Today's News and Commentary

About the public’s health

China seeks to boost certified elderly caregivers by 2 million: As the global population gets older, there is an increased need for trained caregivers. Sweden has had such a program for years and pays the providers a fair wage. In this country, many such workers are poorly educated and are paid low wages. It is interesting to see a country like China take a lead in an important healthcare initiative.

Sweet excess: How the baby food industry hooks toddlers on sugar, salt and fat: The headline speaks for itself. The article also has dietary recommendations. Is there a role for governmental intervention in this problem (aside from the already-required labeling)? What would a social marketing campaign look like that would promote demand for and consumption of healthier baby food? Should food subsidies (like WIC) only cover healthy choices?

What’s in my baby’s food?: IF YOU ARE FEEDING CHILDREN PROCESSED BABY FOOD, READ THIS STUDY! Healthy Babies Bright Futures tested 168 commercially available baby foods and found that 95 percent contained one or more toxic heavy metals- Arsenic 73%, Lead 94%, Cadmium 75%, Mercury 32%.
The report has suggestions for substitute foods that will lower the exposure.

About pharma

CMS' Verma touts value-based pricing—not negotiation—for high drug prices: While the Democrats are advocating price controls for drugs, Republicans want to peg payments to a value-based system. How that would be done is yet to be determined.

Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs: Acting FDA commissioner Sharpless, announced: “I’m delighted to share that our fiscal year 2019 figures overall show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals). This breaks our all-time record of 971 for fiscal year 2018. Additionally, in fiscal year 2019 we approved 125 applications for first generics of medicines that had no generic competition.”

About health insurance

A View from the States: Key Medicaid Policy Changes: Results from a 50-State Medicaid Budget Survey for State Fiscal Years 2019 and 2020: This article is a great summary of five policy areas that state Medicaid directors think will be important in the next fiscal year. It has many specific examples as well.

About healthcare IT

Microsoft, Nuance developing ambient and AI technology to tackle doctors' documentation headaches: Entering documentation in the EMR is a tedious and time-consuming task, contributing to physician burnout. The tech development is truly “next generation.” It is “designed to ‘listen’ to physician-patient conversations, with the patient's consent, during a doctor's visit. ACI [Ambient Clinical Intelligence] then synthesizes the conversation, integrates the data with contextual information from the EHR and updates the patient’s medical record. The technology also provides workflow, task and knowledge automation.”

Today's News and Commentary

About the public’s health

Children’s Drinks: Food Advertising to Children and Teens 2019: This study is a very complete analysis of how unhealthy drinks are marketed, with recommendations to address the problem. You can also check what drinks your kids may be consuming.

California Governor’s Bill-Signing Marathon Offers Glimpse Of 2020 Issues: California has been at the forefront of a spectrum of healthcare reforms. This article is a great summary of those initiatives which could become models for national or other local agendas.

About healthcare information systems

AI platform screens for diabetic retinopathy in 60 seconds: This AI platform will do a retina screens on undilated pupils in 60 seconds with an accuracy of 95.5%. Currently its status in the U.S. is for investigational use only; it is not yet available for sale. If it proves accurate and the cost is reasonable, these devices can be placed in primary care offices.

About health insurance

Accountable Care Organizations in the United States: Market and Demographic Factors Associated with Formation: Researchers are looking at the institutional success/failure factors for ACO performance. This research looks at environmental settings that may influence that performance. The conclusion is: “Much of the US population resides in areas where ACOs have been established. ACO formation has taken place where it may be easier to meet quality and cost targets. Wider adoption of the ACO model may require tailoring to local context.”

Physician-Led Accountable Care Organizations Outperform Hospital-Led Counterparts: On the same theme of ACO savings, “analysis from Avalere finds that physician-led accountable care organizations (ACOs) in the Medicare Shared Savings Program (MSSP) outperformed hospital-led ACOs by a significant margin. Additionally, MSSP ACOs continue to achieve higher savings the longer they participate in the program.” Why are physician-led organizations so much better? They are closer to patient care decisions that look at alternatives to hospital care and wasteful high cost diagnostics and treatments. Why do they pay more attention to this management in the ACO setting than in fee for service? With respect to fee for service care, I am reminded of what Upton Sinclair said : “It is difficult to get a man to understand something, when his salary depends upon his not understanding it!”

Promoting access to Medicare hospice benefit could save taxpayers, benefit underserved communities: “Racial and ethnic minority patients with terminal illnesses are much less likely to enter hospice care than their white counterparts—even when controlling for socioeconomic factors such as age, education, income and area population. There is also evidence that addressing this issue will save the Medicare program millions of dollars.”

Sutter Health, California settle massive antitrust case: “One of California’s largest hospital systems has reached an agreement to settle a massive class-action lawsuit over allegations that it abused its market power and has been overcharging patients for medical bills…
The antitrust lawsuit against Sutter Health, which operates 24 hospitals with 5,500 doctors across Northern California, was first brought by employers and unions in 2014 and later joined by California’s attorney general, Xavier Becerra, who filed a similar lawsuit last year after a six-year investigation.”

Schumer seeks focus on health care amid impeachment fever: “Senate Democrats plan to force vulnerable Republicans to vote on legislation that would overturn a controversial Trump administration directive on ObamaCare…Schumer is taking advantage of a little-known law, the Congressional Review Act, which allows the minority party to seize the initiative to overturn an administrative rule as long as it’s done within a certain time period.” There is little chance it will pass, but it forces Republicans to make public their views on healthcare.

Top Republican rejects Democratic chairman's approach to stopping surprise medical bills: “The top Republican on the House Ways and Means Committee on Wednesday rejected a proposal from the Democratic chairman of the panel to protect patients from surprise medical bills, saying a different approach is needed to solve the problem.” Another case of concordance in the goal but a difference of opinion about tactics that prevents action.

About pharma

House Democrats are pushing forward on their partisan drug-pricing bill (Washington Post- may require subscription): This article builds on yesterday’s report of progressive Democrats’ suggestions to modify Speaker Pelosi’s drug-pricing bill. While the modifications may be made before the vote, the more of them there are, the greater the Republican opposition. Again, the issue being argued is not the goal (lower drug prices), but how to do it.

The Bristol-Myers Squibb-Pfizer Alliance and Fitbit Collaborate to Address Gaps in Atrial Fibrillation Detection with the Aim of Accelerating Diagnosis: Why this deal is being done is not in the article, i.e., the pharma companies make anticoagulants (“blood thinners”) used in patients with atrial fibrillation.

Today's News and Commentary

About the public’s health

California pushes back school start times for middle and high school students: Teens have their own biological clocks, which have not been in synch with early school starts. California is making some changes to re-align school starting times.

Canada Opens the Door to Public Scrutiny of Clinical Drug Trials: This article explains that Canada and the EU make the application information for drugs and devices open to public review. The FDA treats that information as confidential.

Three drug distributors in negotiations to settle opioid litigation for $18 billion: report: “McKesson, AmerisourceBergen and Cardinal Health are in discussions to collectively pay $18 billion over 18 years to resolve multiple US opioid lawsuits…” The article updates the status of other settlement offers.

About health insurance

Elizabeth Warren takes heat for evasive answers on Medicare-for-all: Nothing new about healthcare from last night’s Democratic debate. Warren and Sanders still favor Medicare for All; Warren will not say anything about taxes for middle income people, while Sanders says taxes will go up; Biden wants to build on “Obamacare;” and others are for expanding solutions like Medicare for those who want it. We will need a much narrower debate field before we can nail down operational specifics. Also, read this story of a pre-debate poll of the public’s opinion of healthcare proposals and what candidates are not discussing: “58% of Democrats and Democratic-leaning independents believe the candidates are not spending enough time talking about women’s health, including access to reproductive health services, for instance. And more than half said the candidates were spending too little time discussing surprise medical bills and ways to lower the costs people pay for care.”

From Incremental to Comprehensive Health Reform: How Various Reform Options Compare on Coverage and Costs: READ THIS STUDY! The Urban Institute and Commonwealth Fund explain the cost and coverage of the major insurance proposals. Bottom lines for the two “extremes”: For expansion of the current system to achieve near-universal coverage: “Federal government spending would increase by $122.1 billion in 2020, or $1.5 trillion over 10 years.” For a single payer system with no out of pocket costs: “National spending on health care would grow by about $720 billion in 2020. Federal government spending would increase by $2.8 trillion in 2020, or $34.0 trillion over 10 years.” For the detailed analysis of eight proposals see: Urban Institute site or Commonwealth Fund site.

Federal judge overturns ObamaCare transgender protections: Remember Federal Judge Reed O’Connor of the Northern District of Texas? He was the one who ruled that the ACA is unconstitutional because there is no longer a penalty for not having health insurance. Yesterday he “overturned ObamaCare protections for transgender patients, ruling that a 2016 policy violates the religious freedom of Christian providers.” Undoubtedly, this decision will also be appealed.

House progressives plot overhaul of Pelosi drug pricing bill (Statnews- limited access): Some progressive House members are trying to tweak Speaker Pelosi’s drug pricing bill. It is a classic case if the perfect (or at least as they see it) being the enemy of the good. This action will only delay possible passage and implementation.

About diagnostics

Genealogy company Ancestry launches consumer genetic health testing as a rival to 23andMe: The headline explains the message. For more background on the regulation of such testing, see Chapter 7, Technology.

About healthcare quality and safety

Child dies in Cuba after receiving vaccine made in India. It’s not the first time: It is unclear if the problem was in the vaccine (MMR) or the liquid needed to prepare it for injection. Both are supplied by Serum Institute of India, which “produces 26 vaccines distributed in 80 countries, most of them with low or medium levels of income.” Investigation is underway.

About pharma

UK Bans ‘Parallel Export’ of 24 Drugs to Protect Supply: White House proposals to lower drug costs depend on importation of less costly medication from abroad. However, some countries face the same shortages as we do and they will limit their export to other countries. This example from the UK is one such instance.

FDA Clears First Transdermal Patch for Schizophrenia: This announcement is a great marketing case discussion. Assuming drug effectiveness, what was is the most important problem that needs to be addressed in medicating this population? (Hint: it is not needle injection avoidance.) Will the patch form of medication solve this problem?

About healthcare professionals

MGMA19: 7 predictions for what lies ahead in healthcare in 2020: What’s on the minds of Medical Group Management leadership? This article provides insights from the 2019 annual meeting. Those priorities are good marketing opportunities.

Today's News and Commentary

About health insurance

Practices will see another 'piddly' MIPS [payment, docs say at MGMA meeting: According to an estimate from the Medical Group Management Association (MGMA), in 2020 CMS’ Merit-based Incentive Payment System (MIPS) will, at most, pay 1.6% in bonuses. Although penalties also apply if targets are not met, there is a point after which the costs of compliance are greater than lost revenue. When calculating the upside of the “break even point,” practices should multiply the percent bonus possible by 80% of the allowable Medicare charge (the portion for which CMS is responsible).

3 areas of the Stark overhaul likely to give providers compliance headaches: This article provides some cautionary advice for those who think relaxation of the anti-kickback statutes will be an immediate boon to provider organizations,

About healthcare quality and safety

Overzealous in preventing falls, hospitals are producing an ‘epidemic of immobility’ in elderly patients (NY Times-subscription may be needed): Pros and cons exist to many measures intended to improve quality. This article explains how attempts at preventing elderly falls are resulting in greater immobility.

Comparative Efficacy of Interventions for Aggressive and Agitated Behaviors in Dementia: A Systematic Review and Network Meta-analysis (Annals of Internal Medicine- subscription required): An “easy” way to control aggressive and agitated patients with dementia is by giving them sedating medication. However: “ Nonpharmacologic interventions seemed to be more efficacious than pharmacologic interventions for reducing aggression and agitation in adults with dementia.”

About healthcare professionals

Interstate medical licensure by the numbers: This article is a good current summary of the Interstate Medical Licensure Compact (IMLC)- in which some states participate to enhance the ease of applications for physicians who want licensure in more than one state. Recall that for purposes of telemedicine, the physician must be licensed in the state where the patient resides.

About pharma

Scientists Designed a Drug for Just One Patient. Her Name Is Mila (NY Times- subscription may be required): This article explains the ultimate in personalized medicine- genetic treatment for a single patient. It raises issues of quality of life and resource use, including cost.

About healthcare IT

2019 Healthcare Consumer Study: This research has some interesting consumer attitudes about the healthcare system. One of the findings that was unusual was that 41% of responders said they would change to a provider who could offer a better digital experience. While different groups are more sensitive to digital experiences, we need to ask which specific digital features would be most important. Does it vary by age group, gender, health status or other factors? Also see this site.

Today's News and Commentry

About the public’s health

War on diabetes: Unhealthy label for high-sugar drinks, total ban on ads to be introduced in Singapore: At least one country is serious about this public health problem.

Trump EPA proposes overhaul of lead in drinking water rule, critics call plan weak: However, critics say “the rule slows down the removal of service lines where levels exceed 15 parts per billion to 33 years from the 13 years in the original rule.”

Lung function decline in former smokers and low-intensity current smokers: a secondary data analysis of the NHLBI Pooled Cohorts Study: Mark Twain is supposed to have said: “Giving up smoking is the easiest thing in the world. I know because I've done it thousands of times.” The “common wisdom” has been that lungs of former smokers can return to some baseline normal level after quitting. However, this study found that: “Former smokers and low-intensity current smokers have accelerated lung function decline compared with never-smokers. These results suggest that all levels of smoking exposure are likely to be associated with lasting and progressive lung damage.”

When a Steady Paycheck Is Good Medicine: “Forty-one nonprofit medical systems across the United States, plus four government providers, have formed the coalition, the Healthcare Anchor Network, with the mission of doing more business with local companies in the communities they serve. Most are concentrated in major American cities, from Chicago to Los Angeles.
The American health network is part of a global movement through which activists are pressuring companies to target spending toward improving local fortunes, rather than contracting with distant corporations.”

About health insurance

With health care costs projected to rise another 5% in 2020, employers look to new strategies to control costs: This 24th annual Best Practices in Health Care Employer Survey from Willis Towers Watson found that curbing “the cost of health care and increasing its affordability remain the top priorities for almost all employers over the next three years (93%).” Three strategies employers will use are controlling pharmaceutical costs (particularly high cost specialty drugs); implementing value-based programs; and focusing on employee well-being.

Government Watchdog Faults Trump Administration’s Approval of Medicaid Work Requirements (Wall Street Journal- subscription required): “The Trump administration has approved states’ plans to impose work requirements on people who get Medicaid even though estimated implementation costs are in the hundreds of millions of dollars,” according to a Government Accountability Office report.

About pharma

FDA guidance aims for loophole to avoid rebates: “FDA has completed a draft guidance that would create a legal loophole for drug companies to bypass legal commitments to pay rebates to PBMs and payers. The guidance, which is under review at the Office of Management and Budget, is intended to allow companies to sell drugs at net prices that don’t include rebate payments. 
If and when it is implemented, HHS believes the guidance would enable drug companies to create a parallel market that would function alongside regular supply chains. In this separate channel, imported drugs could be sold at lower list prices to patients who are uninsured or who have large deductibles. 
The guidance could also give companies the ability to free themselves from long-term contracts and negotiate new contracts for distributing drugs through conventional supply chains.”
The tracking of imported medications can be done through newly issued National Drug Codes (NDCs).This process has the potential to be a major disrupter of supply chains and how the pharma business is conducted.

Today's News and Commentary

About pharma

ICER [Institute for Clinical and Economic Review] Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence: “In 2017 and 2018, out of nine identified drugs that had substantial price increases on top of already high current spending, seven drugs had no new important evidence to support their price increases. The net price increases on these seven drugs alone cost American insurers and patients an additional $5.1 billion over two years.” The top 3 on the list are Humira® (adalimumab, AbbVie); Rituxan® (rituximab, Genentech); and Lyrica® (pregabalin, Pfizer). The other drugs and contributions of all to the excess costs are included in a table. Will Congress use this list to lower drug costs?

2020 Democrats embrace aggressive step on drug prices: Continuing the theme of high drug costs, “Democratic presidential candidates are threatening to take a drastic step that even the Obama administration rejected to lower drug prices without congressional approval.

 The move involves invoking an obscure section of a 1980 law to break the patent on a drug when it is priced too high. The idea, known as ‘march-in rights,’ would allow the government to ‘march in’ and break a patent to allow a cheaper version of a drug to be made by another company.”

J&J emerges unscathed in retried California talcum powder suit: This article is a nice summary of the status of the lawsuits against J&J for alleged contamination of baby powder with asbestos.

Jury smacks J&J with $8B Risperdal verdict, but will it stand up in appeals?: “Plaintiff Nicholas Murray sued the company in 2013 alleging his off-label use of Risperdal caused him to develop breasts. Risperdal was approved in 1993 to treat schizophrenia and bipolar mania in adults, but Murray alleged the drugmaker marketed its drug for unapproved uses [in his case, autism spectrum disorder] and didn't adequately warn about its risks.” J&J is appealing the jury award of $8 billion.

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: This guidance was prepared by the Office of New Drugs (Center for Drug Evaluation and Research (CDER)), in cooperation with the Center for Biologics Evaluation and Research(CBER),at the FDA. It is “the second in a series of four methodological patient-focused drug development (PFDD) guidance documents that the FDA is developing to describe in a stepwise manner how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.” In other words, the FDA is interested in gathering input from users of medical products, not just safety and efficacy data.  

AbbVie, Bristol-Myers Among Patient Advocacy Groups’ Big Backers: Abbvie, Bristol-Myers Squibb, Pfizer, Merck, AstraZeneca and J&J contributed more than $680 million to hundreds of nonprofit organizations last year. Many of those organizations are now lobbying against federal legislation to lower pharmaceutical costs. This article is a good analysis of this backdoor politics. See the graphic for how much each firm is contributing.

Priority Review Voucher Fees Cut for Fiscal Year 2020: “Effective Oct. 1, drugmakers will have to pay $2,167,116 million to redeem a priority review voucher for a newly approved drug or biologic for treatment of a rare pediatric disease, a tropical disease or for a medical countermeasure.” This change is part of the update in the FDA’s Medical Countermeasures Initiative.

About healthcare quality and safety

HHS Proposes Stark Law and Anti-Kickback Statute Reforms to Support Value-Based and Coordinated Care: So-called “Stark laws” were passed to prevent conflicts of interest in healthcare transactions. But recent trends in value-based care have required combinations of organizations and changes in payment incentives that would conflict with those laws. HHS has recognized these problems and is proposing changes explained in this statement. Links to OIG and CMS proposed rules are also at this website.

CMS launching tool on nursing home website to warn of abuse violations: “Later this month, the Trump administration will add an alert to its Nursing Home Compare website to warn consumers about homes that have been flagged for violations including abuse and neglect.
The Centers for Medicare & Medicaid Services (CMS) said the addition of the consumer alert icon is part of a larger approach to boost nursing home safety and quality.”

Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database: Post-marketing surveillance for product problems is an important FDA function. As previously reported in March, a Kaiser Health News report revealed that “the FDA had allowed device manufacturers to file reports of malfunctions in a hidden database.” That data base was closed in June. However, another reporting miscategorization is occurring through the Manufacturer and User Facility Device Experience (MAUDE) database. The authors of this report “found a substantial misclassification of patient deaths in the FDA’s MAUDE database for the Sapien 3 and MitraClip devices, which resulted in the underreporting of deaths…[which] raise concerns about the accuracy of adverse-event reports for high-risk devices.” Clearly the FDA needs to improve the process to ensure the public’s safety.

Hospitals and health systems

Commonspirit Health reports losses of $582M in first financial report since merger: “Chicago-based CommonSpirit Health posted a $582 million loss last year in the wake of the merger that created the Catholic health giant, officials reported this week.
The new health system—the largest nonprofit health system in the country by revenue—was created in February through a merger between Catholic Health Initiatives and Dignity Health.” The article provides more details about the loss and future plans for the organization.

About the public’s health

How PG&E’s historic blackouts will put California’s medical emergency planning to the test: Pacific Gas & Electric is shutting down power to hundreds of thousand of residents in northmen California, including in the San Francisco Bay area. The utility states that the measure is needed to prevent a recurrence of sparks that caused recent wildfires. Those who depend on electricity for medical devices and refrigeration for medications will be in trouble unless special emergency measures can be implemented.

About healthcare professionals

Changes and Variation in Medicare Graduate Medical Education Payments: “Graduate medical education (GME), the training of resident physicians, is funded by GME payments to hospitals and health systems, largely from Medicare and Medicaid…Medicare provides 2 types of GME payments to hospitals: direct medical education, based on the proportional Medicare patient load and the number of resident physicians; and indirect medical education, an add-on to Inpatient Prospective Payment System reimbursements based on a resident-to-bed ratio, such that hospitals with higher Medicare patient loads, resident physician-to-bed ratio, and Medicare reimbursements get paid more…. Medicare GME payments per resident FTE grew nearly 20% from 2000 to 2015, largely driven by increasing inpatient reimbursements. This raises the question of whether linking GME payments mechanically to inpatient reimbursements without assessing the association with teaching costs is sensible policy. The variation between hospital GME rates suggests some hospitals could support GME at lower payment rates. If Medicare GME were capped at the $150 000 rate of the Teaching Health Centers program, $1.28 billion would have been available for redistribution to address other US health workforce needs. Wide rate variation also suggests the need for caution and pacing in GME payment reform, with attention to how payment reductions may affect hospitals receiving lower payments.”

About healthcare IT

UnitedHealthcare launches new app with on-demand telemedicine: “UnitedHealthcare has launched a new app for its members that will make it far easier for them to access virtual visits around the clock. 
The app, which will be available for free on both Apple and Android devices, will allow UnitedHealthcare’s 27 million employer plan members to access on-demand telemedicine 24/7 alongside tools that allow them to track their benefits and compare pricing…” The article has a screenshot of the menu of quick links.

NLM [National Library of Medicine]taps EHRs, FHIR to improve sharing of medical research data: “The National Library of Medicine is developing analysis tools to mine electronic health records to help discover adverse drug reactions, identify promising drug targets and detect transplant rejection earlier.”

1.5 million patients' data exposed in September-reported healthcare breaches (Modern Healthcare- subscription may be required fro this article): ”Nearly 1.5 million people had data exposed in healthcare breaches reported to the federal government last month.
That's more than double the roughly 730,000 people who had data compromised in healthcare breaches reported the month prior.” The “top 10” are included.

About health insurance

Colorado proposes running public health care option through private insurers: As previously reported, some states are planning to implement their own public insurance options. Under Colorado’s plan (details of which have now been issued), insurers will administer the the state-designed insurance. “The plan, which the agencies are calling the ‘state option,’ will be available to Colorado residents who purchase their own insurance…
Under the proposal, the state will create a reimbursement fee schedule, basically setting rates for how much hospitals can receive in return for treating individuals on the public option plan. The state intends to set the rates between 175% to 225% of what Medicare charges for services, which is below the current average on the individual market.” Now that they have the prices checked, what are they going to do to control the volume and intensity of services?

Today's News and Commentary

About the public’s health

Walgreens and Kroger will stop selling electronic cigarettes: Retail outlets are joining state actions in cutting access to e-cigarettes.

HIV prevention drugs will be available without a prescription in California: This action is a major step in HIV prevention. What are the pros and cons of making prescriptions such as this available over the counter?

Review of Progress on Antimicrobial Resistance: Antimicrobial resistance is an important global public health problem. This study is a nice summary about the lack of progress addressing this issue and the reasons why it has become so prevalent. Of particular concern is the over-the-counter sales of antibiotics in low and middle income countries (LMICs), which substitutes for the availability of professional services. Further, the Review found that (no surprise) a “major reason for the use of antibiotics in LMICs is the prevalence of unhygienic conditions in the community and in healthcare facilities, which contribute to infection and limit the impact of messages about awareness and infection prevention and control.”

The Cannabis Effect on Crime: Time-Series Analysis of Crime in Colorado and Washington State: The authors conclude that: “results suggest that marijuana legalization and sales have had minimal to no effect on major crimes in Colorado or Washington. We observed no statistically significant long-term effects of recreational cannabis laws or the initiation of retail sales on violent or property crime rates in these states.”

U.S. firearm health rate rose sharply in recent years across most states & demographic groups: “In all, the United States saw a 14% rise in the rate of firearm deaths from 2015 through 2017, compared with the rate seen in the years 1999 through 2014.
During the entire 19-year period, 612,310 Americans died from firearm injuries that were self-inflicted, caused by others, accidental or of undetermined cause. Nearly one-fifth of the deaths happened in just the last three years of that time.” However, as the map in the article shows, there is wide variation is those rates- some (like California, NY and RI) even decreasing by about 12.5%. What makes some states successful and others very dangerous?

About pharma

FDA: US Heparin Supply Not Impacted by African Swine Fever in China: This article highlights the fragile value chain for US pharmaceuticals.

Does Zantac Break Down Into a Carcinogen?: A new development in the recall of ranitidine (Zantac):
“The generic Zantac that's being shelved across the country isn't necessarily ‘contaminated’ with N-nitrosodimethylamine (NDMA); rather, the carcinogen may stem from breakdown of the ranitidine molecule…The carcinogenic breakdown doesn't appear to be a class effect for H2 antagonists, and it doesn't seem to extend to proton pump inhibitors (PPIs), the other major heartburn drug class.” The question is why it has taken so long for this problem to surface when Zantac’s commercial launch was in 1981.

California bans pharma's infamous 'pay-for-delay' deals: “When generic challengers come for a branded med’s patent, drugmakers have in the past chosen to pony up and stall their rivals with an anticompetitive pact better known as “pay for delay.” In an effort to keep drug prices down, California is looking to end the practice.
California Gov. Gavin Newsom signed a new bill Tuesday that will make California the first state to ban pay-for-delay deals in pharma.”

Drug Super Spenders: 2016 to 2018 Growth in Number of Members and Total Pharmacy Plus Medical Benefit Drug Cost for Members with Extremely High Annual Drug Cost in a 17 Million Member Commercially Insured Population: This detailed summary highlights how few patients account for a large portion of pharma costs. For example: “In 2018, there were 4,869 members (0.0275% of all members) accounting for $2.119B drug spend, which was 8.6% of all drug spend.”

About health insurance

As Medicare enrollment nears, popular price comparison tool is missing: The enrollment site for Medicare plans was recently redesigned. In August, CMS Administrator Seema Verma said: “The new tool will provide more enhanced price and quality information.” However, “the plan finder can no longer add up and sort through the prescription costs plus monthly premiums and any deductibles for all those plans…Medicare officials say the total cost calculator will be fixed in time for the annual enrollment season, which starts nationwide Oct. 15 and runs through Dec. 7.” If not fixed, Medicare beneficiaries could spend thousands of dollars more per year by not closing the best plan. NOTE: Beneficiaries should check prices every year, since annual out-of-pocket costs can vary significantly.

MA [Medicare Advantage] insurer startup Devoted Health first to subsidize Apple Watch: The headline is self-explanatory. Apple is working to get approval from other plans as well.

Survey: Site of care, biosimilars key for employers to lower drug prices: Employers are trying to shift payment for these high cost pharmaceuticals to the drug benefit portion of insurance coverage and away from inpatient settings. The supposition is that they are more expensive in the latter setting. However, with payment methods like per diems and DRGs, the drug costs are part of the fixed costs of a hospital stay. So changing the method of payment instead of the site may offer more savings. Likewise, as more provider organizations change to value-based payments, payers will not have to worry how those firms handle internal charges.

Trump’s New Order For Medicare Packs Potential Rise In Patients’ Costs: A second look at last week’s executive order on Medicare reveals some surprises. One touted feature is that it makes it easier for individuals and physicians to contract outside of the Medicare system. Currently, that option is illegal unless physicians withdraw from the plan entirely (for a 2 year minimum). This action is supposed to help people find physicians who will take on Medicare patients. The problem with that reasoning is there is not a problem. Physician shortages (when they occur) are not caused by reluctance to see Medicare patients. The other issue is that all physicians who are part of the Medicare program must abide by CMS rules that limit the amounts they can charge patients. Making opt-out participation easier, patients may unknowingly be exposed to “surprise medical bills.”

Study: Coordinated care model cuts unscheduled hospital visits: Since 2012, Oregon has had a unique plan to care for its Medicaid population. It is based on Coordinated Care Organizations (CCOs), which have far more population control than Accountable Care Organizations. “Oregon’s 15 CCOs emphasize primary care, disease prevention and population health measurements, not just individual outcomes. They work with Medicaid patients under a lump sum payment system that rewards the CCOs for hitting certain quality standards, including efficient use of hospital emergency rooms.” This system has resulted in a decrease in preventable hospital admissions compared to pre-CCO implementation.

About healthcare quality and safety

Top 10 Health Technology Hazards for 2020: This annual list by the ECRI Institute is topped by “Misuse of Surgical Staplers.” See the article for the rest of the list.

About hospitals and health systems

Almost a year into rules requiring hospitals to post prices online, how are they doing?: The answer to the question posed by the headline emphasizes the great variability in actions. The article summarizes the responses. In addition to what they are (or are not doing), one problem is that some “hospitals made no or little attempt to translate medical jargon that describes what a procedure is into a format that patients could understand.”

Today's News and Commentary

About health insurance

Trump administration plans to delay any changes if the ACA loses in court: “The Trump administration, with no viable plan for replacing critical health benefits for millions of Americans, plans to seek a stay if a federal appeals court invalidates all or part of the Affordable Care Act in the coming weeks — and may try to delay a potential Supreme Court hearing on the matter until after the 2020 presidential election, according to current and former administration officials.”

Pre-Existing Condition Prevalence for Individuals and Families: If the ACA is entirely invalidated, the provision that prohibits exclusion of pre-existing conditions will be eliminated. This Kaiser Family Foundation study estimates how many people could be turned away when they apply for insurance.
”Consistent with our previous analysis, we estimate that 27% of nonelderly adults have a declinable health condition, which is about 53.8 million people in 2018. We further estimate that 45% of nonelderly families have at least one nonelderly adult member with a declinable health condition. Finally, we update our state-based estimates of the prevalence of declinable pre-existing conditions with the most current data available, showing that the share of non-elderly adults with pre-existing conditions ranges from 22% in Colorado to 37% in West Virginia.”

Private equity has inflated US medical bills (Financial Times- subscription required): The thesis of this article and the referenced research paper is that private equity investments in physician practices have led to increased billing, including so-called “surprise medical bills.”

About the public’s health

Waste in the US Health Care System Estimated Costs and Potential for Savings: Authors of this research looked at the literature on waste in the US healthcare system and focused on: failure of care delivery, failure of care coordination, overtreatment or low-value care, pricing failure, fraud and abuse, and administrative complexity. The conclusion was that “the estimated cost of waste in the US health care system ranged from $760 billion to $935 billion, accounting for approximately 25% of total health care spending, and the projected potential savings from interventions that reduce waste, excluding savings from administrative complexity, ranged from $191 billion to $282 billion, representing a potential 25% reduction in the total cost of waste.” See Table 2 for estimates by domain. See also the excellent editorial analysis.

Trump issues proclamation to deny visas to immigrants who can't pay for health care: The headline speaks for itself.

Australia Just Had a Bad Flu Season. That May Be a Warning for the U.S.(NY Times- subscription required): Based on the earlier appearance of influenza in Australia this year, the director of the influenza division of the Centers for Disease Control and Prevention said . “…the best move is to get the vaccine right now.” Check the CDC website for more detailed recommendations.

Scientist Who Discredited Meat Guidelines Didn’t Report Past Food Industry Ties (NY Times- subscription required): The lead author in this study had ties to the food industry that should have been reported. The technicality is that the ties fell just outside of the time period for which he was questioned. The authors still claim their conclusions were valid, i.e., meat consumption has not been proven to have deleterious health consequences.

Potentially preventable intensive care unit admissions in the United States, 2006 - 2015: Recall that costs of care are a function of price volume and intensity. This article deals with the latter feature. This research found that an “appreciable proportion of US ICU admissions may be preventable with community-based interventions. Investment in the outpatient infrastructure required to prevent these ICU admissions should be considered as a complementary, if not alternative, strategy to expanding ICU capacity to meet future demand.”

Healthcare mergers and acquisitions

10 healthcare deals that made headlines this year: Not all of these combinations succeeded. Each one had its unique set of circumstances and warrant their own case study discussions.

Today's News and Commentary

About pharma

FDA OKs Descovy, Second Drug for HIV PrEP: Another drug in this class has been approved. “The US Food and Drug Administration (FDA) has approved a second drug for HIV-1 preexposure prophylaxis (PrEP) as part of ongoing efforts to end the HIV epidemic.
Descovy (Gilead Sciences) is a fixed-dose combination of emtricitabine (200 mg) and tenofovir alafenamide (25 mg). It is indicated to reduce the risk for HIV-1 infection from sex (excluding those who have receptive vaginal sex) in at-risk adults and adolescents weighing at least 35 kg (77 lb).
Descovy is not indicated in individuals at risk for HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated, the FDA said.”

After much fanfare, Civica Rx delivers its 1st drugs: As previously reported, a consortium of providers formed a pharma company (Civica Rx) to lower costs and increase access to drugs that experience shortages. “Riverton Hospital, an Intermountain Healthcare facility in Utah, received the first batch of vancomycin hydrochloride, an injectable antibiotic that is commonly in short supply for hospitals across the country, Civica Rx said Wednesday. The antibiotic will be available to all health systems by the end of the month. Shortly after that, another essential antibiotic, daptomycin, will be made available, according to the company.”

More do-it-yourself docs are finding pharma answers on their own as sales rep contact declines: This marketing channel has changed quickly. “In the 2019 survey, only 54% of physicians say they see pharma reps in person, down from 67% in 2018. That’s the lowest contact rate the ePharma survey has recorded since it started asking similar questions in 2014… Meanwhile, the percentage of doctors who had no interactions with pharma reps at all jumped from 24% last year to 39% this year.”

Big Pharma CEOs' Chinese names: Here's how they look and what they mean: A “fun” article.

HHS Appeals Court Decision on Proposed TV Ad Rule: “HHS has formally appealed a July ruling by a federal court in Washington, D.C., which blocked the department from requiring drug companies to disclose the prices of drug prices in their direct-to-consumer TV ads.”

About the public’s health

Breast cancer statistics, 2019: Some good news: despite an increase in incidence, breast cancer mortality has decreased. The bad news is that there is still great racial disparity in the mortality figures, with black women lagging far behind.

Association of Optimism With Cardiovascular Events and All-Cause Mortality: Always look at the bright side of life. “The findings suggest that optimism is associated with a lower risk of cardiovascular events and all-cause mortality.”

About healthcare professionals

Drop in primary-care docs hasn't hurt patient access yet, MedPAC says: The Medicare Payment Advisory Commission (MedPAC) was classifying hospitalists as primary care physicians because both groups used the same billing codes for hospital-based services. MedPAC found that “that the number of primary-care physicians was closer to 140,000 in 2017 than the 186,000 it initially reported, a decrease of about 46,000.” Given the declining rate of increase in primary care physicians, MedPAC is concerned that their future supply may create problems in quality care in the near future.

Risk Factors Associated With Food Insecurity in the Medicare Population: “Nearly 1 in 10 Medicare enrollees 65 years and older and 4 in 10 enrollees younger than 65 years experience food insecurity, suggesting both poor eating patterns that threaten health and inadequate access to other basic needs… We found disabled status, lower incomes, Medicaid dual enrollment, chronic condition burden, depression, and anxiety to be distinct factors. However, our cross-sectional analyses cannot establish causality.” Clearly a pervasive problem that needs to be addressed to improve health.

About hospitals and health systems

High Medical Bills Set Up Major Legal Showdown in California: Research consistently shows that hospital consolidation causes price increases. “In a less than a week, Sutter Health, a sprawling system of 24 hospitals and 5,500 doctors, will face a court trial over accusations that it used its dominance in Northern California to stifle competition and force patients to pay higher medical bills.”

About health insurance

Humana's chief strategy officer: Insurance giant is shifting to be a healthcare company: “Insurance giant Humana operates a mail-order pharmacy, has more than 230 owned or alliance primary care clinics and a large home health care provider, Kindred at Home. And the payer continues to build out capabilities to address members' social determinants of health.

These healthcare services are part of Humana's shift from ‘an insurance company with elements of healthcare to a healthcare company with elements of insurance,’ Vishal Agrawal, chief strategy and corporate development officer at Humana, said during CB Insights' Future of Health event in Manhattan Wednesday.”
Recall Humana started as a nursing home chain, then became a hospital company, added an insurance function and dropped the hospitals. Now it is adding the above-mentioned services. Where will the cycle go next?

Walmart unveils major employee health benefit changes aimed at cost cutting: On the heels of Sam’s club announcement (previously reported) that it is extending its employee benefits, Walmart unveiled five initiatives: a list of “featured” providers; expanded telehealth; a personal healthcare assistant; a national quality provider resource; and nationwide access to fitness clubs.

BCBSA: ACA premiums in 23 states expected to rise an average 2.3% in 2020: While average premiums are expected to rise 2.3%, as in the past, there are wide variations. According to preliminary filings, rates will “range from an 18% decrease in Colorado to a 13% increase in New Mexico.”

Today's News and Commentary

About healthcare IT

Virtual Visits: Telehealth and Older Adults: This University of Michigan study found that: “Among older adults who had a telehealth visit, about half said the overall convenience of a telehealth visit was better than an in-person office visit (47%), 36% believed an in-person office visit was better, and 18% thought the overall convenience was the same. However, more than half indicated that in-person office visits were better than telehealth visits with regard to feeling cared for (56%), communicating with the health care professional (55%), and the amount of time spent with the health care professional (53%). Additionally, more than half viewed in-person office visits as better than telehealth visits in terms of overall quality of care (58%).” Findings reinforce the notion that the mode of communication as well as the content need to be customized.

Does telehealth save money? The jury’s still out.: Studies showing both savings and increases in costs vary, among other factors, by specialty and location. More research needs to be done about when and how telehealth can improve health and possibly save money. This case is another tradeoff- telehealth increases access, but does it improve quality and lower cost?

About the public’s health

Pathology of Vaping-Associated Lung Injury: While the exact chemical causing vaping deaths and injuries is still being sought, a brief correspondence in the New England Journal of Medicine from the Mayo Clinic says the pathology of the lung looks like a chemical burn- similar to mustard gas used in WWI.

2019’s States that Vaccinate the Most: Check the site for details.

Global Atlas on Childhood Obesity: The problem is worse than first thought. “The first global atlas on childhood obesity by the World Obesity Federation (WOF) shows that no country has a better than fifty percent chance of meeting their target for tackling childhood obesity…8 out of 10 countries (156) countries have less than a ten percent chance of meeting their target.” Select this link to read the full report.

Virginia doctor sentenced to 40 years in prison after conviction on more than 800 opioid counts: The conviction was in May; this article explains the final sentencing.

Trump signs $1.8 billion autism funding bill:The bill is called: H.R. 1058: Autism Collaboration, Accountability, Research, Education, and Support Act of 2019. “The funding, which backs autism research and autism-related support programs, will also prioritize grants for rural and underserved areas.”

About health insurance

Alignment Health Plan to Offer Concierge, Social Determinants of Health Benefits: While many health plans are offering extended benefits for members, this one is offering two that are unique.
”The grocery benefit will provide members with a monthly allowance to buy groceries at participating stores, including CVS, Walgreens, and Walmart. The allowance is automatically uploaded onto member’s “black cards” which can be used as a debit card to purchase items at over 50,000 retailers.
The companion care benefit Alignment will connect members with college students who can help with non-medical tasks such as household chores and technology lessons. In addition to routine tasks, the college students offer elderly members general companion care, which the plan refers to as “grandkids on-demand.”

Trump Administration Invitation for States to Design Wellness Programs Draws Swift Backlash: (Wall Street Journal- subscription required): As previously reported, the “Trump administration will let states offer wellness programs in the individual insurance market that tie premium costs to health goals…” But patient advocates and health policy experts are criticizing the plan since it could penalize individuals who cannot comply with the goals because of pre-existing conditions.

Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors: This executive order is part action and part explicit politics.

Three of the more specific orders are:

“ (i) encourage innovative MA benefit structures and plan designs, including through changes in regulations and guidance that reduce barriers to obtaining Medicare Medical Savings Accounts and that promote innovations in supplemental benefits and telehealth services;

(ii)   include a payment model that adjusts supplemental MA benefits to allow Medicare beneficiaries to share more directly in the savings from the program, including through cash or monetary rebates, thus creating more incentives to seek high-value care; and

(iii)  ensure that, to the extent permitted by law, FFS Medicare is not advantaged or promoted over MA with respect to its administration.”

About pharma

Pfizer reportedly to launch Avastin biosimilar in December: The headline is the message. It could result in significant cost savings.

More than Half of Health Plans Use Outcomes-Based Contracts: This research by the consulting company Avalere found “that 59% of payers have executed an outcomes-based contract (OBC). This type of contracting structure is an agreement between a health plan and drug and device manufacturers that ties product reimbursement to clinical, quality, utilization, or financial outcomes. When Avalere first conducted this survey in 2017, 24% of health plans had an OBC in place.

Thirty-one percent of health plans reported having more than 5 OBCs. In 2017, this number was 12%. Additionally, 21% of payers had 2 to 5 OBCs in place, indicating a 17% increase from 2017.”

Today's News and Commentary

About pharma

Trump set to nominate Stephen Hahn as FDA commissioner, pending vetting process: “Hahn, an oncologist, is the chief medical executive at MD Anderson Cancer Center in Houston…The Trump administration’s decision goes against the advice of four former FDA commissioners and an array of advocacy organizations, all of which had called for [acting director Dr. Ned] Sharpless to be named the permanent agency head.”

340B allies rally Congress to ensure Pelosi drug price plan doesn't imperil discounts: House Speaker Pelosi’s Lower Drug Costs Act calls for the Department of Health and Human Services to annually select the costliest 25 drugs and negotiate a lower price. However, language in the bill also says that any drug subject to a negotiated lower price will “not be considered a covered outpatient drug subject to an agreement under … 340B.” Covered entities such as hospitals and Federally Qualified Health Centers are concerned that this provision will cause large income losses because their acquisition costs for those drugs will go up. (Read about the 340b program in Chapter 7 of the text.)

OptumRx Drug Pipeline Insights Report: Q3 2019-Five drugs in the pharmaceutical pipeline anticipated to make the biggest impact: The headline is self-explanatory.

Drugmakers considering to use Purdue bankruptcy to settle opioid lawsuits: reportOther drug makers involved in the opioid suits want to limit their liability by piggy-backing onto the Purdue Pharma settlements.

Drugstores are pulling Zantac-like heartburn drugs off the shelves over potential cancer risk: In addition to the manufacturer’s withdrawal, now retail stores are also pulling these H2 blockers.

About the public’s health

Integrating Social Care into the Delivery of Health Care: Moving Upstream to Improve the Nation’s Health: The national Academies of Sciences, Engineering and Medicine issued this report, whose purpose is explained in the headline. The summary goals are:

  1. “Design health care delivery to integrate social care into health care, guided by the five health care system activities—awareness, adjustment, assistance, alignment, and advocacy…

  2. Build a workforce to integrate social care into health care delivery… 

  3. Develop a digital infrastructure that is interoperable between health care and social care organizations… 

  4. Finance the integration of health care and social care…

  5. Fund, conduct, and translate research and evaluation on the effectiveness and imple- mentation of social care practices in health care settings…”

Bloomberg Philanthropies Announces $120 Million Reinvestment to Expand its Data for Health Initiative: Without data, we don’t know what or where the problems are. Here is the issue we need to address: “Less than half of all deaths around the world are registered with a cause given, meaning that 29.4 million deaths go unrecorded each year. This lack of data disproportionately affects low- and middle-income countries with 60% of these countries—representing 2 billion people—not reporting any data. In addition, the births of nearly 40% of the 128 million children born each year are not officially recorded, potentially denying the child access to healthcare, education and government services.” The Data for Health Initiative was started to correct this lack of data. “With today’s announcement, the total amount committed to Data for Health comes to $220 million.”

Unprocessed Red Meat and Processed Meat Consumption: Dietary Guideline Recommendations From the Nutritional Recommendations (NutriRECS) Consortium: Many media outlets have carried the story about lack of randomized controlled experiments that would lead to recommendations to reduce unprocessed red meat consumption. The link is to the original article. “The panel suggests that adults continue current unprocessed red meat consumption (weak recommendation, low-certainty evidence). Similarly, the panel suggests adults continue current processed meat consumption (weak recommendation, low-certainty evidence).”

Opportunity for States to Participate in a Wellness Program Demonstration Project to Implement Health-Contingent Wellness Programs in the Individual Market: CMS issued this bulletin calling for applications for demonstration projects for wellness projects. The bulletin is also a great summary of what is and is not allowed vis-a-vis incentives for participation in wellness initiatives, i.e., they must be non-discriminatory.

Marine Omega‐3 Supplementation and Cardiovascular Disease: An Updated Meta‐Analysis of 13 Randomized Controlled Trials Involving 127 477 Participants: Use of omega -3 fish oil to prevent heart disease has been controversial. This meta-analysis combines research with the largest patient population yet. The authors conclude: “Marine omega‐3 supplementation lowers risk for myocardial infarction, CHD [coronary heart disease] death, total CHD, CVD [cardiovascular disease] death, and total CVD…” There is also a dose-response relationship for benefit. However, other factors that also improve health cannot be ruled out. (See Chapter 3 in the text and on the Book tab).

Draft Recommendation Statement: Illicit Drug Use in Children, Adolescents, and Young Adults: Primary Care–Based Interventions: Does primary care counseling work to prevent illicit drug use in children, adolescents and young adults? Here is the draft recommendation for comment: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care–based behavioral counseling interventions to prevent or reduce illicit drug use, including nonmedical use of prescription drugs, in children, adolescents, and young adults.” Perhaps the way it is done needs to be changed or we may also need a different combination of strategies.

The FDA approves a breakthrough treatment for the world's deadliest infectious disease — now what?: The FDA approved a breakthrough drug to treat TB. More money needs to be raised for the treatment, but even if available, there is still the problem of distribution (access). How can we get the drug where it is needed at a reasonable cost? What parts of the access equation need to be addressed (see Chapter 1 in the text and Book tab)?

About healthcare quality and safety

New round of Medicare Readmission Penalties Hits 2583 Hospitals: CMS announced the recent results of readmission bonuses or penalties. In summary:

  • “1,177 hospitals received a higher penalty than they did last year.

  • 1,148 hospitals received a lower one than last year.

  • 64 hospitals received the same penalty as last year.

  • 194 hospitals that had not been penalized last year are being punished this year.

  • The maximum penalty — a 3% reduction in payments — was assessed against 56 hospitals.

  • 372 hospitals avoided penalties in both years.

These figures do not include 2,142 hospitals that Medicare exempted from the program this year, either because they had too few cases to judge; served veterans, children or psychiatric patients; or were critical-access hospitals, which are the only hospitals within reach of some patients.”

CMS estimates the penalties will cost hospitals $563 million for the year.

About healthcare IT

VA bolsters medical info sharing with community care providers: Recognizing that many veterans receive care outside the VA system, the VA is adopting an “opt-in” policy of sending information (including electronically) to other providers. Veterans will now need to “opt out” if they do not want to share information. The problem of electronic interoperability still needs to be addressed.

Novartis, Microsoft ink deal to use AI to accelerate drug development : One of the latest partnerships in the field of using Artificial Intelligence to speed drug development.

RGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication: This article was perhaps the most cited by media outlets today. According to the FDA: “A security firm has identified 11 vulnerabilities, named ‘URGENT/11.’ These vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function.” Read the announcement for more information about the threats and appropriate actions.

About health insurance

Democratic chairman proposes new fix for surprise medical bills: Proposed methods for solving the problem of surprise medical bills have generated lots of controversy among affected stakeholders. Now, the Chair of the House Ways and Means Committee, Richard Neal (D-Mass) is proposing to
”essentially punt the details of the fix to a committee consisting of stakeholder groups and the departments of Health and Human Services, Labor, and Treasury. The committee would come up with recommendations that would then be issued in a regulation from the administration.
Neal's letter was first reported by Politico.”

CIGNA Expands Its Medicare Advantage [MA] Offerings and benefits While Minimizing Costs : This article is a press announcement, but there are three newsworthy items in it. First, is the cost: “plans in every market that feature a $0 premium and 89 percent of plans that have a $0 copay for primary care physician office visits. In addition, Cigna is maintaining or reducing premiums in 86 percent of its plans nationally compared to last year, and is offering plans that have no out-of-pocket costs for specialist care.” Second, is an expansion of benefits in line with what CMS has recently allowed. Finally, is plan design: “Cigna is launching its first-ever MA PPO plans in 43 counties…” Most MA plans are HMOs. It is likely other big players in this market, like United and Humana will match some of these initiatives.

About hospitals

The largest healthcare real estate projects announced in 2019: In the past few years, the number of large hospital construction projects decreased significantly compared to the first decade of the 2000s. The list of projects announced this year, amounting to about $700 billion, is a significant rebound for this sector.

Today's News and Commentary

About the public’s health

Only half of Americans plan to get a flu shot this year. Here's why that's a problem: “While 60% of adults think that the flu vaccine is the best preventive measure against flu-related deaths and hospitalizations, only 52% said they planned to get one this season, according to a survey by the National Foundation for Infectious Diseases (NFID).” If fewer people are immunized the population as a whole will not be protected. What incentives will get people to increase vaccination rates, given that the main reasons they do not get the shots are:

  • 51 percent do not think flu vaccines work

  • 34 percent are concerned with side effects from the vaccine

  • 22 percent are concerned about getting flu from the vaccine

Advisory Committee Supports GSK’s OTC Nicotine Spray: “The Nonprescription Drugs Advisory Committee voted 8-7 for the product’s efficacy, 9-6 for its safety, and 9-6 for its overall risk-benefit profile to reduce withdrawal symptoms associated with quitting smoking for consumers ages 18 years or older.” Is this nicotine delivery mechanism going to replace vaping?

About health insurance

Essential Hospitals Thank Senate for Vote to Delay DSH Cut: As previously reported, the federal government was going to cut $4 billion in Disproportionate Share Hospital payments. The Senate voted to delay that action.

Sam's Club, Humana team up to mitigate high out-of-pocket healthcare costs: “Sam’s Club is teaming up with Humana and telehealth startup 98point6 to pilot a program aimed at helping its members mitigate some out-of-pocket healthcare costs…The program, called Care Accelerator, is not meant to replace a health insurance plan but to make it easier for those with high deductibles and others with high upfront costs for care get access to basic services and prescriptions…Sam’s Club members that opt into the program will be able to purchase service bundles ranging from $50 to 240 per year that include a range of services.  
At the lowest price point, individual members can get certain generic drugs for free at Sam’s Club pharmacies, pay $1 for telehealth primary care visits at 98point6 and save on eye exams and glasses or dental care. 
Humana will manage the provider network…”

Democrats to force vote on Trump health care rule: Democrats wants the Senate to vote on the Trump administration’s policy to relax health plan requirements. Their theory is that that they win either way- A “NO” vote can block the White House plans (once the Democratically controlled House weighs in). A “YES” vote for waivers can be publicized as Republican desire to weaken a health plan that Americans have grown to favor. The catch is that even with 100% Democratic backing, 4 Republican Senators will need to agree to hold the vote.

Association of Bundled Payments for Joint Replacement Surgery and Patient Outcomes With Simultaneous Hospital Participation in Accountable Care Organizations: Are there differences in costs between ACOs that have bundled payments for lower extremity joint replacements and traditional Medicare fee-for-service? Not overall, but the mix of services was more appropriate with bundles. “In a cohort study of 483 008 Medicare fee-for-service beneficiaries, compared with participation in joint replacement bundled payments alone, coparticipation was not associated with differential changes in episode spending. However, coparticipation in accountable care organizations was associated with differentially greater decreases in hospital length of stay and home health care use, greater increases in postdischarge outpatient follow-up, and smaller reductions in unplanned readmissions.”

UnitedHealthcare Consumer Sentiment Survey, 2019 Executive Summary: This survey gathered information by different age segments for three topics: Open Enrollment Preparedness; Technology & Transparency Trends; and Health Literacy & Consumer Preferences. One surprise was that, overall, only “20% said the internet or a mobile app is the first source they usually consult for information about specific health symptoms, conditions or ailments.” Millennials’ use was 30% and Baby Boomers’ use was 14%. One caveat: it is not clear from the methodology if the people surveyed at random were UnitedHealthcare members. The health literacy figures are higher than from other research I have seen.

About healthcare quality and patient safety

CMS’ Discharge Planning Rule Supports Interoperability and Patient Preferences: CMS has issued its final rules regarding hospital discharge procedures. In summary, hospitals must “provide patients access to information about PAC [post-acute care, that is, after-hospital care] provider choices, including performance on important quality measures and resource-use measures – including measures related to the number of pressure ulcers in a given facility, the proportion of falls that lead to injury, and the number of readmissions back to the hospital. The rule also advances CMS’s historic interoperability efforts by requiring the seamless exchange of patient information between healthcare settings, and ensuring that a patient’s healthcare information follows them after discharge from a hospital or PAC provider.”

CMS finalizes hospital antibiotic stewardship requirements (Modern Healthcare, subscription required): The headline speaks for itself. These requirements are now part of the infection control provisions that are in CMS’s conditions of participation for hospitals.

About healthcare information technology

Sen. Rand Paul continues fight against patient identifier, introduces bill to overturn authority under HIPAA: As previously reported, the Senate did not include funding to roll out a national patient identifier. To add to the impediments, Senator Paul introduced legislation “called the National Patient Identifier Repeal Act of 2019, that would repeal the original authority to create the ID under the Health Insurance Portability and Accountability Act of 1996.” His rationale is fear of jeopardizing patient privacy by centralizing sensitive data. He should look to most of the other developed countries that have secure single identifiers that are used for healthcare, drivers licenses, taxes and financial services.

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Today the FDA issued its final (non-binding) guidance covering what types of medical software are subject to regulation as devices. To reflect changes in this document over the draft of last December, “the title of the guidance has been revised to ‘Policy for Device Software Functions and Mobile Medical Applications.’” The categories it covers are: Software Function Intended for Administrative Support of a Health Care Facility; Software Function Intended for Maintaining or Encouraging a Healthy Lifestyle; Software Function Intended to Serve as Electronic Patient Records; and Software Function Intended for Transferring Storing, Converting Formats, Displaying Data and Results. In general, if the app helps a patient to maintain a healthy lifestyle, communicate with a practitioner or store data, it is exempt from FDA regulation. But read the details (it is actually written in understandable English).

Today's News and Commentary

About pharma

Zantac’s Original Maker Halts Shipping on Carcinogen Concern: In the ongoing story of a carcinogenic contamination of Zantac, GlaxoSmithKline, the original branded maker of of the drug, stopped its global distribution.

FTC Flags Potentially Unlawful TV Ads for Prescription Drug Lawsuits: “The Federal Trade Commission staff has sent letters to seven legal practitioners and lead generators expressing concerns that some television advertisements that solicit clients for personal injury lawsuits against drug manufacturers may be deceptive or unfair under the FTC Act. The FTC is not publicly identifying who received the letters.
The letters state that some lawsuit ads may misrepresent the risks associated with certain pharmaceuticals and could leave consumers with the false impression that their physician-prescribed medication has been recalled.”

About health insurance

2019 Employer Health Benefits Survey: The Kaiser Family Foundation has published its latest survey on employer-sponsored health insurance (and other benefits). All healthcare decision makers should read this survey each year (at least the executive summary). Understanding the trends explained in the research is extremely important to formulating strategic plans in your sector. The takeaways are very clear from the many graphics.
The part of this report that made headlines today in many media was that this year the average annual premium for family coverage rose 5 percent to $20,576. The figure for single coverage increased 4 percent to $7,188.
While figures vary by firm and between employer sectors, employees are largely isolated for these large premium costs. Employers paid 82% of the cost for single coverage and 70% percent of the cost for family coverage. However, these subsidies come at the cost of increasing out-of-pocket expenses for patients.

New Survey: Just Over a Quarter of U.S. Adults Favor ‘Medicare for All,’ but Many Need More Information: The Commonwealth Fund issued this opinion poll today about views on Medicare for All and other healthcare issues. The question interviewers asked was whether people were in favor of eliminating all private insurance and replacing it with a single governmental payer, like Medicare. While these answers are certainly skewed by political party affiliation, overall, 27% strongly or somewhat favor the proposal, 32% strongly or somewhat oppose the proposal and 40% “don’t know enough to say.”

About healthcare IT

How Successful Are Healthcare Organizations at Achieving ROI with Analytics?: “HIMSS Analytics asked 109 senior healthcare executives involved with analytics use and decision-making about which metrics they measure through analytics, how they determine ROI, and how successful they have been at measuring success.” The survey has a lot of good information about how analytics are being used in clinical, operational and financial areas and how success is being measured. Overall:
”Of organizations that are leveraging analytics, 84% are doing so in multiple areas (clinical, financial, operational), while two-thirds are leveraging analytics across the organization.

Organizations feel their analytics solutions have been most effective towards improving financial performance, but they have actually been able to see the most measured success with clinical analytics (77.7%) vs. financial analytics (73.5%) or operational analytics (70.3%).”

Today's News and Commentary

About culture

German Court Says a Hangover Is an Illness (NY Times- subscription may be required): In response to claims of an over-the-counter hangover treatment, a Frankfurt court ruled “that a hangover is an illness, and it is illegal in Germany to claim that foods or supplements can cure human ailments or disease.”

About the public’s health

U.S. joins 19 nations, including Saudi Arabia and Russia: ‘There is no international right to an abortion’: This announcement was part of a gathering of international leaders at the UN to discuss a number of issues, such as healthcare and climate change. “The Trump administration declared there’s no ‘international right to abortion,’… calling on other countries to join a coalition pushing the elimination of what it calls ‘ambiguous’ terms and expressions, such as sexual and reproductive health, from U.N. documents.”

Massachusetts to ban sale of all vaping products for 4 months in toughest state crackdown (Washington Post- subscription may be required): This action was taken by Republican governor Charlie Baker, who was former CEO at Partners HealthCare.

Juul says its chief executive is stepping down, accepts proposed ban on most flavored vaping products (Washington Post- subscription may be required): Juul is responding to the deaths and illnesses caused by vaping. In addition to a CEO change and acceptance of ban on flavored products (except tobacco-flavored), the company said it is “suspending all broadcast, print and digital product advertising in the United States.”

Trends in Dietary Carbohydrate, Protein, and Fat Intake and Diet Quality Among US Adults, 1999-2016: “From 1999 to 2016, US adults experienced a significant decrease in percentage of energy intake from low-quality carbohydrates and significant increases in percentage of energy intake from high-quality carbohydrates, plant protein, and polyunsaturated fat. Despite improvements in macronutrient composition and diet quality, continued high intake of low-quality carbohydrates and saturated fat remained.” Good news, but we still have a long way to go. (Also read the editorial about this research.) How can we accelerate this change?

Nutrition in medical education: a systematic review: In a related article and answer to the above question, this research found that: “nutrition is insufficiently incorporated into medical education, regardless of country, setting, or year of medical education… A modest positive effect was reported from curriculum initiatives.”

About pharma

CVS launching new pharmacy solution aimed at making it easier for patients to obtain specialty drugs: “CVS is launching a new pharmacy solution aimed at cutting down the time it takes for patients to obtain specialty drugs. The new tool is built in two parts: Specialty Expedite and Specialty Connect. The former is designed to cut down the prior authorization and onboarding process significantly with the goal of reaching a three-day process…Specialty Connect is the patient-facing element of the platform, according to CVS. It allows members to select where and how they want to receive their specialty drugs…Through the communication tool, patients are also kept up to date on needed insurance information and financial supports, CVS said. To date, patients using this prong of the solution are 17.5% more likely to refill their prescription.”

Pharmaceutical companies face steeper price cuts in China as country expands drug bulk-buying scheme nationwide: As the US looks to governmental pricing of drugs, we can look to the experience of other countries. China is expanding a negotiation program it started last December in 11 major cities. The result was an average 52% drop in prices. The “ latest round of winning bids are a further 25% lower on average.”

Sanofi Faces First State Lawsuit Over NDMA: It was bound to happen. After Sanofi announced that Zantac contained the carcinogen NDMA, a Florida man sued, claiming it caused him to get breast cancer. It is not known how long the contaminant has been in Zantac. Given propensities for malpractice awards in some jurisdictions, does it matter how long?

The Democrats shepherding Pelosi’s drug pricing bill have taken plenty of campaign cash from pharma: The headline speaks for itself. The article tells “who and how much.”

About health insurance

CMS: 2020 Medicare Advantage rates lowest since 2007 as supplemental benefits take hold: “The average monthly premium for a MA plan will be $23 in 2020, a decline from the average premium of $26.87 in 2019. Since 2017, the average monthly premium for MA plans has decreased by nearly 30%, and 2020's average premium is likely to be the lowest since 2007, CMS said in a release. The agency added that the number of plan choices per county increased from about 33 plans in 2019 to 39 plans in 2020.” Good news for seniors as these plans become much more attractive.

CMS finalizes rule on DSH [Disproportionate Share Hospital] cuts worth up to $8B annually through 2025: DSH payments supplement Medicare and Medicaid reimbursements for hospitals taking care of a “disproportionate share” of patients insured by those plans and the uninsured. “Under the rule implementing reductions under stipulations in the Affordable Care Act, DSH payments will set cuts worth $8 billion for the following five years. The cuts are set to take effect Nov. 22.” Hospitals are already vowing to fight these cutbacks.

CBO [Congressional Budget Office]: Fix backed by doctors for surprise medical bills would cost billions: ”The CBO looked at an approach that is featured in a bill from Reps. Raul Ruiz (D-Calif.) and Phil Roe (R-Tenn.), and backed by doctors, finding it would cost ‘double digit billions’ of dollars over 10 years.
In contrast, the approach used in bipartisan bills that have passed out of the House Energy and Commerce Committee and the Senate Health Committee would both save more than $20 billion over 10 years, the CBO has found.” We will see if analysis wins over financial clout.

Wiping out medical debt would be a lot harder than Bernie Sanders makes it sound (Washington Post- subscription may be required): This article is a really good, in-depth critique about why the Sander’s medical debt relief plan is logistically very difficult and may actually cost much more than he said it would.

UnitedHealth report: Connecting Medicare patients with 'high-value' docs could save billions: This report from United Health Group says that “connecting all fee-for-service Medicare patients with physicians who provide high-quality care at a lower cost could save the federal health program $20.5 billion in 2020 and $286.8 billion over the next decade.” The cost will be lower also for patients, as their out-of-pocket expenses will be lower. The study used value criteria for UnitedHealthcare’s Medicare beneficiaries. Those “who were treated 75% of the time by high-value docs had 64% fewer inpatient hospital days and 35% fewer emergency department visits—leading to 21% lower risk-adjusted spending per member per month compared to other patients.”
The report further recommends that special focus should be on primary care. “As primary care physicians see by far the largest volume of patients among the specialties in the study (about 59% of patient volume), improving cost efficiency in this area could lead to $14.5 billion in savings to Medicare in 2020 and $202.9 billion over the next decade. That’s just over 70% of the total projected savings in the study…”

About healthcare IT

Amazon launches pilot of virtual employee medical service Amazon Care: “Officials said Amazon Care provides a mobile application to allow [Seattle area] employees to access virtual and in-person healthcare services from its partner, Washington-based Oasis Medical Group P.C. Services include video care, in-app text chat with clinicians, mobile care visits and prescription delivery from a care courier. The virtual services offered Monday to Friday from 8 a.m. to 9 p.m., and Saturday and Sunday, 8 a.m. to 6 p.m.” If this program is successful it will undoubtedly be rolled out to healthcare partners Berkshire Hathaway and JP Morgan Chase.

Amazon unveils Voice Interoperability Initiative to speed adoption: Interoperability among computer systems is one of the biggest problems in healthcare IT. Attention has focused on such medical record content as data, text and images. With increasing use of Voice in healthcare software and communication, this element also needs to be interoperable.
Yesterday, Amazon announced the “Voice Interoperability Initiative, a group of some 36 companies committed to ensuring voice software made by different companies works seamlessly together.
However, notably absent were two of Amazon’s biggest rivals in voice technology: Apple and Alphabet’s Google, two companies that hold keys to a smartphone market that Amazon has yet to crack.” Looks like the inter-fighting is causing the same problems with Voice as with other healthcare IT.

About diagnostics

Exact Sciences’ Colorectal Cancer Test Gets Expanded Indication: This article is a reminder that FDA approval includes use of drugs and devices for specified age groups. As colon cancer incidence has been rising in the “under 50” population, an approved method for screening has become necessary. The FDA extended approved use for this product from over age 50 to over age 45.

Today's News and Commentary

About pharma

Upcoming Product-Specific Guidances for Complex Generic Drug Product Development: This FDA announcement is not important to the general reader for its specifics. It is a reminder that although general parameters are in place for generic definition and compliance, the Agency still can issue product-specific guidance (PSG) for individual drugs.

As off-label use spreads for lifesaving niche drugs, supplies grow scarce, leaving patients in the lurch: Off-label use of medications not only increases costs and may cause serious side effects, but, as the article points out, can cause shortages for patients who really need the medication. What can be done to address this problem? One missing IT app is connecting the prescription drug code with diagnosis codes to monitor appropriateness.

A Painful Pill to Swallow: U.S. vs. International Prescription Drug PricesThe U.S. could save $49 billion annually on Medicare Part D alone by using average drug prices for comparator countries: This report from the House Ways and means Committee concluded that “The U.S. could save $49 billion annually on Medicare Part D alone by using average drug prices for comparator countries.”

New CRISPR approach could improve gene and cell therapies: “The most commonly used gene editing technology, CRISPR-Cas9, uses just one Cas protein to cut DNA. In the CRISPR field, this is known as a ‘class 2’ system. Class 1 systems, by contrast, are more complicated because they rely on multiple proteins to bind to DNA and then recruit a Cas3 protein to cut it. That network of proteins is called Cascade (CRISPR-associated complex for antiviral defense).” However, “Class 1 CRISPR–Cas systems represent about 90% of all CRISPR systems in nature [and] remain largely unexplored for genome engineering applications.” This new technique allows access to that 90%. Further, it allows modification of epigenomic changes, which control the gene function. This method is a real scientific breakthrough.

About healthcare quality and patient safety

NCQA Health Insurance Plan Ratings 2019-2020- Summary Report (Private /Commercial): The geographic distribution of these plans is very uneven. 38 scored 4.5/5 or above. Read the methods as well as the actual rankings.

About healthcare IT

California Looks to Expand Coverage for Telehealth Services: “A bill awaiting Governor Gavin Newsom's signature would require payers to cover telehealth services 'on the same basis and to the same extent' that providers are reimbursed for the same care delivered in person.”

Types of Information Compromised in Breaches of Protected Health Information (Annals of Internal Medicine- subscription required for full article):”Our analyses of 1461 PHI breaches over the past 10 years indicated that 71% of the breaches affecting 159 million patients (94%) compromised sensitive demographic or financial information that could be exploited for identity or financial fraud. Two percent of the breaches affecting 2.4 million patients (1%) compromised sensitive medical information, potentially threatening their clinical privacy.”

New robot offers in-home monitoring, medication dispensing: “Black+Decker has partnered with tech company Pillo Health to launch a new robot assistant named Pria to help with in-home adherence to medication.” This device is a far cry from the plastic pill pack strips now in common use. Check the Pria website to see how it works.

Amazon plans Alexa wireless earbuds with fitness-tracking built in, bigger Echo with better sound, source says: The healthcare part of this announcement is the wireless earbuds that will act as a fitness-tracker- competition for Fitbit and Apple.

New consortium works on mixing in IT to improve care outcomes: “The Object Management Group has launched BPM+ Health to aid healthcare stakeholders in leveraging health information technology to improve the quality of clinical care…Founding members include providers, vendors, universities, specialty societies and the Department of Veterans Affairs. Among those groups include the Agency for Healthcare Research and Quality, the Healthcare Information and Management Systems Society, HL7, the Healthcare Services Platform Consortium, the National Committee for Quality Assurance. The goal is to advance the consistency, efficiency and quality of care by improving the sharing of health practice patterns, workflows and clinical pathways among vendors and institutions.”

About the public’s health

UN welcomes ‘most comprehensive agreement ever’ on global health: Read about the UN’s commitment to achieving Universal Health Coverage by 2030. What is the US doing to help?

About healthcare professionals

Walmart announces plan to build healthcare workforce, offering education for $1 a day: Walmart announced today that “its 1.5 million associates will be able to apply for one of seven bachelor’s degrees and two career diplomas in health-related fields for $1 a day through Live Better U, Walmart’s education benefit program…The health and wellness courses include career diploma programs for pharmacy technicians and opticians through Penn Foster and seven bachelor’s degrees in health science, health and wellness and healthcare management/administration offered through Purdue University Global, Southern New Hampshire University, Bellevue University and Wilmington University.” The benefit is aimed at increasing personnel for Walmart’s expanding in-store healthcare services.

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About health insurance

A New Way Of Paying For Maternity Care Aims To Reduce C-Sections: This article is a nice summary for why we need global payments for pregnancy services. But it is not a new method. On behalf of our capitated medical group, I negotiated global maternity care fees starting about 30 years ago. The one fee included prenatal care, routine ultrasound and labs, one non-stress test, and vaginal or c-section delivery.

Sanders unveils plan to eliminate Americans' medical debt: The Democratic candidates seem to be “one upping” each other on healthcare. Medicare for all and the elimination of private insurance does not go far enough for Sen. Sanders. According to his website the plan is to:

“Eliminate the $81 billion in past-due medical debt.

  • Under this plan, the federal government will negotiate and pay off past-due medical bills in collections that have been reported to credit agencies.

  • End abusive and harassing debt collection practices.

    • Prohibit the collection of debt beyond the statute of limitations.

    • Significantly limit the contact attempts per week a collector can make to an individual through any mode of communication, regardless of how many bills are in collection.

    • Require collectors to ensure information about a debt is fully accurate before attempting to collect.

    • Substantially limit the assets that can be seized and the wages that can be garnished in collection to ensure consumers do not lose their homes, jobs, or primary vehicles and will be able to financially support their families.

  • Instruct the IRS to review the billing and collection practices of the nearly 3,000 non-profit hospitals to ensure they are in line with the charitable care standards for non-profit tax status, and take action against those who are not.”

The process for most of these measures is straightforward. The one calling for governmental negotiation and payment of the $81 billion is still lacking details.

U.S. Voters Support Expanding Medicare but Not Eliminating Private Health Insurance (Wall Street Journal, subscription required): In the latest Wall Street Journal/NBC poll, two-thirds “of registered voters support letting anyone buy into Medicare,” but “56% of registered voters oppose a Medicare for All plan that would replace private insurance…” Only 36% of all registered voters thought the government should provide healthcare to illegal immigrants.

Centene-WellCare merger gets OK from regulators in 17 states: The $17.3 billion merger announced in March is proceeding.

Judge dismisses Oscar's suit against Florida Blue over broker deals: Insurer Oscar sued the Florida Blues plan claiming it's tying up of the insurance broker network was anti-competitive. The courts disagreed and dismissed the case. Consider this decision as a precedent regarding nearly exclusive holds on broker networks. We will need to see how it plays out in other states.

4 major questions on Tennessee's bid to become first state to get a Medicaid block grant: This article is a nice short summary of the questions raised by Tennessee’s announcement last week that the state will apply to CMS for a Medicaid waiver to receive bock grants for that program.

About healthcare professionals

Nurses in Four States Strike to Push for Better Patient Care (NY Times, subscription may be required for this article): “Thousands of nurses across the country went on strike Friday morning, pushing for better patient care by demanding improved work conditions and higher pay. 
About 6,500 National Nurses United members at 12 Tenet Healthcare hospitals in California, Arizona and Florida organized a 24-hour strike, which began at 7 a.m., to protest current nurse-to-patient ratios that they contend are burning out employees and making it difficult to provide the best possible care. 
In Chicago, more than 2,000 nurses walked off the job after contract negotiations between National Nurses United and the University of Chicago Medical Center broke down on Wednesday night.”

The nursing shortage is very uneven around the country and poses an increasing problem as the population ages and hospital acuity increases.

1 in 5 surgeons plans to retire early due to physical toll, survey finds: “Nearly 20% of surgeons in the U.S. think they may need to retire early due to the physical problems that result from performing laparoscopic surgery, a survey commissioned by CMR Surgical finds. CMR Surgical, a British medical device company, has developed a robotic system for laparoscopic or minimal access surgery.

That’s the same percentage as surgeons in the U.K. and similar to the 15% of surgeons surveyed in Germany contemplating early retirement from their chosen profession….A 2018 study published in the journal Surgery estimated that by 2050 there will be a deficit of over 7,000 general surgeons in the U.S.”

This finding is an unintended consequence of improved surgical technique. Better back ergonomics for these devices would go a long way to helping.

About healthcare quality and patient safety

CMS Could More Effectively Ensure Its Quality Measurement Activities Promote Its Objectives:

The Bipartisan Budget Act of 2018 contains a provision for the GAO (government accountability office) to review CMS’s quality measurement activities- both its funding and assessment of the appropriateness of the chosen metrics. In its review, CMS told the GAO that “the information it maintains does not identify all of the funding the agency has obligated for quality measurement activities. Further, it does not identify the extent to which this funding has supported CMS’s quality measurement strategic objectives, such as reducing the reporting burden placed on providers by CMS’s quality measures.”  Further, the GAO found that “CMS lacks assurance that the quality measures it chooses address its quality measurement strategic objectives. This is because CMS does not have procedures to ensure systematic assessments of quality measures under consideration against each of its quality measurement strategic objectives… In addition, CMS has not developed or implemented performance indicators for each of its quality measurement strategic objectives.”  

Give these finding, the GAO recommended “that CMS (1) maintain more complete and detailed information on its funding for quality measurement activities, (2) establish procedures to systematically assess measures under consideration based on CMS’s quality measurement strategic objectives, and (3) develop and use performance indicators to evaluate progress in achieving its objectives. HHS concurred with all three recommendations.”

Health System Leaders Shift Top Focus from Costs to Patient Outcomes: This survey of 140 health system clinicians and executives found some significant changes since last year. For example: “Nearly six-in-ten (57 percent) health system leaders (both executives and clinicians) ranked improving patient outcomes as a key area of focus for 2019, up from 48 percent in 2018. Reducing costs is still a top concern; however, it has decreased in importance for health system leaders in just one year’s time. Seventy-five percent of health system leaders selected reducing costs as a top priority in 2018, and in 2019 that number decreased to 55 percent.” If one were to administer the same questions to the general public, the answers would undoubtedly be very different.

About pharma

Novo prices oral Rybelsus on par with injectable rivals, ending discount fears: As previously reported, the first oral GLP-1 was approved by the FDA on Friday. The pricing was not released until today. The list price of $26 per day, or $772 per 30 tablets across all doses, is comparable with the injectables from that same class. Of course, the injectables incur costs of other supplies, such as needles and syringes. The next step is getting the drug on formularies.

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About pharma

Oral GLP-1 Drug Wins FDA Nod: In this class of diabetic treatments (such brands as Victoza, Trulicity and Byetta), all drugs are currently injectable. This breakthrough medication can be taken orally. Barring unforeseen side effects, it should be a blockbuster- potentially replacing the injectables.

Pelosi unveils signature plan to lower drug prices: Here is the Speaker’s plan to lower pharma costs as previously reported. No surprise, the insurance lobbying group, AHIP, endorsed the plan. However, it may be difficult to get Senate Republican support.

About the public’s health

DHS formally backs off plans to deport sick immigrant children: The headline says it all, as the Trump administration reverses course on this issue.

Cumulative risk analysis of carcinogenic contaminants in United States drinking water: This article is particularly timely given the EPA’s relaxation of water pollution standards. The authors conclude that: “Cumulative risk analysis of contaminant occurrence in United States drinking water for the period of 2010–2017 indicates that over 100,000 lifetime cancer cases could be due to carcinogenic chemicals in tap water. The majority of this risk is due to the presence of arsenic, disinfection byproducts and radioactive contaminants. For different states within the U.S., cumulative cancer risk for drinking water contaminants ranges between 1 × 10−4 and 1 × 10−3, similar to the range of cumulative cancer risks reported for air pollutants.”

Trump signs order to improve flu-vaccine development: The President has given HHS 120 days to come up with a plan “to improve the country’s ability to prepare for a potential future outbreak of pandemic flu, and to develop better vaccines to protect against seasonal outbreaks.” Part of the goal is development of a universal vaccine that won’t depend on seasonal subtype variations.

About health insurance

Medicare Beneficiary Identifiers (MBIs): CMS just announced that the trial period of conversion to the new Medicare Identifiers will end December 31, 2019. After that date, providers “MUST submit claims using MBIs (with a few exceptions),” even if the date of service was prior to 2020.

Marketplace Pulse: A Long Look at the Individual Market: The Robert Wood Johnson Foundation published its latest look at the ACA marketplace. Overall, the news is good: “Based on the expansions for which county-level information is available, the number of one-carrier counties will decline by at least 13 percent in 2020. The final figure will be somewhat larger when all of the plans release the full extent of their expansions.” You can look up your county on an interactive map to find the offerings in your area.

Are Medicare Advantage Plans Using New Supplemental Benefit Flexibility to Address Enrollees' Health-Related Social Needs?: This research is based on focused interviews with Medicare Advantage plans about their decisions to introduce more flexible benefits. Some summary findings:

  • “In 2019, the average MA plan received $107 per member per month in rebates to spend on cost-sharing reductions or supplemental benefits. However, rebate amounts substantially varied across states.” Many plans said the amounts were not enough to cover the extra benefits and called for more funding.

  • The decision about which benefits to offer has been hampered by lack of data about the potential return on investment of each.

  • Sometimes there are no community organizations available that can offer the benefit they want to provide to their members.

  • CMS allows the expanded benefits to be offered based only on clinical criteria. However, many of these services should be determined by social needs. The plans are therefore calling on CMS to expand these need criteria.

About healthcare IT

Industry efforts to lift ban on federal funding for unique patient identifier hits roadblock in the Senate: Although the Senate Finance Committee increased NIH funding, it failed to allocate money to implement a unique patient identifier. As previously reported, Congress outlawed this identifier after it was included in the HIPAA. Leaders from across the healthcare industry have been calling for repeal of the ban in order to facilitate interoperability.

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About pharma

Speaker Nancy Pelosi To Unveil Plan To Negotiate Prices Of 250 Prescription Drugs: The previously reported proposal to lower drug prices is expected to be released today. One of its lynchpins is the ability of HHS to “negotiate prices for the top 250 most expensive drugs on the market that don't have at least two competitors.”

Estimates of all cause mortality and cause specific mortality associated with proton pump inhibitors [PPIs} among US veterans: cohort study: “Taking PPIs is associated with a small excess of cause specific mortality including death due to cardiovascular disease, chronic kidney disease, and upper gastrointestinal cancer. The burden was also observed in patients without an indication for PPI use. Heightened vigilance in the use of PPI may be warranted.” If it is as effective, H2 blockers may be safer. Except…(see next article)

Novartis halts distribution of its Zantac versions amid probe into impurities: “Novartis AG’s Sandoz unit said on Wednesday it was halting distribution of its versions of the drug commonly known as Zantac in all its markets, including the United States and Canada, after contaminants were found in the heartburn drug. 
The Swiss drugmaker’s steps follow an investigation by U.S. and European regulators into the presence of the impurity, N-nitrosodimethylamine (NDMA), in the drug, ranitidine, and a distribution halt in Canada announced late Tuesday.”
Estimation of Hospital Share of Gross Profits for Physician- Administered Medicines Reimbursed by Commercial Insurers: In addition to being able to bill more for professional services (see yesterday’s blog), research indicates “that commercial payers reimburse hospital clinics at a higher rate than physician offices. Hospital clinics also are eligible for discounts not offered to physician practices, such as the 340B Drug Pricing Program” (see Chapter 6, Payers, section on Medicaid). According to this study, physician offices and hospital clinics “treat similar numbers of patients in the commercial market, but hospitals receive a larger share of the gross profits. Hospitals collect 91% of the gross profit margin while serving 53% of patients receiving physician-administered medicines.” Another skewed advantage for hospitals over independent physician practices.

Why prescription drugs cost so much more in America (Financial Times, subscription required): Not much new here but this article is a good summary of pharma pricing issues in the US and other countries.

About the public’s health

Prevalence of Screening for Food Insecurity, Housing Instability, Utility Needs, Transportation Needs, and Interpersonal Violence by US Physician Practices and Hospitals: “Screening for all 5 social needs was reported by 24.4%…of hospitals and 15.6%… of practices, whereas 33.3%… of practices and 8.0%… of hospitals reported no screening. Screening for interpersonal violence was most common…, and screening for utility needs was least common… among both hospitals and practices…Academic medical centers were more likely than other hospitals to screen.” What programs can be implemented to increase the rate of screening?

Estimating the Health‐Related Costs of 10 Climate‐Sensitive U.S. Events During 2012: One of the arguments against climate change prevention measures is that they cost too much and their implementation would hurt the economy. This study (published two days ago) looked at the total cost of climate-sensitive events in 2012 and estimated the cost was about $10 billion. Wouldn’t climate control measures, then, be cheaper in the long run?

India bans e-cigarettes as global backlash at vaping gathers pace: Yesterday, India banned all e-cigarettes. A great public health measure! However the country still has an immense problem from smoking and chewing tobacco.

Kids’ Share 2019: Report on Federal Expenditures on Children through 2018 and Future Projections: This report is the 13th annual evaluation by the Urban Institute. Among the findings:

  • “In 2018, the federal government spent about $6,200 per child younger than 19, less than in 2017 after adjusting for inflation. This decline is driven by a reduction in federal spending on education and nutrition programs and a temporary reduction in child-related tax credits.

  • As a share of the economy, federal investments in children fell to 1.9 percent of GDP in 2018, the lowest level in a decade [emphasis added]..

  • The share of federal expenditures for children targeted to low-income families has grown over time, reaching 61 percent in 2018…

  • Assuming no changes to current law, the children’s share of the budget is projected to drop from 9.2 percent to 7.5 percent over the next decade, as spending on Social Security, Medicare, Medicaid, and interest payments on the debt consume a growing share of the budget.

  • By 2020, the federal government is projected to spend more on interest payments on the debt than on children” {emphasis added].

Clearly, children are being short changed at the expense of rising deficits and care for older adults. How can we rebalance this funding?

Situations Leading to Reduced Effectiveness of Current Hand Hygiene against Infectious Mucus from Influenza Virus-Infected Patients: As we approach the flu season this article provides some important advice: “the efficacy of AHR [antiseptic hand rubbing] using ethanol-based disinfectant against mucus is greatly reduced until infectious mucus adhering to the hands/fingers has completely dried. If there is insufficient time before treating the next patient (i.e., if the infectious mucus is not completely dry), medical staff should be aware that effectiveness of AHR is reduced. Since AHW [antiseptic hand washing] is effective against both dry and nondry infectious mucus, AHW should be adopted to compensate for these weaknesses of AHR.”

A State-by-State Examination of the Economic Costs of Gun Violence: The U.S. Congress Joint Economic Committee Democratic Staff issued this report yesterday. It needed to come from this party because the Republican administration forbids such research, e.g., by the CDC.
In brief: “In 2017, for the first time, the rate of firearm deaths exceeded the death rate by motor vehicle accidents. That year, nearly 40,000 people were killed in the United States by a gun, including approximately 2,500 school-age children. That is over 100 people per day and more than five children killed each day. Sixty percent of gun deaths each year are firearm suicides…Gun homicides are also associated with fewer jobs, lost businesses and lower home values in local economies and communities across the nation. The latest estimate is that gun violence imposes $229 billion in total annual costs on the United States—1.4 percent of GDP [emphases added].”

Health Drinks, Healthy Kids: These age-specific recommendations from major child health organizations emphasize milk (including breast milk or, if not possible, formula) and water for children. It advocates against juices.

About healthcare IT

Concordance Between Electronic Clinical Documentation and Physicians’ Observed Behavior: “In this case series of 9 licensed emergency physician trainees and 12 observers of 180 patient encounters, 38.5% of the review of systems groups and 53.2% of the physical examination systems documented in the electronic health record were corroborated by direct audiovisual or reviewed audio observation….These findings raise the possibility that some physician documentation may not accurately represent actions taken, but further research is needed to assess this in more detail.” Is this lack of behavior also a case of cut-and-paste that is prevalent in using EMRs? What about the reimbursement implications? The increased, non-performed documentation will cause higher billing codes.

About health insurance

News Reports about a Weakening Economy Impacting How Some Patients Seek Medical Treatment: This report confirms what other studies found in the previous recession- a weak economy causes reduction in health-seeking behavior. Also, anticipation of a weakening will accelerate such activity.

Physician groups call court ruling on site-neutral payments 'bad news': As reported yesterday, the payment site differential between hospitals and independent practitioners was upheld in court. Naturally, physician groups are expressing their dissatisfaction with the decision.

Today's News and Commentary

About health insurance

Judge strikes down Trump administration's site-neutral payments rule: This story is today’s most impactful. “District of Columbia Judge Rosemary Collyer ruled Tuesday that the Centers for Medicare & Medicaid Services (CMS) overstepped its authority when it finalized a plan to extend a site-neutral payment policy to clinic visits with the goal of paying the same in Medicare for evaluation and management services at physician offices and hospitals.

Hospitals have the ability to charge patients and insurers more for the same services because they can add a facility charge that non-hospital-owned practices cannot. In fact, that’s how they financed physician practice acquisitions- charging more for the same services these practitioners provided before the sale. CMS sought to level the playing field and save the Medicare program $150 million a year by eliminating this differential. The American Hospital Association fought back and won.
The site neutrality payment policy can still be implemented with Congressional action.

10 states with the least competitive health insurance markets: According to this AMA study, 63% of state-level markets are “highly concentrated,” meaning very uncompetitive. That figure goes up to 75% when considering 382 metropolitan statistical areas. Of further concern is the concentration is worsening.

House panel delays vote on surprise medical bills legislation: “The dispute is centered on how doctors and hospitals will be paid once patients are protected from these massive bills. The bipartisan Energy and Commerce legislation essentially sets the payment rate that an insurer would pay the doctor. 

Doctors and hospitals are lobbying hard against that approach, including by spending millions of dollars in ads, warning it would lead to damaging cuts to doctors’ pay.”

Four People Charged In $99 Million Scheme To Commit Health Care Fraud And Wire Fraud And Pay Kickbacks To Doctors And Their Employees: This NJ case involved payoffs and kickbacks for steering referrals to pharmacies that supplied high cost pharmaceuticals. How can we redesign the process to eliminate the incentives to commit fraud?

About healthcare IT

The role of medical smartphone apps in clinical decision-support: A literature review: This study concludes that: “Whilst diagnostic accuracy studies are plentiful, clinical trials are scarce.” Further, methods of data collection vary (e.g., cameras, motion sensors, electrical activity), so research approaches need to be individualized for each test.

Millions of Americans’ Medical Images and Data Are Available on the Internet. Anyone Can Take a Peek: “Hundreds of computer servers worldwide that store patient X-rays and MRIs are so insecure that anyone with a web browser or a few lines of computer code can view patient records.” This research from Propublica and German broadcaster Bayerischer Rundfunk identified “187 servers…in the U.S. that were unprotected by passwords or basic security precautions.” This article is definitely worth a read.

HHS wants to give you your health data — do you want it?: As the federal government pushes providers to make patient data more available, recent research shows patients are either not ready to accept/access their data or do not want to download it. The article is a nice summary of the recent studies about this subject.

Israel Prepares to Unleash AI on Health Care (Wall Street Journal, subscription required): This article is a great insight into what can be done with Artificial Intelligence in healthcare when good design meets efficient interoperability.

About the public’s health

The U.S. abortion rate falls to lowest level since Roe v. Wade: “There appears to be no clear pattern between efforts to ban or restrict abortion and the continuing decline in abortion rates, which has been going on for nearly 40 years. The declines were seen across regions and in states that are more supportive of abortion rights as well as those that are more restrictive.” The reasons for this decline are not clear but they do coincide with decreasing birth rates as well.

Yesterday, the Financial Times had a series of articles about dementia. If you are interested in social issues, policy and business aspects of this condition, these articles are worth reading. (Subscription required).

Ambient black carbon particles reach the fetal side of human placenta: Another reason to eliminate particulate pollution: “Particle transfer across the placenta has been suggested but to date, no direct evidence in real-life, human context exists. Here we report the presence of black carbon (BC) particles as part of combustion-derived particulate matter in human placentae…”

How Health Systems Are Meeting the Challenge of Climate Change: This article is a nice summary of what some major healthcare institutions are doing to reduce their carbon footprint over the next ten years.

Survey: What Employees Want Most from Their Workspaces: “The results of a recent Harvard study suggest that wellness programs, offered by 80% of large U.S. companies, yield unimpressive results — and our findings mirror this. Future Workplace and View recently surveyed 1,601 workers across North America to figure out which wellness perks matter to them most and how these perks impact productivity.” Read the article to find out what employees really want. First on the list is air quality.

About hospitals and health systems

Premier Inc. Survey: Health Systems Report that Changes are Needed to Accelerate Adoption of Risk-Based Payment Arrangements: “Across all payer types, most respondents indicate that less than 20 percent of their population was covered in a risk-based arrangement. Twenty-nine percent reported that fee-for-service Medicare relationships are currently managed in a risk-based model, while 22 percent reported that to be the case for Medicare Advantage. Sixty-four percent of respondents reported that less than 20 percent of their patient population was covered by risk-based arrangements with employer-sponsored health plans.” Despite all the talk about risk-based arrangements and how they are growing, the field is nowhere near where it needs to be. The issues are the same as they have been for the past twenty years or so. Read the report for more details.

About healthcare quality and patient safety

WHO: Millions of Patients Die Every Year Seeking Health Care : “The World Health Organization reports one in 10 patients is harmed in high-income countries. It says 134 million patients in low-and-middle-income countries are harmed because of unsafe care leading to 2.6 million deaths annually. WHO notes most of these deaths are avoidable…Besides the avoidable and tragic loss of life, WHO reports patient harm leads to economic losses of trillions of dollars globally each year. It says medication errors alone cost an estimated $42 billion annually.
On the other hand, WHO says a study in the United States finds safety improvement in patient care has resulted in estimated savings of $28 billion in Medicare hospitals between 2010 and 2015.”
One of the major reasons for this problem is lack of a “patient safety culture,” as has been adopted by many highly functioning US healthcare systems.

About pharma

Decision Resources Group 2019 ePharma Physician® Report Finds U.S. Physicians Increasingly Too Busy to See Pharma Sales Reps: It used to be that pharmaceutical company representatives were a major source of information for physicians about established and new products. In recent years, many institutions have banned such contacts, fearing undue influence. Now, a limiting factor for practitioners who want to see reps is time. This study reports, among other findings, that the share of physicians seeing reps in-person declined in the last year from 67% to 54%. Further, the number of physicians that have not communicated with a representative within the last six months increased from 24% to 39%. Clearly, different marketing channels are needed for these companies.

Today's News and Commentary

About health insurance

Tennessee becomes first state with a plan to turn Medicaid into a block grant (Washington Post, subscription may be required): Over the past several years, a number of proposals have been floated for changing Medicaid payment methods, including block grant to states. This one is the first to implement such a change. The big implication is not just this program, but what it may portend for all of Medicaid- especially in Republican-controlled states.

About healthcare professionals

Cornell’s Medical School Offers Full Rides in Battle Over Student Debt (NY Times, subscription may be required): Many medical schools have revised their student scholarship policies to make the education tuition-free. This article is an update on those programs as Cornell joins their ranks.

About hospitals and healthcare systems

Healthy Marketplace Index: This research from the Health Care Cost Institute compared “hospital system concentration levels in 112 metro areas across the country from 2012 to 2016. In 2016, 81 metros of the 112 studied (72%) had hospital markets with [measures] that could qualify as a highly concentrated per the Department of Justice (DOJ)… Hospital markets tended to be less concentrated in larger metro areas. For instance, New York City, NY…, Philadelphia, PA …, and Chicago, IL … had three of the five least concentrated hospital markets studied . Conversely, the three most concentrated markets were in metro areas with populations of less than 300,000 in 2016: Springfield, MO…, Peoria, IL…, and Cape Coral, FL ...”
Read the entire report for a really interesting discussion of this issue of hospitals consolidation.

About pharma

Trends in Off-Label Drug Use in Ambulatory Settings: 2006–2015 (Pediatrics- subscription required for entire article): “Physicians ordered ≥1 off-label systemic drug at 18.5%… of visits, usually (74.6%) because of unapproved conditions. Off-label ordering was most common proportionally in neonates (83%) and in absolute terms among adolescents (322 orders out of 1000 visits).” These rates increased over the ten years of study. An accompanying editorial calls for more research and focused treatments for children.

About the public’s health

Patient Perceptions of Diabetes Guideline Frameworks for Individualizing Glycemic Targets: This article highlights the need to assess patient attitudes toward standardized recommendation and craft customized treatment plans.Many older adults do not place high importance on factors recommended by guidelines to individualize diabetes treatment, especially when deciding to stop use of diabetes medications. Moreover, when considering treatment aggressiveness, many older adults weighted several factors in the opposite direction than suggested by the guidelines. Individualizing diabetes care in older adults will require effective communication regarding the benefits and consequences of making changes to treatment plans.”