligible for subsidized insurance through the marketplace or their state’s expanded Medicaid program.

Two-thirds (67%) of uninsured adults had not gone to the marketplace to examine their coverage options. Of those, one-third (36%) said they didn’t think they could afford health insurance.

Following the ACA individual market subsidies and reforms, the share of adults who had tried to buy a plan in the individual market and reported difficulties finding an affordable plan fell from 60 percent to 34 percent. In 2018, 42 percent of adults reported difficulty finding affordable coverage.

Despite affordability concerns and changes made by Congress and the Trump administration, 62 percent of adults with individual coverage and 84 percent with Medicaid rated their coverage as ‘good,’ ‘very good,’ or ‘excellent.’”

Annual Spending per Patient and Quality in Hospital-Owned Versus Physician-Owned Organizations: an Observational Study: Bottom line: “We find that financial integration between physicians and hospitals raises patient spending, but not care quality.”

In largest healthcare fraud case, Florida executive sentenced to 20 years in prison: A nursing home operator was “found guilty of submitting fraudulent claims for services that were not provided, not medically necessary or were procured through the payment of kickbacks. He was convicted of 20 charges including money laundering, receiving healthcare kickbacks, bribery conspiracy and obstruction of justice.” The amount of Medicare and Medicaid fraudulent billing was put at $1.5 billion.

Where do the Democratic candidates stand on healthcare issues? Last night’s portion of the candidates’ debate on healthcare issues focused insurance and the “big 3 (Biden, Sanders, Warren) had predictable answers. Here are some summaries: CNBC; The Atlantic; NPR; and The Washington Post

A majority of physicians now take part in an ACO: According to the AMA: “Overall, 53.8% of physicians reported participation in at least one ACO type in 2018…” We still need to see if practice behavior changed as a result.

2020 Global Medical Trend Rates Report: This report from Aon concludes, among other findings, that U.S. employers' medical costs will increase 6.5% next year and global employer health benefit costs are predicted to rise by 8%. For comparison, the inflation prediction for 2020 is 3.8%.

About healthcare quality and patient safety

Nearly 1 in 6 Docs Say They Make Diagnostic Errors Every Day: “One in six physicians estimated in a Medscape poll that they make diagnostic errors every day.

That number varied by specialty. Pediatricians were less likely to say they made diagnostic errors every day (11%) and emergency medicine (EM) doctors were more likely, at 26%. In between were physicians in family medicine (18%), general practice (22%), and internal medicine (15%).

Nurses, advanced practice registered nurses, and physician assistants (PAs) answered similarly: in all three categories, 17% said they estimated they made diagnostic errors daily…

Physicians and NPs/PAs agreed on the top three reasons diagnostic errors occur: ‘lack of feedback on diagnostic accuracy’ … time constraints, [and] ‘a culture that discourages disclosure or errors…’”

Today's News and Commentary

About health insurance

White House may have given up on health plan it says it is writing (Washington Post- subscription may be required): Remember several months ago the Trump administration said it would release a new health plan in the near future? This report says the Republicans may have abandoned that tactic and are now trying to figure out what would happen if the appeals courts void the entire ACA. The electorate is now in favor of the benefits the ACA provides, even if it criticizes some of its administrative problems and costs. We will need to see how this issue unfolds in the coming weeks.

Virginia governor and UVA vow to revamp practice of suing patients as CEO exits: On the heals of the story about the University of Virginia’s aggressive collection methods, the CEO announced her departure and Virginia governor Northam, a pediatric neurologist, vowed changes.

California legislature advances bill that caps dialysis profits: Major dialysis providers, like Fresenius and DaVita, make large donations to charitable funds which, in turn pay insurance premiums for dialysis patients. The companies can then bill insurers commercial rates for their services, thus reaping large profits. The California legislature, with support from Governor Newsom, is advancing a measure to impose Medicare rates on companies that participate in this practice.

Socioeconomic, Insurance Status Can Affect Patient Benefit from Clinical Cancer Trials: “Health insurance status and living in a socioeconomically deprived area may affect whether a patient will benefit from experimental treatments offered in cancer clinical trials…”

370 organizations signed a letter to Congress laying out principles for reform for the prior authorization process for Medicare Advantage patients.

About the public’s health

Purdue inks multibillion-dollar opioid deal with thousands of local governments, more than 20 states: reports: More details are coming out about the $10-12 billion settlement agreement with 23 states and nearly 2,300 cities, counties and tribes. I cannot find any mention of the individual or hospital lawsuits being part of this settlement. A related article looks at ten other large settlements in the pharma industry (none even close to this one).

A trailblazing professor turns 100 next month. He’s still doing ‘incredibly complex’ research funded by the NIH (Washington Post- subscription may be required): This is a good-news story about Dr. Jeremiah Stamler, the father of preventive cardiology, who will be 100 next month. It was my privilege to have him guest lecture on epidemiology in my classes for MBA students for a number of years. He was always insightful, witty and interesting. Ever the public health advocate, before one lecture he criticized the junk food in the vending machines and advocated for fresh fruit instead.

About pharma

Surescripts terminates contract with ReMy Health, hindering PillPack's access to patient prescription data: Read this article for a summary of the latest about the electronic prescription ordering area.

Today's News and Commentary

About healthcare quality and patient safety

Proposed Framework for the Optimal Measurement of Quality Assessment in Percutaneous Coronary Intervention: The authors “propose ending quality assessment based mainly on procedural mortality. Instead, numerous, carefully selected factors associated with high-quality, disease-based outcomes would take its place. By supplementing operator reporting with random case reviews and using disease-based outcomes as benchmarks, a more accurate and actionable assessment of PCI quality can be expected.” For the non-clinical reader, what is important is expanding the criteria of evaluation to achieve a more accurate quality measure.

Association Between Dialysis Facility Ownership and Access to Kidney Transplantation: “Among US patients with end-stage kidney disease, receiving dialysis at for-profit facilities compared with nonprofit facilities was associated with a lower likelihood of accessing kidney transplantation. Further research is needed to understand the mechanisms behind this association.”

About healthcare insurance

H.R. 3 - Drug Price Negotiation Bill Summary: Bloomberg news leaked a draft copy of Speaker Pelosi’s drug cost control proposal. Here are the highlights:

Broad Power to Negotiate Lower Drug Prices for All Americans: Every year, the HHS Secretary would be empowered to directly negotiate prices on the top 250 drugs with the greatest total cost to Medicare and the entire U.S. health system without competition from at least two generic, biosimilar or interchangeable biologics on the market…

An International Price Index to End Drug Companies Ripping Off Americans: …To ensure negotiations produce real price reductions, the law sets a maximum price for any negotiated drug with an International Price Index. 

Tough Penalties to Keep Drug Companies at the Table & Prevent Interruption to Access:
If a drug manufacturerrefuses to participate in any part ofthe negotiation process or does not reach agreement with HHS, they will be assessed a Non-Compliance Fee equal to 75 percent of the gross sales of the drug in question from the previous year…
If a manufacturer agrees to a price and then overcharges Medicare or fails to offer the negotiated price to other payers, the manufacturer will be subject to a civil monetary penalty equal to 10 times the difference. 

Reverse Price Hikes Above Inflation Across +8,000 Drugs in Medicare: …all +8,000 drugs in Medicare Part B and D would face a new inflation rebate. If a drug company has raised the price of a drug in Part B or D above the rate of inflation since 2016, they can either lower the price or be required to pay the entire price above inflation in a rebate back to the Treasury. 

Stakeholder Coalition Launches New Advertising Campaign To Show What’s “Behind The Curtain” With Surprise Medical Bills: “The Coalition Against Surprise Medical Billing, the leading national group representing employers, unions, health insurance providers and other stakeholders, launched its second multi-million dollar digital and TV advertising campaign to urge policymakers to protect consumers from surprise medical bills, particularly from medical practices owned by private equity firms that have created this nationwide affordability crisis.” The article has the two clips that make the case for this action.

We Asked Prosecutors if Health Insurance Companies Care About Fraud. They Laughed at Us:This article is an in-depth study of why insurance companies let (some) fraudulent practitioners get away with their scams. The subtitle is a good summary: “To protect their networks and bottom lines, health insurers don’t aggressively pursue widespread fraud, making it easy for scammers. Then they pass the costs off to you.”

Data Note: 2019 Medical Loss Ratio Rebates: Insurers who have exceeded Medical Loss Ratios defined under the ACA will owe about $1.3billion in rebates to their policy holders. This article is a nice summary (with a graph) of the rebates since the ACA’s inception.

Drug Prices for Rare Diseases Skyrocket While Big Pharma Makes Record Profits: This article is from AHIP-the trade group of health insurers. Among the findings:

• From 1998 to 2017, the average per-patient annual cost for orphan drugs increased 26-fold, while the cost for specialty and traditional drugs merely doubled

• The average annual orphan drug cost rose from $7,136 in 1997 to $186,758 in 2017

• Orphan drugs are 25x more expensive than non-orphan drugs

In interpreting these findings one must keep in mind that many more of today’s orphan drugs are biologicals, so they have that factor also contributing to price increases.

About the public’s health

Net zero: Global healthcare sector emits more than 500 coal power plants:The headline speaks for itself. The healthcare industry needs to look more closely at reducing its carbon footprint.

Purdue Pharma reaches tentative deal in federal opioids lawsuit: The deal is expected to cost the company and its owners about $10-12 billion.

Progress on health equity is stalling across Europe; new WHO report reveals gaps can be reduced within the lifetime of a single government: While this article is about disparities in Europe, it also looks at their sources, so that actions can be formulated to reduce them.

Trump moves to ban flavored e-cigarettes: The headline speaks for itself.

Court blocks law that would force physicians to mislead patients: Physicians in North Dakota were required to offer women government-printed materials that said: “it may be possible to reverse the effect of an abortion-inducing drug if she changes her mind, but time is of the essence, and information and assistance with reversing the effects of an abortion-inducing drug are available.” The AMA sued not only because the requirement prohibited an honest discussion between physician and patient, but also because the statement was false. Judge Daniel Hovland ruled that: “State legislatures should not be mandating unproven medical treatments, or requiring physicians to provide patients with misleading and inaccurate information. The provisions of [this law] violate a physician’s right not to speak and go far beyond any informed consent laws addressed by the United States Supreme Court, the 8th Circuit Court of Appeals, or other courts to date.”

Life's Simple 7: Not Simple at All? [Medscape, free subscription required]: Life's Simple 7 (LS7) is the American Heart Association's 2010 program for enhancing cardiovascular health in the US population. It measures: smoking, diet, physical activity, body weight, blood pressure, cholesterol, and blood glucose levels in the absence of pharmacological treatment. Unfortunately, the scores have declined. Improving those scores will need different approaches for each measure and possibly also individualized plans.

About healthcare IT

320,000 patient files at risk from ransomware in a Utah attack: What is unusual about this report is that this size attack usually affects hospitals or insurance companies. This one involved Premier Family Medicine-- a large organization with 10 locations around Pleasant Grove, Utah.

Prevalence and Predictability of Low-Yield Inpatient Laboratory Diagnostic Tests: “The findings suggest that low-yield diagnostic testing is common and can be systematically identified through data-driven methods and patient context–aware predictions. Implementing machine learning models appear to be able to quantify the level of uncertainty and expected information gained from diagnostic tests explicitly, with the potential to encourage useful testing and discourage low-value testing that incurs direct costs and indirect harms.” Imagine a physician ordering a test and having immediate feedback (via AI) on the probability of getting a useful result, or at least those results would mean.

Social engineering helping hackers break past providers’ defenses: “In the past year, less than 1 percent of cyberattacks exploited a hardware or software vulnerability to get through a healthcare provider’s defenses and compromise data.” It is the human factor that allows the compromise- clicking a link, etc. Organizations should clearly spend more time training those who work in the organization.

'Siri, how's the research going?' Apple launches new app to study health: “Researchers at Harvard T.H. Chan School of Public Health and the NIH’s National Institute of Environmental Health Sciences will work with Apple on a long-term study focused on menstrual cycles and gynecological conditions. The study will inform screening and risk assessment of conditions like polycystic ovary syndrome (PCOS), infertility, osteoporosis, pregnancy and menopausal transition.”
Apple’s previous FDA-approved indication was for heart rhythm detection. However: “the Apple Watch paired with an algorithm designed to detect atrial fibrillation performed well among sedentary patients undergoing a medical procedure. But among an ambulatory group of more than 1,600 participants, the watch and algorithm were just 68% accurate.”

OCR Settles First Case in HIPAA Right of Access Initiative: The federal Office of Civil Rights is responsible for enforcing HIPAA provisions. HIPAA covers not only data privacy, security and standardized format requirements, but also patients’ rights to get their medical data in a timely fashion and at a reasonable cost. This report is about the first case settled with respect to that latter requirement.

Resistance to Medical Artificial Intelligence: While “consumers” like to research their medical conditions online and many like to communicate electronically with healthcare systems and providers, they do not like to interact with artificial intelligence making medical decisions. One conclusion from this very in-depth study is that “consumers might be reluctant to adopt medical AI because they believe it unable to account for the unique facets of a person’s case. Changing this belief will be fundamental to harness the full potential of medical AI to benefit our society in the future.”

Today's News and Commentary

About health insurance

Share of Americans With Health Insurance Declined in 2018 (NY Times- subscription may be required): “About 27.5 million people, or 8.5 percent of the population, lacked health insurance for all of 2018, up from 7.9 percent the year before, the Census Bureau reported Tuesday. It was the first increase since the Affordable Care Act passed in 2010, and experts said it was at least partly the result of the Trump administration’s efforts to undermine that law.
The growth in the ranks of the uninsured was particularly striking because the economy was doing well. The same report showed the share of Americans living in poverty fell to 11.8 percent, the lowest level since 2001.”

‘UVA has ruined us’: Health system sues thousands of patients, seizing paychecks and putting liens on homes: In a related story, the University of Virginia hospital appears to be more aggressive than peer organizations in its debt collection efforts, leading to financial ruin for many patients.

Gearing up for Medicare’s imaging decision support requirements: Appropriateness of radiologic diagnostic services is coming to CMS payment decisions. As a result of Medicare’s Appropriate Use Criteria Program, which launches January 1, the financial responsibility for noncompliance with the diagnostic imaging requirements will fall on providers of those tests.  
“…2020 will be an educational and testing year for the program. Then, beginning Jan. 1, 2021, the Centers for Medicare and Medicaid Services will stop reimbursing radiologists and other providers who perform imaging for certain outpatient advanced diagnostic imaging claims if the ordering professional did not consult a qualified clinical decision support (CDS) mechanism, incorporating evidence-based appropriateness criteria.” This pre-authorization check has been in use for many years in the private sector.

States Pass Record Number Of Laws To Reel In Drug Prices: “Among the new measures are those that authorize importing prescription drugs, screen for excessive price increases by drug companies and establish oversight boards to set the prices states will pay for drugs.” This week Speaker Pelosi is expected to release a drug price control plan at the federal level.

About the public’s health

Global patterns and trends in colorectal cancer incidence in young adults: We often think about colon cancer as an “over 50” disease. However, while not a universal finding, this research found that colorectal cancer “increased exclusively in young adults in nine high-income countries spanning three continents, potentially signalling changes in early-life exposures that influence large bowel carcinogenesis.” We have identified certain carcinogenic substances, like nitrosamines, but what else is responsible? In a related article, Meat Intake and Cancer Risk : Prospective Analysis in UK Biobank, “Higher intakes of red and processed meat were associated with a higher risk of colorectal cancer.”

California governor signs vaccine bills he demanded: As previously reported, California was legislating very tough vaccine exemption laws. Yesterday, California Gov. Gavin Newsom signed bills “to crack down on doctors who write fraudulent medical exemptions for school children’s vaccinations.”

Is setting a deadline for eradicating malaria a good idea? Scientists are divided: Good discussion question. Shall we set deadlines, and if so how high should they be set relative to the “ideal” goals? What do we do if we miss the deadline? The Healthy People initiatives in the US (See Chapter 9 of the text) and previous WHO Millenial Development Goals provide examples.

Millions of diabetes patients are missing out on Medicare's nutrition help: An estimated 15 million traditional “Medicare enrollees with diabetes or chronic kidney disease are eligible for the benefit, but the federal health insurance program for people 65 and older and some people with disabilities paid for only about 100,000 recipients to get the counseling in 2017, the latest year billing data are available. The data do not include the 20 million enrollees in private Medicare Advantage plans.” What programs can we implement to increase access to needed dietary counseling?

Potential Effects of Regionalized Maternity Care on U.S. Hospitals: “Though only 2.41% of deliveries occurred at hospitals with an inappropriate level of maternal care, a substantial fraction of women at risk for maternal morbidity delivered at hospitals potentially unequipped with resources to manage their needs. Promoting triage of high-risk patients to hospitals optimized to provide risk-appropriate care may improve maternal outcomes with minimal effect on most deliveries.” This article points out that appropriate specialized services need some coordination to be accessible. How do we accomplish this task using private sector and/or governmental interventions? For an article commenting on this original research, see this one from Reuters.

About healthcare IT

Telemedicine CEO pleads guilty to role in $424M Medicare fraud scheme: If there are more ways to bill, there will be more opportunity for fraud. The Department of Justice said “ that the involved medical device companies paid kickbacks and bribes to physicians at telemedicine companies in exchange for referrals for back, shoulder, wrist and knee braces that were not medically necessary.
All told, more than $1.7 billion was billed to Medicare under the scheme, with $900 million paid out.”

UCSF, Cornell working on Android health record app to rival Apple: “UC San Francisco and Cornell Tech are leading a project to create an open-source platform to enable Android phone users to access and share their health records on par with Apple's mobile health records feature.
The project, called CommonHealth, will use data interoperability standards, including HL7 Fast Healthcare Interoperability Resources (FHIR)…”

Today's News and Commentary

About Health Insurance

Groupons For Medical Treatment? Welcome To Today’s U.S. Health Care: Interesting article on how discount coupons are being used for a variety of medical services. The overall charges can be less than insurance company negotiated prices, but it is unclear if patients will get deductible “credit” for out of pocket expenses.

AMA Releases 2020 CPT® code set: ALL healthcare providers and payers need to review these changes. “There are 394 code changes in the 2020 CPT code set, including 248 new codes, 71 deletions, and 75 revisions…
Among this year’s important additions to CPT are new medical services sparked by novel digital communication tools, such as patient portals, that allow health care professionals to more efficiently connect with patients at home and exchange information.” See, also, CPT® Overview.

Insurers Pitch New Ways to Pay for Million-Dollar Therapies (Wall Street Journal- subscription may be required): This article augments the previous post about one method for dealing with gene therapy drugs by omitting the patient’s out-of-pocket payment. Another method mentioned here is called a subscription model. However, it is not different from a pharma capitation scheme used decades ago with HMOs.

Administering Specialty Drugs Outside Hospitals Can Improve Care and Reduce Costs by $4 Billion Each Year: The headline and reporting in other media outlets is misleading. What the study shows is that it is cheaper to administer high-cost specialty drugs in settings that are not hospital affiliated rather than places that are owned by those facilities. (The headline erroneously implies inpatient versus outpatient costs.)

How much is the savings? $16,000-37,000 per patient per year, or $4 billion overall.

The Relative Value Scale Update Committee:Time for an Update: This article provides a nice analysis about why the relative value system needs updating. To what is in the article, I add two more reasons:
1. Cognitive services are undervalued compared to procedural services. This imbalance is the result of the composition of the committee that sets the relative values.
2. Geographic adjustments for work units never made sense and should be eliminated.

About the public’s health

Association of Race/Ethnicity With Emergency Department Destination of Emergency Medical Services Transport: Add one more item to health disparities in care provision. “This study found race/ethnicity variation in ED destination for patients using EMS transport, with black and Hispanic patients more likely to be transported to a safety-net hospital ED [instead of closest hospital ED] compared with white patients living in the same zip code.”

Emergency Department Closures And Openings: Spillover Effects On Patient Outcomes In Bystander Hospitals: ED closures in most urban areas do not affect quality of care, since travel times to the next facility are relatively short. Closing those EDs decreases access but saves money. But how far would you need to travel so that quality is affected? When heart attacks were studied, closure of an ED that resulted in a 30 minute or greater trip to the next closest high-occupancy ED resulted in a one-year mortality and thirty-day readmission rates increase of “2.39 and 2.00 percentage points, respectively, while the likelihood of receiving percutaneous coronary intervention (PCI) declined by 2.06 percentage points.”

Impact of Rural and Urban Hospital Closures on Inpatient Mortality: A similar question to the one above must be posed vis-a-vis closure of rural versus urban hospitals. “This paper examines the impact of California's hospital closures occurring from 1995-2011 on adjusted inpatient mortality for time-sensitive conditions: sepsis, stroke, asthma/chronic obstructive pulmonary disease (COPD) and acute myocardial infarction (AMI)…rural closures increase inpatient mortality by 0.46% points (an increase of 5.9%), whereas urban closures have no impact. Results differ across diagnostic conditions; the general effect of closures is to increase mortality for stroke patients by 3.1% and for AMI patients by 4.5%, and decrease mortality for asthma/COPD patients by 8.8%.”

Marijuana use by US college students up, highest in 35 years: “U.S. college students are using marijuana at the highest rates in 35 years, according to a report released Thursday.
About 43% of full-time college students said they used some form of pot at least once in the past year, up from 38%, a University of Michigan survey found. About 25% said they did so in the previous month, up from 21%.
The latest figures are the highest levels seen in the annual survey since 1983.”

2019 Update on Medical Overuse: This article reviews evidence for many commonly used diagnostics and treatments, and presents evidence-based recommendations to curb their overuse.

About healthcare IT

Physicians’ gender and their use of electronic health records [EHRs]: findings from a mixed-methods usability study: Usually age and prior IT experience are evaluated when EHR usability is evaluated. However, this article indicates gender may be an important factor as well. “ Overall task performance scores were similar for men (90% ± 9.3%) and women (92% ± 4.4%), with no statistically significant differences (P = .374). However, female physicians demonstrated higher efficiency in completion time (difference = 7.1 minutes; P = .207) and mouse clicks (difference = 54; P = .13). Overall, men reported significantly higher perceived EHR workload stress compared with women (difference = 17.5; P < .001). Men reported significantly higher levels of frustration with the EHR compared with women (difference = 33.15; P< .001). Women reported significantly higher satisfaction with the ease of use of the EHR interface than men (difference = 0.66; P =.03). The women’s perceived overall usability of the EHR is marginally higher than that of the men (difference = 10.31; P =.06).”

ONC awards The Sequoia Project coordinating responsibilities for TEFCA: “In a major step toward advancing its strategy for nationwide data sharing, the Office of the National Coordinator for Health IT (ONC) awarded The Sequoia Project a cooperative agreement to serve as the recognized coordinating entity (RCE) for the Trusted Exchange Framework and Common Agreement (TEFCA).

As the coordinating entity, The Sequoia Project—a nonprofit that advocates for nationwide health information exchange—will be responsible for developing, updating, implementing and maintaining the common agreement component of TEFCA.” See Chapter 8 of the text for detailed background of these organizations.

Today's News and Commentary

About health insurance

Medicaid Expansion and Health Assessing the Evidence After 5 Years: This article is a nice summary of how Medicaid has affected the population in states where it expanded after ACA implementation. The “short” bottom line is: “An increasing number of studies have provided rigorous evidence that Medicaid expansion, which has increased the number of Medicaid recipients by more than 10 million since 2013, has been associated with improved health of low-income US residents in various ways, including self-reported health, acute and chronic disease outcomes, and mortality reductions. However, this literature is less definitive than the evidence demonstrating that Medicaid increases access to care and promotes financial well-being.”

Spending On Postacute Care After Hospitalization In Commercial Insurance And Medicare Around Age Sixty-Five [Health Affairs- abstract only available]:This study compared “postacute care spending between patients with commercial insurance and those with Medicare around age sixty-five. Spending was 68–230 percent greater among fee-for-service Medicare beneficiaries than among similar commercially insured people across varied medical and surgical conditions. Despite greater spending, there were no differences in readmission rates. These findings suggest that postacute care utilization is highly sensitive to payer influence, and there may be an opportunity for additional savings in Medicare without sacrificing quality.”

Annual Spending per Patient and Quality in Hospital-Owned Versus Physician-Owned Organizations: an Observational Study: The authors found that “financial integration between physicians and hospitals raises patient spending, but not care quality.” See yesterday’s blog for the AHA study on effects of hospital mergers.

Cigna rolls out new plan to fully cover multi-million dollar gene therapies: “Health insurer Cigna Corp said on Thursday it had introduced a plan to fully cover costs for expensive gene therapies, eliminating any out-of-pocket payments for customers.” The therapies are so expensive that any patient contributions would not have any impact on cost reduction. A good move to increase financial accessibility and quality of care.

Medicare Advantage has little impact on traditional Medicare spending (Modern Healthcare- subscription required): “…MedPAC's study found that fee-for-service spending was just 2% lower in markets with high Advantage penetration compared to those with the lowest numbers. High Advantage penetration averaged 52.2% compared to 13% in low markets.” Check yesterday’s full presentation since the study has not yet been published.

Quality of Home Health Agencies Serving Traditional Medicare [TM] vs Medicare Advantage [MA] Beneficiaries: “Compared with TM beneficiaries, MA beneficiaries residing in the same zip code enrolled in either high- or low-quality MA plans may receive treatment from lower-quality HHAs. Policy makers may consider incentivizing MA plans to include higher-quality HHAs in their networks and improving patient education regarding HHA quality.”

About the public’s health

Lung illness tied to vaping has killed five people, may be a new ‘worrisome’ disease, officials say: The death toll from vaping is now five. The vitamin E reported yesterday as the cause of deaths appears to have been from black market marijuana cartridges. The cause for all the illness has yet to be identified.

Mortality Patterns Between Five States With Highest Death Rates and Five States With Lowest Death Rates: United States, 2017: This just-published report from the CDC details the dramatic health disparities among states. Overall, the “average age-adjusted death rate for the five states with the highest rates (926.8 per 100,000 standard population) was 49% higher than the rate for the five states with the lowest rates (624.0).”

Stronger focus on nutrition within health services could save 3.7 million lives by 2025: This WHO report illuminates how important improving nutrition is as a life-saving measure.

Kentucky hospitals sue drugmakers, distributors and retailers for opioid epidemic costs: Yesterday’s blog reported Texas hospitals are suing opioid manufacturers over the epidemic’s cost. Now Kentucky hospitals are following suit (pun intended). Expect a cascade of further such hospital actions.

The Dartmouth Atlas of Neonatal Intensive Care: This extensive report on national (and some local) neonatal care is a rich source for policy study and was done in cooperation with insurer Anthem. One important conclusion that reflects on inappropriate intensity of care is that “more than half of NICU [neonatal intensive care units] admissions and close to half of special care days are now for lower-risk newborns.” More appropriate use of services would not only lower costs but hopefully also reallocate resources to those locations in true need of this specialized care. (See page 41 for a full summary of this section of the research).

70 Million Flu Vaccines Delayed This Year, According to CDC: “Sanofi Pasteur, the largest company that exclusively produces vaccines, delayed delivery of the flu vaccine by three to four weeks.
The delay affects Fluzone Quadrivalent, Fluzone High-Dose, and Flublok Quadrivalent. According to CDC data, these products make up approximately 40 percent of the U.S. flu vaccine market.”

Civil rights groups sue Trump administration over immigrant medical care cases: The headline speaks for itself.

About medical devices

Humanitarian Device Exemption (HDE) Program: The FDA just finalized its guidance “to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program.”

About healthcare IT

Feds turn over CONNECT messaging platform to private sector: “The Federal Health Architecture and the Office of the National Coordinator for Health IT are ending support for an open source software project that promotes healthcare interoperability.

CONNECT enables secure electronic health data exchange among providers, insurers, government agencies and consumer services. However, it’s been 10 years since federal agencies first co-developed the messaging platform, and the government now wants to transition the project to the private sector.”

See Chapter 9 of the text for more background information.

Today's News and Commentary

About hospitals

Hospital Merger Benefits: Views from Hospital Leaders and Econometric Analysis - An Update: Perhaps the most widely cited report in healthcare news of the past couple days is this American Hospital Association study about the effects of hospitals mergers, conducted by economists at the firm Charles River.  Below are their findings with commentary.

“Acquisitions decrease costs due to the increased scale of the combined system and the data-driven clinical standardization that can be realized. Consistent with our previous analysis, hospital acquisitions are associated with a statistically significant 2.3% reduction in annual operating expenses at acquired hospitals…” 
This finding has face validity since mergers take advantage of economies of scale

“At the same time, quality is enhanced: our new empirical analysis shows statistically significant reductions in rates of readmission and mortality. This is consistent with health system leaders’ reports on their extensive efforts to use their systems’ data to develop clinical best practices and hold hospitals accountable to measurable outcomes in ways that require scale and resources that individual community hospitals may lack…”
Interpretation of this finding is a bit more complex.  The authors compared differences between merged hospitals and unmerged hospitals using a “differences in differences” analysis. However, the characteristics of institutions that merge or are attractive for merger were not studied, e.g., unique location, financial health, local labor pool, etc. These characteristics could account for these differences. Also, some of the outcomes they use have been recently questioned. For example,  extended ED or observation stays have substituted for readmissions (see previous blog post). This criticism is somewhat mitigated by the fact that the authors combine outcomes into composite indices. 

“Revenues per admission at acquired hospitals also decline relative to non-merging hospitals by a statistically significant 3.5%. These results suggest that savings that accrue to merging hospitals are passed on to patients and their health plans…
While not solely a measure of prices negotiated by hospitals and health plans, we would expect (all else equal) revenue per adjusted admission to increase if negotiated commercial or Medicare Advantage prices increased following an acquisition. However, since changes in revenue per adjusted admission may also be affected by changes in payor mix or service mix, results involving this measure should be interpreted with care[emphasis added].”
In addition to this caveat must be added many well-done economic studies that show mergers increase healthcare costs. 

Above all, the healthcare environment is changing so results may continue to evolve. 

For more background see the text chapters on Hospitals and Healthcare Systems as well as Quality.

About healthcare IT

Prompt notification eases pain of data breaches, consumers say: Frank and prompt discussions with patients when medical errors occur is the preferred method of disclosure. The same seems to be true about data breaches. According to a recent Experian survey: “Some 90 percent of the survey respondents said they would be at least somewhat more forgiving of an organization if they knew it had a prior plan in place for communicating after a data breach.”

Need birth control? Planned Parenthood says there's an app for that: “Weeks after a high-profile exit from Title X, Planned Parenthood has launched a mobile app designed at providing birth control and urinary tract infection (UTI) treatment to women struggling to find time and resources to make it into a clinic.” The app is called Planned Parenthood Direct.

About the public’s health

Associations of Aerobic Fitness and Maximal Muscular Strength With Metabolites in Young Men: What is the best exercise to promote cardiovascular health? Aerobic exercise beats weight training in this study.

Regional Variation in the Association of Poverty and Heart Failure [HF] Mortality in the 3135 Counties of the United States: “County poverty is the strongest socioeconomic factor associated with HF and CHD [coronary heart disease] mortality, an association that is stronger with HF than with CHD and varied by census region. Over half of the association was explained by differences in the prevalence of diabetes mellitus and obesity across the counties.”

“HF mortality increased by 5.2 deaths/100 000 for each percentage increase in county poverty prevalence…”

Facebook Debuts Vaccine Pop-Up Windows To Stop Spread Of Misinformation: Facebook is joining other firms that have popups of legitimate websites when users search on vaccination information.

Oregon death is 2nd linked to vaping, 1st tied to pot shop: As illness spreads from vaping, the second death has occurred, this time in Oregon.

Contaminant found in vaping products linked to deadly lung illnesses, state and federal labs show: In a related story, the chemical now identified as the cause of this vaping illness is an oil derived from vitamin E.

Nearly 30 Texas-based hospitals sue J&J, Purdue, CVS and more over opioid epidemic: 30 Texas-based hospitals have joined governmental agencies in suing manufacturers and suppliers over the opioid epidemic. No doubt other hospitals will follow in other states.

Opioid Prescribing After Surgery in the United States, Canada, and Sweden: Researchers in Canada, the US and Sweden found that “the United States and Canada have a 7-fold higher rate of opioid prescriptions filled in the immediate postoperative period compared with Sweden. Of the 3 countries examined, the mean dose of opioids for most surgical procedures was highest in the United States.” There is more blame to go around for the opioid problem aside from the pharma companies.

About health insurance

Court again blocks Medicaid work requirements, this time in New Hampshire: HHS’ work requirements for Medicaid eligibility have not been upheld in the courts. The latest example is in New Hampshire.

IRS says reinstating ACA insurance tax would cost insurers $15.5B in 2020 [Modern Healthcare, subscription required]: When the ACA was passed, there was a provision for insurance companies (among many other healthcare entities) to pay a certain amount to finance the provisions of the law. Although the the insurance company tax has been on hold, CMS plans to implement it next year. The IRS says the tax will cost insurers (or benefit the federal government- depending on your view) $15.5 billion in 2020. Premiums have been moderating, but this tax may cause insurance companies to rethink their rates.

US judge approves CVS purchase of insurer Aetna: Several critics of the merger, including the AMA, sued to undo what the Justice Department had OK’d. Judge Richard Leon of U.S. District Court for the District of Columbia approved the sale yesterday. No word on appeals.

California's Medicaid expansion led to fewer evictions: The headline explains another benefit to Medicaid expansion— this time a non-medical one.

US Physicians’ Reactions To ACA Implementation, 2012–17[Health Affairs- subscription required but the abstract is available on this link]: “More physicians agreed in 2017 than in 2012 that the ACA ‘would turn United States health care in the right direction’ (53 percent versus 42 percent), despite reporting perceived worsening in several practice conditions over the same time period. After we adjusted for specialty, political party affiliation, practice setting type, perceived social responsibility, age, and sex, we found that only political party affiliation was a significant predictor of support for the ACA in the 2017 results.”
This type of reversal in support for such a program is not new. For decades, “organized medicine” was vehemently opposed to national health initiatives prior to enactment of Medicare in 1965. After its implementation a year later, opinions changed dramatically and have been persistently positive—despite operational criticisms.

Today's News and Commentary

In Memorium

Dr. Donald Lindberg, 85, Dies; Opened Medical Research to the World: Dr. Lindberg was responsible for guiding the National Library of Medicine into the modern era, making research possible for scientists all over the world.

About medical practice

Complete Revascularization with Multivessel PCI for Myocardial Infarction: When someone has an acute heart attack, a standard treatment is to immediately visualize the circulation of the heart and open the “clogged” blood vessel responsible for the problem. But often disease is found in other blood vessels. What is to be done about them? According to this Canadian study, taking care of those other blockages is better than just treating the offending one. Such a comprehensive approach results in reduced risk of death from heart disease. If results of this research influence further practice we could see more procedures at a higher short-term cost, but better outcomes.

Association of Primary Care Clinic Appointment Time With Opioid Prescribing: We know from behavioral research that time of day influences decisions, such as judges granting parole. This paper concludes that “even within an individual physician’s schedule, clinical decision-making for opioid prescribing varies by the timing and lateness of appointments.”

About the public’s health

Food insecurity adds $53 billion annually to healthcare costs. Food insecurity is more than about being hungry, it's about the estimated 1 in 8 Americans who do not have access to nutritious food: The headline is self explanatory and explains why health systems are now paying so much attention to the social determinants of health. Read the original study from the CDC.

.A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial: “A comprehensive model of care led by NPHWs [non-physician health workers], involving primary care physicians and family that was informed by local context, substantially improved blood pressure control and cardiovascular disease risk. This strategy is effective, pragmatic, and has the potential to substantially reduce cardiovascular disease compared with current strategies that are typically physician based.” Read the article for more details. To what other problems can this strategy apply?

New York City declares end to measles outbreak: The headline speaks for itself. This case study is a great example of overcoming prejudice to vaccination in a specific location. The epidemic is not necessarily over elsewhere. See also the CNN report.

Michigan becomes first state to ban flavored e-cigarettes: Which states will be next?

New hypertension cases halved with community-wide salt substitution: The headline is self-explanatory and you can read the article for details. This concept, however is not new. Comprehensive community-wide activities were the reason for the success of the North Karelia project in Finland starting in the early 1970s. What is taking other countries to catch on?

Feasibility of Core Antimicrobial Stewardship Interventions in Community Hospitals: What is the best way to conduct antibiotic stewardship programs? This crossover study provides some useful answers. “Two antimicrobial stewardship strategies targeted… [certain antibiotics] on formulary at the study hospitals: (1) modified preauthorization (PA), in which the prescriber had to receive pharmacist approval for continued use of the antibiotic after the first dose, and (2) postprescription audit and review (PPR), in which the pharmacist would engage the prescriber about antibiotic appropriateness after 72 hours of therapy. Two hospitals performed modified PA for 6 months, then PPR for 6 months after a 1-month washout. The other 2 hospitals performed the reverse.” Most hospitals now use the PA strategy. However, the research showed that strict “PA was not feasible in the study hospitals. In contrast, PPR was a feasible and effective strategy for antimicrobial stewardship in settings with limited resources and expertise.”

Cancer overtakes heart disease as biggest rich-world killer: For a number of years, chronic diseases have replaced acute episodes (like infections) as the #1 killer worldwide. Now we just have a trading of places for the top slot. Still, much work needs to be done on all fronts because each country “is unhappy in its own way.”

About pharma

Biomarkers (such as genetic profiles) have been used to guide treatments, particularly in oncology. One newer term for biomarkers used in this fashion is companion diagnostics.

$3K for folic acid? CVS Caremark takes aim at 'hyperinflated' drug prices: By removing five drugs with “hyperinflated” prices from its formulary, clients are saving $4.60 per member per year and patients are saving $15 per 30-day supply. One caveat— those drugs have very effective generic alternatives.

Big Pharma Sinks to the Bottom of U.S. Industry Rankings: In this Gallup poll, the" “pharmaceutical industry is now the most poorly regarded industry in Americans' eyes, ranking last on a list of 25 industries that Gallup tests annually. Americans are more than twice as likely to rate the pharmaceutical industry negatively (58%) as positively (27%), giving it a net-positive score of -31.” The “healthcare industry” is two notches higher. At the top? Restaurants!

Cannabidiol may interact with rheumatologic drugs: Many drug interactions are already known. but with widespread introduction of new or existing substances, there needs to be more education about these interactions. This article points out which rheumatologic drugs interact with CBD.

Walmart tests dentistry and mental care as it moves deeper into primary health: Like other pharmacies, such as CVS, Walmart is expanding into healthcare services. While it already has clinics in some stores, it is expanding its offerings into hearing screens, dentistry and behavioral health services.

About healthcare IT

Wearables market to hit $54B in 2023: "Wearables, which are smart electronic devices that can be worn or incorporated into clothing to track various health and wellness measures, are already ramping up in the healthcare space and taking on some serious clinical work.” These devices can help track patient health status, progress to recovery and also predict disease exacerbations.

Machine learning approach looks to reduce MRI scan times, costs: MRI scans take a long time. Speeding up the process can make better use of equipment and perhaps lower the price per scan. This article looks at the use of AI to reduce these scan times. One caveat— making MRIs more accessible may increase volume, and hence, overall costs. However, an MRI is one test that has been subject to strict utilization management.

Is that medical device interoperable? Center for Medical Interoperability program will verify it.: One of the big problems in healthcare IT is interoperability of devices with enterprise-wide systems. Now, “Nashville-based Center for Medical Interoperability is launching an industry-wide verification program to confirm medical device interoperability.

The project, called C4MI Verified, will test and verify medical devices to determine compliance with selected interoperability specification requirements…”

When Apps Get Your Medical Data, Your Privacy May Go With It [NY Times-subscription may be required]:While pending federal regs will require release of medical information to Apps after consumer permission, several large medical organizations point out that once released, that information is no longer protected by the HIPAA regulations. Since there are no laws governing further use, patient data can be sold for research or used for fraudulent purposes.

Industry Voices—8 ways technology plays a vital role in value-based healthcare: This article is a nice summary of what can be done using information to improve quality and patient satisfaction.

About health insurance

CMS extends ACO patient notification deadline to Oct. 1: “CMS at first required an ACO to notify a beneficiary they were in one when the program started in 2014, but the agency scrapped the requirement due to the extra staff time and confusion the notices caused seniors. However, CMS reinstituted the requirement when it set up ‘Pathways to Success,’ an overhaul of the Medicare Shared Savings Program. Pathways requires an ACO to take on financial risk earlier compared to the MSSP.” Perhaps out-of-network utilization will go down once patients are aware they are part of an ACO. Still, they are under no obligation to stay with the organization for care.

Did Medicare Advantage [MA]Payment Cuts Affect Beneficiary Access and Affordability?: The short answer is : No. “Although MA payment cuts were expected to reduce the attractiveness of the MA program to both plans and enrollees, the program’s enrollment grew steadily from 2009 to 2017. Over this period, plans reduced their costs for providing Part A and Part B benefits to their enrollees, thereby preserving room for rebates. Our findings show that plans made such cost reductions without significantly affecting enrollees’ access to or affordability of care compared with TM [traditional Medicare] beneficiaries.”

Today's News and Commentary

HealthcareInsights is on vacation starting tomorrow and will resume September 4.
Have a great Labor Day!

About the public’s health

Effectiveness of Interventions Aimed at Increasing Statin-Prescribing Rates in Primary Cardiovascular Disease Prevention:A Systematic Review of Randomized Clinical Trials: “Statins remain one of the cornerstone medications in CVD prevention, with a recent meta-analysis demonstrating that they decrease cardiovascular mortality by 31% among people with no prior history of CVD.” However their use is far lower than guidelines warrant. How do we increase their appropriate use? “As opposed to more education about generic recommendations, tailored patient-focused and physician-focused interventions were more effective when they provided personalized cardiovascular risk information, dynamic decision-support tools, or audit-and-feedback reports in a multicomponent program.” What other types of therapies would benefits from this customized approach?[See the Highmark article below.]

Pinterest to direct vaccine-related searches to health orgs: “Pinterest said Wednesday it will try to combat misinformation about vaccines by showing only information from health organizations when people search.” Finally, a company that is showing some social responsibility.

About healthcare IT

Allscripts offers Apple Health Records to enable patient data access: “Healthcare IT vendor Allscripts is jumping on the Apple Health Records bandwagon by making the solution for transferring electronic medical records available to its customers and their patients. 

The company’s Professional EHR, Sunrise and TouchWorks products now offer Apple Health Records, which leverages HL7’s Fast Healthcare Interoperability Resources (FHIR) standard for data transfer and OAuth 2.0 security profiles for authentication to enable consumers to securely access their health data on their iPhones.”

Statistics reveal healthcare is the sector most affected by personal data breaches: This study showed that: “Healthcare topped the list of industries most likely to suffer a personal data breach… 18% of all breaches were reported within the sector, compared with 16% within central and local government, 12% within education, 11% within justice and legal, and 9% within financial services.”

“Of those incidents, nearly half (43%) was the result of incorrect disclosure – made up of 20% posting or faxing data to the incorrect recipient, 18% emailing information to incorrect recipients or failing to use Bcc, and 5% providing data in response to a phishing attack.”

Data Integration, Analytics Support Public Health in Rhode Island: “The usefulness of healthcare big data — that is, the ability to create a more holistic view of individuals and populations — depends on the ability of stakeholders to share data sets across systems and institutions. Yet, data from one department within an organization is often not cohesive with data from another. Trying to analyze patterns in benefits, health care utilization, and social services is, therefore, hindered by a lack of data liquidity.

In Rhode Island, government agencies worked together to create the Executive Office of Health and Human Services (EOHHS) Data Ecosystem. This integrated data system blended data sources from multiple organizations to help create a holistic view of Rhode Islanders.” This is a fascinating project that could be used as a model for other state/area-wide population management programs.

Fitbit expands healthcare ambitions with new devices, subscription service: “Wearables company Fitbit is deepening its reach into healthcare with a new premium subscription service for users that offers coaching and personalized insights mined from the health data it collects from 27.3 million users.”

 Highmark Health funds pilot for meal planning software startup: The insurer Highmark has invested in PHRQL (pronounced freckle), a Carnegie Mellon University spinout, that creates artificial-intelligence based-software for creating personalized meal plans. Customization may be the way to go with this intervention. Hopefully independent studies of its effectiveness will be conducted.

About healthcare insurance

OIG: Latest audit finds Part D paid for $160M drugs hospices should have covered in latest audit: Many Medicare programs are on a prospective payment basis, which bundles drugs into the global amounts. The HHS Office of the Inspector General found that $160 million was paid by Part D when it should have been covered in the prospective rate paid to hospices. As mentioned before, such errors do not occur as often with private insurance. Higher administrative costs do pay for some useful activities.

Blue Cross Minnesota Announces $0 Insulin Copay, More Access to Care: The headline speaks for itself. This project is an example of value-based pharmacy benefits.

CMS won't enforce its ACA copay accumulator plan in 2020: This issue is whether drug company coupons that cover copays can be counted against annual deductibles or out-of-pocket limits. Recall that pharma firms increase prices and provide discount coupons for patients so they can afford the medication- leaving insurance companies to pay higher rates. In April, CMS issued a final rule that “would block insurers from applying the value of drugmaker coupons to patients’ out-of-pocket limits when a generic drug is available.” Now CMS is saying they will not enforce the policy nor will they penalize states that do not enforce it.

Today's News and Commentary

About the public’s health

Cheer up! Optimists live longer: Don’t worry, be happy! “Optimistic people live as much as 15% longer than pessimists, according to a new study spanning thousands of people and 3 decades.” It is more advantageous for optimistic women, though.

Association Between Educational Attainment and Causes of Death Among White and Black US Adults, 2010-2017: This research is more evidence for an association between education and health/longevity. “In this serial cross-sectional study, estimated life expectancy at age 25 years declined overall between 2010 and 2017; however, it declined among persons without a 4-year college degree and increased among college-educated persons. Much of the increasing educational differences in years of life lost may be related to deaths attributed to drug use.”

Draft Recommendation Statement: Hepatitis C Virus Infection in Adolescents and Adults: Screening: In this draft statement, the US Preventive Task Force “recommends screening for hepatitis C virus (HCV) infection in [all] adults ages 18 to 79 years.” The statement is open for comments until September 23, 2019.

Federal agency ends policy protecting migrants who receive medical care: “U.S. Citizenship and Immigration Services (USCIS) said this week it has ended a policy that allows migrants to not be deported while they or their family members receive life-saving medical treatments.” A spokesperson for USCIS said “that the policy is not ending, but will instead be handled through Immigration and Customs Enforcement (ICE).” However, “The Associated Press, which first reported the policy change, said it obtained USCIS letters sent to applicants in the Boston area and that the correspondence made no mention of ICE taking over the program. Instead, the letters ordered the immigrants to exit the U.S. in 33 days or face deportation, according to the AP.”

Edited genes are not ready to be inherited: DNA changes should benefit patients but not yet their descendants (Financial Times, subscription required): As we consider the ethics of gene therapy for those afflicted with genetic diseases, we should be aware of the consequences of passing along those modifications to the next generation. In most cases we do not know what those consequences are.

About healthcare IT

Epic to gather records of 20 million patients for medical research: “Called Cosmos, the initiative aims to aggregate patients’ [de-identified] medical information from its customers to offer a wider base of information from which to enable real-world evidence based practice of medicine, even for conditions that are now currently rare and on which it’s difficult to have a large enough sample size on which to make medical decisions.”

Today's News and Commentary

About the public’s health

Can Plant-Based Meat Alternatives Be Part of a Healthy and Sustainable Diet?: This article is a really good summary of the issues regarding meat-based substitutes. One issue it does not discuss is whether ingredients are organic.

Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality: In a related article, Japanese researchers found that: “higher plant protein intake was associated with lower total and CVD-related mortality. Although animal protein intake was not associated with mortality outcomes, replacement of red meat protein or processed meat protein with plant protein was associated with lower total, cancer-related, and CVD-related mortality.”

Insurance companies continue to expand programs to address social determinants of health: Here are a couple more examples: Blue Cross Plan Doubles Housing Investments To Address Social Determinants and Cigna earmarks $5 million in grants to reduce child food insecurity.

DEA to expand marijuana research after years of delay: “The U.S. Drug Enforcement Administration said on Monday that it will move ahead with a long-delayed expansion of its marijuana research program, in a sign that the Trump administration’s hostility to the drug may be waning as a growing number of states have legalized its use.”

The Clinical Course after Long‐Term Acute Care Hospital [LTACH] Admission among Older Medicare Beneficiaries: What happens after an elderly patient is transferred to an LTACH? “Of 14 072 hospitalized older adults transferred to an LTAC hospital, median survival was 8.3 months, and 1‐ and 5‐year survival rates were 45% and 18%, respectively. Following LTAC admission, 53% never achieved a 60‐day recovery. The median time of their remaining life a patient spent as an inpatient after LTAC admission was 65.6%… More than one‐third (36.9%) died in an inpatient setting, never returning home after the LTAC admission. During the preceding hospitalization and index LTAC admission, 30.9% received an artificial life‐prolonging procedure, and 1% had a palliative care physician consultation.” As the authors points out, given the very high mortality rate and very low palliative care referrals, we need to change the service mix provided to this population.

Effect of Different Financial Incentive Structures on Promoting Physical Activity Among Adults: Different schemes have been tried to get people to engage in healthier behavior. This randomized control study found that: " financial incentives for physical activity were more effective during a payment period when they were offered at a constant rate rather than an increasing or decreasing rate. However, this effectiveness dissipated shortly after the incentives were removed.”

About healthcare IT

Groups oppose HHS efforts to change SUD [substance use disorder]privacy rules: This article is a fascinating example of legitimate competing interests. As previously reported, the federal government is trying to ease the confidentiality requirements for transmission of behavioral health information in order to facilitate treatment of opioid- dependent patients. Now, patient-rights advocates are claiming that such relaxation may concern patients enough so that they will not seek treatment. Is there evidence for either opinion?

Americans’ views on data privacy and e-cigarettes: This survey by POLITICO and the Harvard T.H. Chan School of Public Health found that more “than half of adults say they are very concerned that unauthorized people may gain access to their Social Security number (63%) or their credit card number (57%).” Although physician offices rank highest in trust among all institutions studied, the confidence level was only 34%. By contrast, banks were 29% and social media scored 3%. What do these figures say about the public’s willingness to have a unique identifier necessary for optimal interoperability of medical information?

Risk of Wrong-Patient Orders Among Multiple vs Singleton Births in the Neonatal Intensive Care Units of 2 Integrated Health Care Systems: This problem is an IT issue. The authors concluded that: “This study suggests that multiple-birth status in the NICU is associated with significantly increased risk of wrong-patient orders compared with singleton-birth status. This excess risk appears to be owing to misidentification between siblings. These results suggest that a distinct naming convention as required by The Joint Commission may provide insufficient protection against identification errors among multiple-birth infants. Strategies to reduce this risk include using given names at birth, changing from temporary to given names when available, and encouraging parents to select names for multiple births before they are born when acceptable to families.” A simpler strategy would be to assign a unique identifier at birth.

About health insurance

Inside North Carolina’s Big Effort to Transform Health Care (NY Times, subscription may be required): This article is a good in-depth look at how one state is changing to value-based care from traditional fee-for service. What are insurance companies doing and what are the changes provider must make to comply?

About pharma

One third of pre-approved prescription drugs have not completed the FDA approval process: “The Food and Drug Administration’s (FDA) Accelerated Approval Program was created in 1992 to significantly accelerate the ability to bring certain new drugs to market. New research to be published in an upcoming issue of Manufacturing & Service Operations Management reveals a large number of drug manufacturers are failing to complete the approval process, meaning a significant number of drugs on the market are not yet fully approved.”

Don’t Give Up on Biosimilars—Congress Can Give Them a Boost: This op-ed piece in the Wall Street Journal by former FDA Commissioner Gottlieb offers some solutions to the high cost of biosimilars that will still preserve some of the free market advantages to the initial developer.

Trends in Prices, Market Share, and Spending on Self-administered Disease-Modifying Therapies for Multiple Sclerosis [MS] in Medicare Part D: The recent focus on drug costs has been on diabetes. This article is a reminder that other conditions are likewise affected: “prices of self-administered DMTs [disease modifying treatments] for MS increased dramatically between 2006 and 2016. This resulted in a 7.2-fold increase in patient out-of-pocket costs.”

The Alliance for Regenerative Medicine Releases Statement of Principles on Genome Editing: “The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine sector, today released a Therapeutic Developers’ Statement of Principles, setting forth a bioethical framework for the use of gene editing in therapeutic applications.” One of the stated principles is: “We assert that germline gene editing is currently inappropriate in human clinical settings.” It appears that in this field, ethics is catching up to technology.

BREAKING NEWS: Purdue Pharma offers up to $12 billion to settle opioid cases: report: According to two people familiar with the matter, Purdue Pharma and its owners are prepared to offer $10 billion to $12 billion to settle more than 2000 lawsuits accusing the company of fueling the US opioid crisis, NBC News reported.

About healthcare devices

CDRH [FDA Center for Devices and Radiological Health] Regulatory Science Priorities: The CDRH has listed its top 10 priority areas. While some are device-specific, others are of general healthcare interest, e.g., patient input, big data and computational modeling.

FDA Clears Biobeat’s Cuffless Blood Pressure Monitors: This device is a true monitoring breakthrough. Here is more information.

Today's News and Commentary

About pharma

BREAKING NEWS: Johnson & Johnson is responsible for fueling Oklahoma’s opioid crisis, judge rules in landmark case:”A judge …found Johnson & Johnson responsible for fueling Oklahoma’s opioid crisis, ordering the health care company to pay $572 million to redress the devastation wrought by the epidemic on the state and its residents.”

Pharma's shift away from TV to digital is inevitable, report says: With requirements for price transparency and inability to reach only targeted audiences, this prediction seems inevitable.

Four Generic Drugmakers Settle Pay-for-Delay Lawsuit: “Amneal Pharmaceuticals, Upsher-Smith Laboratories, and Sun Pharmaceuticals agreed to pay a combined $1.2 million, while Wockhard agreed to pay the remaining $340 thousand…” to settle pay-for-delay allegations over the Alzheimer’s drug Namenda (memantine).

The $6 Million Drug Claim (NY Times, subscription may be needed): This article takes an in-depth look at the incredibly high price of treating rare diseases.

About healthcare quality and safety

Minnesota Blues strikes up outcomes-based cancer care arrangement (Modern Healthcare- subscription required): “Blue Cross and Blue Shield of Minnesota and Minnesota Oncology have entered a five-year value-based arrangement to pay for cancer care based on patient outcomes rather than the number of services performed.” The British call pay-for-performance “pay by results.” This Minnesota example is an example of a shift from paying for process compliance to outcomes.

10 Lessons From Health Care on Quality Improvement: This article, by authors from the Institute for Health Improvement, is a really good summary of some important lessons about how to implement quality healthcare programs. It also has many international examples.

About healthcare IT

Industry Voices—Survey shows 83% of patients want virtual health, but there's a problem:
“…83% of those consumers [in the survey] said they are interested in receiving virtual care, yet only 17% reported they have access to it.” Are we hyping a product before we can deliver it or will the hype spur faster development?

VA's paper health records digitization backlog is 5 miles high, VA OIG says: “If every single one of the paper documents that still need to be digitized at Veterans Health Administration medical facilities were stacked, it would reach more than five miles up, a federal watchdog said.

In addition, VHA medical facilities currently have a backlog of nearly 600,000 electronic documents that still need to be entered into the electronic health record system of July 2018, with some documents dating back to October 2016, according to an audit conducted by the VA's Office of Inspector General.”

Abernethy: FDA working with ONC on universal unique device identifier linked to EHR patient data:”The Food and Drug Administration is in discussions with multiple stakeholders to create a universal unique medical device identifier to be stored in electronic health records and linked to patient outcomes to improve medical device surveillance, said FDA principal deputy commissioner Amy Abernethy, M.D.”

Massachusetts General Hospital privacy breach exposed 10,000 patients' records, genetic information: While the headline is self explanatory, two lessons come from this mishap. First, even prestigious institutions are not immune to this problem. Second, third party breaches are becoming more common. “More than half of hospitals (56%) have experienced one or more vendor-related data breaches in the past two years, at an average cost of $2.9 million…”

About health insurance

U.S. Medicare readies new plan-shopping website, but timing prompts concern: In anticipation of open enrollment for health plans this fall, CMS says it will release its Plan Finder software by September 2. The new version is supposed to correct such problems as incomplete or incorrect information and difficulty with navigation.

Here's a look at health systems' financial performance in 2019 so far: “The nation's largest health systems made nearly $1 billion in profit in the second quarter as inpatient admissions largely grew across some of the top health systems.” The article provides more detail by systems.

Immigrant sponsors' assets will factor into Medicaid eligibility (Modern Healthcare- subscription required): “The CMS on Friday told states on Friday they can count the assets and income of the sponsors of legal immigrants when they're determining whether the immigrants qualify for Medicaid or Children's Health Insurance coverage.”

Today's News and Commentary

About the public’s health

First death reported from vaping-related lung illness, officials say: The previously reported respiratory illness associated with vaping has claimed its first life.

Human Papillomavirus–Attributable Cancers — United States, 2012–2016: This report from the CDC was published today. Despite the data’s age it has some good news: 92% of HPV-related cancers were attributable to the types targeted by the 9-valent HPV vaccine. With more widespread use, the incidence of these cancers should be dramatically reduced over time.

Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial: This Iranian study published in the Lancet appeared in many media outlets today. It showed effectiveness of a 4 drug “poly pill” (aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan) used for primary and secondary prevention of cardiovascular disease. Since all those components are available in cheap generic versions, the authors recommend such pill be should be considered in low or middle income countries.

More than Twice as Many Employers than 10 Years Ago are Planning to Increase Investments in Employee Health and Wellness, Optum Study Shows: The headline speaks for itself. With a tight labor market, this strategy makes sense, provided the right programs are implemented correctly. Such data-driven programs should be a good business opportunity.

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season: Today the CDC released its 2019-2020 recommendations for flu vaccines. Recommendations for who should receive the vaccine are basically the same: “ Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. Recommendations regarding timing of vaccination, considerations for specific populations, the use of specific vaccines, and contraindications and precautions are summarized” in the article.

Fitbit to Work With Singapore to Promote Public Health: Singapore is a very health-conscious country. Also, its people heavily rely on government-sponsored social welfare programs. Could a joint venture like this one work in this country?

Feds to revamp confidentiality rules for addiction treatment: Despite usual confidentiality rules mandated by HIPAA (see Chapter 9 of the text), behavioral health records are held to a higher standard. While securing very sensitive information, this protection has hampered information sharing among professionals and institutions who treat those affected by the opioid crisis. “Federal health officials proposed Thursday to revamp stringent patient confidentiality regulations from the 1970s to encourage coordination among medical professionals treating people caught in the nation’s opioid epidemic.

Health and Human Services Secretary Alex Azar said the goal is to make it easier to share a patient’s drug treatment history with doctors treating that person for other problems. That can stave off serious — even fatal — errors, like unwittingly prescribing opioid painkillers to a surgical patient with a history of dependence. A patient’s consent would still be required.”

About pharma

China vows to maintain stable drug prices: Which one of these measures (if any) could we implement in this country to stabilize or lower drug prices?

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US: Since the FDA does not have the resources to police drug approvals and manufacturing worldwide, it has made agreements with other entities to act on its behalf. This study looked at the “alignment in marketing application decisions between” the FDA and the EMA (the counterpart for the EU). The two agencies agreed on more than 90% of marketing authorization decisions for new medicines. ”The most common reason for diverging decisions at the two agencies were differences in conclusions about efficacy. Differences in clinical data submitted in support of an application were the second most common root of divergent FDA and EMA decisions.”

Has the FDA been approving some drugs without proper evidence?: This article is a nicely balanced presentation of the FDA’s conflicting missions of quick drug approvals to aid the health of the population versus its responsibility to make sure those products are safe and effective.

About health insurance

Did the Affordable Care Act Reduce Racial and Ethnic Disparities in Health Insurance Coverage?: This just-released research from the Commonwealth Fund found that: “All racial and ethnic groups saw gains in health coverage between 2013 and 2016, but these gains were especially pronounced for minority groups and individuals with incomes below 139 percent of the federal poverty level. In 2017, gains for minority groups generally flattened. The ACA’s disparity-reducing effects have been strongest in states participating in the Medicaid expansion.”

Hospital revisits within 30 days after discharge for medical conditions targeted by the Hospital Readmissions Reduction Program in the United States: national retrospective analysis: “In the United States, total hospital revisits within 30 days of discharge for conditions targeted by the HRRP [Hospital Readmissions Reduction Program] increased across the study period. This increase was due to a rise in post-discharge emergency department visits and observation stays, which exceeded the decline in readmissions.{Emphasis added] Although reductions in readmissions have been attributed to improvements in discharge planning and care transitions, our findings suggest that these declines could instead be because hospitals and clinicians have intensified efforts to treat patients who return to a hospital within 30 days of discharge in emergency departments and as observation stays.” This research shows the importance of measuring total episodes of care, not just their components.

Calif. surprise medical bill law boosts number of in-network docs: The results of a study on California health plans (excluding Kaiser and plans with fewer than 10,000 members) showed that after California passed its 2016 law limiting surprise medical bills, the number of in-network specialty doctors either remained flat, or increased by as much as 26 percent (depending on specialty). Overall there was a 16% increase in in-network participation.

Health Insurers Set to Expand Offerings Under the ACA:[Wall Street Journal- subscription may be required]: While the article starts with the good news that Oscar, Cigna and Centene plan ACA expansions, at the end it mentions that “UnitedHealth Group Inc. said it expects to be in the same three ACA markets next year as this year. CVS Health Corp. ’s Aetna and Humana Inc. both said they have no plans to offer ACA products in 2020.”

Some major exchange insurers post lower star ratings (Modern Healthcare- may require subscription): Speaking of expanding plans…About 64% of 195 ACA plans received an overall quality rating of four or five stars, and across all plans, the average rating was 3.8 stars. Kaiser scored 4.8 stars while Centene, Corp., which has the highest enrollment at 1.9 million received 3.3 stars. Cigna rated 3.3 stars and Molina Healthcare received 2.7 stars.

About healthcare IT

Telehealth is here to stay, so why won’t employees sign up?: While almost 75% of major employers offered some type of telehealth benefit in 2018, “the average employee sign-up rate for large employers who offered telehealth services either through their health plan or a specialty vendor was only 8% in 2017…[and] only 9.6% of Americans have used telehealth services of all types, including those provided by employers.” Three reasons for these low enrollments and usage, according to Stephany Verstraete, chief marketing officer at Teladoc Health, are:
“First, many times employees don’t know they have the benefit. Second, employees don’t remember they have the benefit at the moment they need it. Third is the notion of behavior change. Employees are hesitant at first, asking themselves is this quality care?”
The implication is that educational programs addressing these barriers should increase usage.

Beyond Compliance: Cyber Threats and Healthcare: This short monograph is a really good overview of cyberthreats with many specific examples.

Today's News and Commentary

About the public’s health

2018 Antibiotic Use Update in the United States: This CDC report updates the last one, done in 2017. Among other findings:
—At least 30% of antibiotic prescriptions are unnecessary, with large variation in prescribing by state.
— Urgent care and EDs have the greatest percent of unnecessary antibiotic use (46% and 25%, respectively).
— The one bright spot was a continuing increase in hospitals’ antibiotic stewardship programs.

Forecasted Size of Measles Outbreaks Associated With Vaccination Exemptions for Schoolchildren: As recently reported, the measles outbreak is not over; and in some areas it could even come back with increasing numbers. “This study suggests that vaccination rates in some Texas schools are currently low enough to allow large measles outbreaks. Further decreases are associated with dramatic increases in the probability of large outbreaks. Limiting vaccine exemptions could be associated with a decrease in the risk of large measles outbreaks.” Also recall lack of immunizations for illegal immigrants.

Increasing the perceived relevance of cervical screening in older women who do not plan to attend screening: Framing is very important when making recommendations to patients. This study in women ages 50-64 found that one reason for the declining rate of cervical cancer screening is their perception that the risk is low because of lack of sexual activity. Explanation of risk of cervical cancer, even years after HPV exposure increased willingness to participate in such screenings.

Poll: Nearly 1 in 5 Americans Says Pain Often Interferes With Daily Life: This NPR-IBM Watson poll found that 18% of the population says pain often interferes with their daily lives; for those older than 65 the figure is 22%, but only 9% for those under 35. Sixty percent of those in pain use over the counter medication while only 15% use prescription medications. Exercise, massage and heat/ice were also popular remedies.

Ambient Particulate Air Pollution and Daily Mortality in 652 Cities: “We evaluated the associations of inhalable particulate matter (PM) with an aerodynamic diameter of 10 μm or less (PM10) and fine PM with an aerodynamic diameter of 2.5 μm or less (PM2.5) with daily all-cause, cardiovascular, and respiratory mortality across multiple countries or regions. Daily data on mortality and air pollution were collected from 652 cities in 24 countries or regions…Our data show independent associations between short-term exposure to PM10 and PM2.5 and daily all-cause, cardiovascular, and respiratory mortality in more than 600 cities across the globe. These data reinforce the evidence of a link between mortality and PM concentration established in regional and local studies.” Yes, air pollution is real and dangerous.

About health insurance

Strategies Used by Adults With Diagnosed Diabetes to Reduce Their Prescription Drug Costs, 2017–2018: Some of the findings of this study:

• Among adults with diagnosed diabetes, women (14.9%) were more likely than men (11.6%) to not take their medication as prescribed.

• Those under age 65 with diagnosed diabetes were more likely than those aged 65 and over to not take their medication as prescribed (17.9% and 7.2%, respectively) and to ask their doctor for a lower-cost medication (26.3% and 21.9%, respectively).

• Among adults aged 18–64 with diagnosed diabetes, the percentage who did not take their medication as prescribed or asked their doctor for a lower-cost medication was highest among those who were uninsured.

• Among adults aged 65 and over with diagnosed diabetes, the percentage who asked their doctor for a lower-cost medication was lowest among those with Medicare and Medicaid coverage.

  Such knowledge can, of course, help with insurance strategies to increase compliance.

Sen. Bernie Sanders changes how Medicare-for-all plan treats union contracts in face of opposition by organized labor: Starting more than a hundred years ago, labor unions used negotiation power for benefits to build membership. That is one reason unions have not backed single payer systems. Another reason is that such schemes may not have as good benefits as the ones unions have negotiated. Further, unions traded benefits for salary increases. All those advantages would go away with a single payer system such as the one Senator Sanders is advocating. Bowing to these union concerns, yesterday he slightly changed his stance, saying he “would effectively give organized labor more negotiating power than other consumers would have… by forcing employers to pay out any money they save to union members in other benefits.” Of course, this plan assumes there will be savings under a single payer system. Another question is how “savings” will be calculated, since insurance premiums will go away but taxes will be higher.

About pharma

HHS files appeal to keep plan for drug prices in TV ads alive: Recall that several months ago HHS issued regulations requiring pharma companies to advertise their prices in ads. In a decision on a lawsuit by Merck, Eli Lilly, and Amgen to block the requirement, Judge Amit Mehta, of the U.S. District Court for the District of Columbia ruled that HHS overstepped its authority. Now the government is appealing that decision.

About healthcare IT

Keeping a Pulse on Cybersecurity in Healthcare: In this Kaspersky survey of people in a variety of roles in healthcare organizations in North America the need for better cybersecurity education was dramatic:

—Nearly a third of all respondents (32%) said that they had never received cybersecurity training from their workplace but should have.

—Nearly 1 in 5 respondents (19%) said there needed to be more cybersecurity training by their organization.

—Almost a third of healthcare IT respondents (32%) said that they are aware of their organization’s cybersecurity policy and have read it only once.

—2 in 5 respondents (40%) of healthcare workers in North America are not aware of cybersecurity measures in place at their organization to protect IT devices.

There is a real business opportunity to remedy these problems.

About healthcare quality and safety

Here's what hospital groups had to say about CMS' plan to update Star Ratings: This article summarizes comments on the previously reported CMS announced revisions to the hospitals’ Star reports.

Today's News and Commentary

About health insurance

MaineHealth, Anthem team up for joint insurance venture: A new Medicare Advantage plan is not really news, but the coalition forming it is noteworthy. “MaineHealth and health insurance provider Anthem Blue Cross and Blue Shield of Maine are collaborating on a joint venture with the intent to offer Medicare Advantage health insurance plans for 2020.”

The Collapse Of A Hospital Empire — And Towns Left In The Wreckage: How do you save your local hospital? In a fee for service world, insurance fraud is a tempting option. Read this fascinating story.

Cigna seeks sale of group benefits insurance business - sources: Sources close to the company said Cigna is seeking to sell its non healthcare businesses (disability, life and accidental death and dismemberment insurance). The sale could be worth $6 billion. In the past, insurance companies covered many different types of insurances. Over the past 2-3 decades, they have specialized in certain segments or shed focused divisions. Is the era of the comprehensive insurance company really gone?

About the public’s health

After Trump blames mental illness for mass shootings, health agencies ordered to hold all posts on issue: ”A Health and Human Services directive on Aug. 5 warned communication staffers not to post anything on social media related to mental health, violence and mass shootings without prior approval.”

Children of Anti-Vaxxers Should Have Access to Doctors’ Offices Restricted, Say Almost 75% of Parents: The headline is the bottom line of the survey conducted by the C.S. Mott Children's Hospital (University of Michigan) National Poll on Children's Health. Perhaps peer pressure will help get more children vaccinated?

Acute Effects of Electronic Cigarette Aerosol Inhalation on Vascular Function Detected at Quantitative MRI: Even the aerosol in e-cigarettes causes problems in the lining of the blood vessels.

Migrants in US border detention centers won't receive flu vaccine: Policy and political views aside, this decision is bad for the public’s health.

About healthcare IT

2019 Predictive Analytics in Health Care Trend Forecast: Among the findings of this study by the Society of Actuaries:

—60% of executives are using predictive analytics within their organizations, which is a 13-point year-over-year increase from 2018 (47%) and a 6-point increase from 2017 (54%).
—60% of payers and providers expect to dedicate 15% or more of spendingto predictive analytics in 2019. And, they’re expecting the investment to pay off: nearly two-thirds of executives (61%) forecast that predictive analytics will save their organization 15% or more over the next five years.
—16% of providers cite “too much data”as the top barrier to implementing predictive analytics, while payers cite “lack of skilled workers” (15%) as the greatest hurdle.

New HL7® FHIR® Accelerator Project Aims to Improve Interoperability of Social Determinants of Health Data:  “Health Level Seven® International (HL7®), the global authority for interoperability in health information technology, and the American Academy of Family Physicians (AAFP)… announce that the Gravity Project is now part of the HL7® FHIR® Accelerator Program.

The Gravity Project aims to standardize medical codes to facilitate the use of social determinants of health-related data in patient care, care coordination between the health and human services sectors, population health management, value-based payment and clinical research. Social determinants of health (SDOH) are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life.” [For more on FHIR, see Chapter 8 of the text.]

Pharmacy Customers Slow to Adopt Digital Offerings but Satisfaction Increases When They Do, J.D. Power Finds: Among findings of this study: “Mobile app users more satisfied, but usage is stagnant: Only 20% of customers use a pharmacy’s mobile app, but those who did have satisfaction scores as much as 23 points higher than those who do not.” In addition to this IT finding: “Health and wellness customers spend more at the pharmacy: About two-fifths (42%) of customers who are aware of their pharmacy’s health and wellness services have used one of the services in the past year. While those who have taken advantage of health and wellness services spent 12.5% more on their most recent prescription order, significantly less health and wellness customers received a prescription as a result of their participation in 2019 as compared with 2018.” This latter revelation bodes well for CVS’s HealthHub initiative.

Today's News and Commentary

About the public’s health

Planned Parenthood Refuses Federal Funds Over Abortion Restrictions: “Planned Parenthood said Monday that it would withdraw from the federal family planning program that provides birth control and other health services to poor women rather than comply with a new Trump administration rule that forbids referrals to doctors who can perform abortions. 
Planned Parenthood receives about $60 million annually through the federal program, known as Title X.”

Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: US Preventive Services Task Force Recommendation Statement: “The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing. (B recommendation) The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations. (D recommendation).” See, also, the accompanying editorial.

The economic case for prevention of population vitamin D deficiency: a modelling study using data from England and Wales: Researchers at the University of Birmingham calculated that adding vitamin D to wheat flour would prevent 10 million new cases of vitamin D deficiency in England and Wales over the next 90 years. The addition was extremely cost-effective; the combination of supplementation and fortification was £9.5 per QALY gained.

Flavonoid intake is associated with lower mortality in the Danish Diet Cancer and Health Cohort: The good news is that you can lower risk for mortality by eating foods you may like. “Results from our study indicate that for total flavonoid intake, risk of all-cause and CVD mortality was lower for flavonoid consumption until intakes of approximately 500 mg/d, after which higher intakes afforded no added benefit. This threshold was higher, approximately 1000 mg/d for cancer-related mortality. That the thresholds for each of the flavonoid subclasses approximately sum to the threshold for total flavonoid intake is consistent with the idea that all are important and afford added benefit. Interestingly, these threshold levels exist well within daily dietary achievable limits: one cup of tea, one apple, one orange, 100 g of blueberries, and 100 g of broccoli would provide most of the flavonoid subclasses and over 500 mg of total flavonoids. In this population it is likely that tea, chocolate, wine, apples, and pears were the main food sources of flavonoids.”

Self-sampling for human papillomavirus (HPV) testing: a systematic review and meta-analysis: Self-testing can increase compliance. “A growing evidence base, mainly from high-income countries and with significant heterogeneity, suggests HPV self-sampling can increase cervical cancer screening uptake compared with standard of care, with a marginal effect on linkage to clinical assessment/treatment.” Note that the evidence is from high income countries. There should be a business opportunity for more self-care products.

Business Roundtable Redefines the Purpose of a Corporation to Promote ‘An Economy That Serves All Americans’: This joint statement by many of the largest US firms changes the purpose of the corporation from maximizing shareholder value to stating: “Each of our stakeholders is essential.” Consider how this change will affect healthcare organizations.

About healthcare IT

First Survey of the Strategic Health Information Exchange Collaborative (SHIEC) Shows Health Information Exchanges (HIES) Provide Critical National Infrastructure: Ninety-two percent of the U.S. population is served by America’s health information exchanges (HIEs) who are members of the Strategic Health Information Exchange Collaborative (SHIEC). [See Chapter 8 of the text for more information about this initiative.]

Interoperability: Health data-sharing is lacking inside and outside of hospitals, survey says: Despite the “good news” in the above announcement, this article is another update about the lack of interoperability among data systems. This problem was reinforced by CMS Administrator Verma.

About healthcare insurance

Democrats back off once-fervent embrace of Medicare-for-all: This article explains why, “in recent months, amid polling that shows concern among voters about ending private insurance, several of the Democratic hopefuls have shifted their positions or their tone, moderating full-throated endorsement of Medicare-for-all and adopting ideas for allowing private insurance in some form.”

About healthcare quality and safety

CMS Announces Upcoming Enhancement of Overall Hospital Quality Star Ratings:”The Hospital Compare website’s Overall Hospital Quality Star Ratings rate hospital quality on a scale from one to five stars. CMS last updated the Star Ratings in February 2019, and has full confidence in their accuracy and reliability. Yet, to ensure the Star Ratings are as helpful as possible, CMS routinely refines the methodology used to calculate them. Today’s announcement means CMS plans to next update the Star Ratings in early 2020 according to the current methodology. CMS plans proposed rulemaking in 2020 to enhance the methodology and aims to finalize these rules prior to the release of the Star Ratings in calendar year 2021.” While CMS is to be praised for keeping the measures current and accurate, changing the criteria too often does not help quality improvement or the public’s understanding of the ratings. It takes time to make improvements and several years to evaluate the statistical significance of the outcomes of those efforts.

About pharma

AbbVie prices new rheumatoid arthritis drug at $59,000 a year: Last week Abbvie announced its successor to Humira for use in arthritis. “A four-week supply of Humira, the world’s best-selling medicine, has a list price of about $5,174, amounting to more than $60,000 for a year. However, the list price is not necessarily what patients actually pay as ‘out-of-pocket’ costs vary based on the duration of the treatment and individual healthcare plans…  The newly approved treatment, Rinvoq [upadacitinib] belongs to a class of medicines known as JAK inhibitors that block inflammation-causing enzymes called Janus kinases and will be available later this month… AbbVie said it planned to offer a co-pay card that could reduce out-of-pocket costs to $5 per month for eligible, commercially-insured patients, as well as a patient support program.”

Today's News and Commentary

About healthcare IT

Two of the country's largest HIEs team up to share data on Midwest patients: “Two of the largest health information exchanges in the country, Missouri Health Connection and the Kansas Health Information Network, have signed an agreement to enable providers to have access to 20 million patients' health records in Kansas, Missouri and some areas of surrounding Midwest states.” While this action is laudable the question remains why there need to be so many local efforts to integrate data bases when the federal government has been trying to launch The Trusted Exchange Framework and Common Agreement (TEFCA)- now in its second draft.

About health insurance

Development and Testing of Improved Models to Predict Payment Using Centers for Medicare & Medicaid Services Claims Data: “In this comparative effectiveness research study of risk models on 1 667 983 patients with 1 943 049 Medicare fee-for-service hospitalizations, use of present on admission codes and single diagnosis codes and separation of index admission codes from codes in the previous year improved models predicting payment that were compared with models based on Centers for Medicare & Medicaid Services grouped codes.” The study was done on data collected from July 1, 2013, through September 30, 2015, when ICD 9 codes were used. Such methodology would now need to be adapted using ICD 10 codes.

The ‘follow-up appointment’: This Washington Post article looks into medical debt for those living in rural areas. For example: “So far this year, Poplar Bluff Regional Medical Center has filed more than 1,100 lawsuits for unpaid bills in a rural corner of Southeast Missouri, where emergency medical care has become a standoff between hospitals and patients who are both going broke.”

Health Insurance Coverage Declined for Nonelderly Americans Between 2016 and 2017, Primarily in States That Did Not Expand Medicaid: “The uninsured rate climbed from 10.0 percent in 2016 to 10.2 percent in 2017, the first increase since 2013, after significant declines driven by the Affordable Care Act (ACA). This decline resulted in 700,000 more uninsured people in 2017 than in 2016.

The uninsured rate held stable in Medicaid expansion states at 7.6 percent, but increased from 13.7 percent to 14.3 percent in states that did not expand Medicaid.”

About public health

CDC, states investigating severe pulmonary disease among people who use e-cigarettes: Once again, vaping is not safe! According to the CDC: “94 possible cases of severe lung illness associated with vaping were reported in 14 states from June 28, 2019, to August 15, 2019.” What type of social media campaign will reduce vaping? Hint: scare tactics do not work.

Fast-Food Joints in the Neighborhood? Heart Attack Rates Likely to Go Up: This Australian study found that for “every additional fast-food outlet in a neighborhood, there were four additional heart attacks per 100,000 people each year…” Is there another role for zoning laws?

Nearly Half of U.S. Patients Keep Vital Secrets From Their Doctors: “Nearly half of U.S. patients don't tell their physicians about potentially life-threatening risks such as domestic violence, sexual assault, depression or thoughts of suicide, a new study finds.” How can we build trust between patients and their physicians? Perhaps we need more attention to strengthening relationships with a regular primary care physician instead of our current fragmented-care system.

Changes in Age Distribution of Obesity-Associated Cancers: Another reason to control the obesity epidemic in the young. These researchers found “there has been a shift of obesity-associated cancer burden to younger age groups and that interventions to reduce obesity and to implement individualized screening programs are needed.”

Impact of Carers’ Smoking Status on Childhood Obesity in the Growing up in Ireland Cohort Study: On a related theme…These findings of this Irish study “emphasize the health burden of childhood obesity that may be attributable to maternal smoking postnatally and through early childhood…”

Today's News and Commentary

About pharma

Another hit for Roche: UnitedHealthcare backs Amgen biosims over blockbuster oncology meds: Biosimilar drugs have been slow to make an impact on healthcare costs in the U.S. As a start to remedy this situation, “UnitedHealthcare (UNH) will put Amgen biosimilars of oncology meds Avastin and Herceptin first in line as preferred products in its commercial, community and Medicare Advantage plans starting Oct. 1… The two biosims, Mvasi and Kanjinti, launched in the U.S. in mid-July at a 15% discount off the original brands.” While the discount is not as much as traditional generics, it is a significant savings.

As specialty drug costs skyrocket, Anthem tests new idea for curbing 'shock' claims: Speaking about the high cost of specialty drugs, “Anthem is launching a new program in Kentucky that aims to work with providers to protect patients from ‘shock’ bills for these therapies. 
Anthem has teamed up with St. Elizabeth Healthcare, one of the state’s largest providers, as the first partner in the new program. In the model, the health system will absorb part of the cost of these services, discounting them by as much as 45%.” This project is a step short of the payer captitating the provider for such services.

Verma: CMS working 'fast and furious' on IPI drug pricing model, but doesn't say when it will be released: Earlier this year, The Trump administration announced its intention to lower drug costs by implementing an International Pricing Index (IPI) model- using prices outside the country as a guide to domestic costs. CMS administrator Verma has an update on this proposal, saying that “we are fast and furious” about getting the model done. When it will be implemented is not yet clear.

New drug disposal regulations to be implemented next week: “Starting Aug. 21, drugs like opioids and chemotherapies will need to be disposed of through proper channels rather than down the drain…” While the regulations are long overdue, compliance will be costly. For example Cleveland Clinic is expected to spend $500,000 per year to set up a complaint system. Perhaps manufacturers of those drugs can offer disposal solutions to customers as a “value-added” service.

About the public’s health

Without court action, Planned Parenthood says its health centers will withdraw from Title X over 'gag rule': “Planned Parenthood Wednesday notified the Ninth Circuit Court of Appeals that unless it steps in by Aug. 19 to block the Trump administration’s new Title X rule, its health centers will be forced out of the federal program in just days.” The previously reported rule bans Title X funding recipients from making referrals for abortion services.

New Look For Cigarettes? FDA Proposes Graphic Warnings On Packages And Ads: If you have seen packs of cigarettes in some other countries, you noticed the graphic “photo-realistic” images warning about the health risks of smoking. Such warnings were supposed to appear on American cigarette packs after passage of a law in 2009. Tobacco companies complained that such a requirement was a violation of their freedom of speech. As a result of an American Lung Association lawsuit against the FDA, “acting FDA commissioner Ned Sharpless told reporters that the 13 warnings the agency plans to plaster on cigarette packs, hew close to the factual dangers of smoking.” That decision is not yet a “done deal,” as tobacco companies are expected to sue. In any case, these messages would not appear at the soonest until 2021.

New York City Is Giving Out Prescriptions For Free Fruits And Vegetables: This article describes “New York City’s Pharmacy to Farm program, which provides extra money each month for fresh produce to people who receive Supplemental Nutrition Assistance Program (SNAP) benefits and are on medication for hypertension. One in five New Yorkers is on SNAP; one in four has high blood pressure.” As the program name explains, the benefits are distributed through a patient’s pharmacy.

For a decade, Francis Collins has shielded NIH—while making waves of his own: This article is a balanced, insightful look at the man running the NIH.

About healthcare quality and patient safety

CMS to require ACA plans to display star ratings for plans starting in 2020: “The Trump administration will require Affordable Care Act exchange plans to display their star ratings received for quality, in a move aimed at boosting transparency.” The requirement will apply to plans offered in the 2020 contract year and appear on such sites as Healthcare.gov.

About health insurance

American Medical Association leaves coalition fighting 'Medicare for All': “The AMA said it is leaving the industry group called the Partnership for America’s Health Care Future, which has been running ads against Medicare for All and public option proposals from the leading Democratic candidates for president. However, the doctors group’s CEO, Dr. James Madara, said in a statement that the AMA still opposes Medicare for All. It just wants to focus its energies on advocating for solutions, such as improving ObamaCare by making its subsidies for helping people afford coverage more generous.” 

Tracking the rise in premium contributions and cost-sharing for families with large employer coverage: The Kaiser Family Foundation has updated its employer-sponsored health insurance survey. Some of the highlights: “…the average family spent $4,706 on premiums and $3,020 on cost-sharing, for a combined cost of $7,726 in 2018. This represents an 18% increase in the health costs borne by employees and their families from five years earlier ($6,571 in 2013), outpacing the 8% increase in inflation and a 12% increase in workers’ wages over the same period.”

Today's News and Commentary

About pharma

FDA Plans Meeting on Real-World Evidence, Patient-Focused Drug Development: “The FDA has scheduled a Nov. 7 public meeting to discuss how to improve its drug development programs in the Office of New Drugs (OND) with the use of real-world evidence and an increase patient focus.”

U.S. FDA approves TB Alliance's treatment for drug-resistant tuberculosis: The FDA approved the non-profit TB Alliance’s triple drug regimen to treat multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB). The therapy is over 6 months versus the standard 2 year course- a significant improvement to aid compliance.

Top 10 all-star drugs in 2024: Humira's captain, but who else makes the roster?: The headline is a teaser for which drugs will reach the top of the sales charts in 5 years. As you read the list, contrast which are biologics and which are traditional “small molecules.”

Boehringer, MD Anderson build out 'virtual R&D center' for cancer research: This partnership is the most recent example of industry-medical center cooperation, in this case to develop oncology drugs.

Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018: “Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.”

About healthcare IT

VA releases tool for better integrating agency’s dozens of apps: “The VA’s new Launchpad app includes the ability to view and share electronic health records, book medical appointments, refill prescriptions, as well as communicate with the agency’s healthcare providers.”

About health insurance

Harvard Pilgrim Health Care, Tufts Health Plan to merge: This merger will give significant local market power to the new organization, which will “serve 2.4 million members in Massachusetts, Maine, Rhode Island, Connecticut and New Hampshire and would offer both employer-sponsored and government plans.”

Appeals court revives changes to Medicaid DSH payment rules: DSH [Disproportionate Share Hospital] payments are federal government subsidies to those facilities providing high volumes of care to Medicaid and uninsured patients. In 2017, CMS formalized a previous opinion that DSH payments should subtract third-party payments, such as those from private insurers and Medicare. That CMS decision prompted a group of children's hospitals to “ file a lawsuit claiming CMS overstepped its authority.” A federal judge ruled in favor of the hospitals, finding that the rule is inconsistent with the plain language of the Medicaid Act. CMS appealed the ruling, and the U.S. District Court of Appeals for the D.C. Circuit overturned the lower court's ruling. Will this decision be appealed by the plaintiffs and reach the Supreme Court? Many hospitals’ finances will depend on this critical decision.

As States Strive To Stabilize Insurance Marketplaces, Insurers Return: The Kaiser Family Foundation writes that since more states have implemented programs to stabilize their insurance markets (like premium subsidies and reinsurance programs), more private insurers will enter or return to them.

Will Increasing Primary Care Spending Alone Save Money?: Authors of this study point out that evidence for an affirmative answer to the title question is lacking. What they fail to point out are three important factors about primary care. First, many practitioners are not trained or inclined to deliver broad-based services. For example, many internists refer their diabetic patients to podiatrists to cut toenails when they could deliver the same service as part of routine office visits. Second, even if primary care physicians did deliver such services, they are also not trained or inclined to manage entire episodes of care. Finally, higher payments are needed to attract physicians to primary care specialties. Compare primary care physician income to other specialties and it is no wonder there is such shortage.

About healthcare quality and patient safety

Rating the Raters: An Evaluation of Publicly Reported Hospital Quality Rating Systems: Six experts in quality methodology graded four hospital quality rating reports. This is a landmark evaluation of the reported evaluating the reporters. Their findings? “There were no hospital quality rating systems meriting an A or A-. The highest grade received was a B by U.S. News. The CMS Star Ratings received a C. The lowest grades were for Leapfrog (C-) and Healthgrades (D+) (Table 3). We qualitatively agreed that the U.S. News rating system had the least chance of misclassifying hospital performance. There was considerable agreement in overall grade assignments among the six individuals who performed the ratings.” Read the study for details.

Today's News and Commentary

About health insurance

Large Employers Double Down on Efforts to Stem Rising U.S. Health Benefit Costs which are Expected to Top $15,000 per Employee in 2020: The National business Group on Health polled its members about how they will deal with the projected 5% increase in healthcare costs next year. “Employers identified implementing more virtual care solutions (51%) and a more focused strategy on high cost claims (39%) as their top initiatives for 2020. The survey also found that managing prescription drug benefit costs remains a high priority for employers in 2020.” Further, “ 49% of respondents plan to pursue an advanced primary care strategy in 2020, and another 26% are considering one by 2022…The number of employers offering full replacement consumer-directed health plans will shrink to 25% in 2020, down from 30% this year and 39% in 2018. Instead, employers will offer more plan choices like a preferred provider organization (PPO) plan.”

Use of Pharmacy Benefit Managers and Efforts to Manage Drug Expenditures and Utilization: The Government Accountability Office examined “the role of PBMs in the Part D program. This report examines, among other objectives, (1) the extent to which Part D plan sponsors use PBMs, (2) trends in rebates and other price concessions obtained by both PBMs and plan sponsors for Part D drugs, and (3) how PBMs earn revenue for services provided to Part D plans.” Among its findings: “PBMs primarily earned Part D revenue through a volume-based fee paid by plan sponsors based on PBM-processed claims; a per-member, per-month fee paid by plan sponsors; or a combination of the two. PBMs also earned revenue from the rebates they negotiated with manufacturers for Part D drugs, which accounted for $18 billion of the $26.7 billion in rebates in 2016. PBMs retained less than 1 percent of these rebates, passing the rest to plan sponsors. Plan sponsors in turn may use rebates to help offset the growth in drug costs, helping control premiums for beneficiaries.”

Where Tourism Brings Pricey Health Care, Locals Fight Back: Because local residents of this Colorado tourist town could not afford the local hospital’s charges, they created an alliance plan whereby members could obtain 30% discount off published charges. A related comment: purchasing power is an important tool to lower healthcare costs. That is why employer-sponsored insurance remains a viable option.

About the public’s health

Treating Parents for Tobacco Use in the Pediatric Setting: Improving care can be about the setting/context as much as the message. “In this trial, integrating screening and treatment for parental tobacco use in pediatric practices showed both immediate and long-term increases in treatment delivery, a decline in practice-level parental smoking prevalence, and an increase in cotinine-confirmed cessation, compared with usual care.”

Association of Intensive vs Standard Blood Pressure Control With Cerebral White Matter Lesions: What is an appropriate target for systolic (the “upper number”) blood pressure control? This research used brain imaging measures and concluded 120 was better than and older target of 140.

Public Comment on Draft Recommendation Statement and Draft Evidence Reviews: Screening for Illicit Drug Use, Including Nonmedical Use of Prescription Drugs: Many media outlets reported that the US Preventive Task Force recommended screening all adults for illicit drug use. The reporting was not quite correct, reinforcing that going to the original source is important. While “The Task Force found that clinicians should screen all adults for illicit drug use [and] More research is needed to make a recommendation for teens,” these were part of a draft recommendation statement open for comment until September 9.

Evaluation of the Cascade of Diabetes Care in the United States, 2005-2016: Control of blood sugars, lowering high cholesterol levels and blood pressure, and eliminating smoking are all important in mitigating the long term effect of diabetes. However, these researchers found that these factors have not improved significantly between 2005 and 2016. These gaps in care particularly affect “younger adults (18-44 years), women, and nonwhite individuals…” Another instance of knowing what to do but not doing it.

Roles of cyberbullying, sleep, and physical activity in mediating the effects of social media use on mental health and wellbeing among young people in England: a secondary analysis of longitudinal data: Adverse behavioral outcomes from excessive social media exposure is a recognized problem. Why it occurs and what to do about it are not always clear (other than cutting out use entirely). Researchers found that mental health “harms related to very frequent social media use in girls might be due to a combination of exposure to cyberbullying or displacement of sleep or physical activity, whereas other mechanisms appear to be operative in boys.” Clearly solutions need to be tailored, especially by gender.