Today's News and Commentary

About the public’s health

Congress reaches deal to fund gun violence research for first time in decades: As part of the budget compromise, Democrats were able to get funding for gun violence research: $12.5 million each for the Centers for Disease Control and Prevention (CDC) and National Institutes of Health. Previously the Republicans had held up such funding.

From Border Security To Tobacco Age, Both Parties Tout Key Wins In Spending Deal: Another benefit from the budget compromise is raising the national smoking age to 21.

Flexible Hierarchical Wraps Repel Drug-Resistant Gram-Negative and Positive Bacteria: Diverse solutions have been offered to stem the spread of pathogenic bacteria, This latest one is unique: “a flexible plastic wrap that combines a hierarchical wrinkled structure with chemical functionalization to reduce bacterial adhesion, biofilm formation, and the transfer of bacteria through an intermediate surface. These hierarchical wraps were effective for reducing biofilm formation of World Health Organization-designated priority pathogens Gram positive methicillin-resistant Staphylococcus aureus(MRSA) and Gram negative Pseudomonas aeruginosa by 87 and 84%, respectively.”

Association of E-Cigarette Use With Respiratory Disease Among Adults: A Longitudinal Analysis: Recently, the acute (often fatal) consequences of e-cigarette use has been in the news. This study looks at long term effects of such use. The authors found: “Use of e-cigarettes is an independent risk factor for respiratory disease in addition to combustible tobacco smoking. Dual use, the most common use pattern, is riskier than using either product alone.”

Chili Pepper Consumption and Mortality in Italian Adults: “In a large adult Mediterranean population, regular consumption of chili pepper is associated with a lower risk of total and CVD death independent of CVD risk factors or adherence to a Mediterranean diet. Known biomarkers of CVD risk only marginally mediate the association of chili pepper intake with mortality.”

About health insurance

Congress poised to repeal HIT, medical device and 'Cadillac' ACA taxes as part of spending deal: “Congress is expected to repeal the Affordable Care Act’s (ACA's) health insurance, medical device and ‘Cadillac’ taxes as part of a must-pass spending agreement set to be passed this week.” With the continued repeal of sources of income to operate the ACA, how will it be able to function?

Judge strikes down AHA's bid to halt CMS' site-neutral payment cuts for 2020: In September, U.S. District Court Judge for the District of Columbia Rosemary Collyer ruled that CMS could not impose site-neutral payments on hospitals. (Site neutral payments do not increase hospital compensation just because a service was performed there.) However, that ruling only applied to 2019. Yesterday she ruled that starting Jan. 1 the cuts can continue. “The ruling means that hospitals could face a 60% reduction in Medicare payments for off-campus hospital outpatient departments.”

Moody's: Insurers' 2020 outlook stable, though political, legal risks loom: “Moody’s projects health insurers will continue to see strong earnings growth amid stable economic and demographic trends, with financial growth likely in the mid- to high-single digits. That’s slightly below 2019, with some headwinds coming from the potential reinstatement of the Affordable Care Act’s (ACA's) health insurance tax and from the cost of an aging population. 
Moody’s also estimates that medical costs will continue to increase, though the industry has made strides in mitigating those expenses. Short-term trends, such as growth in Medicare Advantage enrollment and the growing number of pricey specialty drugs, could negate some of those gains.” The report was issued before the above story about elimination of the health insurance tax as part of the federal budget negotiations.

U.S. government extends deadline to sign up for Obamacare insurance plans: Because of online glitches, CMS has extended the ACA enrollment deadline to tomorrow. With a surge in signups the past couple days and the extension, enrollment totals may be on track to match recent years’ numbers.

CVS subsidiary accused by DOJ of fraudulent billing: “The federal government has joined a lawsuit alleging Omnicare, a subsidiary of CVS Health, fraudulently billed Medicare, TRICARE and Medicaid for thousands of drugs. 
The Department of Justice on Tuesday joined the whistleblower suit (PDF) that charges Omnicare dispensed hundreds of thousands of drugs to elderly patients at thousands of long-term care facilities between 2010 and 2018.”

About healthcare quality and safety

Top Hospitals: The Leapfrog Group just issued its annual top hospital report. Some very interesting omissions of academic medical centers nationwide.

About healthcare IT

CMS Made an Estimated $93.6 Million in Incorrect Medicare Electronic Health Record Incentive Payments to Acute-Care Hospitals, or Less Than 1 Percent of $10.8 Billion in Total Incentive Payments: The headline speaks for itself. Reasons for the errors are in this report from the Office of the Inspector General of HHS.

About pharma

Inaccessible Insulin: The Broken Promise of Eli Lilly’s Authorized Generic: “To assess the impact of authorized generics, like ‘Insulin Lispro,’ on patients’ access to insulin, the Offices of U.S. Senator Elizabeth Warren and U.S. Senator Richard Blumenthal conducted a national telephone survey of pharmacies to determine if they had access to and were providing patients with the lower-cost authorized generic version of Humalog insulin. The investigation found that, contrary to the promises made by Eli Lilly, the vast majority of patients who seek to use this less expensive drug are not able to obtain it at their local pharmacy. Specifically, a 50-state survey of 190 chain and 196 independent pharmacies reveals that:
…In 83% of pharmacies surveyed, the less expensive, authorized generic promised by Eli Lilly was not in stock and available for consumers…
Pharmacies are unaware of and not adequately informing consumers about the availability of Eli Lilly’s authorized generic insulin. In many cases, consumers cannot get the generic version of a drug if they do not know to ask for it…”

Today's News and Commentary

About the public’s health

Characteristics of Americans With Primary Care and Changes Over Time, 2002-2015: “From 2002 through 2015, a decreasing proportion of Americans had an identified source of primary care, especially Americans who were younger, less medically complex, of minority background, or living in the South…” The reasons are detailed and can be addressed by proper structural reforms.

FDA clears Boston Scientific's disposable duodenoscope, the world's first: “The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients by the notoriously difficult-to-clean devices…” The cost has not been released.

The Next Vaping:Big Tobacco claims to have created a safer cigarette. Is unleashing it a big mistake?: A store in a retail mall in Atlanta is the first to offer a Philip Morris International product that is an electrified cylinder that can be kept in your pocket. The “IQOS” device is “the first in what’s expected to be a new class known as ‘heated tobacco’ or ‘heat not burn’ products. They’re not vaping or smoking, but another way of inhaling the addictive stimulant nicotine.” The product is available only to those over 21 who claim to be smokers. What as-yet unknown side effects will this version of nicotine delivery system cause?

Georgia Is Funneling Millions of Dollars to Fake Abortion Clinics: In 2017, the Georgia law “Positive Alternatives for Pregnancy and Parenting Grant Program” went into effect to fund “crisis pregnancy centers. (CPCs).” By June 2020, these centers will have received at least $6.7 million in funding. Vice reports that the CPCs  “are nonprofits that are typically religiously affiliated and claim to provide free, legitimate medical services but actually use deceptive language on their websites and in their advertisements to get pregnant people considering abortion to walk through their doors. Once there, staff members and volunteers who typically lack medical training give the client faith-based misinformation about abortion, dissuade them from terminating their pregnancy, or tell them they have more time to think about it.”

About health insurance

Out-Of-Network Billing And Negotiated Payments For Hospital-Based Physicians (Health Affairs, full article access requires subscription): “Using data for 2015 from a large commercial insurer, we found that at in-network hospitals, 11.8 percent of anesthesiology care, 12.3 percent of care involving a pathologist, 5.6 percent of claims for radiologists, and 11.3 percent of cases involving an assistant surgeon were billed out of network. The ability to bill out of network allows these specialists to negotiate artificially high in-network rates. Out-of-network billing is more prevalent at hospitals in concentrated hospital and insurance markets and at for-profit hospitals. Our estimates show that if these specialists were not able to bill out of network, it would lower physician payments for privately insured patients by 13.4 percent and reduce health care spending for people with employer-sponsored insurance by 3.4 percent (approximately $40 billion annually).” Unfortunately Congress is unlikely to act soon on this fixable, serious problem.

About healthcare IT

Cigna to expand AI-enabled medication management solution: “An artificial intelligence system that tracks chronic disease treatment will soon be available to all Cigna and Express Scripts employer clients…
Health Connect 360 relies on medical, pharmacy, lab and biometric data and analytics tools from both Cigna and Express Scripts to track patients' medication adherence, trigger alerts regarding health data and missed medications, and offer personalized recommendations to address any gaps in care. This information can also be automatically fed into EHR systems.”

Krounda Medical fined $85K for failing to give patient access to EHR data: The fines levied by the HHS Office for Civil Rights (OCR) are usually for unauthorized data leaks. This instance shows the breadth of possible penalties. In only the second case of its kind, the OCR found that Korunda medical group failed to provide requested medical records to a third party, and “also failed to provide them in the requested electronic format and charged more than the reasonably cost-based fees allowed under HIPAA…”

Prevalence and Factors Associated with Family Physicians Providing E-Visits: “Fewer than 10% of family physicians provided e-visits. Physicians in HMO and VA settings (ie, capitated vs noncapitated models) were more likely to provide e-visits, which suggests that reimbursement may be a major barrier.”

Today's News and Commentary

About pharma

House passes Speaker Nancy Pelosi’s drug pricing bill: But the bipartisan Senate version is different and a reconciliation is not expected before year’s end.

About health insurance

Billions in Estimated Medicare Advantage Payments From Chart Reviews Raise Concerns: The HHS Inspector General is concerned about the inaccuracy of risk adjusted payments to Medicare Advantage organizations (MAOs). The calculations, supported solely through chart reviews, “raise potential concerns about the completeness of payment data submitted to CMS, the validity of diagnoses on chart reviews, and the quality of care provided to beneficiaries.” One obvious problem is “that over 99 percent of chart reviews… added diagnoses” while deletions are not being made. Another finding is that “CMS based an estimated $2.7 billion in risk-adjusted payments on chart review diagnoses that MAOs did not link to a specific service provided to the beneficiary―much less a face-to-face visit.” Better review of these conditions is recommended.

Medicare to Make Good on Millions in Back Payments to Hospitals: “The American Hospital Association estimates that hospitals were shorted some $380 million in Medicare payments in 2019 under the “site neutral” payment policy implemented by the Centers for Medicare & Medicaid Services.”

About the public’s health

Grocers Amp Up Customer Health, Wellness Programs: “Of the respondents, 85% reported employing registered dietitians, with 70% of those at the corporate level and 27% of those at the regional level. One in three grocery stores reported having an in-store clinic for shoppers.”

Today's News and Commentary

About the public’s health

America’s Health Rankings: The United health Foundation released its rankings of the health of individual states. Notice the geography of the healthiest versus least health states.

Top 10 health-related questions consumers asked Google in 2019: An interesting list…do the questions correlate with what professionals target? For example, # 3 is: “How to get rid of hiccups.”

Senate confirms oncologist Stephen Hahn as FDA commissioner: The headline speaks for itself.

Antibiotic prescribing without documented indication in ambulatory care clinics: national cross sectional study: “Antibiotics were prescribed during 13.2%… of the estimated 990.8 million ambulatory care visits in 2015. According to the criteria, 57% (52% to 62%) of the 130.5 million prescriptions were for appropriate indications, 25% (21% to 29%) were inappropriate, and 18% (15% to 22%) had no documented indication. This corresponds to an estimated 24 million prescriptions without a documented indication. Being an adult male, spending more time with the provider, and seeing a non-primary care specialist were significantly positively associated with antibiotic prescribing without an indication. Sulfonamides and urinary anti-infective agents were the antibiotic classes most likely to be prescribed without documentation.”

Home is now the most common place of death in the U.S.: Not really a public health issue for patients, but certainly affects those caring for them. Knowing preferences can help our health system structure appropriate supportive resources.

About healthcare professionals

2019 Fall Applicant, Matriculant, and Enrollment Data Tables: The American Association of Medical Colleges published its 2019 data on medical schools. Matriculation is up 1.1% and for the third year in a row, women comprise the majority of matriculants. Those three years have added up- for the first time, women are now the majority of all medical students.

Military Health System in the Crosshairs: The military healthcare system will now be divided between taking care of battlefield casualties and all other healthcare needs (including the Tricare system for families of active service and retirees.)

US Geographical Variation in Rates of Shoulder and Knee Arthroscopy and Association With Orthopedist Density: Unlike treatment of some other conditions, the differences in rates of performance of these orthopedic procedures are not explained by density of those professionals.

Primary Care Physicians’ Role In Coordinating Medical And Health-Related Social Needs In Eleven Countries (Health Affairs, subscription required for entire article): “Compared to physicians in other countries, substantial proportions of US physicians did not routinely receive timely notification or the information needed for managing ongoing care from specialists, after-hours care centers, emergency departments, or hospitals. Primary care practices in a handful of countries, including the US, are not routinely exchanging information electronically outside the practice. Top-performing countries demonstrate the feasibility of improving two-way communication between primary care and other sites of care.”

About pharma

Walmart will continue accepting paper prescriptions in 2020, but for how long?: The message in the headline updates a previous blog post.

About health insurance

New IRS rule will help lower drug costs for those with chronic conditions: In order for someone to enroll in a Health Savings Account plan, they must be subject to an IRS-determined deductible. Recognizing the financial burdens of chronic diseases, the “IRS recently released formal guidance that allows insurers who sponsor high-deductible health plans (HDHPs) linked to health savings accounts (HSAs) to cover 14 essential services used to treat chronic diseases like diabetes and asthma before patients hit their deductibles.” Notice that the guidance “allow insurers.” We will need to see if they structure the benefits to help out these members.

Today's News and Commentary

About healthcare IT

DOJ to review Google's $2.1B deal to buy Fitbit amid data privacy concerns, according to media reports: The headline speaks for itself.

Top health industry issues of 2020: Will digital start to show an ROI?: This report is the 14th annual PwC review of where healthcare is going. It is more than just IT, but tat is the headline’s theme. Always worth a read.

About healthcare professionals

U.S. Physician Employment Report 2019: There is a mismatch between the top paid specialties and those in greatest demand.

Private equity may be repeating mistakes with physician practice management companies: This article is a great summary about why physician practice management companies failed in the 1990s…and why current efforts are repeating the same mistakes.

About the public’s health

FDA can regulate e-cigarettes just like conventional cigarettes, appeals court says: The headline speaks for itself.

About pharma

Democrats, White House forge new North American trade deal: The healthcare aspect is that ”Democrats succeeded in tossing overboard a 10-year protection for manufacturers of new drugs, including so-called biologics, that had won reprieve from lower-cost competition in the original accord.”

Pelosi reaches deal with progressives to avert showdown over drug price bill: The compromise that speaker Pelosi reached is to “increase the minimum number of drugs subject to negotiation under the bill from 35 to 50 and…extend protections against drug price spikes to people on employer-sponsored health insurance plans, not just those on Medicare.”

Pelosi drug pricing plan would save $456 billion over 10 years: “The bill would also provide dental, vision and hearing benefits to Medicare beneficiaries, with the CBO putting the cost at $358 billion over 10 years. In all, the CBO estimates the bill would reduce the deficit by $5 billion over 10 years.” See the above article; the estimate is based on price control for 30 drugs.

Civica Rx to ship 8 critical drugs to member hospitals by year-end: The hospital-owned pharma company will add 8 more drugs to its portfolio to help avoid shortages. The drugs are ones that are in common use, like heparin and morphine.

Foreign Drug Inspections Decline as FDA Hiring Struggles Continue: “The US reliance on imported pharmaceuticals and ingredients is rising as foreign drug facility inspections decreased by about 10% from 2016 to 2018. Part of the reason for the decline: The US Food and Drug Administration (FDA) said it’s still struggling to hire new inspectors.”

Today's News and Commentary

About pharma

Sanofi exits diabetes, CV research in strategy shake-up as it prioritises key growth drivers Dupixent, vaccines: “The company said it would instead focus growth efforts on Dupixent (dupilumab) and vaccines, while also highlighting several potentially ‘practice changing’ therapies in its pipeline. ‘Additional core drivers include treatments for oncology, haematology, rare diseases, neurology, and [our] strong presence in China,’ Sanofi added.” In general, pharma companies are trimming their scope of investments in disease categories.

AMA urges Walmart to delay policy that restricts patients' access to critical drugs : “Walmart will only accept electronic prescriptions for controlled substances starting in 2020… But, the AMA said that a majority of physicians in the U.S. cannot provide electronic prescriptions for controlled substances, as 44 percent of them don't have the technology, hardware and certifications required.”

Patient Charity Settles DOJ Allegations it Helped MS Drugmakers Pay Kickbacks: “Orlando-based patient charity The Assistance Fund (TAF) agreed to pay $4 million to settle allegations that it helped pharmaceutical companies pay kickbacks to Medicare patients taking their multiple sclerosis drugs. TAF is the third foundation to settle allegations of kickbacks.”

About the public’s health

Federal Courts Have Diminishing Appetite For Claims Of Obesity Discrimination: “The U.S. Court of Appeals for the Seventh Circuit, which is based in Chicago, joined three other federal circuits earlier this year in a ruling that limits the protection of extremely obese workers under the Americans with Disabilities Act (ADA).
The ADA prohibits discrimination against employees and job applicants who have physical or mental impairments that substantially limit ‘major life activities.’
Four federal circuits now have ruled that obesity is not a qualified impairment under the ADA unless it is shown to be the result of an underlying “physiological disorder or condition.”  No federal circuit has issued a contrary ruling.”

Supreme Court rejects challenge to Kentucky abortion ultrasound law: “The Supreme Court on Monday rejected a challenge to a Kentucky law requiring doctors to describe ultrasound images and play fetal heartbeat sound to abortion seekers…The court rejected the case without comment or noted dissent by any of the justices…The law had been upheld by the 6th US Circuit Court of Appeals, but that ruling was on hold pending the Supreme Court appeal.” This case was significant for what it might portend as more abortion-related cases come before the court.

About health insurance

Improving Serious Illness Care in Medicare Advantage: New Regulatory Flexibility for Supplemental Benefits: This monograph from Duke is an excellent summary of the current status of supplemental benefits offered by Medicare Advantage plans.

Republicans, Democrats Diverge in Views of Own Healthcare: For example, in answer to the Gallup Poll question: “Are you generally satisfied or dissatisfied with the total cost you pay for your healthcare?”, 73% of Republicans said yes, while only 52% of Democrats answered affirmatively.

More Americans Delaying Medical Treatment Due to Cost: In a related story, 34% of Democrats said they or a family member delayed care in the past 12 months because of costs. The Republican figure was 15%.

About healthcare IT

Patients intrigued by digital health services, but still value face-to-face interactions: “When asked to consider a hypothetical health plan that offered these virtual visits and online services, 45% of respondents said they would be willing to pay more for them, averaging $25 per month across all respondents. 
But when required to prioritize, respondents ranked other aspects of healthcare interactions -- like high-quality interactions with their doctor -- much higher than access to digitized services.”

Oracle Health Sciences Participates in TOP Tech Sprint: “Oracle Health Sciences is once again participating in The Opportunity Project (TOP) Technology Sprint: Creating the Future of Health.
This year’s entry joins Oracle technology with de-identified precision oncology open data sets from the United States Department of Veterans Affairs and the National Cancer Institute. The demo will highlight how Artificial Intelligence (AI) and customer experience solutions could be used to connect cancer patients with available clinical trials and experimental therapies.”

Today's News and Commentary

About healthcare quality and safety

New rule on 'bad actors' means more work for practices: “Effective November 4, 2019… CMS will now require Medicare, Medicaid and Children’s Health Insurance Program (CHIP) providers and suppliers to disclose certain affiliations they may have with other providers and suppliers who are ‘bad actors,.’.. [who] may include providers or entities who have had previous negative interactions with CMS, such as having been previously sanctioned, experienced a payment suspension, been excluded from federal programs, had billing privileges denied, revoked, or terminated or an outstanding debt owed to the government (including federal student loans). It does not matter whether these particular issues were corrected by the affiliated person or entity, only that they occurred.”

Access, Quality, And Financial Performance Of Rural Hospitals Following Health System Affiliation [Health Affairs, subscription required] : “Following health system affiliation, rural hospitals experienced a significant reduction in on-site diagnostic imaging technologies, the availability of obstetric and primary care services, and outpatient nonemergency visits, as well as a significant increase in operating margins (by 1.6–3.6 percentage points from a baseline of −1.6 percent). Changes in patient experience scores, readmissions, and emergency department visits were similar for affiliating and nonaffiliating hospitals. While joining health systems may improve rural hospitals’ financial performance, affiliation may reduce access to services for patients in rural areas.”

About healthcare IT

Health system deploys cost calculator to offer patients price transparency: University Health Care System in Augusta, Georgia, has a website calculator that allows patients to enter some demographic data, the procedure code and their insurance policy number. They can then receive an estimate of their out of pocket expenses. The system claims to be 95% accurate.

10 largest data breaches of 2019: The headline speaks for itself. The top three breaches are by labs affecting a combined 21.8 million people.

AR and VR technology may eclipse use of 3D-printed models: While 3D printing has made significant strides in helping to guide treatments, this article explains how augmented and virtual reality may provide more benefits at a low cost.

About pharma

FDA Testing Levels of Carcinogen in Diabetes Drug Metformin: On the heels of the investigation of ranitidine for containing nitrosamines, the FDA is conducting similar studies on metformin. The difference this time around is that there are many substitutes for ranitidine, but metformin is the starting drug of choice for oral treatment of Type 2 diabetes.

What side effects? Problems with medicines may be vastly underreported to the FDA [Stat+, subscription required]: The headline speaks for itself. For some classes of drugs only about 1% of side effects are reported. Project question: How can we increase reporting of these events? Is it an IT issue or something else?

FDA Seeks to Speed Insulin Biosimilar Approvals with New Guidance: “…acting FDA Commissioner Brett Giroir highlighted the upcoming transition on March 23, 2020 of all approved New Drug Applications (NDAs) for biological products to approved Biologicals License Applications (BLAs), noting the change will mean that currently-approved insulin products can be listed as reference products for biosimilars and interchangeables products. 
’The availability of approved biosimilar and interchangeable insulin products is expected to increase access and reduce costs of insulin products,’ he said.”

Biotech companies defend prices of one-off gene therapy [Financial Times, subscription required]: Biotech companies are trying to justify the extreme prices for their newer treatments by pointing out that a lifetime of therapy is often given in a short period of time and gene therapy potentially provides a total cure. Further, some costs, like home care and lost wages, are often not included.

About the public’s health

US flu season arrives early, driven by an unexpected virus: “The U.S. winter flu season is off to its earliest start in more than 15 years…There are different types of flu viruses, and the one causing illnesses in most parts of the country is a surprise. It’s a version that normally doesn’t abound until March or April.”

About health insurance

House-Senate fix could break gridlock on 'surprise' medical bills: “Leaders of the House Energy and Commerce Committee and the chairman of the Senate health panel announced a deal Sunday they said would rely on ‘a new system for independent dispute resolution often called arbitration.’ The lawmakers didn't elaborate…
But while there was bipartisan desire to help consumers, nearly every health sector wanted somebody else to foot the bill when a patient inadvertently sees an out-of-network provider.”

Democrats open door to repealing ObamaCare tax in spending talks: Both major parties still need to agree on a permanent appropriations bill for this year. In order to garner bipartisan support for the funding, Democrats say they are open to repealing the ObamaCare's Cadillac tax, which has never gone into effect, but is scheduled to start in 2022. It “was meant to keep health care costs down by discouraging overly-generous ‘Cadillac’ health insurance plans.” This offer is not new, since earlier this year the House voted to repeal the measure (419-6).

Implementing a Statewide Healthcare Cost Benchmark: “Seeking methods to better understand and control healthcare costs, states are assessing how to build on Massachusetts’ benchmarking model, since adopted, in varying forms, by three other states: Delaware, Rhode Island, and Oregon. All four states share common elements of the program: establishing a statewide cost benchmark; collecting data to measure health spending against the benchmark; publishing health spending reports to identify systemic cost drivers; and using a variety of levers, including public hearings and performance improvement plans (PIPs), to enhance transparency and contain spending growth that exceeds the benchmark.”

Medicare Advantage [MA] rebates to hit new highs in 2020: “Medicare pays plans through bids, where plans submit bids that are compared to a benchmark amount. If a bid is lower than the benchmark, the plan gets a rebate. The benchmark is based on a formula that looks at traditional Medicare costs for the geographic area where the plan is based.
Rebates have been steadily increasing for MA plans from 2016 to 2020.” Rebates are also linked to quality performances.
These data speak to the overall strengths of the MA plans.

About medical devices

RightEye’s Parkinson’s Diagnostic Gets Breakthrough Status: “RightEye received a breakthrough designation from the FDA for the RightEye Vision System, a device that helps assess patients for Parkinson’s disease.
The device records and analyzes data on patient eye movement in search of persistent ocular tremors that are caused by the disease. The data can help doctors both diagnose the disease at an earlier stage, the company said.” If this device proves itself in continuous real-world use, it could be a real breakthrough in diagnosis and screening.

About healthcare professionals

Higher physician compensation driven by demand, not productivity: Higher physician compensation is driven by the increasing institutional demand to hire, not by physician productivity or value-based compensation.

Today's News and Commentary

TODAY’S MUST-READ

National Health Care Spending In 2018: Growth Driven By Accelerations In Medicare And Private Insurance Spending: Every year Health Affairs publishes a summary of national healthcare costs by category and explains changes, which usually have different causes from year to year. This open-access article is the latest update. One major take-away is: “Much of the faster spending growth in 2018 was associated not with expenditures for goods and services but instead with the net cost of health insurance (the amount of insurance spending attributed to nonmedical expenses, including administration, taxes, and underwriting gains or losses). The net cost of health insurance grew more rapidly in 2018, increasing 13.2 percent after growing 4.3 percent in 2017. The faster growth in 2018 was driven primarily by the health insurance tax, a fee that was reinstated in 2018 following a one-year moratorium in 2017.”

About health insurance

Americans Still Favor Private Healthcare System: According to a recent Gallup poll: “Americans continue to prefer a healthcare system based on private insurance (54%) over a government-run healthcare system (42%). Support for a government-run system averaged 36% from 2010 to 2014 but has been 40% or higher each of the past five years.”

ACA health coverage enrollments down 300K from same time last year: After a slow start, enrollment accelerated and it looked like it was on track to match last year’s numbers. The figures are now 300,000 behind the same time last year. “CMS reported that technical issues prevented some people from choosing a 2020 plan on the first day of open enrollment, which may have contributed to the lower sign-up total.”

MedPAC: Hospitals got $201B in Medicare payments last year, a 3.6% bump from 2017: “While payments to hospitals overall grew by 3.6% last year, payments for outpatient services increased by 7.2% under Medicare’s Outpatient Prospective Payment System. The reason for the hike was due to increases in physician-administered drugs in Part B and new and expensive drugs.
Another reason was hospitals shifting services from inpatient to outpatient departments…”

About pharma

House Republicans will unveil their own drug pricing bill as countermove to Nancy Pelosi: House Republicans met to craft their own drug pricing bill in anticipation of Speaker Pelosi’s release of her plan next week. In the meantime the bipartisan Senate bill, cosponsored by Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) is still on the table. We need to see how the details of all the proposals will get reconciled; but most policy experts do not see any law being passed before year’s end.

The top 15 biopharma M&A mistakes of the last decade: The article is an interesting overview of where biopharma companies “went wrong” in the last decades. Lots of material for case discussions.

About the public’s health

More than 6 million US middle and high schoolers used tobacco products in 2019, report says: The CDC survey “found that 1 in 3 high school students and around 1 in 8 middle school students are current tobacco users, meaning they had used the product at least once in the 30 days.
For the sixth year in a row, e-cigarettes were the most commonly used tobacco product among high school and middle school students. More than 55% of students reported using e-cigarettes only. Other tobacco products used by students included cigars, cigarettes, smokeless tobacco, hookahs and pipe tobacco.
More than 53% of high school students and more than 23% of middle school students reported ever trying a tobacco product.” Clearly we still have a big problem. The most successful strategy to lower smoking rates has been to increase prices (mostly through taxes).

About healthcare IT

Deep learning identifies colorectal cancer tumors with 100 percent accuracy: Combining visual inspection during colonoscopy with “deep learning,” called optical coherence tomography (OCT), can detect nearly 100% of tumors.

Today's News and Commentary

About hospitals and health systems

Hospital groups file lawsuit to stop Trump price transparency rule: The previous strategy was to delay implementation because of its complexity. Now, the American Hospital Association (AHA), among other hospital groups, is suing the Centers for Medicare and Medicaid Services (CMS) claiming that the transparency rule “violates the First Amendment by provoking compelled speech and reaches beyond the intended meaning of ‘standard charges’ transparency in the Affordable Care Act.”

About pharma

The most viable drug pricing bill in Congress is getting a makeover: “Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) are poised to unveil a 2.0 version of their Prescription Drug Pricing Reduction Act of 2019, which caps out-of-pocket costs for Medicare enrollees and requires drugmakers to pay rebates if they hike prices faster than inflation.” The White House supports this bipartisan effort.

About healthcare IT

The Pros and Cons of a National Patient Identifier (NPI) System: This article provides a good update on the NPI system. The pros basically center on enhanced interoperability, while the cons focus on privacy concerns.

Today's News and Commentary

About pharma

DOJ inks price fixing settlement with small generics player. Will others follow?: “Under a deferred prosecution agreement, Rising Pharmaceuticals admitted to price fixing and working with a competitor to rig the market on” hypertension drug Benazepril HCTZ. Seems like the DOJ’s strategy is to go after the smaller companies before finalizing agreements with such giants as Teva.

Amgen snags another Enbrel outcomes-based payment deal as it seeks to prop up aging blockbuster: One strategy companies are now using to extend revenue from drugs going off patent is inking deals with payers for outcome-based payments. In the latest of these deals, Amgen signed an outcomes-based contract for use of Enbrel with pharmacy benefits manager (PBM) Abarca.

Senate panel advances Trump’s nominee for FDA commissioner: The Senate Committee on Health, Education, Labor and Pensions approved Dr. Stephen Hahn to be the next Food and Drug Administration commissioner, sending his nomination to the full Senate. 

Comments on Pelosi drug pricing bill: The White House Council on economic advisors issued two cautions about Speaker Pelosi’s drug pricing bill. The first claim is that it will cost $1 trillion per decade due to lost innovations. The related concern is that by lowering drug prices and thus stifling innovation, the country will be deprived of 100 new drugs over that time. These figures don’t jibe with other estimates. For example, the “CBO analysis estimated Ms. Pelosi's bill would save Medicare $345 billion over seven years and result in eight to 15 fewer drugs hitting the market…” The assumption is that the forgone new drugs would be of significant public value, not “me-too” medications.

About the public’s health

HHS seeks to end HIV epidemic with Ready, Set, PrEP initiative: The U.S. Department of Health and Human Services announced a new initiative to help to to end the HIV epidemic by 2030: “The Ready, Set, PrEP program, which will make pre-exposure prophylaxis (or PrEP) medications available at no cost for qualifying patients…
HHS will initially be covering the costs of dispensing medication, but after March 30, 2020, CVS Health, Walgreens and Rite Aid will be donating their pharmacy dispensing services to the government agency, allowing consumers access to free PrEP medications either in person or via no-cost delivery by mail. Patients will also have access to counseling and steps to promote medication adherence.”

Survey: 37 percent of Americans plan to skip flu vaccine this season: “A survey conducted by NORC at the University of Chicago found those who don't plan to get shots have concerns about the side effects of the vaccine or think it doesn't work very well.
Others said they never get the flu, don't like needles or are concerned they will get the flu from the vaccine.”
This public health problem creates a real opportunity for effective social marketing initiatives.

Today's News and Commentary

About pharma

Walgreens, Kroger sue drugmakers, allege $2.8B in overcharges for diabetes med: “According to the lawsuit, Assertio and Santarus entered into a pay-to-delay deal with Lupin in 2012 to ensure the generic drugmaker wouldn't release a cheaper version of the diabetes drug [Glumetza] until 2016.
The deal allegedly allowed the brand-name drugmakers to hike prices, leading to $2.8 billion in overcharges.”

U.S. considers easing drug protection to break deadlock over trade pact: Wall Street Journal:”The Trump administration is considering scaling back intellectual-property protections [from 12 to 10 years] for biologic drugs… to help win Democratic support for a new trade pact with Mexico and Canada…”

Astellas dives into gene therapy with $3-billion deal to buy Audentes Therapeutics: Another multibillion dollar transaction, as large pharma companies seek to add gene therapies to their portfolios. Other recent activity includes Novartis' $8.7-billion purchase of AveXis and Roche’s ongoing effort to complete its $4.3-billion acquisition of Spark Therapeutics.

About health insurance

Affordable Care Act open enrollment figures jump in Week 4: Early in the enrollment preriod signups were lagging behind last year. Now with “less than two weeks to enroll, both the number of new and renewing consumers increased this year over last.”

Trends in Peritoneal Dialysis [PD] Use in the United States after Medicare Payment Reform: Show me how someone is paid and I will tell you how they behave:
“In 2011, the Centers for Medicare and Medicaid Services (CMS) implemented the ESKD [End Stage Kidney Disease] prospective payment system (PPS), which altered payment for dialysis treatment by bundling dialysis, medications, and ancillary services into a single payment, adjusted for patient- and facility-level characteristics . The PPS also provided a training add-on for home dialysis. Because PD has historically been associated with lower costs than HD [hemodialysis], dialysis facility revenues under the PPS were expected to increase by $330 per month for PD and decrease by $117 per month for in-center HD. Thus, it was anticipated that the PPS would increase supply and use of PD across the country…In the initial years after Medicare payment reform, late PD use increased significantly, as more patients initiated dialysis with PD and more patients switched from HD to PD. Our results suggest that Medicare’s PPS for dialysis may be achieving one of its intended goals in the initial years of payment reform implementation.”

OIG expects to recover $5.9B in fraud investigations, doubling last year's haul: “The Office of Inspector General (OIG) recovered $5.9 billion from fraud investigations during fiscal year 2019, according to a semiannual report (PDF) to Congress released Monday.” When was the last time you heard of private insurers being bilked for that kind of money?

ACOs saved Medicare $755M from 2013 to 2017, new analysis finds: “The analysis found that net federal savings for the Medicare Shared Savings Program (MSSP), which oversees the 518 ACOs in the program, was $755 million from 2013 to 2017.” The savings were not evenly spread across organizations.

No Itch to Switch: Few Medicare Beneficiaries Switch Plans During the Open Enrollment Period: “Overall, a small share of MA-PD [Medicare Advantage- Prescription Drug Plans] and PDP [Free-standing Prescription Drug Plans] enrollees without low-income subsidies (8% and 10%, respectively) voluntarily switched to another plan during the 2016 annual open enrollment period for the 2017 plan year... more than one in three (35%) Medicare beneficiaries living in the community said it is very or somewhat difficult to compare Medicare options, and this share increased among beneficiaries in fair or poor self-reported health (44%) and with five or more chronic conditions (40%). In 2017, nearly half (45%) of people on Medicare living in the community said they rarely or never review or compare their Medicare options; the share was substantially higher among beneficiaries ages 85 and older (57%).” Since prices and out of pocket provisions can change substantially from year to year, there needs to be a way to reach to to seniors to help them make correct decisions. The online tools are there, they just need to be able to use them.

Reconciliation limitations led CMS to overpay hospitals $500M: “Hospitals were overpaid by roughly $502 million from 2011 to 2014, according to a report from the Office of Inspector General (OIG), which blamed the overpayment on CMS limitations on the reconciliation period.
Sixty hospitals were paid $502 million more in net outlier payments than they were owed, the report found…
According to OIG, the payment errors were not found by CMS because they didn’t meet the reconciliation requirements of a 10% threshold of cost reports. Hospitals charged higher prices than the rate of cost increases below the 10% threshold, which meant their cost-to-charge ratio (CCR) didn’t trigger reconciliation. CMS set this threshold because the agency believed it would capture the outlier payments that were substantially inaccurate.”

Today's News and Commentary

About healthcare quality and safety

Patient Photo on Health Record Curtails Medication Errors: The headline speaks for itself.

About pharma

Mylan and Biocon Launch Trastuzumab Biosimilar, Ogivri™ (trastuzumab-dkst), in the U.S.: This drug is a biosimilar to often-used breast cancer drug Herceptin.

About healthcare IT

A consumer-centered future of health: The findings are from Deloitte’s 2019 global health care consumer survey, focusing on consumer’s views of IT use. Among the findings:

• “Increasing use of technology and willingness to share data: A growing number of consumers are using technology for measuring fitness, ordering prescription drug refills, and monitoring their health… Many consumers are willing to share their health data in various scenarios.

• Interest in and use of virtual care: Consumers appear to be warming up to the idea of virtual health. More than half of those who have seen a care provider virtually report being satisfied and would likely have another virtual visit.

• High levels of self-efficacy and prevention behaviors: People today seem more willing to tell their doctors when they disagree…

• Use of tools to make decisions about prescriptions and care: Consumers are interested in using tools to compare pricing and for user reviews. This tends to be highest in countries where consumers have more exposure to out-of-pocket spending…

• Interest in emerging technologies: Between 20 and 35 percent of people expressed interest in technologies leveraging robotics and artificial intelligence (AI) for health care, preventive care, monitoring, and caregiving.”

Today's News and Commentary

About healthcare IT

USDA Invests $42.5M in Rural Distance Learning and Telemedicine: “The U.S. Department of Agriculture says that it is investing $42.5 million in 133 distance learning and telemedicine projects in 37 states and two territories. The projects, which will be funded through the USDA Distance Learning and Telemedicine (DLT) grant program, could impact 5.4 million rural residents.”

I Invented the World Wide Web. Here’s How We Can Fix It (NY Times, subscription may be required): This editorial is by Sir Tim Berners-Lee who invented the WWW at CERN in Geneva, Switzerland. (See Chapter 8, Information Systems, in the book). He decries that “…prejudice, hate and disinformation are peddled online. Scammers use the web to steal identities, stalkers use it to harass and intimidate their victims, and bad actors subvert democracy using clever digital tactics. The use of targeted political ads in the United States’ 2020 presidential campaign and in elections elsewhere threatens once again to undermine voters’ understanding and choices.” To address these and other problems he explains the Contract for the Web.

About pharma

HHS Proposes ‘Most Favored Nation’ Approach to Lower Drug Prices: “An HHS proposed rule currently under review at the Office of Management and Budget would have the U.S. pay less than other developed countries for some Medicare drugs by using a “most favored nation” approach, HHS Secretary Alex Azar said.”

Qualitative study on the price of drugs for multiple sclerosis: Pharma executives say the high price of medications is needed to recoup R&D expenses. But this study of confidential interviews with insiders in those companies yields different explanations.
”Participants consistently stated that initial price decisions were dictated by the price of existing competitors in the market. Revenue maximization and corporate growth were drivers of price escalations in the absence of continued market penetration. Lower revenue predictions outside the United States also informed pricing strategies. The growing complexity and clout of drug distribution and supply channels were also cited as contributing factors. Although decisions to raise prices were motivated by the need to attract investment for future innovation, recouping drug-specific research and development costs as a justification was not strongly endorsed as having a significant influence on pricing decisions [emphasis added].”

About hospitals and health systems

Partners rebrands to Mass General Brigham: The headline speaks for itself.

About healthcare quality and safety

Association of the Work Schedules of Hospitalists With Patient Outcomes of Hospitalization: “Hospitalist schedules promoting inpatient continuity of care may be associated with better outcomes of hospitalization.” What a surprise!

About health insurance

The $11M dollar Medicare tool that gives seniors the wrong insurance information: The online tool that helps Medicare beneficiaries choose Part D drug plans recently underwent an $11million “improvement.” Yet this article provides many examples of how the new version provides incorrect information about plan choices. Having used the old tool for family members every year since it was available in 2005, I can vouch that it worked. If it isn’t broke…

Today's News and Commentary

About health insurance

Brigham Young University-Idaho reverses decision to reject Medicaid coverage for students: Bowing to public pressure, the BYU-Idaho campus reversed its policy to reject Medicaid coverage as evidence of health insurance for students. See yesterday’s story.

Proposed Rule Would Require Health Plans to Disclose Out-of-Pocket Costs by Providers: “In a proposed regulation to be published Nov. 27 in the Federal Register, federal agencies suggest a rule that would require employer-sponsored group health plans to provide plan enrollees with estimates of their out-of-pocket expenses for services from different health care providers. Plans would make this information available through an online self-service tool so enrollees could shop and compare costs for services before receiving care. 
Comments are due by Jan. 14, 2020, on the transparency-in-coverage rule issued by the departments of Health and Human Services, Labor and the Treasury.”

About the public’s health

CDC recommended that migrants receive flu vaccine, but CBP rejected the idea (Washington Post, subscription may be required): Customs and Border Protection refused to administer flu shots to immigrants. They obviously forgot the issue is not providing free care to non-citizens, but protecting the health of citizens.

About pharma

Trump draws ire after retreat on drug prices pledge: “President Trump is backing off his 2016 campaign pledge to negotiate drug prices for Medicare with pharmaceutical companies, drawing fire from Democrats after months of talks on the issue with Speaker Nancy Pelosi (D-Calif.).”

Generic drugmakers in talks to end long-running US antitrust probe: The headline speaks for itself.

Today's News and Commentary

About healthcare quality and safety

Superbugs should be entered as a cause of death on death certificates, say experts: It is hard to quantify a problem if the data is not being gathered. People who die from “superbugs” (antibiotic-resistant bacteria) have causes of death attributed to such “generic” reasons as sepsis. This article calls for more precise data capture.

About health insurance

University to Students on Medicaid: Buy Private Coverage, or Drop Out (NY Times, subscription may be required): Brigham Young University requires students to have health insurance to be eligible to enroll- a situation not unlike most universities and colleges. However, effective in 2020, its Idaho campus will not accept Medicaid as an insurer. The other part of the story is: “The policy change is likely to push more students into a health plan administered by Deseret Mutual Benefits Administration, which, like the university, is owned by the Church of Jesus Christ of Latter-day Saints.
That plan limits annual benefits and doesn’t cover birth control — provisions that would violate the Affordable Care Act, but for a little-noticed Obama-era exemption for universities that fund their own health plans.” The rule and unethical nature of these moves speak for themselves.

UnitedHealthcare to Open Member Medicare Services Centers in Select Walgreens Stores: This offering is for insurance enrollment and other such business issues. It is not a clinical center.

2020 Global Medical Trends Survey Report: Willis Towers Watson just released its annual report of employer-sponsored health insurance. “The cost of medical care is rising at a similar rate to previous years, a rate that remains relatively stable. The global trend is for a projected 6.8% increase in 2020 where in 2019 it was 6.7%. The most dramatic rise is in the Middle East and Africa, where costs are expected to jump to 9.3% from 8.5%. The European rate of increase will remain stable at 4.3%, and in Latin America medical costs are projected to decrease from 12.2% to 11.7%.” Of course individual countries can vary widely from regional averages. Of significance is that within the next five years, “27% of health insurers predicted that mental and behavioral conditions will be among the three most common conditions, and 26% predict that they will be among the three most expensive.” Also, pharmacy “services cost increases appear to be slightly moderating compared with prior years outside of the U.S.”

2 physician payment model advisers abruptly resign from MACRA committee: “Two members of a government advisory committee tasked with overseeing physician-focused payment models abruptly resigned out of frustration with federal agencies, according to their resignation letters.” Harold Miller, president and CEO of the Center for Healthcare Quality and Payment Reform, said: “I do not want to be part of a process that misleads physicians and other stakeholders into thinking that if they develop a good physician-focused payment model, go through the rigorous review process PTAC has established, and receive a positive recommendation, they will have a chance of seeing their work implemented.”

Moody's: Higher deductibles, surprise billing legislation will increase hospitals' bad debt: The headline speaks for itself.

About healthcare technology

Best inventions 2019: Check this Time Magazine list of best inventions, including a section on healthcare.

About healthcare IT

VA reports 235% increase in video telehealth visits in FY19: “The Department of Veterans Affairs, which already has the country’s largest telemedicine program, delivered more than 2.6 million episodes of telehealth care in Fiscal Year 2019.”

VA put millions of people, including doctors, at risk of identity theft, agency audit finds: “The Department of Veterans Affairs (VA) put millions of people, including medical professionals, at risk of identity theft by disclosing their Social Security numbers in copies of veterans' benefits claims, an agency audit found.
When responding to veterans' requests for copies of their medical benefits claims, the VA failed to redact personally identifiable information of other service members and doctors treating the veteran, according to a report from the VA Office of Inspector General (OIG). That information included names and Social Security numbers.”

Hospital alarms prove a noisy misery for patients: ‘I feel like I’m in jail.’ (Washington Post, subscription may be required): “Alarms have ranked as one of the top 10 health technological hazards every year since 2007, according to the research firm ECRI Institute. “ And according to the Joint Commission, “an estimated 85 to 99 percent do not require clinical intervention.” So why are devices measuring irrelevant information? What information do we really need to monitor patients to make sure they are safe?

About the public’s health

Obesity declined among toddlers on food assistance after Obama-era reforms. But now enrollment is falling (Washington Post, subscription may be required): “In a report released this week, researchers found the obesity rate among more than 12.4 million 2- to 4-year-olds enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) dropped from 15.9 percent in 2010 to 13.9 percent in 2016.” The reason? “Starting in 2009, WIC state agencies were required to provide food packages that hewed more closely to the U.S. Dietary Guidelines for Americans as well as infant feeding practice guidelines of the American Academy of Pediatrics. This led to increased availability of fruits, vegetables, whole grains and lower-fat milk for WIC enrollees.”

Trump Warns a Flavor Ban Would Spawn Counterfeit Vaping Products (NY Times, subscription required): The headline says it all. By analogy, maybe we should legalize heroin so we can eliminate its black market.

About pharma

Novartis to acquire The Medicines Company for USD 9.7 bn: This acquisition is today’s biggest business story. Novartis was looking to get into the next generation cholesterol-lowering space by adding adding inclisiran to its portfolio.

Medicine Price Index 2019: This report quantifies how much more we pay than other countries. It also gives examples of specific drugs.

Harvard, MIT spearhead $50M manufacturing center to speed cell, gene therapy R&D: Universities usually produce the product (or science behind it), leaving manufacturing to private companies. Now MIT and Harvard are partnering with other Massachusetts life sciences players to set up a new manufacturing center projected to open in 2021.

Miscellaneous

29 best-managed healthcare companies: “Twenty-nine healthcare companies made the Management Top 250, a ranking that measures corporate effectiveness developed by the Drucker Institute.” The top fourteen of these are product companies.

Today's News and Commentary

About healthcare IT

Google runs into data fears over $2.1bn Fitbit deal:Privacy concerns over access to non-regulated health information on 27m users (Financial Times, subscription required): Not long after Google announced its deal to buy Fitbit, legislators are calling for the deal to be called off because of privacy fears.

About healthcare professionals

Lawmakers introduce bill to fund more medical residency slots to combat physician shortage, opioid crisis: “Senate and House lawmakers introduced a bill that would fund 1,000 additional medical residency positions in the next five years to address an anticipated physician shortage and to combat the ongoing opioid crisis.
The Opioid Workforce Act of 2019 (S. 2892/H.R. 3414) would fund additional Medicare-supported graduate medical education positions in hospitals that have or are in the process of establishing approved residency programs in addiction medicine, addiction psychiatry or pain management.”

About hospitals and health systems

Hospitals' uncompensated care continues to rise: “Large hospitals with more than 250 beds saw their uncompensated/unreimbursed costs increase to $39.7 million in 2018, up from $33.2 million in 2015, growing at an average annual rate of 6.2%, according to Definitive data. Meanwhile, the average for hospitals with less than 25 beds reached $2.3 million in 2018, up from $1.8 million in 2015, increasing at an average annual rate of 8.5% a year. 
Uncompensated/unreimbursed costs at system-owned hospitals reached $15.6 million in 2018, up from $13.7 million in 2015. That compared to independent hospitals' average of $5.8 million in 2018, rising from $4.9 million in 2015. The average annual increase at system-owned hospitals was 4.6%, compared to 6% at independent facilities.”
Uncompensated care should not be confused with free or charitable care. Analysis of the reasons for the rise in these amounts revealed a major cause is increasing individual out-of-pocket expenses, like deductibles.

About the public’s health

Most Intended Home Births in the US Are Not Low Risk: 2016-2018: Although “natural” home births are sometimes preferred, this research provides some caution for the practice in the US. “Our study shows that well over 60% of all intended home births in the US are not low risk and have at least a single or several combined obstetric risk factors.”

Today's News and Commentary

About pharma

Circular ecDNA promotes accessible chromatin and high oncogene expression (Nature, subscription required, though you can read the abstract): This article explains the potential for treating cancers by modifying extra-chromosomal DNA.

Walgreens opens first VillageMD site: These sites are primary care clinics in or next to the drug stores.

About healthcare IT

(Another) roadblock identified in VA, DOD transition to Cerner EHR: This article updates the increasing delay of implementing Cerner systems in the VA.

About health insurance

Addiction and mental health vs. physical health: Widening disparities in network use and provider reimbursement: The headline tells the story. This report is a detailed analysis by the actuarial firm Milliman.

Tennessee becomes first state to ask permission for Medicaid block grants: Despite yesterday’s news about the government rethinking block grants, Tennessee is asking for a waiver to change how it gets paid for Medicaid.

Higher Costs for Workers and Their Families: This Commonwealth Fund study looks at individuals’ insurance costs by state. Which have the highest deductibles? Four of the top six are in New England (NOT Massachusetts).

In This Democratic Debate, Health Care Issues Took A Back Seat: Not much new on healthcare in last night’s debate (unless you count family leave policy). This article is a good short summary of the debate’s healthcare content.

FINALLY (This article defies classification)

Top Trump health official spent $3 million on contractors who helped boost her visibility:The health official is CMS administrator Seema Verma.

Today's News and Commentary

About pharma

31 biopharmas at high risk of bankruptcy in 2020: Interesting piece about biopharma firms at high risk of bankruptcy next year. The most well-known is Teva. “While bankruptcy is a rare outcome for biopharmas, 2019 has bucked that trend with an uptick in Chapter 11 filings. Eleven companies have declared bankruptcy so far this year, compared to an average of four per year during the past decade, according to a review of data tracked by the firm BankruptcyData.”

Big Pharma has failed: the antibiotic pipeline needs to be taken under public ownership: Interesting analysis of the problem and one solution.

Regulatory agenda lays out timetable for major rules on drug pricing, interoperability: “The Trump administration estimates it will release rules on drug prices and information blocking this month but punted finalizing a rule on interoperability until as late as 2022.” The Nifty Pharma Index hit a two month high today.

Generic-Drug Approvals Soar, But Patients Still Go Without (Wall St. Journal, subscription required): Nothing new in this article for those keeping track of this issue. But it is a nice summary of the problems bringing generics to market after FDA approval- particularly lawsuits by the brand manufacturers. The tactics pharma companies use to extend patents is extensively discussed in Chapter 7, Technology, in the text.

About health insurance

House stopgap funding bill delays payment cuts to safety net hospitals for a month: “The House passed on Tuesday on a stopgap government funding bill that includes a month delay of $4 billion in payment cuts to safety-net hospitals.
The bill, which passed by a vote of 231 to 192 and heads to the Senate, would delay the cuts to disproportionate share hospitals (DSH) until Dec. 21.” The cuts were mandated by the ACA.

Anthem plans sue for $100M in federal payments: What is unusual about this story is that usually small plans (like the startup COOPs) have sued the federal government for not paying for losses based on promised risk-corridor payments.

CMS withdraws guidance on Medicaid block grants from OMB website: No reason was given for this action; however, “CMS Administrator Seema Verma announced last week that the federal government will issue new guidance outlining initial opportunities for states to test new Medicaid financing approaches, such as block grant and per capita cap proposals, for certain optional adult populations.”

About the public’s health

Primary Care Appointment Numbers Dropping, Despite ACA: Reasons range from longer appointments to alternatives such as televisits. Specialist and ER visits have not increased.

Today's News and Commentary

About health insurance

Health insurance stocks rally as 'Medicare for All' threat weakens: For example, Senator Warren said she would phase in an insurance plan and only propose her Medicare for All plan in the third year of her presidency.

Press Release Finance, Insurance, and Health Care 2018-2019: The American Consumer Satisfaction Index ranked service industries, including healthcare. While this sector ranks lower than others, this year it registered the highest scores in a decade. Read about the rankings of the major plans.

Open enrollment: 83% selecting Medicare Advantage choose plans with $0 premiums: “The number of consumers selecting such plans represent an increase from the 76% who did so last year.”

An Analysis of Charity Care Provided by Hospitals Enrolled in the 340B Discount Program:
“…analysis confirms the average amount of charity care provided by 340B hospitals has declined since 2011, with nearly two out of three 340B hospitals consistently providing below average rates of charity care.”

Medicare improper payment rate fell as new fraud prevention efforts take hold: “The improper payment rate for federal fiscal year 2019 was 7.25%, a decrease from 8.12% in fiscal year 2018, according to a release from the Centers for Medicare & Medicaid Services (CMS) Monday. This is the third consecutive year that the improper payment rate for fee-for-service payments fell below 10%.” Yet Medicare still Lost $31.6 billion in preventable billing errors in FY2018.

Medicare buy-in for older Americans could raise premiums for younger consumers: This article is a summary of a much more complex RAND analysis of a Medicare buy-in plan. (Note: this plan is NOT Medicare for All.) A few interesting takeaways:

1. Buy-in could attract between 2.8 million and 7.0 million older adults

2. Creating a Medicare buy-in program for individuals between the ages of 50 and 64 would lower premiums for that age group but also increase premiums for younger consumers on the individual market. While most Medicare premium costs for older Americans would be $10,000 per year in 2022 under a buy-in program, premiums would increase between 3% to 9% for younger consumers.

3. Savings for an average 50-year-old buying into Medicare would be $2,500 less than buying a gold-level plan on the insurance exchanges established by the Affordable Care Act (ACA). Meanwhile, an average 60-year-old would save $8,000 per year for the same plan (the gold plan—which has an actuarial value comparable to Medicare.

4. The savings result from lower payments to providers than with private plans.

About pharma

Orphan Drug May Be Frequently Used Off-Label, Inflating Revenue, Letter Suggests: This case study provides great examples of what is wrong with protections on orphan drugs. Two examples: First, for many of these medications much of the profit comes from off-label use. Second, this medication has three orphan indications. For pricing, total sales are not considered as long as one indication is for orphan purposes.

About healthcare quality

New AHA/ACC Performance and Quality Statement on Hypertension: “The American Heart Association (AHA) and the American College of Cardiology (ACC) have jointly published new clinical and performance quality measures for adults with high blood pressure (HBP).
The comprehensive paper, which focuses on diagnosis and treatment of HBP, includes 22 new measures and expands the existing model of care by focusing not only on BP control targets but also on broader care delivery systems and approaches.” While attention to quality details is laudable, do we really need 22 new measures? As quality programs proliferate we need to be aware of the administrative burden of all these measures and scale back to look at fewer key factors that are sufficient to measure performance.

Today's News and Commentary

About healthcare technology

Stents and bypass surgery are no more effective than drugs for stable heart disease, highly anticipated trial results show: These findings were presented Saturday at the annual meeting of the American Heart Association ahead of publication in a peer-reviewed journal. The ISCHEMIA study showed that conservative medical treatment (with drugs and lifestyle changes) did just as well as more invasive therapies. Rather than say one treatment is better than another, therapy can be customized to a patient’s age and normal level of activity without worry that inferior care is being provided.

CMS to implement new appropriate use criteria for advanced diagnostic imaging in 2020: “Starting Jan. 1, the Centers for Medicare & Medicaid Services (CMS) will implement new appropriate use criteria (AUC) that will require ordering professionals to consult a qualified Clinical Decision Support Mechanism (CDSM) prior to ordering Medicare Part B advanced diagnostic imaging services for a patient that will take place in those settings.” Claims won't be denied during 2020, but starting Jan. 1, 2021, claims must include information regarding consultation with a CDSM in order to receive payment. Pre-authorization is widespread for private insurance but has not been used with Medicare services before. Portents of other changes?

FDA approves first contact lens to slow childhood nearsightedness: “The FDA has approved its first contact lens designed to effectively slow the progression of nearsightedness in children, starting in ages 8 to 12.”

About pharma

Pfizer scores FDA nod for biosim to AbbVie's Humira, but it'll have to wait til 2023 to launch: When the generic is available it will make a big difference in cost for this frequently used medication.

Bristol-Myers’ $74B Celgene buy wins antitrust nod in FTC party-line split vote: The surprise here is that the approval was not unanimous.

Trump says U.S. states will be able to buy prescription drugs abroad: “‘I’m going to be giving governors the right very shortly to buy ... their prescription drugs from other countries,’ Trump said at a White House event accompanied by Health and Human Services (HHS) Secretary Alex Azar, among other officials.”

About healthcare IT

Is it 1970 or 2019? Nine in 10 in healthcare industry still using fax machines, survey finds: The headline tells the story.

New York estimates state HIE saves up to $195M annually in care spending: ” New York estimates that its statewide health information exchange reduces healthcare costs by $160 million to $195 million dollars annually.
Savings generated by the Statewide Health Information Network for New York (SHIN-NY) includes significant savings for both Medicaid and Medicare programs within the state.
Even if just current users of the HIE used its full capabilities, nearly $1 billion could be saved annually in costs associated with duplicate testing, avoidable hospitalizations and readmissions, and preventable emergency department visits, the state’s research notes.”

Apple launches app to let users enroll in health studies: “People who download the research app would be able to enroll in studies including Apple Women’s Health Study, Apple Heart and Movement Study and Apple Hearing Study, the company said in a study. 
After enrolling, participants using Apple Watch and iPhone can contribute useful data around movement, heart rate and noise levels, captured during everyday activities, from taking a walk to attending a concert. Users can also control the type of data they wish to share with each study.”
The question is: Will such data gathering methods skew reports because of exclusion of non-tech savvy patients?

Google almost made 100,000 chest X-rays public — until it realized personal data could be exposed: In 2017, two days “before Google was set to publicly post more than 100,000 images of human chest X-rays, the tech giant got a call from the National Institutes of Health, which had provided the images: Some of them still contained details that could be used to identify the patients, a potential privacy and legal violation. This Washington Post piece. that came from a freedom of information filing, points out how precarious privacy measures are, even when large, well-respected organizations are involved.

Janssen drops clinical sites for smartphones, wearables in 100% virtual Invokana study: “Johnson & Johnson’s pharmaceutical arm Janssen is launching its first completely virtual clinical trial, using personal smartphones and wearable devices to track participants with no in-person site visits required. The decentralized study, dubbed CHIEF-HF, aims to gather real-world evidence to support a new cardiovascular indication for its diabetes drug Invokana (canagliflozin).”

About the public’s health

Trump Retreats From Flavor Ban for E-Cigarettes (NY Times, subscription may be required):
“…under pressure from his political advisers and lobbyists to factor in the potential pushback from his supporters, Mr. Trump has resisted moving forward with any action on vaping, while saying he still wants to study the issue.”

CDC: The jobs with the highest rates of suicide in the U.S.: Interesting comparison of differences by sex— very different sector ordering,

About health insurance

New York Medical Clinics head convicted in nearly $100M kickback, money laundering scheme: The details of the scheme are in the article; but it raises a question I have previously asked: When did you see such a fraud perpetrated on the private sector?

CMS releases proposed and final rules to make hospitals and insurers post prices, cost-sharing information: “The Trump administration released a final rule to require hospitals to publish payer-negotiated prices and a proposal to mandate insurers post online real-time cost-sharing information.” Covered entities will have until 2021 to comply (previously the date was 1/1/2020).

Blues plans to launch high-performance network nationwide in 2021: “The Blue Cross Blue Shield Association (BCBSA) revealed this week that its member plans would offer Blue HPN [High Performing Network] beginning in January 2021. The network will be available in 55 markets across the U.S. 
Jennifer Atkins, vice president of network solutions at BCBSA, told FierceHealthcare that the goal in launching the network was to build on the plans' existing value-based and patient-centered models.” Multi-location employers should be particularly interested in this initiative.