Today's News and Commentary

About healthcare finance

Healthcare bankruptcies outpacing those in other industries: “Chapter 11 bankruptcies in the healthcare industry are far outpacing filings in other sectors, according to a new distress index report from law firm Polsinelli.
The report, which tracks all Chapter 11 filings with assets over $1 million, found that healthcare bankruptcies increased 125 percent in the fourth quarter of 2019 compared to the benchmark period of the fourth quarter of 2010. In contrast, Chapter 11 bankruptcy filings across all sectors dropped 50 percent in the fourth quarter of 2019, compared to the same period in 2010.” Filings were highest by far in the southeast (35% of the total).

About health law

15 latest healthcare industry lawsuits, settlements: The variety of these cases (“what went wrong”) give insights onto what healthcare organizations can focus to improve performance.

About the public’s health

Coronavirus Could Lead to a US Vape Shortage, Sources Say: Some good news about the Coronavirus epidemic: “Many Chinese factories remain closed, and there is widespread fear that vaping hardware won't be shipped to the U.S. until as late as April.”

All The Hilariously Aggressive Coronavirus Propaganda Banners Found In China: The number of new cases of Coronavirus seem to be declining. How effective do you think these slogans are? Can you think of better slogans that would have more traction?

'Animals live for man': China's appetite for wildlife likely to survive virus: Live animal food markets have been identified as the source for the current Coronavirus epidemic (as well as the SARS epidemic). This article highlights the fact that this practice is so ingrained in Chinese culture that it will not be eliminated. So we wait for the next epidemic…

Today's News and Commentary

About pharma

Eisai complies with FDA request to pull weight-loss drug Belviq from US market due to possible cancer risk: The headline is self-explanatory. Diet drugs have a long history of post-launch problems.

FDA Guidance Seeks to Speed Reviews of Biosimilars for Fewer Conditions of Use: “As part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product.
The 351(k) abbreviated licensing pathway is designed to speed biosimilar approvals by using ‘less than a full complement of product-specific preclinical and clinical data,’ the agency noted.”

South Korean hospital successfully treats coronavirus patient with HIV drugs: “A South Korean hospital announced on Thursday that an HIV combination drug of lopinavir plus ritonavir showed effectiveness in treating a coronavirus patient.” Obviously, more research needs to be gathered.

The 20 Most Expensive Prescription Drugs in the U.S.A.: This article is an update on the most expensive prescription drugs. NOTE: The prices in the chart are per 30 days.

21 States Reject $18 Billion Offer From Drug Wholesalers to Settle Opioid Litigation: ”An $18 billion settlement offer from three major drug wholesalers aimed at resolving litigation over their alleged role in the opioid crisis appears to have fallen apart, after more than 20 state attorneys general rejected it in a letter sent to the companies’ law firms this week.”

Appeals court unanimously strikes down Medicaid work requirements: “In a unanimous decision that blocks the first state that had imposed work requirements, a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit ruled that President Trump’s health officials had been ‘arbitrary and capricious’ in allowing Arkansas to launch a Medicaid program called ‘Arkansas Works’ two years ago.”

About healthcare IT

Patient Matching Hurt by Data Errors, Lack of Government Support: “The biggest contributors to duplicate medical records related to data issues, with 66 percent of respondents cited issues with data entry errors, while 46 percent said poor algorithms, and 42 percent blamed a lack of integration.” This problem makes a strong case for unique identifiers.

About health insurance

2018 Health Care Cost and Utilization: This report from the Health Care Cost Institute was just published. “This year’s report found that average annual health care spending for people with employer-sponsored insurance increased to an all-time high of $5,892 in 2018. From 2014 to 2018, spending grew 18.4%, and about three-quarters of the increase was due to growth in service prices. In 2018, there was a 1.8% uptick in the use of services.” Increased percentages in average price, utilization and total spending were all highest for prescription drugs.

Problems Paying Medical Bills, 2018: This just-published CDC study found that the “percentage of all persons who were in families having problems paying medical bills in the past 12 months decreased 4.5 percentage points from 19.7% in 2011 to 15.2% in 2015 and then decreased 1.0 percentage point from 2015 through 2018 (14.2%).”

About healthcare providers

Hospitals can be sued for battery when patients say 'stop,' appeals court rules: While the case deals with a hospital, one can assume the principle applies to other providers/organizations.
”The opinion was issued in a case against Brigham and Women's Hospital in Boston. The family of a terminal cancer patient sued the hospital for battery and intentional infliction of emotional distress, alleging X-ray technologists continued an exam after the patient asked them to stop.
The Massachusetts Superior Court ruled in favor of the hospital and other named defendants, and the plaintiffs appealed. On Feb. 11, the appeals court held that a patient saying ‘stop’ is enough to withdraw consent and give rise to a battery claim.”

Today's News and Commentary

About healthcare IT

FCC close to finalizing $100M telehealth pilot program: “The Federal Communications Commission will soon move to issue a final order for its new $100 million Connected Care Pilot Program, which is intended to boost the use of telehealth for underserved patient populations.”

FDA, MITRE offer tips for med device cybersecurity: “The U.S. Food and Drug Administration, in partnership with the MITRE Corporation, has already championed two initiatives to improve medical device cybersecurity preparedness and response.
The first is the development and use of a medical device cybersecurity sandbox to enable security research and technical evaluation of medical device vulnerabilities and potential mitigations across health systems, device manufacturers, and the FDA…
The second initiative involves the exploration of the viability and execution of a CyberMed Safety Analysis Board to integrate critical patient safety and clinical environment dimensions into the assessment and validation of high-risk/high-impact device vulnerabilities and incidents.”

Navigating Privacy Laws to Deliver STI Health Services in High Schools: (In Pediatrics- subscription required): This article discusses the fact that information about students’ sexually transmitted infection history (and hence other health issues) can legally make its way into their educational records, which are not protected in the same way as HIPAA projects medical records.

About the publics’ health

Company efforts to stamp out tobacco often go up in smoke: Tobacco cessation and other wellness programs do not always pan out.

About pharma

Why physicians are fighting BCBS plan requiring use of mail-order pharmacies: Physicians claim that if health plans make them order injectable therapies on an as-needed from mail order pharmacies, that there will be delays in care. BCBS in Tennessee argues that such a practice will lower costs and avoid waste from ordering too much. The evidence supports the health plan, since any delays are rarely critical and the process avoids physicians from marking up the medicines when they bill the insurer.

About hospitals

6 hospital, health system construction projects costing $300M or more: Large construction projects are returning to several hospital systems around the country.

Today's News and Commentary

About health insurance

US Statistics on Surprise Medical Billing: 20% of insured adults had a surprise medical bill in the past two years. The graphic in this article highlights the problem and public concern.

House panel advances bipartisan surprise billing legislation despite divisions: “The House Education and Labor Committee on Tuesday approved a bill to protect patients from massive ‘surprise’ medical bills, but not before a vigorous debate that showed the divides within both parties on the issue. 
The vote of 32-13 sent the measure to the full House. But competing proposals must be reconciled before the chamber can vote on the issue, which is a rare area of possible bipartisan action this year… The dispute comes down how much the insurer will pay the doctor once the patient is taken out of the middle.”

About pharma

Department of Health and Human Services launches Foundry for American Biotechnology: “The US Department of Health and Human Services launched the nation's first Foundry for American Biotechnology today, with the aim of producing technological solutions that help the U.S. protect against and respond to health security threats, enhance daily medical care, and add to the nation's bioeconomy…The Foundry for American Biotechnology will be housed in Manchester, New Hampshire, and managed in conjunction with Manchester-based DEKA Research and Development Corp. as part of a public-private partnership.”

McConnell: GOP has 'internal divisions' on bill to lower drug prices: Despite the President’s call for bipartisan support for a bill to lower drug prices, and despite Senate Finance Committee Chairman Grassley (R-Iowa) partnering with Sen. Wyden  (D-Ore.) on such a bill, Senate majority leader McConnell said there are “internal divisions within my party in the Senate” that must be resolved on both that bill and another health care measure aimed at protecting patients from surprise medical bills. What special interests are at work?

Why price of dehydrated alcohol is going from $1,300 to $10K: This article is a perfect case study of a long-established drug that acquires orphan designation causing the price to skyrocket. This consequence was clearly not the intent of the law and begs for correction.

WHO Posts New Procedure for Using Unapproved Drugs in Health Crises: “The new Emergency Use Listing procedure assesses if unapproved vaccines, drugs and diagnostic tests could help mitigate public health emergencies, allowing them to skip parts of the regulatory approval process and reach patients more quickly. and tests needed to complete development must be underway at the time of submission, WHO said, and sponsors should not let the emergency use program interfere with ongoing trials.”

About healthcare IT

VA delays first go-live of Cerner EHR system as project takes longer than expected: This article updates the continuing saga of the VA’s implementation of a single EHR- much delayed and over budget.

AMA sees surge in health IT adoption, 'rise of the digital-native physician': This article is a nice summary of the progress health IT adoption has made in its use among physicians over a variety of applications.

CMS Loosens Restrictions on Telehealth for Certain Shared-Risk ACOs: “Accountable Care Organizations who are at risk of owing money back to Medicare because they haven’t met spending targets on shared-risk beneficiaries now have more freedom to use telehealth.
Under a guidance document released last month by the Centers for Medicare & Medicaid Services, ACOs participating in a Medicare Shared Savings Program that is under two-sided risk and who have selected prospective payment can remove geographic limitations normally applied to fee-for-service plans and allow beneficiaries to receive certain telehealth services at home.”

About the public’s health

Severe acute respiratory syndrome-related coronavirus – The species and its viruses, a statement of the Coronavirus Study Group: The corona virus currently causing an epidemic has lacked a common name (like SARS or MERS). The “Coronavirus Study Group (CSG) of the International Committee on Taxonomy of Viruses, which is responsible for developing the official classification of viruses and taxa naming (taxonomy) of the Coronaviridae family, assessed the novelty of the human pathogen tentatively named 2019-nCoV. Based on phylogeny, taxonomy and established practice, the CSG formally recognizes this virus as a sister to severe acute respiratory syndrome coronaviruses (SARS-CoVs) of the species Severe acute respiratory syndrome-related coronavirus and designates it as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).”

About healthcare technology

Going mobile: FDA clears world's first bedside MRI scanner-on-wheels: “The FDA has cleared the world’s first portable MRI system, designed to be wheeled to a hospital bedside for scanning a patient’s head and brain.
Developed by Hyperfine Research for people age two and older, the point-of-care imaging system weighs about one-tenth that of a conventional, fixed MRI system. About three feet wide and five feet tall, the device fits in an elevator and runs off an everyday power outlet to create both clinical contrast images and 3D renders…
Hyperfine estimates its open-design system will also cost about 20 times less—controlled through a wireless tablet, it does not require trained technicians, shielded electronics or separate hospital facilities.It also features ordinary permanent magnets that require no power or cooling, producing an image using low-power radio waves and magnetic fields.”
The value proposition with this technology is increased access and lower cost, while maintaining quality of imaging.

Today's News and Commentary

About pharma

11 drugs likely to become blockbusters: These drugs are expected to have sales of $1billion or more.

CVS, Walgreens blame ‘Dr. John and Jane Doe’ for Florida opioid epidemic: First pharma companies were held liable for the opioid epidemic. Then it was pharmacies and wholesalers. Now physicians are in the spotlight. “The retailers, which operate more than 1,600 pharmacies in Florida, filed a third-party complaint in January denying liability “in any respect” for the state’s opioid epidemic and asked the 6th Judicial Circuit in Pasco County to shift blame to the real culprit: 500 Dr. John and Jane Does.”

Proposed Bill Would Allow FDA to Destroy Counterfeit Products: Unlike seized narcotics, which are eventually destroyed, the FDA “currently only has the authority to send counterfeit products back to the manufacturer, which risks putting them back in the market. drugs and devices.” This bill would give the agency the authority to destroy them.

About emerging technology

How blocking a 'first responder' in blood vessels could prevent heart disease: “Plexin D1…acts as a ‘mechanosensor’ in endothelial cells. It can respond to the dynamic forces of blood flow by promoting the formation of plaques that clog up the arteries, leading to atherosclerosis, the usual cause of heart attacks and stroke…” If a Plexin D1 blocking drug can be found, it could impede atherosclerotic plaque formation. However, we need to consider the natural protective effect this mechanism has.

GreenBone Ortho Earns CE Mark for Wooden Bone Substitute: “GreenBone Ortho has received CE Mark certification for its Bone Substitute, a ‘nature-inspired biomimetic’ graft that is designed to imitate the chemical composition and architecture of bone.
The device, made of rattan wood, is designed with osseointegration properties to heal large bone damage in the extremities or the pelvis.”
Can’t resist…this product gives new meaning to the term “wooden leg.”

About the public’s health

FDA Report Continues to See No Link Between Cell Phones and Cancer: The headline is self-explanatory…and a relief.

Variation in Tdap and Influenza Vaccination Coverage Among Pregnant Women by Insurance Type — Florida, 2016–2018: While the low rates of immunization for this population are concerning, the sample size was only 341 and the study was limited to Florida. More states and larger populations need to be assessed to validate this result.

Trump Seeks to Halve U.S. Funding for World Health Organization as Coronavirus Rages:”The Trump administration is eyeing steep cuts to global health funds in its 2021 budget proposal, slashing more than $3 billion in overall programs, including half of its annual funding to the World Health Organization (WHO), which is leading the fight against the deadly coronavirus outbreak…

Senior administration officials said they were allocating new resources, including an additional $15 million for the USAID Global Health Security Program, to fight the coronavirus, as government officials worked around the clock to evacuate American citizens from the region of China hit by the deadly outbreak. The budget proposal also includes a request for $25 million for a so-called Emergency Reserve Fund, which, according to a State Department spokesperson, ‘can be quickly deployed to respond to pandemic outbreaks…’
But experts and some on Capitol Hill say a small increase in funds doesn’t outweigh the steep proposed cuts to global health programs overall.”

CVS invested $67M in housing last year. Here's a look at where that money went: “CVS invested $67 million in growing affordable housing options across the U.S. last year—and the healthcare giant said it’s hoping to significantly grow those investments in 2020. 
In 2019, the investments made nearly 300 new permanent supportive housing units available, which target people who are impacted by domestic violence, chronic illness, homelessness and addiction, officials said.
CVS’ funding also backed the creation of 450 units for seniors, 59 for veterans and their families and 38 dedicated to Native Americans and their families. The efforts are a critical part of the company’s Destination: Health initiative, which targets social issues.”

How a new wave of technology startups is tackling social determinants of health [SDOH] challenges: This article presents some examples of new ventures addressing SDOH. One valuable resource for information that is mentioned in the article is the National Alliance to impact the Social Determinants of Health (NASDOH), convened by the consulting firm Leavitt Partners.

About health insurance

Health Insurance Affordability Concerns and Health Care Avoidance Among US Adults Approaching Retirement: Among 1028 respondents aged 50 to 64 years, approximately “one-fourth of respondents… had little to no confidence in being able to afford health insurance over the next year, and nearly one-half… had little to no confidence in their ability to afford health insurance when they retire.”

About healthcare quality

America's Best Hospitals for 2020: This rating is from Healthgrades. Check the methodology as well as the rankings.

Today's News and Commentary

About health insurance

Congress revives surprise billing debate with proposal for 'mediation': “The House Ways & Means Committee released the legislation on Friday as a bid to end an impasse over how to handle surprise billing with a proposal to use a ‘mediation’ process to handle disputes…During mediation, the parties will present the best and final offers along with any supporting information to the mediator, who will consider the median contracted rate specific to the plan, and for similar providers, services and geographic areas…”

Women Shouldn’t Get A Bill For An IUD … But Sometimes They Do: This article explains exceptions to comprehensive contraceptive benefits.

About healthcare IT

New Jerseyans turn to–and trust–MDs, nurses most for health care information: Just because people consult websites for healthcare information does not mean they trust them. “Nine in 10 New Jerseyans report being likely to ask a doctor for information; 8 in 10 say they ask a nurse; and around 9 in 10 trusts each of these sources to provide accurate health information…New Jerseyans rate traditional and social media much lower: a third seek and trust information from television, newspaper or radio, while about 1 in 5 use social media for health-related information, and 1 in 10 trusts it, according to the poll.”

FDA authorizes marketing of software that uses artificial intelligence for cardiac diagnostics: ”The AI user interface offers prescriptive guidance on how to move the ultrasound probe to obtain standard echocardiographic images and video clips of diagnostic quality. It offers real-time feedback on potential image quality, auto-captures video clips and automatically saves the best video clip obtained from a specific view…the software allowed registered nurses to obtain echocardiography images and videos of diagnostic quality.”

About the public’s health

Trump to Propose $4.8 Trillion Budget With Big Safety-Net Cuts: “The White House proposes to cut spending by $4.4 trillion over a decade. Of that, it targets $2 trillion in savings from mandatory spending programs, including $130 billion from changes to Medicare prescription-drug pricing, $292 billion from safety-net cuts—such as work requirements for Medicaid and food stamps —and $70 billion from tightening eligibility access to disability benefits.” The Democratic House is already opposing these measures.

WHO’s aggressive, three-part strategy aims to make cervical cancer a thing of the past: The strategy is called “90-70-90: vaccinating 90 percent of women against multiple strains of HPV, screening 70 percent of women for cervical cancer at ages 35 and 45, and giving care to 90 percent of women diagnosed with cervical cancer.
Taken together, those three steps could eliminate more than 74 million cases and save more than 62 million lives, researchers write.”
Now that we know what to do, we need to have the resources (including personnel) to do it and also enhance population participation in the preventive portions. What techniques of social marketing would help?

Coronavirus: The Latest Problem Big Pharma Won’t Solve: “With the outbreak of the novel coronavirus, 2019-nCoV, a disease for which there is neither a vaccine nor an effective drug treatment, the call for such innovations is growing louder by the day. With global sales  in vaccines alone totaling $54 billion in 2019 and predicted to near $60 billion in 2020, one would think that industry has the reserves to jump at this challenge. But so far, as reported by Barron’s, none of the four top vaccine companies has shown significant interest. It has been the Coalition for Epidemic Preparedness Innovations, a government- and charity-funded initiative to accelerate the development of vaccines to respond to outbreaks, that has been leading the effort to find a vaccine for 2019-nCoV.
The coronavirus seems poised to join a lengthy list of health problems the industry turns its back on unless additional incentives are made available: antimicrobial resistance, pediatric medicines, medicines to treat diseases of the poor, new infectious diseases such as Ebola, neglected tropical diseases, and rare diseases.”
What financial incentives do governments need to provide for companies to actively engage in addressing these problems, some of which, like antibiotic resistance and opioid dependence, they helped create?

2020’s Healthiest & Unhealthiest Cities in America: Here is WalletHub’s annual survey of the health of US cities. Read the methodology first. Top of the list? San Francisco.

1st American dies of coronavirus as death toll surpasses SARS: Update on the corona virus.

About emerging technology

‘Chemical earmuffs’ could prevent hearing loss :”…a team of biologists at the University of Iowa and Washington University… identified a receptor that, when blocked, can prevent a common type of hearing loss…The researchers identified that some receptors involved in the hair-cell-to-nerve-cell transmission lack a protein called GluA2, and it is these receptors that are responsible for synaptopathy, or hearing loss caused by irreparable damage to the synapses.
The biologists employed a drug in mice that selectively blocked the GluA2-lacking receptors, and prevented the mice from experiencing synaptopathy when exposed to noise.”

Today's News and Commentary

About pharma

GlaxoSmithKline's spinoff plan is here—and it may not be limited to consumer health: ”GlaxoSmithKline made clear it intended to spin off its consumer health joint venture with Pfizer when the partners first unveiled the deal. Now, the British drugmaker has officially started a two-year journey toward that split, which may take prescription dermatology along with it.”

Gilead climbs as coronavirus drug shows efficacy, starts trial: This article is a good case study of a pharma company’s R&D department being insightful and nimble. “Remdesivir was one of a clutch of drugs tested against Ebola, but it failed to match the efficacy of its rivals, leading its development against that virus to come to a halt. However, preclinical tests have suggested the drug is effective against murine hepatitis virus and Middle East respiratory syndrome coronavirus, leading Gilead to propose it as an answer to the outbreak that began in Wuhan, China.”

Gilead loses first PrEP patent challenge but vows to defend against HHS lawsuit: This article updates the ongoing battle between Gilead and the federal government over the patent for Truvada as an HIV prophylactic medication.

FDA Revises Policy on Prioritizing Generic Drug Applications:The FDA will no longer prioritize submissions from first filers. But the agency will “prioritize submissions for which final approval depends on the expiration of a patent or NDA exclusivity…[and] if they are related to a drug shortage or public health emergency, or would present significant difficulties for the applicant if delayed.”

About the public’s health

FDA crackdown on vaping flavors has blind spot: disposables: An update on the partial vaping ban- the government forgot something. Yesterday the U.S. government began enforcing restrictions on flavored electronic cigarettes, but forgot to ban cheaper, flavored (such as pink lemonade, blueberry ice and tropical mango), disposable products. So vaping rates may not decrease after all.

About health insurance

House votes to condemn Trump Medicaid block grant policy: “The non-binding resolution won’t have much practical effect. It passed on a mostly party line vote of 224-189 and will almost certainly see no time in the GOP-controlled Senate.”

Today's News and Commentary

About the public’s health

Federal flavor ban goes into effect Thursday, but many flavored vape products will still be available: “A nationwide ban on many flavored e-cigarette products goes into effect Thursday, but teenagers will still have access to nicotine vapes, experts say.
The ban covers a number of kid-friendly flavorings, such as mint and fruit, though menthol and tobacco flavorings will remain legal. However, the ban only applies to specific types of devices: cartridge or pre-filled pod devices, like the ones made popular by Juul. All other devices will be left on the market.”

Recommended Childhood and Adolescent Immunization Schedule: United States, 2020: The headline explains the content.

Higher US Rural Mortality Rates Linked To Socioeconomic Status, Physician Shortages, And Lack Of Health Insurance: “Overall, higher rural mortality at the state level can be mainly explained by three factors: socioeconomic deprivation, physician shortages, and lack of health insurance. To a certain degree, these factors reflect a state’s health policies, such as expansion of eligibility for Medicaid, health infrastructure, and socioeconomic conditions.”

About pharma

Merck & Co. to spin-off women's health, legacy brands, biosimilars units into new company:  “Merck & Co. announced Wednesday that it plans to spin-off products from its women's health, legacy brands and biosimilars businesses into a new independent company, with the transaction expected to be completed in the first half of 2021. Merck noted that it will retain its portfolio of key growth drivers in oncology, including Keytruda (pembrolizumab) and Lynparza (olaparib), as well as vaccines, hospital and animal health.”

The 10 most-valued pharma brands in the world: “Brand Finance released its annual report on the most valuable pharmaceutical brands.”

About healthcare IT

VA to open "America's first" all 5G-enabled hospital in Palo Alto this week: The headline speaks for itself.

About health insurance

CMS may force Part D plans to offer real-time pricing data to members: “The Centers for Medicare & Medicaid Services (CMS) issued (PDF) the second part of its annual Advance Notice governing Medicare Advantage (MA) and Part D plans Wednesday. In it, the agency is proposing a requirement for plans to offer real-time pricing comparisons to members. 
CMS last year finalized a plan that requires Part D plan sponsors to make that available to providers beginning in 2021. If the new proposal is put in place, Part D plans would have to offer real-time drug pricing data to members in 2022.”
Is this requirement really necessary when the healthcare.gov site gives members annual total costs for Part D plans? 

U.S. government proposes higher payments to Medicare insurers in 2021: “The U.S. government on Wednesday proposed an average 0.93% increase in its payments in 2021 to the health insurers that manage Medicare Advantage insurance plans for about 22 million people aged 65 or older or disabled.”

CMS releases proposed Medicare Advantage rule: 5 things to know: Good summary of the MA proposed rule.

A Denver businessman wants to fix America’s health care system — by doing your knee replacement in Mexico: Thus program sends patients to a Joint Commission accredited hospital in Mexico. Physicians get paid more than their US rate; the savings come from hospital, drug and ancillary rates.

Treat Social Needs Like Patient Care: Health Industry Group CEO: Matt Eyles, president and chief executive officer of America’s Health Insurance Plans, said insurance plans should be able to count treatment of social needs as medical care. For purposes of medical loss ratios calculations, such items as transport to get medical care and food are considered administrative expenses.

Supreme Court to consider taking ObamaCare case this month: “The 5th Circuit Court of Appeals ruled in December that the [ACA’s] mandate to have health insurance coverage is unconstitutional, but punted the key question of how much of the rest of the law to strike down back to a lower court.” The Supreme Court previously said it would wait for the lower court ruling; now justices said they will discuss taking it up before then.

About emerging science

Pan-Cancer Analysis of Whole Genomes: The “…Pan-Cancer Analysis of Whole Genomes (PCAWG) Project performed whole‑genome sequencing and integrative analysis on more than 2,600 primary cancers and their matching normal tissues across 38 distinct tumour types.” This approach is very different than previous efforts to find small variations in genomes of cancer patients when compared to those who are not afflicted. The results were published yesterday in a variety of Nature publications (open access) that expound on the implications of this achievement.

Today's News and Commentary

State of the Union

The speech raised a number of healthcare issues, but offered no new programs or policy insights.

For a time-line summary you can check CNBC. Nothing better than the Washington Post for checking the facts (many important statements were stretches or false ).

Three issues are particularly noteworthy.

  1. The President’s attack on Medicare for All garnered applause from some moderate Democrats.

  2. Some House members chanted “HR-3” when Trump said he would sign a drug price control bill. HR-3 was the House Bill to address that issue; it has been held up in the Senate.

  3. The President said he will protect health insurance for pre-existing conditions. However, as noted by most news media, the Republicans have favored complete ACA repeal (which includes such protections) as well as sponsored “skinny” insurance plans which give insurers the right to refuse people with prior illness.

About pharma

Google's dropping third-party cookies. Will pharma marketers need to adapt?:”Google says it will phase out third-party cookie support within two years…
The pharma industry, which has to work within strict privacy and regulatory boundaries, may be better positioned than others. Pharma marketers already use plenty of non-cookie tactics…
Some of those already-in-use pharma strategies include geotargeting, contextual advertising on specific websites, reaching consumers through keyword buys and the use of newer media channels, such as connected TV, that don't use cookies.”

41 brand-name drugs slated to lose patent exclusivity this year: Among the drugs are Enbrel and Byetta. Since some of these listed medicines are biologicals , it may take a while before generics are available.

Physician and Patient Adjustment to Reference Pricing for Drugs: “Under reference pricing, the employer’s or insurer’s payment is limited to the price of the least costly product in each therapeutic class.” “Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to the pharmacy benefit manager to those offering the lowest prices to the employer and employee…In this study, reference pricing was associated with a combination of lower prices paid by employers and lower cost sharing by employees but with a time lag in prescribing habits by physicians.”

About the public’s health

WHO says Wuhan coronavirus outbreak is not yet a pandemic: Update on the corona virus.

U.S. expands use of coronavirus diagnostic test: “The U.S. Food and Drug Administration on Tuesday granted emergency use approval for state public health laboratories to start testing for the new flu-like coronavirus from China using kits developed by the Centers for Disease Control and Prevention (CDC)…Previously, states had to send samples to the CDC for testing. “

Non-Infection-Related And Non-Visit-Based Antibiotic Prescribing Is Common Among Medicaid Patients: “We measured the frequency with which all filled antibiotic prescriptions were associated with infections and in-person visits for Medicaid patients in the period 2004–13. We found that among 298 million antibiotic fills (62 percent for children) for 53 million patients, 55 percent were for clinician visits with an infection-related diagnosis, 17 percent were for clinician visits without an infection-related diagnosis, and 28 percent were not associated with a visit… Large fractions of antibiotic prescriptions are filled without evidence of infection-related diagnoses or accompanying clinician visits. Current ambulatory antibiotic stewardship policies miss about half of antibiotic prescribing.”

Overprescribing of Opioids to Adults by Dentists in the U.S., 2011–2015: ”Twenty-nine percent of prescribed opioids exceeded the recommended morphine equivalents for appropriate management of acute pain. Approximately half (53%) exceeded the recommended days’ supply. Patients aged 18–34 years, men, patients residing in the Southern U.S., and those receiving oxycodone were most likely to have opioids prescribed inappropriately. The proportion of opioids that exceed the recommended morphine equivalents increased over the study period, whereas opioids exceeding the recommended days’ supply remained unchanged.” Dentists are a clear target for educational programs about using opioid alternatives.

About emerging technology

Fungi That 'Eat' Radiation Are Growing on the Walls of Chernobyl's Ruined Nuclear Reactor:The fungi use the radiation as an energy source. If the chemistry can be better defined, the technology can be used to reduce contamination. The Jet Propulsion Laboratory is also looking at the possible implications to reduce the effects of increased ambient radiation for astronauts.

Step aside CRISPR, RNA editing is taking off: CRISPER editing technology has garnered the majority of attention in genetic manipulation therapies. But problems with this process have caused investigators to look at some previous technology- editing RNA in order to influence protein synthesis. This article is a really good summary of this method.

About healthcare quality

The nation's top 22 patient-recommended hospitals: The list was gathered from the latest HCAHPS scores. These hospitals scored at least 93 percent to the choice: "Yes, I would definitely recommend the hospital." 

Today's News and Commentary

About pharma

FDA to Study Drug Endorsements by Instagram Influencers: Because of the prevalence of false information, the FDA will be conducting this study.

About health insurance

ACOs warn future of Next Gen program appears bleak: “The five-year demonstration program will expire at the end of 2020 unless the Department of Health and Human Services Secretary Alex Azar decides to extend it or make it permanent. But an industry group and several participants say that the Centers for Medicare & Medicaid Services is already telling Next Gen ACOs, which take on high amounts of financial risk, that the program will not be around for 2021.That's due to an evaluation report that found the program hadn’t saved Medicare money…
Another reason some in the ACO industry are speculating about the demise of Next Gen is the emergence of the new payment model called Direct Contracting, which goes online in 2021…
The Next Gen ACO program started in 2016 and required participants to take on a high amount of downside risk, where the ACO must pay CMS for not meeting savings targets. However, Next Gen ACOs got a higher share of savings than those in the MSSP.”

Humana, private equity firm team up to open Medicare-centric primary care clinics: “Humana is teaming up with New York-based private equity firm Welsh, Carson, Anderson & Stowe (WCAS) on a joint venture to launch senior-care-centric primary care clinics…The clinics will be payer-agnostic and operated by Humana’s primary care subsidiary, Partners in Primary Care.” The “payer-agnostic” model has been tried before with poor results. Competitors will not send patients to these clinics unless they have no other choice.

Top 10 health insurance companies in the US: The article provides information about these ten companies.

About emerging science

Unique new antiviral treatment made using sugar: “Using modified sugar molecules the team showed that the outer shell of a virus can be disrupted, thereby destroying the infectious particles on contact, as oppose to simply restricting its growth. This new approach has also been shown to defend against drug resistance.”

About the public’s health

Quantifying Health Systems’ Investment In Social Determinants Of Health, By Sector, 2017–19:” We identified seventy-eight unique programs involving fifty-seven health systems that collectively included 917 hospitals. The programs involved at least $2.5 billion of health system funds, of which $1.6 billion in fifty-two programs was specifically committed to housing-focused interventions. Additional focus areas were employment (twenty-eight programs, $1.1 billion), education (fourteen programs, $476.4 million), food security (twenty-five programs, $294.2 million), social and community context (thirteen programs, $253.1 million), and transportation (six programs, $32 million). Health systems are making sizable investments in social determinants of health.”

Today's News and Commentary

About healthcare quality

Malpractice Liability and Health Care Quality: One reason given by advocates for large malpractice awards is that it improves quality by making practitioners more cautious. “In this systematic review, most studies found no association between measures of malpractice liability risk and health care quality and outcomes. Although gaps in the evidence remain, the available findings suggested that greater tort liability, at least in its current form, was not associated with improved quality of care.” Don’t expect the trial lawyers to be persuaded by evidence, though.

How Chaos at Chain Pharmacies Is Putting Patients at Risk: This investigative piece by the NY Times details how pharmacist fatigue at the large chain pharmacies is causing prescription filling errors. Well worth the read.

2019 Update on Pediatric Medical Overuse: This article details the evidence concerning examples of misuse of pediatric medical treatments: “misdiagnosis of ADHD in students who are simply young for their grade, NICU admission and pharmacologic therapy for infants with NAS, antibiotic prophylaxis for UTIs, routine treatment of PDAs, prolonged antibiotic courses for latent TB, and overprescription of opioids.”

4 in 10 patients harmed by medical errors in primary and outpatient settings: “Globally, as many as 4 in 10 patients are harmed in primary and outpatient healthcare settings, with up to 80% of those medical errors preventable, according to a new white paper released today by the nonprofit Foundation for the Innovation and Development of Health Safety.”

About pharma

2020 could be a record year for drug approvals: This quarterly report from OptumRx projects that this year:

  • 150 new drug approvals. Over 150 new drug approvals, including new molecular entities and other approvals, will be evaluated by the FDA.

  • 64 drugs filed with FDA. Currently, 64 total drugs have been filed with the FDA and have anticipated approval dates in 2020.

  • 11 U.S. blockbusters. 11 are potential blockbusters with expected $1B+ in U.S. sales.”

Oncology is the leading therapeutic category; orphan drugs will continue to play a significant role in healthcare costs (each already costing at least $147,000 a year on average).

The 10 most-anticipated drug launches of 2020: In a related article, read about each of these 10 drugs.

About health insurance

CMS Releases Proposed Notice of Benefit and Payment Parameters Rule for 2021: The big news in this announcement is that CMS is going to more closely scrutinize eligibility for ACA plan subsidies. One way they will do so is by stopping automatic re-enrollment, so beneficiaries will have to document their eligibility each year.

Hospitals clobber Medicaid supplemental payment rule as unworkable cut to program: States have a variety of ways to supplement funds that they use to get federal Medicaid matches. The federal government is proposing to crack down on these other sources, which could cut $50 billion annually. Hospitals are obviously opposing this change.

Out-Of-Network Primary Care Is Associated With Higher Per Beneficiary Spending In Medicare ACOs: Using data from 2012-2015, the authors found that: “While there was no association between out-of-network specialty care and ACO spending, each percentage-point increase in receipt of out-of-network primary care was associated with an increase of $10.79 in quarterly total ACO spending per beneficiary. When we broke down total spending by place of service, we found that out-of-network primary care was associated with higher spending in outpatient, skilled nursing facility, and emergency department settings, but not inpatient settings. Our findings suggest an opportunity for the Medicare program to realize substantial savings, if policy makers developed explicit incentives for beneficiaries to seek more of their primary care within network.” The findings of higher costs are something practitioners have known for a while. The problem is that freedom of choice is built into the ACO model. Medicare Advantage, on the other hand, has the workable structure.

About the public’s health

Flu season continues, with H1N1 diagnoses picking up, CDC says: While the corona virus has garnered almost all of the public health attention, the flu epidemic is much more significant. The CDC estimates more than 19 million cases, 180,000 related hospitalizations and 10,000 deaths. It is not too late to get a flu shot.

Recommended Adult Immunization Schedule, United States, 2020: The figures are an easy-to- understand display of recommended adult immunizations.

Associations of Processed Meat, Unprocessed Red Meat, Poultry, or Fish Intake With Incident Cardiovascular Disease and All-Cause Mortality: “These findings suggest that, among US adults, higher intake of processed meat, unprocessed red meat, or poultry, but not fish, was significantly associated with a small increased risk of incident CVD, whereas higher intake of processed meat or unprocessed red meat, but not poultry or fish, was significantly associated with a small increased risk of all-cause mortality. These findings have important public health implications and should warrant further investigations.”

Today's News and Commentary

About the public’s health

Health workers may not use hand sanitizer properly: “Healthcare workers may not be using the right amount of hand sanitizer or letting it dry on their hands long enough to achieve maximum protection against the spread of germs… dispenser volume to achieve 20-30 seconds of drying time as per WHO recommendations is required for effective hand hygiene.”

Quality of Meals Consumed by US Adults at Full-Service [FS] and Fast-Food [FF] Restaurants, 2003–2016: Persistent Low Quality and Widening Disparities: Eating out is frequently bad for your health (duh!). “Between 2003 and 2016, FF and FS meals provided 1 in 5 calories for US adults. Modest improvements occurred in nutritional quality of FF, but not FS, meals consumed, and the average quality for both remained low with persistent or widening disparities. These findings highlight the need for strategies to improve the nutritional quality of US restaurant meals.”

EXCLUSIVE-OxyContin maker Purdue is 'Pharma Co X' in U.S. opioid kickback probe -sources: Practice Fusion [ a unit of Allscripts Healthcare Solutions Inc's MDRX.O ] is alleged to have solicited payments from Pharma Co. X [which the article identifies as Purdue Pharma] in late 2013 in exchange for creating an physician alert designed to boost opioid prescriptions by suggesting doctors focus on assessing and treating a patient's pain symptoms with opioid medication as a preferred option.
Practice Fusion pitched the software as a way to influence doctors and counter the unnamed company's declining opioid sales, stemming from heightened public awareness of addiction risks, according to court documents.
The goals of the alerts was to create new opioid patients and convert current users from immediate-release opioid medications to highly addictive extended-release drugs, according to court documents.
The alert on the Practice Fusion platform, used by tens of thousands of healthcare providers, was triggered 230 million times from July 2016 until the spring of 2019, according to court documents.”

UPDATE, replaces previous post: Data from the National Vital Statistics System

● Life expectancy for the U.S. population in 2018 was 78.7 years, an increase of 0.1 year from 2017, largely because of decreases in mortality from cancer, unintentional injuries, chronic lower respiratory diseases, and heart disease.

● The age-adjusted death rate decreased by 1.1% from 731.9 deaths per 100,000 standard population in 2017 to 723.6 in 2018.

● The 10 leading causes of death in 2018 remained the same as in 2017. From 2017 to 2018, age-adjusted death rates decreased for 6 of 10 leading causes of death and increased for 2.

● Age-specific death rates decreased from 2017 to 2018 for age groups 15–24, 25–34, 45–54, 65–74, 75–84, and 85 and over.

● The infant mortality rate decreased 2.3% from 579.3 infant deaths per 100,000 live births in 2017 to 566.2 in 2018.

● The 10 leading causes of infant death in 2018 remained the same as in 2017.

Update on the Corona virus: Coronavirus case count nears 10K; WHO declares public emergency; and China marks deadliest day as WHO declares global health emergency in fight against Wuhan coronavirus

About healthcare quality

Several 'Best' U.S. Hospitals Penalized Over Too-High Rates Of Infection, Injury: This story highlights at least a couple issues. First, what is “best?” The way it is measured clearly uses a composition score. If you want to know how good a hospital is at treating your condition, you need to look at data for that condition; you cannot generalize from the quality of other treatments. Second, one response raises the quality defensive statement of poorer scores resulting from higher vigilance (see Chapter 9 in the book):
”Only UCSF commented to Kaiser Health News on the penalties, blaming its high HAC [Hospital Acquired Conditions] rates on its thoroughness in identifying infections and reporting them to the government.”

About pharma

Not a kickback: Novartis’ Kymriah travel assistance program gets a green light from HHS: “Normally, a pharma company paying a patient to take its drug looks suspicious—like a kickback—and it’s considered so under federal law. But HHS has just made a special ruling for a novel therapy.
The federal health agency now allows Novartis to pay for travel, lodging, meals and other out-of-pocket expenses for Medicare and Medicaid patients taking its CAR-T therapy Kymriah…
The so-called Kymriah Travel Assistance Program assists “eligible low-income patients” with expenses incurred during their travel to receive the drug—and the ensuing post-infusion monitoring phase—at one of some 100 designated treatment centers across the U.S. under an FDA-required safety program.”

About health insurance

Insurers: Price transparency rule puts 'staggering,' expensive burden on us: “The Blue Cross Blue Shield Association (BCBSA), which represents 36 Blues plans, said that an economic analysis from the firm Bates White found that the total setup and maintenance cost for an insurer to comply with the rule was $13.63 million. That is 26 times higher than the administration’s estimate of $510,000…
The rule would require plans to publish machine-readable files with their payment amounts for all health services and items. Insurers would also be required to post a tool that can help consumers get an estimate on out-of-pocket costs for any item or service before they get care.”

The Trump administration calls it 'Healthy Adult Opportunity.' Critics call it less Medicaid: This deeper dig by the Washington Post comments on the Medicaid funding waivers announced yesterday. Most of the criticisms are unfounded. For examples, the new program must address the essential health benefits of Medicaid and the ACA and the limit on available drugs is already widespread with traditional Medicaid and managed care Medicaid formularies. The very important difference is a state’s ability to cap the number of eligible enrollees. This ability raises the question of how the state will make those determinations, e.g., lottery, income criteria, etc. The program fact sheet does say the waiver must comply with “all federal disability and civil rights laws.”

Today's News and Commentary

About the public’s health

Heart Disease and Stroke Statistics—2020 Update: This publication is an extensive review of cardiovascular, lipid and diabetes statistics. Overall, progress is being made in such areas as smoking and lowering lipid levels, but obesity and the lifetime risk of hypertension are still major problems. You can read the chapter summaries starting on page e3.

Despite new regulations, FDA still fails to protect youth from e-cigarette epidemic, American Lung Association says: “The US Food and Drug Administration received its fourth consecutive failing grade on regulation of tobacco products in the American Lung Association's annual State of Tobacco Control report.
A key factor in the grade was the Trump administration's decision  to exempt menthol and tobacco-flavored e-cigarettes from the policy it finalized this month to clear the market of cartridge-based e-cigarette flavors.” 

Dietary flavonols and risk of Alzheimer dementia: Eat your fruits and veggies: “In this community-based prospective study of older per- sons, we found evidence that higher flavonol intake through food sources, and kaempferol and isorhamnetin in particular, may be protective against the development of Alzheimer dementia. The associations were independent of many diet and lifestyle factors and cardiovascular- related conditions.”

U.S. life expectancy increases for first time in 4 years: The increase was due to a decrease in cancer deaths and reductions opioid overdoses and suicides. See the CDC site for the details.

About pharma

Drug Price Forecast 2020, Vizient Integrated Pharmacy Solutions: This forecast has lots of great data, including costliest drugs and price trends. One continuing trend is the effect specialty pharmaceuticals is having on overall costs. “Although they only account for 2.2% of total prescription volume, specialty drugs now account for 49.5% of total spending by institutional and retail pharmacy settings. About half of the more than 40 novel molecular entities approved in 2019 can be classified as specialty drugs.” (See Chapter 7 in the book for strategies to lower these costs.)

About health insurance

CBO: Medicare spending projected to hit $1.7 trillion in 2030: “In 2020, spending on federal health programs [Medicare and Medicaid] is expected to total $1.3 trillion. That number is projected to rise to $2.5 trillion in 2030…The increase in spending over the next 10 years is largely attributable to an increasing number of Medicare beneficiaries. The number of people in the U.S. age 65 or older is now more than twice what it was 50 years ago, and that number is expected to continue to rise.” Read the full CBO report and search for Medicare.

Healthy Adult Opportunity Fact Sheet: Healthy Adult Opportunity is the name for the new federal block grant initiative for Medicaid. The program will be available in all states under a 1115 waiver and will “focus on a limited population – adults under age 65 who are not eligible for Medicaid on the basis of disability or their need for long term care services and supports, and who are not eligible under a state plan.” In order to assess the quality of care, participating states “will be required to report 25 quality and access measures drawn from the CMS Adult Core Set, which are currently optional…” We will need to see which states will sign up. It is unlikely that states which have expanded Medicaid under the ACA will participate.

About pharma

More than half of clinical trials still hidden from public view: report: “Researchers from the University of Oxford… found of the 4,209 trials registered on ClinicalTrials.gov that were due to report results, only 1,722 (41%) did so by the one-year deadline. More than a third of the trials (1,523) had still not been reported by Sept. 16, 2019.
This is despite new rules that began at the start of last year mandating these tests be shared within a year of completion, and the researchers argue regulators such as the FDA need to clamp down on this lack of reporting.”

About healthcare quality

Patient Sentiment Report: This compilation of 8.4 million provider reviews by Healthgrades and the Medical Group Management Association found some interesting opinions:

  • “Patients most often mention a doctor’s skill or care quality when writing reviews.

  • In negative reviews, patients mention the factors of wait time, visit time, and office staff up to three times more often than they do in positive reviews.

  • Male providers receive higher average star ratings than female providers.

  • Reviewers more often mention factors like bedside manner, communication, and visit time in feedback about female providers, while reviews of male providers more often highlight skill and care quality.

  • Patient sentiment varies across states: New Jersey and Idaho doctors are among the most highly-rated in the country, while providers in Maine and West Virginia receive lower ratings across many factors.”

About healthcare IT

Using AI to advance the health of people and communities around the world: Microsoft is launching a program it calls “AI for Health, a new $40 million, five-year program to empower researchers and organizations with AI to improve the health of people and communities around the world.” The program will focus on three areas:

  • “Quest for discovery. Accelerating medical research to advance prevention, diagnoses and treatment of diseases

  • Global health insights. Increasing our shared understanding of mortality and longevity to protect against global health crises

  • Health equity. Reducing health inequity and improving access to care for underserved populations…"

Today's News and Commentary

About the public’s health

Loneliness is at Epidemic Levels in America: This Cigna study found that “loneliness in Americans is up 7-percentage points from 54% in 2018 to 61% in 2019. Why?
Not enough social support
Too few meaningful social interactions
Poor physical and mental health
Not enough balance in our lives.”
The study and media comments suggest more social support in the workplace will help.

Coronavirus in the U.S.: Map of where the virus has been confirmed across the country: This article is an update on the coronavirus spread.

Association of Simulated Patient Race/Ethnicity With Scheduling of Primary Care Appointments: This article makes a great discussion piece both for why the findings occur and remedies. The research found that “black and Hispanic patients were more likely to be offered an appointment, but they were asked more frequently about their insurance status than white callers. Black and Hispanic callers experienced longer wait times than white patients, indicating a barrier to timely access to primary care.”

Major Asia gene study to help doctors battle disease: This research seeks to address the problem that Asian populations are under-represented in clinical studies. For example there are differences in diseases patterns and drug metabolism profiles.

Maximizing the Impact of Surgical Health Services Research: The Methodology Toolbox: This editorial is in the latest issue of JAMA Surgery. See the Table for a summary of strengths and limitations of health services research methodologies. Other articles in the issue go into detail about these research approaches. Well worth a read for those involved in teaching health services research.

About pharma

OPDP to Study How Drug Names Affect Consumer Perceptions: “The Office of Prescription Drug Promotion plans to study how the name of a prescription drug affects consumer perception.
ODPD will be looking into how names that suggest the drug’s indication affect the perceptions of consumers and healthcare providers and if a name that overstates the efficacy of a drug affects perceptions.”

Walgreens teams up with Microsoft to launch 'health corners': “Walgreens is piloting the ‘health corners’ at 12 pharmacies in Tennessee. The pilot sites will feature two clinic-like rooms, where patients can meet with a pharmacist to discuss medications and health-tech devices. This is a different approach than Walgreens is taking with its retail clinics, which are staffed by nurse practitioners and other clinicians, according to the report.
As part of the partnership entered into last year, Microsoft manages Walgreens' data storage, and the pharmacy chain leverages Microsoft's AI platform and retail solutions. After the ‘health corners’ launch, Microsoft will help analyze the visits to develop a model that works best for Walgreens' customers…”

Publix betting big on in-hospital pharmacies: As previously mentioned, many supermarkets are getting out of the pharmacy business. This article explains how Publix is bucking this trend.

CVS Health RxZERO Solution Eliminates Member Out-of-Pocket Costs for Diabetes Medications: “CVS Health today announced a new solution eliminating member out-of-pocket costs associated with all diabetes prescription medications, including insulin. Offered through the company's pharmacy benefit manager (PBM), CVS Caremark, RxZERO enables employers and health plan sponsors to leverage formulary and plan design approaches to offer all categories of diabetes medications at zero dollar out of pocket for their members without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.”

Rare Disease Drugs Turning Huge Profits Catch Congress’ Eye: In order to encourage development of treatments for rare conditions, companies that garner an orphan drug designation get an extra seven extra years of exclusivity. (See Chapter 7 of the book for details.) The House Energy and Commerce Health Subcommittee is looking at options to change the protection if the drug becomes profitable.

Anthem's Medicare Advantage enrollment grew by 20% in 2019: This article is in the pharma section because Anthem attributed its increase in revenue to the launch of IngenioRx, the company’s pharmacy benefit manager.

About healthcare quality

Hospital Compare overall hospital rating: Medicare has updated its hospital “star report.”

About healthcare IT

Judge says no-can-do on HIPAA rules {scroll down for this story]: “Major sections of HHS' work to facilitate cheaper access for patients to their data are not permissible under the Administrative Procedure Act, a federal judge ruled late Tuesday night. 
The HHS actions, which allowed third parties like insurers and law firms to make record requests on patients' behalf and separately capped allowable fees for retrieving records, had been opposed by record-retrieval firm Ciox Health, which had sued the federal government.”

Insurers, CMS Seek to Ease Prior Authorizations: “AHIP [America's Health Insurance Plans] is rolling out a project known as Fast Path that it hopes will smooth the automated process for PA for drugs and for medical procedures and devices. The project is expected to begin in 60-90 days and run for about six months. Two vendors -- SureScripts on the pharmacy side and Availity on the procedure and device side -- are partnering with AHIP on the system; the seven plans participating provide health insurance to about 60 million Americans…”

About health insurance

Trump administration to offer states Medicaid block grant option: “A letter to every state Medicaid director, to be dispatched on Thursday, will offer the possibility of trading away an entitlement program that expands and contracts depending on how many poor people need the government health coverage. In exchange, for able-bodied adults in the program, states could apply to receive a fixed federal payment and freedom from many of the program’s rules, according to several individuals familiar with the plans.”

Today's News and Commentary

About pharma

Illinois law caps insulin patient costs at $100 monthly: “Gov. J.B. Pritzker signed a law Friday capping monthly insulin costs at $100 for people covered by state-regulated commercial health insurance plans.”

A National Survey of the Frequency of Drug Company Detailing Visits and Free Sample Closets in Practices Delivering Primary Care: Lots of caveats attached to the results but the practices that are more likely to see drug reps are smaller, independent practices in the South. The same characteristics apply to sampling practices. See also the accompanying commentary that reviews the evidence about pharma costs and detailing.

Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support: Should the public benefit from lower drug prices when the basic research is funded with government money (grants or primary development at the NIH)? “In 1989, the U.S. Public Health Service—the parent organization of the NIH—incorporated a fair pricing condition into its model cooperative research and development agreement (CRADA), which allows private institutions to work with government agencies and negotiate exclusive licenses for inventions stemming from such work. However, the NIH removed this condition 5 years later, with the then–NIH director claiming it chilled government–industry collaboration.” But this paper shows the “chilling” did not take place. Perhaps it is time to look at this model again?
For years, Finland has had a successful model to fund private innovation, including healthcare ventures in biotech. The organization, now known as Business Finland, was started in 1983 to fund the country’s startups with non recourse loans/investments. If the business is successful, the government will get a return on its investment.

About healthcare IT

Survey: 3 out of 5 Americans want stronger privacy protections: Americans want access to their medical data but are still very concerned about privacy.

Today's News and Commentary

Obituary

Pete Stark, congressman with a passion for healthcare, dies at 88: This story broke this afternoon. Much more will be written in media outlets tomorrow. Congressman Stark is responsible for the ethics laws that, among other things, prevent inducements for referrals and self-dealing. They are commonly called “Stark laws.”

About technology and ethics

An Ethical Future for Brain Organoids Takes Shape: In 2008 researchers created cerebral organoids, pea-sized tissue derived from stem cells that "can replicate aspects of human development and disease once thought impossible to observe in the laboratory. Scientists have already used organoids to make discoveries about schizophrenia, autism spectrum disorders and the microcephaly caused by the Zika virus.” But if they behave so much like human brain cells, what are the ethical implications if the are used for research? Do the organoids experience pain? What do we do with the tissue after research is finished? Clearly another case of science moving faster than ethics.

About the public’s health

U.S. Notches Fifth Coronavirus Case as Global Count Nears 3,000: As China quarantines cities with millions of people during lunar new year celebrations, the US has its fourth and fifth cases of the corona virus.

Z Codes Utilization among Medicare Fee-for-Service (FFS) Beneficiaries in 2017: “This study represents the first analysis of Medicare FFS claims data for the utilization of Z codes.” “Z codes are a subset of ICD-10-CM codes, used as reason codes to capture ‘factors that influence health status and contact with health services.’” The two most frequent codes were: Homelessness (Z590) – 223,062 claims and Problems related to living alone (Z602) – 196,551 claims. While this study’s data is older, it is still the best (and only) such analysis.

GSK hands TB vaccine to Gates Foundation's nonprofit biotech: “GlaxoSmithKline has licensed a tuberculosis vaccine to the Bill & Melinda Gates Medical Research Institute (MRI). The deal sets the stage for a push to build on recent phase 2b data and make the vaccine available in low-income countries where TB is prevalent.”

About health insurance

Accounting for the burden and redistribution of health care costs: Who uses care and who pays for it: This study by the RAND Corporation found that: “Higher‐income households pay the most to finance health care in dollar amounts, but the burden of payments as a share of income is greater among lower‐income households.” Further, Medicare beneficiaries get the most for their money while those with employer-sponsored plans get the least value for what they pay . There are many policy implications of the information in this study, ranging from addressing the regressive payments to viability of the Medicare system.

Newly updated formulary tool aims to help payers get early information on unapproved drugs: Insurance companies need time to incorporate newly approved drugs into their formularies. Also, since these approvals occur year-round, payers and PBMs do not have enough advanced opportunity to evaluate the impact of their costs on member premiums and out of pocket expenses. To address these problems, in 2018 the FDA allowed pharma companies greater flexibility to share information on products that were pending approval. This article is about the recent update in this system by The Academy of Managed Care Pharmacy (AMCP).

Trump says he will 'save' Social Security after signaling openness to entitlement cuts: I previously referenced a Davos interview with the President in which he said entitlement cuts were on the table. Now he appears to have reversed his position.

Supreme Court Allows Trump’s Wealth Test for Green Cards: “The new policy revised the so-called public charge rule, making immigrants ineligible for permanent legal status if they use public benefits like Medicaid and food stamps.” Lower courts had stayed this policy.

About healthcare IT

Apple, Cerner call for interoperability rule release 'without further delay' highlighting industry rift: Apple and Cerner have taken issue with Epic in their support of using for expedited interoperability.

About pharma

The Pharmacist Is Out: Supermarkets Close Pharmacy Counters: This Wall Street Journal article is a great case study in strategy. Many supermarkets have/had pharmacies to lure customers for impulse grocery purchases and to take advantage of margins on drugs. Now, some are divesting themselves of this activity because of competition from larger chain stores (like Walmart), pharmacy chains (like CVS and Walgreens) and mail order programs.

Today's News and Commentary

About the public’s health

Suicide Rates by Industry and Occupation — National Violent Death Reporting System, 32 States, 2016: The CDC issued this report today. It is a good resource for those dealing with potential patient suicides. As an example, men working in construction and mining trades have a much higher risk of suicide than the average population.

US Surgeon General: Not enough smokers are being told they should quit: This story was in many media outlets today. The basic message is in the headline with details in the Surgeon General’s report.

About healthcare quality

CMS tool to help consumers make informed care decisions: “Administrator Seema Verma announced on Thursday that the agency is planning to combine and standardize its eight separate Compare tools on Medicare.gov—Hospital, Nursing Home, Home Health, Dialysis Facility, Long-term Care Hospital, Inpatient Rehabilitation Facility, Physician and Hospice)—to enable consumers to better differentiate providers.” The revised tool is scheduled to be available later this year.

About healthcare IT

FDA issues cybersecurity warning on GE medical equipment that monitors patients: “The Food and Drug Administration released a warning on Thursday to health-care providers, facilities and consumers about a vulnerability in certain electronic health-care data equipment made by General Electric.
The flaw could allow a person to tamper with the devices in order to “silence alarms, generate false alarms and interfere with alarms of patient monitors connected to these devices,” the release says.” This instance is yet another example of the hack-ability of medical peripherals.

Epic releases software update to help identify coronavirus infections: The update revises Epic’s standard travel screening questionnaire “to remind clinicians and other front-line staff to ask patients about recent international travel. If the patient has traveled from China or has symptoms of Wuhan novel coronavirus, the provider is advised to start isolation precautions to contain potential infection.”

About pharma

Want to know how contentious drug pricing is in Washington? Check the receipts: “Pfizer, Johnson & Johnson, Merck, and the 31 other major drug makers that belong to the trade group PhRMA together spent more than $120 million lobbying Congress in 2019, according to recently released federal disclosures.
That helped pay for an army of over 450 lobbyists who helped the drug makers and their trade group vehemently oppose the sweeping proposals lawmakers and the Trump administration put forth in their efforts to lower prescription drug prices.
PhRMA also broke its all-time annual lobbying record this year. It spent $28.9 million in 2019, surpassing its previous record of $27.5 million, set last year.”
Read the article for more details of this massive lobbying campaign.

About medical devices

FDA approves Medtronic's tiny, wireless, minimally invasive pacemaker implant: This technology is a real breakthrough: a pacemaker that does not require the wiring of separate electrodes between the implant and the heart.
“Less than one-tenth the size of traditional pacemakers and described as one of the world’s smallest, the Micra AV device is designed to be placed entirely within the heart’s right ventricle and attach itself to the muscle wall using small tines.
It is implanted via a catheter and a minimally invasive procedure…”

About health insurance

The answer to America’s health care cost problem might be in Maryland: Maryland is different from other states in how its hospitals are paid.
”Since the 1970s, the state has set the prices hospitals can charge for medical care, known as all-payer rate setting.” Even Medicare regs dovetail with this system. Further, since 2014, “it’s also capped how much health spending can grow overall, including how much revenue each hospital can take in.”
This Vox article is a good summary of this system and how controls cost.

Today's News and Commentary

About pharma

Blues plans invest in new generic drug company: “Eighteen Blue Cross Blue Shield insurers are investing a combined $55 million to build a new generic drug company as a subsidiary of the nonprofit Civica Rx. The firm will focus on manufacturing generics people get at the pharmacy.” In addition to providers, payers are now getting into the pharma space.

Interesting science

Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study: This promising study shows the efficacy of an oral influenza vaccine. Such technology could revolutionize public health by eliminating temperature restrictions and enhancing portability and ease of administration.

About health insurance

Medicare Surgical Payments Should Be Updated to Reflect Postoperative Care That Is Actually Provided: This research from the RAND corporation and published in the New England Journal of Medicine looks at Medicare payments for post operative services. Post-op care (usually for the first 90 days) is bundled into the payments for the surgical procedure itself. However, many of those visits do not take place. If Medicare (Part B) accounted for those reduced services, it would have saved $2.6 billion in 2018. Recall that the work component of these payments is determined by the AMA committee that sets the RBRVS weights.

Critics: consumers should be wary of short-term health plans: A reminder of the severe pitfalls of choosing a short-term health plan.

Trump 'going to look' at Medicare cuts: This short article summarizes Trump’s statements about Medicare during a wide-ranging interview at Davos with CNBC’s Joe Kernen. No specifics, but entitlement programs were on the budget-cutting table.

About healthcare IT

Humana to allow members to connect hundreds of wearables to Go365 wellness program: “Humana is teaming up with health data company Validic to allow its members to connect a slew of wearable devices to the insurer’s Go365 wellness program.” The article does raise the issue of whether such programs improve health but does not address the security issues when such interoperable software is connected.

2020-2025: Federal Health IT Strategic Plan: This plan from the Office of the National Coordinator lists four overall goals (each with subsections on objectives and strategies):
—Promote Health and Wellness
—Enhance the Delivery and Experience of Care
—Build a Secure, Data-Driven Ecosystem to Accelerate Research and Innovation
—Connect Healthcare and Health Data through an Interoperable Health IT Infrastructure
With regard to the last goal, Epic’s CEO sent a letter to large hospital clients claiming the interoperability requirements would give app makers unauthorized access to patient data. Consumer groups want more interoperability, so one wonders how much of the concern is really over protecting her business.

2019 CAQH INDEX®: Conducting Electronic Business Transactions: Why Greater Harmonization Across the Industry is Needed: CAQH is a consortium of large payers whose mission is: “To accelerate the transformation of business processes in healthcare through collaboration, innovation and a commitment to ensuring value across stakeholders.” This monograph looks at the potential savings of electronic business transactions over manual processes. From a percent improvement standpoint, the greatest potential is in prior authorizations, of which only 13% are being conducted electronically.

About the public’s health

A couple insightful articles about the Chinese corona virus:

Appetite for 'warm meat' drives risk of disease in Hong Kong and China: “For various reasons, the Chinese prefer freshly slaughtered pig, chicken and beef over chilled or frozen meat that has been slaughtered before being shipped.
That desire is at the heart of why diseases such as avian flu in poultry and ASF [African swine fever] been so difficult to eradicate, with huge movements of live animals from all over the country – from farm to slaughterhouse to market – on a daily basis making controlling the spread of disease incredibly difficult.”
The coronavirus outbreak is linked to a market in Wuhan, eastern China where the meat was freshly slaughtered. “Like other respiratory illnesses, the disease was initially transmitted from animal to human, but is now being passed from human to human.” For deep cultural reasons, this habit may be hard to control without strict governmental intervention, not only now (as was quickly done) but in the future.

How China’s slow response aided coronavirus outbreak: This article is a good summary of how the Chinese government reacted to initial cases of the virus. One metric was holding hospital administrators to a “zero infections” target among staff; failure to comply could result in loss of their jobs. Obviously the policy slowed reporting of infections among nurses. This article is from the Financial Times (available by subscription only), so if you can get a copy it is well worth it.

Today's News and Commentary

About the public’s health

7 things to know about the coronavirus outbreak: Good summary to-date of the outbreak.

A self-aggregating peptide: implications for the development of thermostable vaccine candidates: Vaccines delivered to warm areas without refrigeration will quickly degrade. This animal research shows great promise for thermostabile vaccines that will retain their potency for at least a year.

About healthcare quality and safety

ISMP Publishes Top 10 List of Medication Errors and Hazards Covered in Newsletter: The Institute for Safe Medication Practices published its annual errors and hazards list. Among the items is selecting the wrong medication after entering the first few letters of the drug name in the EMR.

About health insurance

UnitedHealth: MA plan holders save nearly 40% more compared to fee-for-service Medicare beneficiaries: “UnitedHealth’s analysis, which was conducted by consulting firm Milliman, found that the average annual healthcare costs for a 72-year-old MA beneficiary were $3,632 and $5,960 for beneficiaries on fee-for-service…The analysis also found that a typical MA beneficiary who also has Part D prescription drug coverage spends $1,477 less than beneficiaries on fee-for-service with Part D coverage.”

340B has minimal effect on health spending, study finds: MedPAC “found that for 340B hospitals, spending on cancer drugs was 2 percent to 5 percent higher than hospitals that don't participate in the program and 1 percent to 7 percent higher than physician offices, a modest increase in overall healthcare spending since 2018.
The spending also depends on the type of cancer. MedPAC found that spending on cancer drugs was only higher among 340B hospitals for prostate and lung cancer. These increases couldn't be definitively linked to incentives from the 340B program and could be due to other factors…”

Today's News and Commentary

About pharma

Prices cut by an average of 53% under China's latest update to centralised procurement programme for generic drugs: What happens when a government starts negotiating pharma prices?

Study finds fewer than half of US clinical trials complied with new regulations on reporting results : “…compliance with US regulations requiring clinical trials to report results within one year of completion remains poor, with about one in three trials remaining unreported. The findings also indicate that studies backed by non-industry sponsors such as universities, hospitals and governments are more likely to breach the rules than those sponsored by industry, with US government-backed trials least likely to post results on time at the ClinicalTrials.gov registry.”

How the 8 biggest U.S. pharmas enriched their shareholders in 2019: These companies did well by taking advantage of new tax laws and buying back shares. The eight companies are profiled in more detail.

How Civica Rx became a force in the generic drug industry: A timeline: I have been reporting on CivicaRx since inception. This article provides a timeline of its development.

10 most expensive drugs for Medicare Part B and
10 most expensive drugs for Medicare Part D: The headlines speak for themselves.

About healthcare policy

Envisioning a Better U.S. Health Care System for All: Coverage and Cost of Care: This comprehensive policy paper from the American College of Physicians is well worth the read. “Part 1 of this paper discusses why the United States needs to do better in addressing coverage and cost. Part 2 presents 2 potential approaches to achieve universal coverage. Part 3 describes how an emphasis on value-based care can reduce costs.”

About healthcare IT

Hospitals Give Tech Giants Access to Detailed Medical Records: “Deals with Microsoft, IBM and Google reveal the power medical providers have in deciding how patients’ sensitive health data is shared.” This article from today’s print edition of the Wall Street Journal is a good summary of how our health data is being shared.

About health insurance

Supreme Court declines to hear case challenging legality of ACA: “The Supreme Court will wait for a federal appeals court to decide on the constitutionality of the Affordable Care Act, meaning that a final decision on the law won’t come before the 2020 election.”

Supreme Court to hear Trump appeal in Obamacare contraception fight: “At issue is a challenge by the states of Pennsylvania and New Jersey to the administration’s 2018 rule that permits broad religious and moral exemptions to the Affordable Care Act’s contraception mandate and expands accommodations already allowed under the 2010 law dubbed Obamacare. The administration has asked the Supreme Court to reverse a nationwide injunction issued by a lower court blocking the rule from taking effect.”

Predicting Hospitalizations From Electronic Health Record Data: Insurance companies want to be able to predict hospitalizations to gauge future costs and hopefully prevent those events. Where can they find data for such predictions? “Prediction models using EHR-only, claims-only, and combined data had similar predictive value and demonstrated strong discrimination for which patients will be hospitalized in the ensuing 6 months.” Combined data was no better than either source alone.

Trump Administration to Soon Issue Guidance on Medicaid Block Grants: “The Trump administration plans to release guidance as soon as this month for granting states waivers to convert Medicaid funding to block grants.”

CMS-specified shoppable services accounted for 12% of 2017 health care spending among individuals with employer-sponsored insurance: This analysis for CMS by the Health Care Cost Containment Institute drew the same conclusions as a previous commercial insurance study. Only a small portion of healthcare expenses are shoppable and can, therefore, be controlled by patients making better decisions: “Our analysis shows that the 70 CMS-specified shoppable services totaled 12 percent of 2017 medical spending (excluding prescription drug spending from the denominator) among individuals with employer-sponsored insurance. These services made up 16 percent of out-of-pocket medical spending.”

About the public’s health

First U.S. case of potentially deadly coronavirus confirmed in Washington state: Since last month, public health authorities have been closely following the spread of this virus (in the same class as SARS) from its origin in the central Chinese city of Wuhan. Now it has reached the U.S. Screening is staring at such major airports as San Francisco (SFO), New York (JFK), Los Angeles (LAX) and Chicago (ORD). The difference between SARS and this viral outbreak is that this time there has been more transparency by the Chinese government.

About promising technology

Discovery of new T-cell raises prospect of ‘universal’ cancer therapy: “Cardiff [University] researchers have now discovered T-cells equipped with a new type of T-cell receptor (TCR) which recognises and kills most human cancer types, while ignoring healthy cells.
This TCR recognises a molecule present on the surface of a wide range of cancer cells as well as in many of the body’s normal cells but, remarkably, is able to distinguish between healthy cells and cancerous ones, killing only the latter.”