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 authorspropose 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.”