Today's News and Commentary

About the public’s health

CDC’s Antibiotic Resistance Threats in the United States, 2019: This latest report from the CDC reveals that the problem of antibiotic resistance is greater than previously thought. “According to the report, more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die as a result.”

Banning E-Cigarettes Could Do More Harm Than Good: This NY Times editorial (may require subscription) makes the point that banning e-cigarettes alone is not a viable strategy to reduce tobacco use. It does advocate for stronger regulation for e-cigarettes, such as limiting the nicotine content (as they do in the UK), prohibiting marketing to children and, in general, dealing with this product as is done with traditional cigarettes.

The Health 202: U.S. to lose thousands of health-care workers if 'dreamers' must leave: The headline speaks for itself. As Sir Michael Marmot said: Every sector is a health sector.

Immunization: vital progress, unfinished agenda: This article in Nature is an excellent review of the history of vaccines and the beneficial role they play in public health. It also points out a problem: poor countries get aid for vaccines; rich countries can pay for them on their own; but developing middle income countries may not be able to afford sufficient vaccinations for its population.

Longitudinal Associations Between Income Changes and Incident Cardiovascular Disease: This research is one in a long series of studies showing the deleterious effect of stress and inequities on health. The study concluded: “Income drop over 6 years was associated with higher risk of subsequent incident CVD over 17 years, while income rise over 6 years was associated with lower risk of subsequent incident CVD over 17 years. Health professionals should have greater awareness of the influence of income change on the health of their patients.”

About healthcare IT

Technology that improves patients’ lives, caregivers’ experience: This press release from Ascension by Eduardo Conrado, Executive Vice President, Strategy and Innovations, is a response to the previously reported Project Nightingale initiative the hospital company has with Google. He makes 8 points in defense of the deal. But…

Google's 'Project Nightingale' center of federal inquiry: Despite the above assurances HHS is investigating this deal to make sure there were no HIPAA violations.

About health insurance

Drug costs to push Medicare Part B premiums 7% higher next year: CMS attributes the increase in Part B premiums to the higher cost of medications administered in physicians’ offices.

CMS seeks to crack down on schemes used by states to get higher federal match in Medicaid: States are using extra, non-allowed, funds to pay for Medicaid services in order to garner more federal matching money than they are entitled to receive. CMS will more closely look at these practices and crack down on the process.

About pharma

Indian Drug Facility Cited for Packaging Violations: Some of these drugs were destined for the US. One more reminder about the global supply chain for drugs.

Pharma ad spenders for October: AbbVie's Humira tops again, joined by next-gen sibling Skyrizi: Just out is this list of top spending pharma company ads and a bit about each. Worth a quick read.

About healthcare quality and safety

Did Hospital Readmissions Fall Because Per Capita Admission Rates Fell?: The answer to the question is : Yes. 30 day readmissions fell because admissions fell. The authors of this study recommend CMS use better criteria for quality.

Today's News and Commentary

About the public’s health

E.P.A. to Limit Science Used to Write Public Health Rules(NY Times- may require subscription): “A new draft of the Environmental Protection Agency proposal, titled Strengthening Transparency in Regulatory Science, would require that scientists disclose all of their raw data, including confidential medical records, before the agency could consider an academic study’s conclusions. E.P.A. officials called the plan a step toward transparency and said the disclosure of raw data would allow conclusions to be verified independently.” However, the “measure would make it more difficult to enact new clean air and water rules because many studies detailing the links between pollution and disease rely on personal health information gathered under confidentiality agreements.”

Disparities in Receiving Guideline-Concordant Treatment for Lung Cancer in the United States:”Between 2010-2014, many lung cancer patients in the United States received no treatment or less intensive treatment than recommended. Particularly, elderly lung cancer patients and non-Hispanic Blacks are less likely to receive guideline-concordant treatment.” Unfortunately treatment disparities are still prevalent.

E-cigarettes hurt heart health, possibly more than regular cigarettes: This article summarizes two studies to be presented at the upcoming meeting of the American Heart Association. E-cigarettes are as bad or worse for health than regular cigarettes.

Merck's Ervebo, the world's first Ebola shot, wins inaugural approval in EU: A big step for public health- the first approved Ebola vaccine.

About pharma

Even a Modest Co-Payment Can Cause People to Skip Drug Doses (NY Times- may require subscription):This article provides a nice summary of recent research showing how people do not fill prescriptions, ask for cheaper medications and skip/reduce doses to save money. These measures occur about twice as often in the US as the next comparison country, Canada.

16 recent pharmaceutical lawsuits, settlements: An interesting summary of activity in this sector. Worth a quick read.

Walgreens Boots receives $70bn buyout proposal from KKR (Financial Times, subscription required): The offer has been confirmed for history’s largest private equity buyout. Walgreens has an equity value of $56bn.

Bayer highlights the human value of its products in its biggest image campaign ever: In the shadow of the Roundup trials that allege it causes cancer, Bayer is launching an image campaign to show all the valuable product it produces. The TV and social media ads are branded under the name “Why We Science.” Do you think the message is credible?

About healthcare IT

Google has collected health data on millions of Americans through new partnership: report: (This story was reported in today’s print version of the Wall Street Journal. This link has open access.) The Ascension system partnered with Google in a venture called Project Nightingale. The agreement allows Google to obtain access to personal health care data from Ascension’s patients in 21 states, including lab results, diagnoses, hospitalization records and health histories with names and date of births. “Neither patients nor doctors were informed that Google was collecting the data, according to the Journal, and at least 150 Google employees have access to the information.” Ascension asserts the data is for internal use only to improve decision making for benefit of patients.

Ancestry's Catherine Ball on why the genealogy company just gave UpToDate a $1M grant: Ancestry announced a $1 million grant to Wolters Kluwer, publisher of UpToDate software “which offers doctors evidence-based medical information on 11,600 topics across 25 specialties…The funding will be aimed at allowing UpToDate to independently develop information for healthcare providers to help them interpret and act on the results of genetic testing.”

About health insurance

Medicare Improperly Paid Acute-Care Hospitals $54.4 Million for Inpatient Claims Subject to the Post-Acute-Care Transfer Policy: HHS Office of the Inspector General found that “Medicare improperly paid acute-care hospitals $54.4 million for 18,647 claims subject to the transfer policy. These hospitals improperly billed the claims by using the incorrect patient discharge status codes. Specifically, they coded these claims as discharges to home (16,599 claims) or to certain types of healthcare institutions (2,048 claims), such as facilities that provide custodial care, rather than as transfers to post-acute care.” For all the talk about how Medicare operates with low administrative costs, when did you last hear about such an error being made by a private insurer?

Private Medicare enrollment for 7 commercial payers: FYI, the latest Medicare Advantage enrollment figures for the top seven commercial payers.

Today's News and Commentary

About health insurance

Medical cost ratios for 7 national payers: Read the article for the exact numbers for the recent quarter. Most importantly, the figures are still under control post-ACA.

2020 Medicare Parts A & B Premiums and Deductibles: CMS released these figures for next year.

36% of Payments Tied to Alternative Payment Models in 2018: “Healthcare payments are moving away from fee-for-service, with 25.1% linked to value and quality and 35.8% tied to bundled payments, shared savings, and other alternative payment models, HCP-LAN [Health Care Payment Learning & Action Network] reported.” The figures were for Medicare Alternative Payment Method (APM) programs.

Kaiser Permanente Chairman Bernard Tyson dies unexpectedly: He was 60 years old and a great leader.

Hospital Consolidation Tied to Rising Costs by Medicare Panel: According to MedPAC senior analyst Dan Zabinski: “Vertical integration increases Medicare program spending and beneficiary cost sharing.” The reason is the extra facility payments hospitals receive when their employed physicians provide services in hospital-owned facilities; that is, they get paid more than physicians doing the same thing in their offices. The “site neutral” scheme CMS advocates “is projected to save Medicare $650 million next year. Program beneficiaries would save another $160 million in out-of-pocket costs…”

About healthcare quality

Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: “Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment. Results support the feasibility of mailing HPV kits to women who are overdue for screening as an outreach strategy to increase screening uptake in US health care systems.”

About healthcare IT

CMS releases research-ready Medicaid and CHIP datasets: The headline speaks for itself. If interested, you must apply to receive the data.

About pharma

KKR Makes Formal Approach to Walgreens Boots on Record Buyout: News about the biggest potential leveraged buyout ever.

About the public’s health

How Germany Averted An Opioid Crisis: Unlike in the US, physicians in Germany treat pain with opioids when other measures fail, not as a first choice by protocol. This article provides some useful recommendations we could adopt in this country.

Today's News and Commentary

About pharma

A bad Rx for what ails Walgreens (Crain’s Chicago Business- subscription required): This week’s big business news in healthcare is Walgreen’s possible leveraged buyout headed by CEO Stefano Pessina. It would add $55 billion in debt, which some critics think would sink the company under interest payment requirements. In the meantime…

At height of crisis, Walgreens handled nearly one in five of the most addictive opioids: The fact in this headline should be a warning that pharmacy companies might be at risk for the same lawsuits as face wholesalers and manufacturers.

CVS touts strong early performance of first HealthHUB stores: “CEO Larry Merlo said on the company's earnings call Wednesday morning that these concept stores, which dedicate more than 20% of retail space to health services, outperform control retail pharmacies in script volume, MinuteClinic visits, front store sales, foot traffic and store margin.”

Senate fight derails bipartisan drug pricing bills: The bipartisan proposals in the Senate to control drug prices are not straightforward and do not agree with one another. Read this article to sort them out. It is unlikely anything significant will happen soon because of the disparities.

After years-long delay, Novartis' Sandoz finally wins Neulasta biosimilar nod: The availability of this generic should have a significant impact on lowering pharma costs.

Health insurance

10 major cities with the highest, lowest uninsured rates: Interesting list. You may be surprised by the rankings.

Amazon-Berkshire-JPMorgan tests new employee health plan in some states: “JPMorgan is offering 30,000 workers in Ohio and Arizona two insurance plans under Haven Healthcare next year. The plan will be run by Cigna and Aetna…” After much hoopla about these companies innovating health insurance, the “new” product will offer some wellness incentives and be administered by existing plans.

Early Problems as Trump’s Signature Veterans’ Health Plan Rolls Out (NY Times- subscription may be required): The recent Mission Act allows veterans, who need to drive for at least 30 minutes to a VA hospital, to receive primary care and mental health services outside the system. But Optum Public Sector Solutions, which is administering the program, “told congressional aides that they were unable to guarantee a health care network large enough to accommodate all the veterans who might seek care under the new system. They suggested that more money — perhaps as much as $75 million — would be needed to help build a larger network.”

Warren’s plan to pay for Medicare-for-all: Does it add up? (Washington Post-subscription may be required): This “fact checker” article says the numbers she claims “add up.” But, you need to: believe the assumptions behind them; that the proposal will get passed (far from likely): and no reactions to proposed measures will take place- like lowered physician prices resulting in higher volumes and intensity of care.

Medicaid Expansion Associated With Reductions In Preventable Hospitalizations (Health Affairs- subscription required): The headline is the important message from the research study.

Primary Care for All: Instead of calling for a reform of Medicare for All, we need to first assure that we are able to deliver primary care to all. That goal will require a change in how we structure and fund our healthcare “system.”

As Congress Works To Curb Surprise Medical Bills, N.Y.’s Fix Gets Examined: The way surprise bills are being adjudicated is important when looking at whether the methods reduce costs. “According to an analysis of newly released data from New York’s Department of Financial Services, the New York model is making health care substantially more expensive in the state. In fact arbiters are typically deciding on dollar amounts above the 80th percentile of typical costs.”

About the public’s health

Federal Judge Voids 'Conscience Rule'-Policy would have allowed providers to refuse care because of "moral objections": “Judge Paul A. Engelmayer of New York's Southern District issued a 147-page decision that ‘vacates HHS's 2019 Rule in its entirety.’ The HHS rule would have allowed healthcare professionals to refuse to perform treatments or provide counseling or referrals ‘on account of religious beliefs or moral convictions.’”

Hospitals pledge $700 million to fight economic, social disparities: (Modern Healthcare-subscription required): “Fourteen of the country's largest hospital systems… pledged to invest more than $700 million toward community-based initiatives aimed at addressing the economic and environmental drivers behind a widening disparity in health outcomes.
The funding over the next five years will go toward projects to tackle housing instability, food insecurity and economic revitalization, among other issues. The effort is part of a national campaign organized by the Healthcare Anchor Network, a collaborative of 45 hospitals and health systems launched in 2017 to help providers learn and share ways to implement strategies aimed at economic inclusion of communities.”

About healthcare quality and safety

Leapfrog Releases Bi-Annual Hospital Safety Grades: “More than 2,600 hospitals graded with the breakdown as follows: 33% earned an "A," 25% earned a "B," 34% earned a "C," 8% a "D" and just under 1% an "F." Check this site for information on specific hospitals. An “A” does not mean the hospital performs even at the average level on all measures.

About healthcare professionals

Geisinger to offer free med school tuition for 40 students per year: “Danville, Pa.-based Geisinger will offer free tuition annually for 40 medical students who commit to working in primary care at the system after graduation. 
Under the Geisinger Primary Care Program, the system's Commonwealth School of Medicine also will give students a $2,000-per-month living stipend. 
In exchange, the students must commit to staying at Geisinger for four years after residency to work in primary care.”

Today's News and Commentary

About pharma

Canadian ambassador says drug imports would not lower U.S. prices: In order to take advantage of lower foreign drug prices, the supply for importation needs to be adequate. That means the pharma companies need to ship a surplus to those countries from which we will reimport the products. Guess what? The supply is not adequate, at least from Canada.

White House distances itself from Pelosi plan to lower drug prices: Congressional drug price-reduction efforts are complicated. The House has a Pelosi proposal and the Senate has its own bipartisan plan. The White House is leaning to the Senate version.

About healthcare IT

The Predictive Performance of Objective Measures of Physical Activity Derived From Accelerometry Data for 5-Year All-Cause Mortality in Older Adults: National Health and Nutritional Examination Survey 2003–2006: This paper concludes that objective data from accelerometers predict mortality rates 30-40% better than standard historical measures like tobacco use or stroke or cancer diagnoses.

About the public’s health

Proposed HHS rule would strip Obama-era protections for LGBTQ individuals: “Citing concerns about religious freedom, Health and Human Services Secretary Alex Azar on Friday proposed a new rule that would effectively eliminate discrimination protections for LGBTQ individuals in all its grant programs.
The most immediate impact would likely be on the nation’s $7 billion federally funded child-welfare system, including foster care and adoption programs.”

About hospitals and health systems

Trump Administration Delays Rule Forcing Hospital-Cost Transparency: “The Trump administration is delaying a rule that would require hospitals to share secret, negotiated rates because officials said they are working to expand the plan to include insurers.” The problems of disclosure will not get any easier, since prices depend on the insurance plan specifics.

About health insurance

State reinsurance programs reduce premiums nearly 17% in first year of operation: Avalere: State plans that offer reinsurance to payers have lowered premiums. This outcome should not come as a surprise, since the lower risk for catastrophic claims allows insurers to reduce premiums. The question is what happens to overall costs of such schemes.

Five things to know about Warren's 'Medicare for All' funding plan: She finally gave some funding specifics. No, there is not a middle class tax increase. But many are skeptical if the other means to raise money are enough to fund the “just under $52 trillion over 10 years, including $20.5 trillion in new federal spending.” Read the article for more details.

Court blocks plan to deny visas to would-be immigrants who can't afford health insurance: The headline speaks for itself.

Window Shopping And Updates On HealthCare.gov: Now that enrollment is open for 2020 coverage, HealthCare.gov is offering some new features to help consumers choose the right plan, including costs and quality ratings.

CMS releases final site neutral and other payment rules: Despite a United States District Court for the District of Columbia ruling, CMS has issued its site neutral payment policy and 340B plan reductions. (Read the article and previous posts for more background about both issues.)

Association Between Switching to a High-Deductible Health Plan and Discontinuation of Type 2 Diabetes Treatment: What is the effect of switching to a high deductible plan on usage of diabetic medication? Keep in mind that patients can use funds in their Health Savings Accounts to pay for expenses before the deductible is met. The answer is not straightforward: “This study showed that the association between HDHP enrollment and antihyperglycemic medication refills and subsequent discontinuation is mixed. Although no statistically significant differences in rates of discontinuation of antihyperglycemic treatment were found, the findings suggest a tendency toward switching to less costly treatment options.” If the outcome is switching to less costly options, then theses plans will have fulfilled their economic incentive-driven purpose.

Today's News and Commentary

About health insurance

Stable costs but more uninsured as ‘Obamacare’ sign-ups open: Today is the first day of open enrollment for ACA signups. Signups in most states close on December 15.

Summary of 2020 changes to the Medicare Physician Fee Schedule, Quality Payment Program, and other federal programs: This monograph from the American College of Physicians is an excellent resource to understand many changes in Medicare payment schemes. It is of further importance because private payers often follow Medicare methods.

CMS finalizes payment rules to spur greater use of innovative kidney drugs, home infusion: CMS finalized payment rules that it hopes will encourage less costly treatment options. For example: “The home infusion therapy benefit—which will be implemented in 2021—will cover the administration of certain medication through a durable medical equipment pump in a patient’s home. It will also cover professional services such as nursing, patient education and training and patient monitoring.”

Rural and Safety Net Hospitals Prepare for Cut in Federal Support: The ACA mandated financial cuts to hospitals that help poor and uninsured. The reason is that more people would be insured. Since the federal government was subsidizing premiums, it reasoned the extra payments would be “double dipping.” But the cuts will cause hardships for many of those institutions. Read the article for more details.

About healthcare quality and safety

Feds Appeal Block on Sanctions for Disclosing Medical Error Info (Bloomberg Law- may need subscription):”The HHS is appealing to the Eleventh Circuit a decision blocking it from penalizing a health-care provider for disclosing medical error-related information privileged under federal law. State law may force the hospital to produce the information in a state court medical malpractice case.” This case raises two issues: First, privileged information is necessary in many quality investigations and must be preserved. Second, this case apparently represents an overlap of federal and state laws that needs resolution.

About pharma

Long-awaited cystic fibrosis drug could turn deadly disease into a manageable condition (Washington Post- subscription may be required): The FDA has approved a new three-drug combination, Trikafta, that is expected to benefit 90% of patients with cystic fibrosis. It is a major breakthrough in treatment. Cost is expected to be $311,000 a year.

About the public’s health

Is chocolate healthy? Alas, the answer isn’t sweet. Here’s why.(Washington Post- subscription may be required): Don’t read this article if you love chocolate. It’s the “skinny” on the purported benefits of this beloved treat.

Today's News and Commentary

About healthcare IT

Final ONC, CMS interoperability rules under review by OMB: Despite industry protests of moving too fast, the Office of the National Coordinator has submitted its final rules regarding interoperability and data blocking to the Office of Management and Budget.

Senators introduce bill to expand use of telehealth in Medicare: This bipartisan bill is called Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019.Its overall aims are to:

  • “Provide the Secretary of Health and Human Services with the authority to waive telehealth restrictions when necessary.

  • Remove geographic and originating site restrictions for services like mental health and emergency medical care.

  • Allow rural health clinics and other community-based health care centers to provide telehealth services.

  • Require a study to explore more ways to expand telehealth services so that more people can access healthcare services in their own homes.”

About the public’s health

Health, United States 2018: This annual publication by the CDC is an excellent resource on US health statistics. Among the “higher level” findings:
”Life expectancy at birth in the United States for the total population was 78.6 years in 2017, 0.5 year higher than in 2007. Despite the higher life expectancy in 2017 compared with 2007, life expectancy at birth has decreased in recent years. Life expectancy at birth decreased 0.2 year between 2014 and 2015, did not change between 2015 and 2016, and then decreased another 0.1 year between 2016 and 2017.”

US effort to remove ‘sexual health’ from UN agreement may violate law, say senators: “The Trump administration may have violated federal law by lobbying more than 70 countries to remove protections for ‘sexual and reproductive health’ from a UN agreement, according to a letter from four US [Democratic] senators…” The claim is that the action violates the Siljander Amendment (1981), which
prohibits the use of funds to lobby for or against abortion- including those used for foreign operations. See: The U.S. Government and International Family Planning & Reproductive Health: Statutory Requirements and Policies for a list and brief explanation of such laws.

White House launches website aimed at addiction treatment: “The Trump administration has unveiled a website aimed at helping millions of Americans with substance abuse issues learn about and locate treatment options… FindTreatment.gov [use this link] modernizes an obscure directory of 13,000 licensed treatment providers maintained by the Substance Abuse and Mental Health Services Administration, adding user-friendly search criteria and tools. For instance, it will now allow users to search based on the type of treatment sought — such as inpatient, detox or telemedicine — by payment option and whether the treatment is medication-assisted.
Users also will be able to select between options that focus on youth, veterans and LGBT Americans.
The website also is meant to be an educational resource for those needing care and their loved ones with information on how to pay for treatment.”

About pharma

Pfizer, GSK, J&J and more strike $248M deal to exit long-running Medicaid fraud suit: “After 14 years of litigation, a slew of drugmakers—including several Big Pharma giants—are finally settling a protracted battle with the state of Illinois over claims they fudged wholesale drug prices to increase Medicaid reimbursements.
For Pfizer, GlaxoSmithKline, Johnson & Johnson and a handful of others, the bill tallies up to $248 million.” 

About health insurance

Senate Democrats fail in bid to block Trump’s Obamacare opt-out: Senate Democrats finally called for a vote to block administration rules aimed at giving states more leeway to circumvent ACA requirements. Except for Senator Susan Collins (R-ME), the vote was along party lines and failed. The Democrats predicted the failure, but wanted Republicans on the record voting for laxer requirements that might take away such protections as no discrimination for pre existing conditions.

American’s values and beliefs about national insurance reform: While this survey was just released and reviewed in the New York Times, the answers were obtained July 10 – August 11, 2019. In more than 2 months, a lot can happen on this very fluid issue. Still, at the time of the data gathering, respondents were about equally split in their preferences among Medicare for All, modifying the ACA and replacing the ACA with state health plans.

Today's News and Commentary

About pharma

Walgreens to Scale Back In-Store Clinics (Wall Street Journal- subscription may be required): Normally stories about pharmacies deal with medications or retail products. Lately, stores have been getting into the” healthcare business,” continuing to expand walk-in clinics and offering wellness services. For the first time, we are seeing some retrenchment. Walgreens announced that “it will close the roughly 160 in-store health clinics the company runs itself in the U.S., while keeping 220 clinics that are run by local health systems. It didn’t provide an estimate for the financial impact.” The article further notes: CVS and Walgreens “are taking different approaches. Walgreens has increasingly sought partnerships with other companies and health systems, while CVS is executing its plan through acquisitions or by building its own new business. 
Walgreens’s roughly 400 walk-in clinics and CVS’s 1,000 Minute Clinic locations have at best barely broken even for the companies. The goal now for both is to shift away from treating minor or acute issues and focus instead on people with chronic conditions such as diabetes, heart disease and hypertension.”
Is it really a good idea to go to a walking clinic at a pharmacy and give it responsibility for chronic care?

An inside look at Walmart's new health clinic: This article provides an update on what Walmart is doing with its clinics.

Revenues and Profits From Medicare Patients in Hospitals Participating in the 340B Drug Discount Program, 2013-2016: This article is a useful read for policy makers as well as those in pharma. As the government contemplates reducing this program, it is important to understand the impact it has on hospitals serving this select population. “Estimated profits that hospitals derived from administering 340B-discounted drugs to Medicare patients are small compared with operating budgets yet substantial compared with uncompensated care costs for many hospitals. Revenue and profit estimates from 340B-discounted drugs represent a lower bound because data on revenue from the sale of outpatient retail dispensed drugs by hospital contract pharmacies and commercial insurer claims are not available.” For details about the 340B program see Chapter 6 (Payers) in the text.

Merck siphons off Gardasil CDC supplies again as global sales surge: “Merck & Co. won’t be able to fully meet global demand for HPV vaccine Gardasil until after 2023 when it completes production of a couple of manufacturing plants. So for now, the drugmaker is again turning to the CDC to borrow doses..to help cover vaccinations in the U.S., which will allow Merck to produce more for other parts of the world where demand is outrunning supply. The move will cost Merck about $120 million in Q4 sales, it said.” This article highlights how much pharma is an interdependent, global business.

 Drug Shortages: Root Causes and Potential Solutions: This FDA report” identifies three root causes for drug shortages:

  • Lack of incentives for manufacturers to produce less profitable drugs;

  • The market does not recognize and reward manufacturers for ‘mature quality systems’ that focus on continuous improvement and early detection of supply chain issues; and

  • Logistical and regulatory challenges make it difficult for the market to recover from a disruption.

The report also recommends enduring solutions to address drug shortages. These solutions include:

  • Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;

  • Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and

  • Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.”

About health insurance

New federal rules to allow employers to '401(k)-ize' health benefits: “A change to the Internal Revenue Service code, set to take effect Jan. 1, allows employers to stop providing insurance for employees -- and instead pay workers pretax funds [through health reimbursement arrangements, or HRAs] to buy coverage themselves.” This change in the tax code is extremely important and could change the way many employers fund health insurance. It could be the first step to defined contribution plans, which employers talked about for years but never implemented. However, this method would not help employees working for large corporations , who get the benefit of their employer’s negotiating power.

Verily, John Hancock collaborating on life insurance solution that offers virtual diabetes management: This article is actually about a life insurance company. “John Hancock is teaming up with Verily Life Sciences to offer a life insurance solution and digital wellness program to help people with diabetes manage and improve their condition.
The new product, John Hancock Aspire, is a unique collaboration between the Boston-based life insurer and Verily, the healthcare division of Google parent company Alphabet, and will leverage the capabilities of Onduo, a virtual diabetes clinic….Plan members have the potential to save up to 25% on their premiums, according to the company.”
Like other such efforts, will results be coordinated with a primary care physician?

CMS wants prior authorization for non-emergency ambulances nationwide: “The CMS wants to expand prior authorization for non-emergency ambulance transportation nationwide and on Friday requested ambulance services for information that could help achieve that goal…The agency would freeze payments for review and approval if the ambulance supplier doesn't submit a prior authorization request after four round trips during a 30-day period.” Ambulance services have been a particular source of fraud and abuse for Medicare. I remember speaking at a CMS conference on fraud and abuse and hearing a panelist comment about a company that billed 1 million miles for a particular vehicle. The announcement is groundbreaking for CMS because the program is a volume-driven utilization process that the agency generally does not have.

With health care costs projected to rise another 5% in 2020, employers look to new strategies to control costs: This press release from Willis Towers Watson summarizes approaches employers are taking to reduce their healthcare costs. “Curbing the cost of health care and increasing its affordability remain the top priorities for almost all employers over the next three years (93%), according to the 24th annual Best Practices in Health Care Employer Survey… Yet nearly two in three (63%) employers see health care affordability as the most difficult challenge to tackle over that same period.” The entire report does not seem to be out yet, but this annual piece is always worth reading.

Premiums and Employee Contributions to Employer-Sponsored Health Insurance by Workforce Gender and Firm Size, Private Industry, 2018: This report from AHRQ shows how firms with a high percentage (>75%) of women have higher premiums than those companies with a low percentages (<25%) of women. The ACA was supposed to erase gender differences.

The Number of Uninsured Children is on the Rise: The key findings from this Georgetown study are:

  • The number of uninsured children in the United States increased by more than 400,000 between 2016 and 2018 bringing the total to over 4 million uninsured children in the nation.[The most since the ACA became law]

  • These coverage losses are widespread with 15 states showing statistically significant increases in the number and/or rate of uninsured children

  • Loss of coverage is most pronounced for white children and Latino children (some of which may fall into both categories), young children under age 6, and children in low- and moderate- income families who earn between 138 percent and 250 percent of poverty.

    States that have not expanded Medicaid to parents and other adults under the Affordable Care Act have seen increases in their rate of uninsured children three times as large as states that have.

    Several of the reasons cited include: confusion about Republican attempt to repel the ACA; elimination of the individual mandate penalty; delay in funding the Children’s Health Insurance Program (CHIP); cuts in outreach and enrollment funding; and shortening of the open enrollment period.

Medical billing is a nightmare, but start-up Ooda is working to make it way easier, and some insurers are optimistic: This program is the first innovation in insurance in decades. “Here’s how it works: Once a patient gets seen by a health provider, the claim gets submitted to the insurance company, which adjudicates it and issues a payment to the hospital or clinic for the insurance portion of the bill. From there, Ooda quickly pays the provider [such as doctors and hospitals] for the patient’s portion of the bill, and Ooda and the insurer jointly manage what the patient owes…
So why would insurers take on the liability when it wasn’t previously their problem? Blue Shield of Arizona’s CEO Pam Kehaly says this was a “worry item” for her. But she’s willing to test it because the financial exposure for her plan is offset by the improvement in experience for members. And it will potentially mean fewer member grievances, and therefore lower costs to staff call centers.”
The business model for Ooda’s carrying the risk of non payment is not clear.

Health Care Service Corporation Aims to Decrease Number of Uninsured Americans Through Be Covered Campaign: “Health Care Service Corporation (HCSC) announced today a multi-state education and outreach campaign aimed at decreasing the number of uninsured and underinsured Americans. Be Covered is a community-based education effort to help people understand the benefits of insurance, identify their options and empower them to make informed, sound health care decisions for themselves and their families.
The campaign focuses on Illinois, Montana, New Mexico, Oklahoma, and Texas, [states where HCSC operates] where nearly 7 million people are uninsured, yet more than 60% qualify for Medicaid or are eligible for a federal insurance subsidy .”

About the public’s health

Johnson & Johnson shares rise after it says no signs of asbestos found in baby powder after testing: After pulling 33,000 bottles of baby powder earlier this month because of FDA findings of asbestos contamination, J&J contracted with two independent labs which found the powder to be free of the contaminant. Undoubtedly, the previously reported lawsuits will continue.

Federal judge temporarily blocks Alabama's near-total abortion ban: The headline speaks for itself. Judge Thompson wrote that “the Alabama law ‘contravenes clear Supreme Court precedent’ and ‘defies the United States Constitution…It violates the right of an individual to privacy, to make 'choices central to personal dignity and autonomy.' " Despite unanimous federal court decisions against stricter abortion laws, these cases are undoubtedly headed to the Supreme Court.

About healthcare IT

Google parent company Alphabet eyeing acquisition of Fitbit, according to media reports: The headline explains a Google strategy to gather health data and tie in customers.

Facebook takes a first step into personal digital health with checkup reminder and screening tool: The reminders are not linked to medical records but are recommendations from major medical/healthcare organizations, such as the American Cancer Society, the American College of Cardiology, the American Heart Association and the Centers for Disease Control and Prevention (CDC).

Uber app to integrate directly into Cerner’s EHR so providers can schedule transportation for patients: The headline speaks for itself. Wonder how Lyft is reacting?

About healthcare quality and safety

Geographical Variation in Outcomes of Primary Hip and Knee Replacement: Volume-quality relationships are well known. Not so well investigated is whether the volume is associated with the doctor, facility (hospital) or both for a given treatment. In this English study, for these procedures it seems to be the experience of both that matters. Also private hospitals in that country had higher quality.

CMS: More hospitals will get value-based purchasing program payment bonuses in FY2020: "The value-based purchasing program adjusts Medicare payments to participating hospitals based on a series of healthcare outcomes that include cost efficiency, patient safety, mortality data and healthcare-associated infections.” According to CMS, “ 55%—more than 1,500 hospitals out of approximately 2,700 facilities participating in the program—got a slightly higher Medicare payment under the program. Overall there will be $1.9 billion in incentive payments for hospitals in federal fiscal year 2020, which runs from Oct. 1 until Sept. 30, the same amount as fiscal 2019.”

Minority heart failure patients may get less access to specialized ICUs: Inequalities persist in cardiac care: ”researchers found that compared to white patients, similarly-sick black patients were 9% less likely to be admitted to cardiac care units and Latinx patients were 17% less likely… women were 9% less likely than men and patients over age 75 were 15% less likely than younger patients to be admitted to cardiac units.” These difference result in poorer outcomes. For example, after “accounting for factors such as age, gender, heart failure features and chronic illnesses, the researchers found that black patients who were admitted to the general medicine service had a higher rate of death within 30 days than those who were admitted to the cardiology unit (3% versus less than 1%).”

About healthcare technology

Cleveland Clinic picks top 10 medical innovations for 2020: Each year Cleveland Clinic picks 10 top medical innovations for the following year. Can you come up with your list?

Today's News and Commentary

About health insurance

Choices for Financing Medicare for All: A Preliminary Analysis: The Committee for a Responsible Federal Budget just issued a comparison analysis of the current estimates for the cost of Medicare for All. In addition to a chart comparing these estimates, the Committee looks at various ways the proposal could be financed:

  • “A 32 percent payroll tax

  • A 25 percent income surtax

  • A 42 percent value-added tax (VAT)

  • A mandatory public premium averaging $7,500 per capita – the equivalent of $12,000 per individual not otherwise on public insurance

  • More than doubling all individual and corporate income tax rates

  • An 80 percent reduction in non-health federal spending

  • A 108 percent of Gross Domestic Product (GDP) increase in the national debt

  • Impossibly high taxes on high earners, corporations, and the financial sector… There is not enough annual income available among higher earners to finance the full cost of Medicare for All. On a static basis, even increasing the top two income tax rates (applying to individuals making over $204,000 per year and couples making over $408,000 per year) to 100 percent would not raise $30 trillion over a decade. 

  • A combination of approaches [see text for some possibilities]”

New York insurance regulator to probe Optum algorithm for racial bias: As previously reported, an Optum algorithm under-scored the severity of illness of black patients. New York's Financial Services and Health departments are now asking Optum for more information about how it is being used.

Employers Are Scaling Back Their Dependence On High-Deductible Health Plans: The reason for the finding in the headline is that a tight labor market makes generous health benefits an attractive recruiting strategy. That means reducing employee out-of-pocket costs, among other strategies.

About the public’s health

Reframing resistance: How to communicate about antimicrobial resistance effectively: This Wellcome Trust monograph is based on a large international study of the best ways to communicate the importance of antibiotic resistance to populations. It is a must-read for public health professionals, not only for its content but to learn how language matters in conveying an important health message. Five strategies that came from the research are detailed.

About pharma

Pelosi's office working to kill progressive change to drug pricing bill: As previously reported, Democratic progressives are trying to amend Speaker Pelosi’s drug pricing bill to expand its reach. It originally looked like the changes were going to be adopted; but now the Speaker is trying to keep to the original terms.

Socially transmitted placebo effects: Not much new in placebo research until this article appeared last week. The message is that if the healthcare provider really believes the placebo will work, the social cues transmitted in interacting with the patient will enhance the treatment’s effectiveness.

Today's News and Commentary

About pharma

Democrats’ new logic on drug pricing: Developing slightly fewer medicines is OK if it means lower prices: The Democrats are accepting the conclusions of a Congressional Budget study that forecasted “Pelosi’s bill would save taxpayers $345 billion in the next decade and cost the drug industry as much as $1 trillion in revenue… drug companies would therefore invest less in research, leading the number of new drug approvals could fall between 2.6% and 5%.” A classic tradeoff of lower cost for lower quality.

GlaxoSmithKline kick-starts first-of-its-kind late-stage antibiotic test: This story is interesting for three reasons. First, GSK is one of very few companies still actively involved in antibiotic research, highlighting the need for expanded efforts in this sector. Second, the drug being tested, called gepotidacin, is part of a new class of compounds called triazaacenaphthylene bacterial topoisomerase inhibitors. Finally, this effort is part of a public-private partnership between GSK, the U.S. government’s Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.

Biopharma's top broken, unfulfilled or abandoned promises: This article provides good insights into some of the inner workings at six large pharma companies.

About health insurance

Medicare Part C and D Performance Data: CMS has just issued its star (quality) reports for these Medicare plans. You can find out the individual plan ratings, but overall:

  • Approximately 52 percent of MA-PDs (210 contracts) that will be offered in 2020 earned 4 stars or higher for their 2020 overall rating.

  •   Weighted by enrollment, approximately 81 percent of MA-PD enrollees are currently in contracts that will have 4 or more stars in 2020.

Experience with New York’s arbitration process for surprise out-of-network bills: “The biggest concern raised about NY’s arbitration process is the state’s guidance that arbiters should consider the 80th percentile of billed charges (as calculated by FAIR Health, an independent insurance claims database) when determining the final payment amount. Providers’ billed charges, or list prices, are unilaterally set, largely unmoored from market forces, and generally many times higher than in-network negotiated rates or Medicare rates. And telling arbiters to focus on 80th percentile of charges—that is, an amount higher than what 80% of of physicians charge for a given billing code—drives this standard still higher.”
This process’ problem is the equivalent of the pre-RBRVS scheme of Usual, Customary and Reasonable charges. For this process to work there needs to be an objective reference, like the Medicare rates.

Freestanding Emergency Department [FrED]Entry and Market‐level Spending on Emergency Care: “Rather than functioning as substitutes for hospital‐based EDs, FrEDs have increased local market spending on emergency care in three of four states’ markets where they have entered.” When costs increased, it was due to both price and volume.

About access to care

What if you call 911 and no one comes? “Ambulance services are closing in record numbers, putting around 60 million Americans at risk of being stranded in a medical emergency.” This is a great article that highlights how emergency medical services are not considered essential as are police and fire.

About healthcare IT

Mastercard launches healthcare products aimed at cybersecurity, predictive analytics: Mastercard Healthcare Solutions is a new business for the credit card company that will, among other services, offer cybersecurity.

About the public’s health

Cleaning plant troubles could lead to hospital tool shortage: “The Food and Drug Administration flagged the issue in an online statement to medical professionals, saying the result could be years of shortages of supplies used in heart surgery, knee replacements, C-sections and many other procedures.” The reason is environmental contamination with ethylene oxide.

Today's News and Commentary

About the public’s health

Global Health Security [GHS] Index 2019: This report looks at the health security of countries using six dimensions. The US is at the top of the combined ratings and does well on the first five measures: Prevention of the emergence or release of pathogens (1); Early detection and reporting of epidemics of potential international concern (1); Rapid response to and mitigation of the spread of an epidemic (2); Suficient and robust health system to treat the sick and protect health workers (1); and Commitments to improving national capacity, financing and adherence to norms. The place where we need improvement is: Overall risk environment and country vulnerability to biological threats (14).
Since we are a global community as far as these threats, the bad news is: “The average overall GHS Index score among all 195 countries assessed is 40.2 of a possible score of 100. Among the 60 high-income countries, the average GHS Index score is 51.9. In addition, 116 high- and middle-income countries do not score above 50.” We really need world-wide, coordinated action on these items.

FDA clears duodenoscope sheath for protection against infections: These instruments have been sources of infection because they are difficult to sterilize. Now the FDA has approved a disposable, sterile cover to reduce contamination potential. The article had a picture of the device.

Economic Impact of Non-Medical Opioid Use in the United States: Annual Estimates and Projections for 2015 through 2019: This report from the Society of Actuaries estimates “that the total economic burden of the opioid crisis in the United States from 2015 through 2018 was at least $631 billion. This estimate includes costs associated with additional health care services for those impacted by opioid use disorder (OUD), premature mortality, criminal justice activities, child and family assistance programs, education programs and lost productivity. Importantly, this estimate does not include impacts for which there is a lack of adequate data, yet that are still meaningful and may be significant, as described throughout this report. For example, a few such impacts include reductions in household (non-paid) productivity, reductions in productive output while at work (presenteeism), and reductions in quality of life for those impacted directly or indirectly by OUD.”

Some Hospitals Sue Opioid Makers For Costs Of Treating Uninsured For Addiction:  Speaking of the opioid epidemic, it was inevitable that other entities would sue to recoup their costs in dealing with this problem- in this case, it’s hospitals.

Big U.S. retailers pull 22-ounce J&J baby powder off shelves after recall: In addition to J&J, retailers are also pulling its baby powder from shelves because of asbestos contamination.

About health insurance

Feds owe health insurers $1.6 billion in unpaid subsidies, judge rules: “A federal judge this week ordered the federal government to pay about 100 health insurance plans a total $1.6 billion in unpaid subsidies.” The subsidies were for cost-sharing reductions that the Trump administration cut - causing premiums to soar. The largest “winner” is Kaiser which stands to get more than $220 million. The federal government will undoubtedly appeal the ruling.

Trump administration delays start of new primary care payment model to 2021: CMS’ Primary Care First model was supposed to be launched next year. Instead, yesterday’s request for applications had a start date of 2021. No reason was given for the change. The new date does not affect the current Comprehensive Primary Care Plus (CPC+) program. One track in this newer model pays primary care physicians in smaller groups (or solo practice) a set monthly fee with bonuses for keeping patients out of the hospital.

About healthcare IT

Amazon acquires startup Health Navigator to build on its Amazon Care program: “Health Navigator will become part of Amazon Care, a new virtual health service benefit for employees and their families in the Seattle region.”

About pharma

Amgen to make cholesterol drug Repatha available only at lower list price next year: “Amgen said Thursday that its PCSK9 inhibitor Repatha (evolocumab) will be distributed exclusively at the 60% lower list price of $5850 per year as of December 31, and will no longer be available at its original price of $14 000.”

About healthcare professionals

HHS announces $319M in loan repayments for docs, providers caring for underserved: The U.S. Department of Health and Human Services (HHS) announced it is providing an additional $319 million for loan repayment and scholarship programs for healthcare professionals who provide care in underserved communities. The awards come from the National Health Service Corps (NHSC).

Today's News and Commentary

About hospitals and health systems

Hospitals can gain profits from outpatient specialty drugs, but with major risks: Moody’s recommended hospitals could access more revenue by a focus on outpatient specialty drugs, for which they can bill separately. However, challenges to the 340B program and Congressional actions to reduce pharma costs could endanger those initiatives.

About healthcare professionals

Taking Action Against Clinician Burnout:A Systems Approach to Professional Well-Being: Burnout has become a significant threat to the adequacy of healthcare professionals. This paper, by the national Academies of Sciences, Engineering and Medicine, is a brief, clear discussion of the problem with some (rather simplistic) solutions.

About the public’s health

DEA unveils new rule on opioid manufacturers after criticism: “Every year, the DEA sets a quota for how many opioid pills drugmakers are allowed to produce in the U.S. The quotas are set by the DEA with input from the Food and Drug Administration (FDA) and drug manufacturers. 
DEA is charged with keeping controlled substances from being diverted for abuse. The proposed rule would require that appropriate quota reductions be made after estimating the potential for pills to be sold illegally…
According to the report, the DEA permitted drugmakers to increase their production of oxycodone, a highly addictive painkiller, by 400 percent between 2002 and 2013.
The DEA didn't substantially cut the quota until 2017, when opioid overdose deaths reached a peak in the U.S.”

House panel approves vaping tax, would levy $1.15 a Juul pod: The headline speaks for itself. The only consistent way to reduce harmful behaviors is by increasing its cost.

About pharma

Need a safe antacid for heartburn? FDA declares Pepcid, Nexium and others free of NDMA: The FDA cleared those drugs to be used instead of Zantac.

About health IT

How private is your health data on “patient portal” websites used by hospitals and doctors’ offices?: The answer to this question is not as straightforward as you think. For example, your information at your doctor’s office or hospital may be used for marketing purposes with de-identified patient characteristics.(You can opt out.) However, if you keep your own data on an app from a variety of sources, it is not protected.

Dissecting racial bias in an algorithm used to manage the health of populations: “Health systems rely on commercial prediction algorithms to identify and help patients with complex health needs. We show that a widely used algorithm [from Optum], typical of this industry-wide approach and affecting millions of patients, exhibits significant racial bias: At a given risk score, Black patients are considerably sicker than White patients, as evidenced by signs of uncontrolled illnesses. Remedying this disparity would increase the percentage of Black patients receiving additional help from 17.7 to 46.5%. The bias arises because the algorithm predicts health care costs rather than illness…”

About health insurance

Payments to high financial risk APMs [Advanced Payment Models] slightly increased in 2018 compared to 2017: survey: “A survey released by the public-private partnership Health Care Payment Learning & Action Network (LAN) showed that nearly 36% of total U.S. healthcare payments in 2018 went to APMs that required some type of financial accountability from providers, a slight increase from 2017. The survey features payers in traditional Medicare, Medicare Advantage, Medicaid and commercial plans…
The report broke APMs into four categories. The first category is fee-for-service with no link to quality, and the second covers fee-for-service payments linked to quality.
The third and fourth categories hold providers financially accountable for not meeting appropriate care measures or cost targets.
LAN found that 35.8% of total U.S. healthcare payments in 2018 were tied to an APM in category three or four, an increase from 34% in 2017. The survey found that 41% of healthcare dollars were sent to category one and 25% sent to category two. The percentage of payments to APMs differed based on the type of payer.”

Today's News and Commentary

About healthcare quality and safety

Safe Ambulatory Care: Strategies for Patient Safety & Risk Reduction: This monograph is a great source for understanding and addressing safety problems in the ambulatory care setting. The four area of focus are: Diagnostic testing errors; Medication safety events; Falls; and Security and safety incidents.

Depression Intervention Flops for Heart Attack Survivors: Depression screening has become an important part of care for heart attack survivors. Some payers even include the process in their quality evaluations. However, this article summaries research that showed mean “quality-adjusted life-years fell by an identical 0.06 over 18 months whether patients were randomized to systematic depression screening plus notification of primary care clinicians and treatment for those with positive results, screening with notification only, or usual care without screening (P=0.98).” This trial is not only important for its specifics, but also highlights why randomized trials are needed, even for measures that seem “obvious.”

Same Day Surgery in the U.S.: Findings of Two Inaugural Leapfrog Surveys: Among the findings of these first Leapfrog surveys of ambulatory surgery centers (ASCs) and hospital out patient departments (HOPDs) are:
—There are gaps in the education, training and national certifications of clinicians in both ASCs and HOPDs.
—ASC and HOPD patients may experience gaps in communication before and after procedures.
—ASCs lag behind HOPD counterparts in implementing best practices for patient safety.
—Patients tend to give higher patient experience ratings to ASCs—but not enough ASCs monitor it.

When Wall Street Took Over This Nursing Company, Profits Grew and Patients Suffered: This in-depth article looks at Aveanna Healthcare, an at-home nursing company that has a dominant market position in caring for “the sick and disabled, mostly children.” It is controlled by two prominent private-equity firms- Bain Capital and J.H. Whitney Capital Partners. The focus of the report is more than “1,000 pages of state health documents, many released under public-records laws, [that] show Aveanna has had a disproportionate number of safety violations.” The implication is that profit motives superseded the desire to provide good patient care.

About health insurance

A group of Republicans has unveiled its healthcare plan. Here is what's new and what isn't: “The Republican Study Committee (RSC), a group of 145 House GOP lawmakers, rolled out a new healthcare plan to counter Democrats’ call for ‘Medicare for All.’
However, the plan itself closely resembles the Affordable Care Act (ACA) repeal bill called the American Health Care Act (AHCA) that the House passed in 2017 and contributed greatly to the loss of the GOP House majority in 2018.” Among the details, is a proposal to retain guaranteed issue of insurance to those with preexisting conditions, but it does not guarantee that the cost are the same for all. Instead, the plan would start high risk pools for individuals who could not afford coverage because of illness.
Given the likelihood of Republicans winning the House in 2020, there is not much chance of this plan going anywhere.

US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced: “Three bills that would supply vision, dental and hearing coverage benefits – including eyeglasses, dental implants and hearing aids – to Medicare recipients was passed by the US House Ways and Means Committee on 22 October. The same troika of bills was approved by the House Energy and Commerce Committee last week, and two Senate committees with health-care jurisdiction are considering similar legislation.” As long as Medicare is so financially solvent, it seems like a good idea to expand benefits when we do not know their future cost.

Trump Birth Control Religious Opt-Out Properly Blocked: Ninth Circuit: “Trump administration rules giving employers with religious or moral objections the right to opt out of Obamacare’s requirement that they provide birth control coverage in employee health plans aren’t enforceable, the Ninth Circuit said…”

75% of Your Employees May Not Plan to Stay for More Than 5 Years: While this article is a business employment piece, the message has profound implications for how employers will look at benefits given this time frame.

About hospitals and healthcare systems

FTC to probe impacts of state antitrust protections for local hospital mergers: Certificates of public advantage (COPAs) are written approvals by state governments that grant state and federal immunity from antitrust actions to merging hospitals. Its aim is to "protect the interests of the public in the region affected and the state." It accomplishes this goal by “replacing competition with state regulation and active supervision.” This exemption was allowed by a 1940s Supreme Court decision. Now the FTC wants to investigate the impact of COPAs.

About the public’s health

FDA grants first-ever modified risk orders to eight smokeless tobacco products: This statement is the epitome of confusion. The FDA says that certain smokeless tobacco products are safer that smoking tobacco. However, in the press release it also said: “All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use.” Why not just try for a tobacco-free society?

FDA recommends new warnings for breast implants: Once again, the harms of breast implants are being highlighted. Today the FDA “recommended that manufacturers use a boxed warning — the FDA’s most serious caution — to identify risks, including that implants are not lifetime devices, that the chances of developing complications increase the longer a woman has an implant, and that they have been associated with a rare form of lymphoma, as well as with symptoms such as fatigue and joint pain.”

Languishing Medicare diabetes program frustrates providers: “A flagship Medicare program that HHS expected to engage up to 110,000 people annually each year in measures to help them avert Type 2 diabetes only managed to enroll about 200 people last year, according to an analysis of CMS data.” This problem is a great case study for social marketing. How can Medicare increase uptake into this program?

23andMe competitor claims direct-to-consumer cancer risk screening produces 'false negatives': “…researchers at medical genetics company Invitae say health reports from limited DTC [direct to consumer] genetic tests can provide consumers with a false sense of security. These tests often miss disease-causing DNA variants, which poses the risk of healthcare decisions based on incomplete information, according to Edward Esplin, M.D., a clinical geneticist at Invitae and lead researcher on the study.”

Today's News and Commentary

About the public’s health

Integrating Social Care into the Delivery of Health Care: Moving Upstream to Improve the Nation's Health (2019): This comprehensive document was published by the National Academies of Sciences, Engineering, and Medicine. The committee of authors formulated “five goals whose accomplishment will result in better integration of social care into health care, which may in turn result in improved health and reduced health disparities. Those goals are to

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 implementation of social care practices in health care settings.”

About healthcare IT

California Enacts Telehealth Payment Parity, Boosts Asynchronous Care: One of the impediments to the spread of telemedicine has been a business model for payment for those services. California now joins about a dozen other states that mandate payers reimburse healthcare providers for telehealth services “on the same basis and to the same extent” as they cover in-person services.

FDA post-market surveillance system enters next phase: “Sentinal” is a national system that uses electronic healthcare data to monitor the safety of FDA-regulated drugs and medical products. Since 2009 it has been operated by Harvard Pilgrim Health Care Institute, which developed the program.

“Under a five-year contract worth $220 million, Harvard Pilgrim Health Care Institute will continue to run the Sentinel Operations Center and to create two new coordinating centers—the Sentinel Innovation Center and the Community Building and Outreach Center—to better leverage clinical data for detecting potential safety problems…

The Community Building and Outreach Center, led by Deloitte Consulting, will focus on communication and collaboration, as well as deepening stakeholder involvement and broadening awareness, access, and use of Sentinel tools and data infrastructure…

Vanderbilt University Medical Center will co-lead the Sentinel Innovation Center with Brigham and Women’s Hospital, Duke Clinical Research Institute and Kaiser Permanente Washington Health Research Institute…”

The activities will center on new ways to “extract and structure information derived from EMRs.” Such techniques will include natural language processing, machine learning and safety signal detection

About medical devices

 Million-dollar marketing juggernaut pushes 3D mammograms: This article is a great case study for a device that has yet to prove benefits but is being marketed as a superior product with a higher charge.

About health insurance

Obamacare is getting more affordable under the Trump administration: “In a marked shift from previous years, average premiums for mid-level ‘silver’ plans will decrease 4 percent for 2020, while the number of plans available on the Affordable Care Act marketplaces will swell 13 percent, according to figures released this morning by the Centers for Medicare and Medicaid Services. Nearly 7 in 10 people will have access to at least three marketplace plans, up from six in 10 last year (the figures don't include the 11 states running their own marketplaces instead of relying on Healthcare.gov.)”

The Future of Medicare Program Integrity: By integrity, CMS administrator Verma means addressing fraud and abuse; in 2018, “improper payments” (including billing errors) accounted for 5% of the total $616.8 billion of Medicare's net costs. Yesterday afternoon she issued this statement that explains five measures CMS will be taking to address this problem:
Stopping bad actors. 
Fraud prevention. 
Tracking “new and emerging” risks. 
Ease provider burdens. 
Take advantage of new technology. 



Today's News and Commentary

About the public’s health

Opioid Trial: 4 Companies Reach Tentative Settlement With Ohio Counties: “Distributors AmerisourceBergen, Cardinal Health and McKesson pledged to pay $215 million, while manufacturer Teva Pharmaceuticals will pay $20 million in cash and an additional $25 million in addiction and overdose treatment drugs, according to Paul Farrell Jr., a co-lead attorney for the two counties. Under the deal, there is no admission of wrongdoing on the companies' part.”

J&J recalls baby powder after trace asbestos found in bottle: “Johnson & Johnson on Friday recalled a single batch of its baby powder as a precaution after government testing found trace amounts of asbestos in one bottle bought online. The recalled lot covers 33,000 bottles, which were distributed last year….The recall comes as J&amp;J fights thousands of lawsuits in which plaintiffs claim its iconic baby talcum powder was contaminated with asbestos and that it caused ovarian cancer or mesothelioma, a rare cancer linked to inhaling asbestos fibers.”

About pharma

We Found Over 700 Doctors Who Were Paid More Than a Million Dollars by Drug and Medical Device Companies: Public disclosure of payments to physicians by drug and device companies was supposed to shame all parties into reducing the practice. However, “ProPublica’s new analysis shows that the public reporting has not dampened the enthusiasm of the drug and medical device industry for having doctors deliver paid dinner talks and sponsored speeches or paying them to consult on products.
In fact, there has been almost no change in how much the industry is spending. Each year from 2014 to 2018, drug and medical device companies spent between $2.1 billion and $2.2 billion paying doctors for speaking and consulting, as well as on meals, travel and gifts for them.” The article lists how much is spent on such promotional activities by product.

About hospitals and healthcare systems
Estimate of Federal Payment Reductions to Hospitals Following the ACA: 2010-2029: “Dobson DaVanzo & Associates was commissioned by the Federation of American Hospitals (FAH) and the American Hospital Association (AHA) to estimate the cumulative federal payment reductions to hospitals from 2010 through 2029 that were beyond those enacted under the Affordable Care Act (ACA).1 Twelve legislative Acts were identified as well as regulatory changes by the Centers for Medicare and Medicaid Services (CMS) that are estimated to reduce federal payments to hospitals by $252.6 billion over this period.” The study details components of those reductions. For example about $86 billion each comes from federal sequestration and MS-DRG Documentation and coding. See the article for further explanations and details.

About health insurance

Spread of ACOs And Value-Based Payment Models In 2019: Gauging the Impact of Pathways to Success: This article is a great update on ACO status. Among the “higher level” findings is that across “all payers, ACO participation growth continued, but slowed, since the start of 2018. By the start of the third quarter of 2019, there were 1,588 existing public and private ACO contracts, covering almost 44 million lives. By comparison, there were 1,611 ACO contracts around this time last year, covering 40.9 million lives…By the start of the third quarter of 2019, about 60 percent of ACO lives were covered by commercial contracts, while about 30 percent were covered by Medicare contracts and 10 percent by Medicaid contracts.”

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.