Today's News and Commentary

About pharma

Think JPM seemed slow this year? You're not alone—and here's why: Here is a rundown of the annual JP Morgan Healthcare Conference. Slower than usual. Here are some thoughtful questions from hospitals CEOs.

FDA says ’no’ to another new opioid: “For the third time this week, a joint FDA advisory committee rejected a new opioid drug, highlighting a growing conviction among experts that abuse-deterrent formulations can do little to slow the opioid epidemic.”

About health insurance

Urban Institute: Premiums for cheapest ACA silver plan fell across 31 states in 2020: The headline is the “bottom line” for the story. This finding is significant because of the “silver loading” of plan premiums (so insurers can get maximum governmental subsidies). Keep in mind, though, rates vary greatly among states and there are some where premiums increased.

MedPAC recommends 3.3% payment boost for hospitals in 2021: The Medicare Payment Advisory Commission is recommending a 3.3 percent raise in Medicare payments for hospitals in 2021; CMS planned on a 2.8% increase. The 3.3% would be divided between a 2% overall increase and a 1.3% quality performance bonus.
”MedPAC said it is recommending the payment boost to reduce the disparity in payments at different care sites and is part of a larger effort to introduce site-neutral payments.”
Congress has the final word on the funding.

About healthcare professionals

29 physician specialties ranked by burnout rates: Physician burnout has been a big topic over the past year. Causes such as stress due to EMR use have been discussed. This article provides a ranking of which specialties are stressed the most and least.

About the public’s health

Millennials least likely to get a flu shot, and anti-vax beliefs may play a role: 55 percent of “people in their 20s and 30s said they did not get the flu vaccine this year. Their reasoning, usually, was that they didn't have time or simply forgot.
But the poll also uncovered another potential reason for forgoing the flu shot: 61 percent of millennials familiar with the anti-vaccination movement said they agreed with at least some of those beliefs.”

About diagnostics

Foxconn backs digital X-ray startup Nanox’s $26M round: The technology explained in this article is interesting but perhaps more so is the business model— pay per scan by the radiologists.

Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study: This article explains how Fitbit can be used as an epidemiologic tool to isolate early cases of the flu: Pulse goes up with fever as activity decreases.

Today's News and Commentary

About the public’s health

Global reach of ageism on older persons’ health: A systematic review: “Ageism led to significantly worse health outcomes in 95.5% of the studies and 74.0% of the 1,159 ageism-health associations examined. The studies reported ageism effects in all 45 countries, 11 health domains, and 25 years studied, with the prevalence of significant findings increasing over time (p < .0001). A greater prevalence of significant ageism-health findings was found in less-developed countries than more-developed countries (p = .0002). Older persons who were less educated were particularly likely to experience adverse health effects of ageism. Evidence of ageism was found across the age, sex, and race/ethnicity of the targeters (i.e., persons perpetrating ageism).” As the global population ages, we clearly need to address this type of discrimination.

How Anti-Vaccine Activists Doomed a Bill in New Jersey: The headline is the story. It is a fascinating (and sad) tale of how lobbying killed a law that would improve the public’s health.

Sex Differences in Blood Pressure Trajectories Over the Life Course: This sex difference is new clinical information. When we construct Artificial Intelligence algorithms for treatment, it must be flexible enough to incorporate such new information.
“In contrast with the notion that important vascular disease processes in women lag behind men by 10 to 20 years, sex-specific analyses indicate that BP measures actually progress more rapidly in women than in men, beginning early in life. This early-onset sexual dimorphism may set the stage for later-life cardiovascular diseases that tend to present differently, not simply later, in women compared with men.”

About pharma

Pharmacy Owners Express Concern Over Amazon’s PillPack Prescription Transfer Requests: “Independent pharmacists are expressing concern over a growing practice involving Amazon’s Pillpack, describing what some believe is the company sending unsolicited phone calls to their patients as a way of requesting transfers of prescriptions.”

Civica Rx Partners with Thermo Fisher Scientific to Develop and Manufacture Drugs with a History of Drug Shortages: Civica announced “it has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications with Civica as the owner of the regulatory pathway. By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug shortages in the future.”

About healthcare professionals

Half of doctors would take a pay cut for less hours, more work-life balance: “Half of physicians said they would take a salary reduction of up to $20,000 per year in exchange for working less hours and achieving a better work-life balance, according to a new survey…Millennials (52%), Generation Xers (48%) and baby boomers (49%) all said they would take a salary cut in exchange for more personal time. That was true even among millennials, who typically earn less than their more established peers. Some 53% of women said they would take a pay cut, versus 47% of men.”

How brands can inspire doctors to take more action: “Our qualitative research, validated though quantitative research, identified four major motivators for physicians, one rational and three emotional.” Key on pages five and six of the report. Think about how you would market products and services to physicians given this decision-making information.

Interesting science

Intratumoral expression of IL-7 and IL-12 using an oncolytic virus increases systemic sensitivity to immune checkpoint blockade: In mouse models, injecting a viral fragment encoded with inflammatory genes resulted in complete tumor regression, even in distant tumor deposits. “Mice achieving complete tumor regression resisted rechallenge with the same tumor cells, suggesting establishment of long-term tumor-specific immune memory. Combining this virotherapy with anti–programmed cell death-1 (PD-1) or anti–cytotoxic T lymphocyte antigen 4 (CTLA4) antibody further increased the antitumor activity as compared to virotherapy alone, in tumor models unresponsive to either of the checkpoint inhibitor monotherapies.” Benefits were seen for melanoma and, to a lesser extent, colon cancer.

About health insurance

Projected costs of single-payer healthcare financing in the United States: A systematic review of economic analyses: This study will undoubtedly be in the news in the coming days. “To achieve net savings, single-payer plans rely on simplified billing and negotiated drug price reductions, as well as global budgets to control spending growth over time.”
Not included in administrative costs for Medicare are all the fraudulent activities the program incurs because of weak oversight compared to private plans. Further, private plans offer a large variety of benefits and payment methods because the public wants such choice; that choice adds to administrative costs of plans.
One further caution, the administrative cost difference between Medicare and private plans is not as great as first appears. One reason Medicare administrative costs are “lower” is healthcare expenses are much higher than commercial populations, i.e., as the denominator increases, the percent decreases.

Repeal of Obamacare taxes stirs questions on durability of offsets: The 2019 Congressional budget resulted in repeal of three health care taxes — a 2.3 percent levy on medical devices, a fee on health insurers and a 40 percent excise tax on high-cost health plans (also known as the Cadillac tax). Despite estimates that these taxes would have produced $373 billion over a decade, the liberal Center on Budget and Policy Priorities found the health care law would still reduce the deficit by between $55 billion and $75 billion in 2025.

Avalere: CMMI will not generate as much savings for Medicare as CBO projected:

“Avalere Health estimates that CMMI’s payment demonstrations will save Medicare $18 billion from 2017 through 2026, compared to $34 billion projected by CBO back in 2016.”

How the Affordable Care Act Has Narrowed Racial and Ethnic Disparities in Access to Health Care: The headline gives the “bottom line” in the study. One example: “The gap between black and white adult uninsured rates dropped by 4.1 percentage points, while the difference between Hispanic and white uninsured rates fell 9.4 points.”

About healthcare quality

Checking in on the checklist: This monograph is a good review of the benefits of surgical checklists in the past 10 years. What is fascinating is the global view of its adoption (see pages 21 and 22). 90% of highly developed countries use checklists while only 33% of lower developed countries do so. Reasons for this huge disparity are given.

Today's News and Commentary

NEW CATEGORY OF NEWS TODAY: INTERESTING SCIENCE.
These postings will have articles about basic science that has potential to make significant inroads in treating disease and improving health

Interesting science

Bacteria shredding tech to fight drug-resistant superbugs: Innovative use of metal nanotech to treat/prevent drug resistant bacteria (and perhaps other organisms).

Study finds potential new treatment for preventing Post Traumatic Stress Disorder (PTSD): University of Toronto scientists discovered a protein complex [Glucocorticoid Receptor-FKBP51] that is elevated in PTSD patients. “The researchers also developed a peptide to target and disrupt the protein complex. They found that the peptide prevented recall or encoding of fear memories in early tests. This suggests that the peptide could treat PTSD symptoms or prevent them entirely.”

About the public’s health

Fewer in U.S. Continue to See Vaccines as Important: From Gallup:

84% in U.S. say vaccinating children is important, down from 94% in 2001
86% say vaccines are not more dangerous than the diseases they prevent
45% of Americans say vaccines do not cause autism in children [46% are unsure]
There is clearly a need for a social marketing campaign to change these dangerous perceptions.

Americans drink about 2.3 gallons of alcohol a year: study: The consumption is rising and is greater than it was before the start of Prohibition.

Spain cracks down on influencers who are bad for your health: “The Health Ministry is working to eliminate videos on social networks such as Instagram that promote drugs and treatments that should only be available on prescription,” such as antibiotics. What about anti-vaxers?

Urgent health challenges for the next decade: This list and explanations are from the WHO. (Go to the photos and then click right arrow for the next item and explanation below.) Items range from the climate crisis to personnel issues. Interesting topics for discussion and term papers.

There's a mismatch in the flu shot -- and it's not good news for children: Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says the current flu vaccine is a 58% match for B/Victoria. As matches generally go its not bad; people should still be immunized with the current vaccine.

More Studies Link Vaping to Asthma, COPD: E-cigarettes were fist touted as safer than regular cigarettes. But the evidence keeps mounting that they have the same health hazards.

More than 100 billion pain pills saturated the nation over nine years: “Newly disclosed federal drug data shows that more than 100 billion doses of oxycodone and hydrocodone were shipped nationwide from 2006 through 2014 — 24 billion more doses of the highly addictive pain pills than previously known to the public.” The issue here is that the government knew there was a big problem sooner than we thought— and did nothing.

About health insurance

Warren and Klobuchar Say They Can Lower Drug Prices Without Congress’ Help: No major news about healthcare insurance in last night’s Democratic debate. Klobuchar raised the issue of long term care. This article is a nice summary of the health issues in the debate.

New York, Rhode Island Spend Highest Percentages of Budgets on Medicaid: The top 7 states now spend about a fifth of their budgets on Medicaid. What has to give to pay these expenses? Education, infrastructure…

CVS to add 600 HealthHUBs, link them to lower Aetna copays: “CVS Health plans to add 600 HealthHUB locations by the end of the year and offer low to zero copayments for Aetna members.” This action continues the company’s efforts to integrate its system.

UnitedHealth raked in $13.8B in profit for 2019: “Much of the company's 2019 performance and its projected 2020 growth is attributable to strong performance of its diverse Optum subsidiary, which posted $3 billion in earnings from operations in the fourth quarter and $9.4 billion in 2019.”

About pharma

FDA Approval and Regulation of Pharmaceuticals, 1983-2018: Here are the major findings of this study:
“Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period.” In other words, “The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.” The question is what about the safety of the faster-approved drugs?

Eli Lilly to offer half-priced versions of two more insulin products: Continuing a trend for insulin manufactures to sell lower price products, “Lilly will sell new versions of Humalog Junior KwikPen and Humalog Mix75/25, which contains a mix of fast- and intermediate-acting insulin, at a list price of $265.20 for a pack of five KwikPens. They will be available at that price by mid-April, the company said.” Recall last year Lilly said it would sell a half price version of Humalog.

To Generic Drug Manufacturers Considering Retiring or Withdrawing ANDAs for Essential Medicines: Civica Rx Is Interested: CivicaRx announced that “it is interested in talking to generic drug manufacturers who are considering retiring or withdrawing their Abbreviated New Drug Applications (ANDAs) for essential medicines that are at risk of being in short supply.
Periodically, the FDA withdraws approvals of ANDAs due to manufacturer inactivity. According to published reports, the FDA is considering withdrawing close to 250 ANDAs for these reasons.” Recall the company is a consortium of hospitals/systems that contract for the manufacture of generic drugs in short supply.

Gene Therapy: Keeping Costs from Negating Its Unprecedented Potential: This informative white paper from CVS Health explains how gene therapy works and gives examples of pending treatments and their costs. Totals for the next 4 years estimated at $15 to 45 billion.

Today's News and Commentary

About healthcare IT

Physician Time Spent Using the Electronic Health Record During Outpatient Encounters: A Descriptive Study: “Physicians spent an average of 16 minutes and 14 seconds per encounter using EHRs, with chart review (33%), documentation (24%), and ordering (17%) functions accounting for most of the time. The distribution of time spent by providers using EHRs varies greatly within specialty. The proportion of time spent on various clinically focused functions was similar across specialties.” Clearly there is much more opportunity for streamlining EHR interaction.

Too many providers are failing to meaningfully integrate data analytics: “Healthcare providers are failing to integrate digital data platforms into their IT infrastructure, and analytics into their clinical and operational workflows. This despite widespread availability of the technology – and a definite need for it, given the demands of value-based reimbursement…
84% of the C-suite execs and board members polled said their health systems only used analytics to a  ‘limited or minimal extent to generate commercial or outcome insights,’ according to the survey.”

About pharma

Hospitals are getting into the biopharma sector. Last month I reported that NYU Langone Health opened a 50,000-square-foot biotech incubator space in Manhattan to host startups. The past couple days, two other hospitals have announced their entry in this space. Nationwide Children's Hospital will build a biofactory to produce gene therapy material while “University of Pittsburgh Medical Center's venture capital arm is committing $1billion in investments toward developing new drugs, diagnostics and devices by 2024.”

Drugmakers Test New Ways to Pay for Six-Figure Treatments [Wall Street Journal, requires subscription]: This excellent article provides a useful video explaining all the stakeholders in the pharma transaction chain and some of the creative arrangements manufacturers of very costly drugs have structured with payers- like pay for success and installment payments.

Supreme Court Declines to Consider Medical Diagnostic Patents: “The U.S. Supreme Court stayed out of the debate over what types of medical diagnostic tests can be patented, leaving in legal limbo companies that discover ways to diagnose and treat diseases based on patients’ unique characteristics.
The justices rejected an appeal by Quest Diagnostics’s Athena unit that sought to restore its patent for a test to detect the presence of an autoimmune disease. A lower court had ruled in favor of the nonprofit Mayo Clinic that the test wasn’t eligible for a patent because it merely covered a natural law—the correlation between the presence of an antibody and the disease.” "Laws of nature, natural phenomena, and abstract ideas" cannot be patented under Section 101 of the Patent Act.

FDA and NIH let clinical trial sponsors keep results secret and break the law: “For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.” The article has a graphic of different prominent stakeholders and their reporting (un)timelines. As the FDA is moving to incorporate more real world evidence for drug evaluations, it needs to be stricter about reporting.

Today's News and Commentary

About health insurance

What's an Individual Coverage Health Reimbursement Arrangement (HRA)? Last June 13, the U.S. departments of Health and Human Services, Labor and the Treasury issued a final rule allowing employers that do not offer a group coverage plan to fund a new kind of health reimbursement arrangement (HRA), known as an individual coverage HRA (ICHRA).
Starting Jan. 1, 2020, employees can these new HRAs to buy individual-market insurance, including ACA exchanges. Previously, employers were forbidden to set up such accounts.

DIFFERENT EMPHASIS ON ACOs DATA IN THE FOLLOWING TWO ARTICLES

Number Of ACOs Taking Downside Risk Doubles Under ‘Pathways To Success’: This information is from CMS administrator Verma: "For the January 1, 2020 start date, CMS approved 53 applications for new ACOs and 100 applications for renewing ACOs. The total number of Medicare beneficiaries served by health care providers in ACOs is now 11.2 million, up from 10.4 million at the start of 2019. Nearly 30 percent of all beneficiaries in fee-for-service Medicare are now served by a health care provider in a Shared Savings Program ACO.
I’m especially proud to report that the number of ACOs taking on risk for cost increases has grown significantly—from 93 ACOs at the start of 2019 to 192 at the start of 2020.” 

Participants continue to drop out of Medicare ACO program: "Just 53 new accountable care organizations joined the Medicare Shared Savings program for the Jan. 1 start date, which is significantly less new entrants compared to previous years. 
There are now 517 ACOs in the Medicare program versus in 2018 when there were 561 ACOs. The drop in new participants follows a recent trend from six months ago when only 66 new ACOs joined. By comparison, in 2018, 124 new ACOs entered the program and in 2017, 99 new ACOs joined. 
The National Association of ACOs blames the changes to the Medicare ACO program for the recent drops in participation. In late 2018, the CMS finalized an overhaul of the program that requires ACOs to take on downside financial risk sooner after years where most organizations were risk averse.”

About pharma

FDA Makes Real-World Data Available on Google Cloud Platform: The FDA has been promoting “real world” data to improve drug evaluations.The FDA’s MyStudies platform is now available on Google Cloud Platform.

Supreme Court to Rule on States’ Right to Regulate Pharmacy Benefit Managers: In what could have profound effects on the way drugs are handled by insurers, the “US Supreme Court has announced it will hear a case in the coming months that could determine whether states have the right to regulate pharmacy benefit managers (PBMs).
The US Court of Appeals for the Eighth Circuit, covering Arkansas and 6 other states, previously ruled on Rutledge v. Pharmaceutical Care Management Association. The Eighth Circuit decision favored the Pharmaceutical Care Management Association (PCMA), ruling that the Employee Retirement Income Security Act of 1974 (ERISA), a federal law that sets minimum standards for voluntarily established retirement and health plans in private industry, superseded an Arkansas law that sought to regulate PBMs.
Passed in 2015, Arkansas Act 900 required PBMs to raise reimbursement rates for drugs if they fell below the pharmacy’s wholesale costs and created an appeal process for pharmacies to challenge PBM reimbursement rates. This effectively prohibited PBMs from reimbursing pharmacies below the pharmacies’ cost of acquisition.
In his brief to the US Supreme Court, Solicitor General Noel Francisco disagreed with the Eighth Circuit decision, stating that the ruling was contrary to higher court’s precedent and should be reviewed and corrected. He urged the court to take up the case, siding with attorney generals from 31 states and the District of Columbia that want the US Supreme Court to reverse the Eighth Circuit’s ruling.”

A ‘radical proposition’: A health care veteran tries to upend the system and bring drug prices down: This story appeared in several news media today. It is about a new company that plans to make “me-too” drugs (those medicines that have a unique composition, but are, perhaps, the 4th or 5th in their chemical class) at lower prices than existing treatments. It is not know which medications the company will initially target; but even these me-too products need to go through the FDA approval process since they are not generics. We will need to wait and see if they can get approval at a fraction of the cost of other drugs, since that is where they hope to achieve the savings to offer the lower prices.

Two Big Drug Flops Show How Health-Care Economics Have Changed: “For years, drug companies have enjoyed the freedom to charge high prices for their latest products. But when Sanofi and Amgen Inc. each marketed a powerful new cholesterol-lowering medicine, something surprising happened: High prices hurt sales. Sanofi’s experience has been especially painful. The French company spent more than five years developing Praluent with Regeneron Pharmaceuticals Inc. before its launch in 2015. But Praluent never caught on. Now Sanofi is cutting its losses, getting out of the U.S. market for the drug, and halting its heart disease research altogether in favor of more lucrative medicines for cancer and other diseases…Praluent’s disappointing sales are the result of insurance giants’ reluctance to pay for expensive new pharmaceuticals that treat chronic disease when far cheaper drugs can often get the job done.” The days of charging whatever the market is thought to bear may be limited.  

CMS Addresses Duplicate Discounts, State Medicaid Rebate Requests: States are submitting requests to the federal government for rebates for 340B drugs- which already carry steep manufacturers’ discounts. New guidance rules are addressing this double dipping.

23andMe licenses 1st drug: Genetic testing company 23andMe licensed a drug to Spanish drugmaker Almirall which is designed to treat autoimmune and inflammatory conditions, such as lupus and Crohn's disease.

About health devices

FDA clears 3D-printed airway stents tailored to patient anatomy: Just a reminder about how 3D printing is making its way into clinical use.

About healthcare IT

A billion medical images are exposed online, as doctors ignore warnings: “Hundreds of hospitals, medical offices and imaging centers are running insecure storage systems, allowing anyone with an internet connection and free-to-download software to access over 1 billion medical images of patients across the world.
About half of all the exposed images, which include X-rays, ultrasounds and CT scans, belong to patients in the United States.”

The Sneaky Genius of Facebook's New Preventive Health Tool: Interesting investigative piece about how the social media company gathers available information and uses it for a preventive health tool.

Today's News and Commentary

About healthcare personnel

Kaiser Permanente, union announce $130M initiative aimed at healthcare workforce shortage: This type of alliance is a new way for a health system to address a worker shortage. Kaiser and
the “Service Employees International Union-United Healthcare Workers West (SEIU-UHW) are launching the $130 million organization, called Futuro Health, as part of the labor agreement reached by the two parties last year. 
Futuro’s goal is to graduate 10,000 new licensed and credentialed allied health workers in California in the next four years. Estimates suggest California alone will face a demand of nearly 500,000 healthcare workers by 2024, Kaiser Permanente said.”

Employment Situation Summary: From the US Bureau of Labor Statistics: “Employment in health care increased by 28,000 in December. Ambulatory health care services and hospitals added jobs over the month (+23,000 and +9,000, respectively). Health care added 399,000 jobs in 2019, compared with an increase of 350,000 in 2018. “

About health insurance

DOJ boasts $2.6B in healthcare fraud settlements, judgments in 2019: “The recoveries involved all sectors of the industry including drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories and physicians. It is the tenth consecutive year the department's civil healthcare fraud settlements and judgments have exceeded $2 billion.”

Today's News and Commentary

About health insurance

HealtHcare affordabililty State Policy Scorecard: Take a look at how Altarum evaluates affordability of healthcare and then ranks states based on the criteria. For example, “The highest ranked state, Massachusetts, performed well on many policy measuresbut should enact stronger protections against surprise medical bills and pursuemore strategies to reduce the cost of high-value care. Massachusetts is a state with relatively high healthcare spending per person, but a comparatively low percentage of residents report affordability problems.”

Blackstone-KKR Hidden Hand in Ad Blitz Unleashes Washington Fury: “Confronted with the rare prospect of defeat on Capitol Hill, private equity titans Blackstone Group Inc. and KKR & Co.unleashed a national advertising blitz last year against legislation that threatened their investments in health-care companies valued at $16 billion.
The $53.8 million campaign sought to derail a crackdown on surprise medical billing, in which patients are unexpectedly hit with exorbitant charges, often following visits to emergency rooms.”

New York State Investigates Christian Health Cost-Sharing Affiliate: “More than one million Americans have joined such groups, attracted by prices that are far lower than the cost of traditional insurance policies that must meet strict requirements established by the Affordable Care Act, like guaranteed coverage for pre-existing conditions. 
These Christian nonprofit groups offer low rates because they are not classified as insurance and are under no legal obligation to pay medical claims. But state regulators are questioning some of the ministries’ aggressive marketing tactics, saying some consumers were misled or did not grasp the lack of comprehensive coverage in the case of a catastrophic illness.”

'Gold rush': Race is on for health data in East Europe's frontier market: This article explains what happens to public systems all around the world.
”Growing numbers of people in Eastern European states, from Hungary and Poland to Romania, are turning to private health. The shift is being driven by rising wages, coupled with low public health spending which has often led to staff shortages and long waiting times for tests and surgery.”
Private insurers are gathering data so they can offer insurance to these populations.

2020 Federal Health Insurance Exchange Enrollment Period Final Weekly Enrollment Snapshot: CMS released the final enrollment numbers yesterday. “Approximately 8.3 million people selected or were automatically re-enrolled in plans using the HealthCare.gov platform during the 2020 open enrollment period,” down slightly from the previous year. The announcement has a breakdown by state and enrollee activity.

Reduce Health Costs By Nurturing The Sickest? A Much-Touted Idea Disappoints: “Researchers tested whether pairing frequently hospitalized patients in Camden, N.J., with nurses and social workers could stop that costly cycle of readmissions. The study found no effect: Patients receiving extra support were just as likely to return to the hospital within 180 days as those not receiving that help.”

About the public’s health

Appeals court refuses to lift injunction on immigrant 'public charge' rule: “A panel of federal judges in New York on Wednesday denied the Trump administration’s request to begin a program aimed at cutting back benefits for immigrants while a lawsuit over the plan plays out in court.
The ruling by a three-judge panel of the U.S. Court of Appeals for the 2nd Circuit keeps in place a nationwide halt on President Trump’s ‘public charge’ rule that links immigrants’ legal status to their use of public benefits.”

.2020’s Best & Worst Cities for an Active Lifestyle: Honolulu and Chicago top the list.

About pharma

Gov. Gavin Newsom announces state-run prescription drug label to lower prices: “California Gov. Gavin Newsom is slated to announce Thursday a plan to create a state-run generic drug label, and also negotiate with prescription drugmakers to set uniform prices for Californians, including those on private insurance.
Under the generic-drug proposal, the state would not make its own medicines, but instead contract with manufacturers to produce certain drugs in an effort to spur competition and hence lower prices.”

Researchers Investigate the Novelty of Costly Drugs: “A new study from Harvard Medical School researchers found that of the 27 active ingredients in 25 brand-name drugs with the highest Medicare spend in 2017, 11 (41%) of the ingredients had previously been approved by the US Food and Drug Administration (FDA) in other formulations or products.
Of these 11, the median time between the first FDA approval and the end of 2017 was more than 19 years, they added.”In other words, according to the original research article, “the novelty of active ingredients in the 25 brand-name drugs with the highest Medicare Part D spending” did not justify the prices.

 Why price of Humira keeps rising despite FDA approval of generic competition: This article is a nice review about tactics branded manufacturers use to keep generic competitors off the market.

About healthcare professionals

HCA buys majority stake in multistate nursing school: “The for-profit hospital operator is now the majority owner of Galen College of Nursing, which has locations in Texas, Ohio, Kentucky and Florida.
The partnership aims to improve access to nursing education and career development opportunities to address the nation's nursing workforce needs.”

About hospitals

U.S. hospitals see first decline in outpatient visits since 1983: T”he American Hospital Association’s newly released 2020 Hospital Statistics report shows the 6,146 hospitals in the U.S. delivered a cumulative 879.6 million outpatient visits in 2018, 0.9% less than in 2017, when they delivered 880.5 million outpatient visits. The data, which covers health system-owned ambulatory surgery centers, outpatient clinics and urgent care clinics, is the first year-over-year decline since 1983, and comes even as health systems work to expand their outpatient offerings beyond hospital campuses.”

About healthcare IT

At CES, Humana offers a glimpse inside its new digital tech hub 'Studio H': More from the Consumer Electronics Show: Humana is leveraging remote monitoring and patient interactions to provide information about health needs of its members.

Healthcare Data Breaches Predicted to Cost Industry $4 Billion in 2020:”The healthcare data breach figures for 2019 have yet to be finalized, but so far 494 data breaches of more than 500 records have been reported to the HHS’ Office for Civil Rights and more than 41.11 million records were exposed, stolen, or impermissibly disclosed in 2019. That makes 2019 the worst ever year for healthcare data breaches and the second worst in terms of the number of breached healthcare records.
The healthcare industry now accounts for around four out of every five data breaches and 2020 looks set to be another record-breaking year. The cost to the healthcare industry from those breaches is expected to reach $4 billion in 2020.”

Today's News and Commentary

For your amusement and disgust

Lown Institute’s 3rd annual Shkreli Awards: Top ten list of reprehensible behavior in healthcare.

About the public’s health

Cancer death rate posts biggest one-year drop ever: Good news! The trend was driven by the decrease in lung cancer deaths, which in turn was due to two factors- better treatments and decline in smoking rates.

Sex differences in cardiometabolic disorders [Nature Medicine-subscription required] If you can get access to this article it is worthwhile. It presents a comprehensive review of the title’s subject. Particularly, it reviews differences in risk factors (such as hypertension, diabetes, obesity and socioeconomic factors) diagnosis and disease manifestations. For example, women “with IHD [ischemic heart disease] are characterized by a higher prevalence of angina, a higher burden of cardiometabolic risk factors, and a higher prevalence of non-obstructive CAD [coronary artery disease] on angiography compared to men (10–25% in women vs. 6–10% in men).” The molecular mechanisms of sex differences in cardiometabolic disorders is also explained.
With more Artificial Intelligence applications being used, it is critical that sex differences are understood and built into algorithms for diagnosis and treatment.

CVS, Walgreens sue Ohio physicians, claim they share blame for opioid crisis: The last shoe has fallen. Physicians have largely been spared from blame for the opioid crisis. Now the major pharmacy chains are sharing the responsibility.

About healthcare IT

Inside the Billion-Dollar Battle Over .Org: This article is not strictly about healthcare but, since many healthcare organizations are non profit, it can have a significant impact on the field. Two months ago, Ethos Capital, a private equity firm, announced that it planned to buy the rights to the “.org” domain for more than $1 billion. The article explains how this purchase could happen and the push-back by non profits.

About pharma

A new biotechnology and pharmaceutical industry commitment to patients and the public: A long list of biotech companies have issued a statement pledging to restrain pricing on their products. But the principles are broad and no numbers (like percent increases or limits) are mentioned. We will need to wait and see how the promise plays out.

The Effect Of Veterans Health Administration [VHA] Coverage On Cost-Related Medication Nonadherence: “Although people with VHA coverage were older and in worse health and had lower incomes than those with other coverage, VHA patients had lower rates of cost-related medication nonadherence: 6.1 percent versus 10.9 percent for non-VHA patients.” The authors say the reason is lower out-of-pocket expenses for veterans who fill their prescriptions at VA facilities.

Allergan settles pay-for-delay lawsuit for $300M: “The lawsuit, filed in 2013, claimed Warner Chilcott entered into agreements with Watson and generic drugmaker Lupin Pharmaceuticals to delay a generic version of Loestrin 24 FE from coming to market…” The FTC continues to prosecute such behavior.

About healthcare IT

A look at the most interesting health tech at CES 2020: Here are some of the most interesting health-related items at the Consumer Electronics Show, including a multipurpose robot.

About health insurance

Report to Congress on Oversight of Institutions for Mental Diseases [IMDs]: This report is from MACPAC (Medicaid and CHIP Payment and Access Commission) and fulfills a statutory requirement for a report on IMDs, which are defined as: a “hospital, nursing facility, or other institution of more than 16 beds that is primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases, including medical attention, nursing care, and related services.” Medicaid payments to IMDs has been prohibited since Title IX was passed in 1965. The services themselves are covered benefits, but not if provided in these institutions. “Even so, nearly all states are making payments for services provided in IMD settings via various exemptions and authorities, including: statutory exemptions related to older adults and children and youth; demonstration waivers under Section 1115 of the Act; a state plan option; and managed care arrangements under certain conditions.” This report looks at seven states and how they are handling this issue.

Today's News and Commentary

About healthcare quality

2018 Quality Payment Program (QPP) Performance Results: This statement is from CMS. In summary, 84 percent of eligible clinicians will receive an additional adjustment for exceptional performance, 13 percent will receive a positive payment adjustment and 2 percent will receive a negative payment adjustment.

Association of Powder Use in the Genital Area With Risk of Ovarian Cancer: “Among women from 4 prospective cohorts, there was not a statistically significant association between use of powder in the genital area and ovarian cancer, but the study may have been underpowered to identify a small increase in risk.” It is not certain what impact this study will have on the pending lawsuits against Johnson & Johnson.

Roughly 10% of U.S. children get unneeded medical care: “…11 percent of publicly insured children and 9 percent of privately insured children received "low-value" care, or care that offered little benefit to their health, at least once. In addition, 4 percent and 3 percent of each group received similar low-value care at least twice during the same period.” Studies show that evidence-based medicine that suggests underutilization results in physicians doing more; however studies like this one that show unnecessary care do not get as much traction. Think it has to do with reimbursements?

Spending And Quality After Three Years Of Medicare’s Voluntary Bundled Payment For Joint Replacement Surgery: We found that over three years, compared to no participation, participation in BPCI [Bundled Payments for Care Improvement] associated with a 1.6 percent differential decrease in average LEJR [lower extremity joint replacement] spending with no differential changes in quality, driven by early participants. Patient selection accounted for 27 percent of episode savings.”

The Impact Of Bundled Payment On Health Care Spending, Utilization, And Quality: A Systematic Review: Do not generalize from the above research. These researchers “performed a systematic review of the impact of three CMS bundled payment programs on spending, utilization, and quality outcomes. The three programs were the Acute Care Episode Demonstration, the voluntary Bundled Payments for Care Improvement initiative, and the mandatory Comprehensive Care for Joint Replacement model. Twenty studies that we identified through search and screening processes showed that bundled payment maintains or improves quality while lowering costs for lower extremity joint replacement, but not for other conditions or procedures [emphasis added].”

Seniors Still Wary of Online Reviews When Picking Doctors: “ Most older Americans don't fully rely on or trust online ratings of doctors, a new study finds. 
Among men and women between the ages of 50 and 80, only 43% have looked online to see how patients rated a doctor…”

About health insurance

CMS wants to use more encounter data for Medicare Advantage payments: “The CMS on Monday proposed changes to Medicare Advantage payments for 2021, including an increase in the percentage of patient ‘encounter data’ used to calculate payments.” Insurers say the data is inaccurate and incomplete, but they are the ones using that data to submit higher intensity payment requests to CMS.

Supreme Court sets Friday deadline for responses in ObamaCare case: ”The Supreme Court on Monday told the Trump administration and a group of [red] states to respond by the end of the week to an effort by Democrats to expedite a challenge to a lower court ruling that struck down a key tenet of ObamaCare.”

Combining medical, pharmacy and behavioral benefits delivers annual savings of more than $850 per customer with an identified health improvement opportunity: Benefits are often fragmented because of expertise in individual functional areas. But this study shows their integration for patients with chronic conditions can save money.

New Fast PATH Initiative Aims to Improve Prior Authorization for Patients and Doctors:”America’s Health Insurance Plans (AHIP), along with several of our member insurance providers, is launching the Fast Prior Authorization Technology Highway (Fast PATH) initiative to improve the prior authorization process…This new initiative will rely upon the proven automated technologies of both Availity and Surescripts to speed prior authorization requests, responses, and information exchange.”

Individual Insurance Market Performance in Late 2019: The main fear this year was that elimination of the penalty for not having insurance would cause healthy people to drop coverage and result in increased insurance premiums. This study found that: “Going into 2019, insurers reported that the reduction of the penalty to $0 drove premiums up by about 5 percentage points. Nonetheless, premiums were largely steady in 2019, on average, in part because insurers had priced too high in 2018. Despite concerns about the continuing impact of the loss of the mandate penalty, the individual market has remained fairly stable through 2019. Enrollment among those not eligible for subsidies declined by 10% in early 2019, but individual market enrollment overall appears to be stabilizing, with total market enrollment falling by just 5%.”

About the public’s health

The downstream air pollution impacts of the transition from coal to natural gas in the United States: Does reducing coal emissions really help improve health? Yes! And crop production as well.
“Between 2005 and 2016 in the continental United States, decommissioning of a coal-fired unit was associated with reduced nearby pollution concentrations and subsequent reductions in mortality and increases in crop yield. In total during this period, the shutdown of coal-fired units saved an estimated 26,610 (5%–95% confidence intervals (CI), 2,725–49,680) lives and 570 million (249–878 million) bushels of corn, soybeans and wheat in their immediate vicinities; these estimates increase when pollution transport-related spillovers are included.”

About healthcare professionals

Nurses Continue to Rate Highest in Honesty, Ethics: “For the 18th year in a row, Americans rate the honesty and ethics of nurses highest among a list of professions that Gallup asks U.S. adults to assess annually. Currently, 85% of Americans say nurses' honesty and ethical standards are ‘very high’ or ‘high’…” Engineers are in second with 66% and physicians are third with 65%.

Best Paying Jobs: The U.S. News report says that the top 11 highest paying jobs are in healthcare professions. #1 is anesthesiology.

Today's News and Commentary

About pharma

The medications that are thrown away: “Last year, Medicare paid for $725 million worth of expensive medications administered in outpatient clinics — things like chemotherapy drugs — that ended up being discarded, according to new data released by the federal government.” See the chart for the most costly wasted drugs.

Internal Deadlines, Drug Approvals, and Safety Problems: Quicker drug approvals have always been a doubled edged sword- the ability to get medications to those in need versus potential harm from overlooked side effects. This important research article quantifies this issue.
“ In the United States, the number of December drug approvals is roughly 80% larger than in any other month…Similar approval spikes occur at the end of each calendar month. Additionally, approvals spike before holidays, such as before Thanksgiving in the United States and the Chinese New Year in China (but not vice versa). Drugs approved in December and at month-ends are associated with significantly more adverse effects, including more hospitalizations, life-threatening incidents, and deaths. This pattern is consistent with a model in which regulators rush to meet internal production benchmarks associated with salient calendar periods: this type of ‘desk-clearing’ behavior results in more lax review, which leads both to increased output and increased safety issues.”

FDA Approves First-of-its-Kind Migraine Treatment: “Allergan’s Ubrelvy (ubrogepant) tablets received the FDA’s approval for the immediate treatment of migraine with or without aura, a visual disturbance or sensory phenomenon caused by the condition.
The novel drug, which is not indicated for preventive treatment, is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists the FDA has approved for acute migraine treatment.”

Lawsuit accuses Pfizer of concealing cancer-causing chemical in Zantac: It was bound to happen: “A proposed class-action lawsuit was filed Jan. 2 accusing Pfizer of hiding the fact that Zantac, which it made from 2000 to 2006…Pfizer never listed N-nitrosodimethylamine, or NDMA, a human carcinogen, as an ingredient in Zantac, the lawsuit alleges.”

About health insurance

House, blue states ask Supreme Court to immediately review ObamaCare case: Rather than wait for the slow wheels of justice, the House and blue state attorneys general asked the Supreme Court to decide the fate of the ACA before the election. Recall where things now stand: the Appellate Court said the insurance mandate was now unconstitutional because there was no longer a penalty (oops…tax) for non compliance. That Court sent the case back to the lower court to decide if the whole ACA is now invalid.

About the public’s health

US on track for one of the worst flu seasons in decades: “Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, said while it's impossible to predict how the flu will play out, the season so far is on track to be as severe as the 2017-2018 flu season, which was the deadliest in more than four decades, according to the US Centers for Disease Control and Prevention.”

Best and worst diets for 2020, ranked by experts, with a popular one near last: Bottom line: Mediterranean diet is best. But read the article for where the others weigh in.

Social inequalities in multimorbidity, frailty, disability, and transitions to mortality: a 24-year follow-up of the Whitehall II cohort study: Read the article for the particulars of the study population and data gathering. The indicators of socioeconomic status considered were education, occupational position, and literacy. The findings showed that: “Socioeconomic status affects the risk of multimorbidity, frailty, and disability, but does not affect the risk of mortality after the onset of these adverse health conditions. Therefore, primary prevention is key to reducing social inequalities in mortality. Of the three adverse health conditions, multimorbidity had the strongest association with mortality, making it a central target for improving population health.”

FDA clears PhotoniCare's handheld OCT scanner for checking ear infections: This article is under The public’s health section because of the high prevalence of ear infections in children. ”PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to check for fluids deep behind the eardrum—one of the main signs of childhood ear infections, According to PhotoniCare, middle ear infections affect more than 80% of children, though they can be misdiagnosed up to half of the time following examination with a traditional otoscope.” If this device proves a better diagnostic tool, it will replace otoscopic assessment of middle ear infections and hopefully reduce prescription of unneeded antibiotics.

About healthcare quality and safety

Psychological safety and infection prevention practices: Results from a national survey: “High psychological safety was reported in approximately 38% of responding hospitals, and was associated with increased odds of regularly using urinary catheter reminders or stop-orders and/or nurse-initiated urinary catheter discontinuation (odds ratio, 2.37; P = .002) for catheter-associated urinary tract infection prevention, and regularly using sedation vacation (odds ratio, 1.93; P = .04) for ventilator-associated pneumonia prevention…A culture of psychological safety should be considered an integral part of HAI [hospital acquired infection] prevention efforts.”

Prevalence of Potentially Unnecessary Bimanual Pelvic Examinations and Papanicolaou Tests Among Adolescent Girls and Young Women Aged 15-20 Years in the United States: “In this population-based, cross-sectional study using data from 2011 to 2017, an estimated 2.6 million women aged 15 to 20 years in the United States (22.9%) received a bimanual pelvic examination in the past year, and 54.4% of these examinations were potentially unnecessary. An estimated 2.2 million young women (19.2%) received a Papanicolaou test in the past year, and 71.9% of these tests were potentially unnecessary.”

An accompanying editorial comments and rebuts reasons usually given for these unnecessary exams: “Some have suggested that the benefit of requiring an annual pelvic examination is that it prompts women to visit a clinician for their annual examination. There is no evidence to support this hypothesis.”

Today's News and Commentary

About the publics’ health

U-Haul will no longer hire smokers in 21 states: Yes, it is legal to discriminate against smokers. Actually the new company policy includes “nicotine products.”

Not sure how to get rid of extra opioids or antibiotics? The pharmacy may not know, either: “Researchers found only 47% of pharmacies gave correct instructions on how to dispose of antibiotics and 34% provided correct information about opioid disposal. On weekends, only 15% correctly directed customers about safe antibiotic disposal and 7% gave the correct information about disposing of opioids.” The FDA has specific instructions on how to dispose of these medications.

About health insurance

Health insurance mandate takes effect in Rhode Island: Even as Republicans try to dismantle the ACA, some states are creating their own mandates for health insurance.

Judge shoots down California law on how kidney dialysis is paid for: “A federal judge has blocked a California law that would limit insurance payment rates at life-saving kidney dialysis clinics and prohibit the clinics from steering patients to private insurers.” Of note is that it is illegal for physicians to steer Medicare patients into a particular Medicare Advantage plan or recommend they drop such a plan to go back to traditional Medicare.

About healthcare IT

Global Healthcare Cloud Computing Market to Reach $51.9B by 2024: “The global healthcare cloud computing market is expected to reach $51.9 billion by 2024, according to a recent Research&Markets report.
The market is projected to increase from $23.4 billion in 2019 at a compound annual growth rate (CAGR) of 17.2 percent during the period, researchers reported. The main growth factors through 2024 will include the increasing adoption of big data analytics, wearable devices, and internet of things (IoT) in healthcare. The market is also slated to grow due to the advantages of cloud usage, such as improved storage, flexibility, and the scalability of data.”

About pharma

First generics to Bristol-Myers and Pfizer's Eliquis are here. But can they launch before 2026?: This story is a perfect example of defending a brand against generic competitors.

“The FDA approved the first two copycats to Eliquis, made by Mylan and Micro Labs, on Christmas Eve. But despite the agency's announcement, which touted its efforts to get generics to market, the Eliquis copies will not get there anytime soon…
In 2017, 25 generics companies told Bristol that they had filed for FDA approval of their copycats. The pair soon erected a patent wall, launching lawsuits against all those drugmakers.
That August, the U.S. Patent and Trademark Office granted Eliquis a key composition of matter patent, extending it from February 2023 to November 2026. Bristol and Pfizer have argued that’s when Eliquis generics can enter.”

Today's News and Commentary

HAPPY NEW YEAR!

About pharma

5 worst pharma deals of the decade: Some cautionary examples for the near future.

Provision in Spending Bill Paves Way for Follow-On Insulins: Sometimes it takes a while for news to “percolate.” Buried in more than 1,500 pages of the fiscal 2020 spending bill is an expanded definition of a biological product that now includes chemically synthesized polypeptides, such as insulin. The change makes it easier for competitors to introduce biosimilar insulins so prices can be lowered.

More drugmakers hike U.S. prices as new year begins: “Reuters reported on Tuesday that drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi SA were planning to increase prices on more than 200 drugs in the United States on Jan. 1. Nearly all of the price increases are below 10% and the median price increase is around 5%…”

Novo Nordisk's new insulin affordability offerings now available in the US: Novo Nordisk launched its “My$99Insulin” program for its authorized generics. “All patients can purchase up to three vials or two packs of FlexPen®/FlexTouch®/Penfill® pens of any combination of insulins from Novo Nordisk Inc. for $99.”

Standard of Evidence Expanded in New FDA Guidance: “In its first updated guidance in more than 20 years on acceptable trial design, the FDA said substantial evidence from a trial proving effectiveness could be gained from one trial instead of two, one adequate well-controlled trial plus confirmatory evidence or reliance on a previous finding of effectiveness from an approved drug. 

The FDA has decided that in some cases the traditional two-trial model can be replaced by other types of trial designs more suited to the study of rare diseases... five types of control are mentioned in the draft guidance: placebo, dose comparison, no treatment, active treatment and historical control.”

Comments on the draft guidance are due Feb. 21, 2020.

About the public’s health

Prevention of tuberculosis in macaques after intravenous BCG immunization: Tuberculosis kills more people than any other infectious agent. To prevent the illness, a vaccine, BCG, has been used for about 100 years, but with widely variable success. This research article shows promise in greatly enhanced effectiveness by administering the vaccine intravenously instead of into the skin, as has been the practice.

About healthcare IT

International evaluation of an AI system for breast cancer screening: This article is highlighted in most major media today. For example: Google’s DeepMind A.I. beats doctors in breast cancer screening trial. This study compares the AI system to a single radiologist reading. But a standard procedure is to have two radiologists read a mammogram. With this double reading, the AI system performs similarly. Further, some of the radiologists had not received special further training in mammography. The AI system is getting really good; if it continues to improve, it may be able to substitute for radiologists in the near future.

Trump administration’s compromise vape ban provokes public health outcry: Public health groups are angry that the president backtracked on part of his promise to curtail vaping. Yesterday the White House announced that fruity and minty cartridges would be banned, but not menthol, as previously promised. Further, e-liquids for “open tank” products that typically are sold by vape shops will now be allowed. An administration “official said the outcome was a compromise between administration officials pushing a comprehensive ban promised by Trump in September and others worried about the political fallout stemming from potential job losses in thousands of vape shops across the country.”

About health insurance

Tenth Circuit Upholds HHS Risk Adjustment Methodology: A number of ACA health plans, particularly the consumer-sponsored startups (COOPs) have sued the federal governments over methodologies it used to pay (or, in this case, not pay) them back for losses that started in 2014. One challenge was to the risk adjustment formula. In this ruling, “the Tenth Circuit upheld HHS’ risk adjustment methodology, concluding that HHS’ use of a statewide average premium and the adoption of a budget-neutral program were not arbitrary and capricious. HHS acted reasonably in explaining why it used the statewide average premium in the risk adjustment methodology for 2014 through 2016. Because HHS subsequently issued new rules covering the 2017 and 2018 methodologies, the challenges over the rules for those years are moot.” If upheld, HHS would not owe these plans any payments (almost all COOPs went bankrupt).

About healthcare quality

Changes in Quality of Care after Hospital Mergers and Acquisitions: Hospital combinations result in increased charges. The participants argue, however, that quality improvement justifies the expense. However, this research shows that: “Hospital mergers and acquisitions were associated with modest deterioration in patient experiences, small and nonsignificant changes in readmission and mortality rates, and inconclusive effects on performance on clinical-process measures. These findings challenge arguments that hospital consolidation, which is known to increase prices, also improves quality.”

Adding Patient-Reported Outcomes to Medicare’s Oncology Value-Based Payment Model: At the end of 2020, CMS will roll out its Oncology Care First (OCF) model, replacing the previous Oncology Care Model (OCM). Reflecting the evolution of payment and evaluation systems, this new model will have two new features: capitation and patient-reported outcomes. Similar changes in other advanced payment models cannot be far behind.

Today's News and Commentary

About pharma

Astellas Enters into Definitive Agreement to Acquire Audentes Therapeutics: The trend of large pharma buying biotech companies continues. In this $3billion deal, Audentes will operate as an independent subsidiary.

Chinese Researcher Who Created Gene-Edited Babies Sentenced To 3 Years In Prison: The headline speaks for itself.

About the public’s health

Prevalence of Human Papillomavirus Infection by Number of Vaccine Doses Among US Women: “Our study suggests that US women who received 1 dose of the HPV vaccine may have gained similar protection against vaccine-type infections compared with those who received additional doses. These findings support previous observational studies and post hoc analyses of vaccine trials that demonstrated comparable effectiveness of 1 dose to 2 or 3 doses.” If this study’s findings prove themselves it could greatly simplify this vaccination- and lower the cost.
Merck (maker of Gardasil) closed at 91.03 USD −0.47 (0.51%).

About health insurance

Governor Cuomo Unveils 14th Proposal of 2020 State of the State: Increasing Transparency in Healthcare Costs: “Under this proposal, Governor Cuomo will direct the Department of Health, the Department of Financial Services and the New York State Digital and Media Services Center - a joint enterprise of the Office of Information Technology Services and Office of General Services - to create a consumer-friendly website, called NYHealthcareCompare, where New Yorkers can easily compare the cost and quality of healthcare procedures at hospitals around the state. The platform will also provide consumers with educational resources designed to help consumers know their rights including financial assistance options, what to do about a surprise bill and more.” Pending federal action on these issues, seems like states are taking the lead. However, sites like Hospital Compare already provide such quality data.

About healthcare devices

FDA Reclassifies Electrotherapies for Anxiety and Insomnia: The reclassification from Class III to Class II for this specific device is not the issue- it is the general way the FDA looks at classifying newer technology.

Today's News and Commentary

About the public’s health

Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk: Risks for several types of cancer can be lowered with regular exercise- or at least the association suggests.

Patient Views on Religious Institutional Health Care: “In a population-based survey study of 1446 US adults, only 6.4% reported that they considered religious affiliation when selecting a health care facility. Most patients (71.4%), particularly women, believed that their personal choices about their health should take priority over a facility’s religious values…Given the growth in ownership of health care facilities by religious entities in the United States and increasing attention to conscientious objections, these findings point to a need for advocacy and legislation that effectively balances protections for religious institutions with protections for patients.”

About pharma

New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices: A recent study by the FDA quantifies how much additional generic entrants lower prices. Compared to the market before generic introduction, one generic product will lower prices by 39%; by the time there are six competitors, the price declines by at least 95%.

Today's News and Commentary

About the pubic’s health

Manipulating the Human Microbiome to Manage Disease: This article is a fascinating summary about how manipulation of our bacterial flora can be used to improve health and treat disease.

About healthcare IT

9 HIPAA settlements of 2019: Chronological listing ranging from $100,000 to $45 million.

Today's News and Commentary

About healthcare quality and safety

Outcomes Before and After the Recall of a Heart Failure Pacemaker: “This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.”

Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221): Patients do not always ask their physicians about use of dietary supplements; and physicians do not always bring up the subject. This research shows a very significant increase in recurrence for breast cancer patients who took certain supplements both before and during chemotherapy. On the list is any antioxidant supplement (vitamins A, C, and E; carotenoids; coenzyme Q10), B12 and iron.

Today's News and Commentary

About health insurance

CMS releases rule to require ACA insurers to send separate bill for abortion coverage: “Affordable Care Act exchange insurers must send separate bills to consumers for the portion of their premiums attributable to certain types of abortion services, according to a final rule.
The rule released Friday by the Centers for Medicare & Medicaid Services imposes the new requirements on insurers to ensure they meet a federal prohibition on public funding for abortion coverage, officials said. It also has new requirements for states to help identify people who are enrolled on both exchanges in addition to other government health programs.”

Open enrollment on ACA exchanges remains stable: “…preliminary figures indicate more than 8.3 million people enrolled for coverage on the ACA exchanges through Dec. 17 for the 2020 open enrollment period. That's down about 2.4% from the approximately 8.5 million individuals who enrolled for 2019 coverage during last year's open enrollment period.” A late surge and short extension accounted for these numbers.

How 2 former debt collectors helped erase $1B in medical bills: A great holiday story! “Craig Antico and Jerry Ashton had decades of experience as medical debt collectors when they founded RIP Medical Debt in 2014. Since then, the nonprofit organization has helped eliminate medical debt for more than 500,000 people across the U.S.
RIP raises funds from individual donors, philanthropists and organizations to purchase medical debt in bulk for pennies on the dollar. Once RIP buys debt, it is forgiven. Over the past five years, the organization has erased $1 billion in medical debt, including $65 million in debt owed by veterans.”

Patient loyalty to healthcare providers is at risk over transparency, finds AccessOne survey: Loyalty has a price: “Two in five consumers say they would switch providers to access affordable payment arrangements to cover their costs of care -- including half of households with children, an AccessOne survey has found.
That's an increase over 2018 survey figures, when 33% of individuals and 43% of households with children said they would be willing to switch providers for more affordable payment options.”
Unfortunately, the study does not detail the amounts over which patients would switch.

Trump signs bills to avoid shutdown, scrap Obamacare taxes and raise tobacco buying age: The tax agreement is now law. See previous posts for healthcare implications.

About healthcare quality

Doctors Online Reviews are Polarized:Compared to hotel and restaurant Yelp reviews, “people’s experiences with doctors are polarized: either awful or spectacular… The most prevalent issues in negative doctors’ online reviews include frustration and difficulty making appointments, long waiting room times, and rude front desk, billing and nursing staff.
There is good news for physicians, however. Patients are almost twice as likely to give doctors good reviews as poor ones.”

Today's News and Commentary

About health insurance

Congress unveils $1.3T spending deal: 5 healthcare takeaways: The Senate passed the House version of the budget, which the President is expected to sign. To summarize its previously-reported healthcare provisions:

1. Provides federal funding for gun violence research for the first time in more than two decades.

2. Repeals the ACA's Cadillac tax, health insurer tax and medical device tax at a cost of nearly $400 million.

3. Delays Medicaid Disproportionate Share Hospital payment cuts for about five months.

4. Raises the national age for tobacco sales to 21.

5. Omits legislation to address surprise medical bills and cutting pharma costs.

Democrats Debate Whether ‘Medicare For All’ Is ‘Realistic’: Nothing new on healthcare from last night’s Democratic debate. This article is a nice summary of who said what (by now, predictable).

What Happens When a Health Plan Has No Limits? An Acupuncturist Earns $677 a Session: The gist of this article is in the headline. Well worth a read!

About pharma

Duke launches privately funded innovation company for drug discovery: “Duke University's Office of Licensing & Ventures partnered with healthcare investment firm Deerfield Management Company to launch Four Points Innovation, a private company aiming to accelerate drug discovery and development.” These types of deals represent an evolution of university-originated tech commercialization. Instead of doing only basic science research and transferring the tech to commercial companies, this step involves the actual product development.

New USMCA Deal Drops Exclusivity for Biologics:  As part of the deal, the US dropped provisions requiring at least 10  years of exclusivity for biologics.

All hail drug reps: Most cancer docs rely on pharma salespeople for info, survey finds: Where do physicians get their information about new drugs? “Seventy-one percent of U.S. oncologists surveyed by Cardinal Health Specialty Solutions agreed sales reps play an important role in their new-product education.” But the reps ability to see these physicians is not as open as it once was: “48% allow full access to sales reps, while 45% allow access with limits.”

FDA Launches App to Identify New Uses for FDA-Approved Drugs: “The FDA launched CURE ID, an app-based web repository that would allow healthcare professionals to report their off-label uses of FDA-approved drugs.”

Low-cost breast cancer drug 'could save lives in low-income countries': “A cheap version of the groundbreaking breast cancer drug Herceptin has been approved by the World Health Organization, raising the possibility of lifesaving treatment for the first time for women in low-income countries…The WHO listed it as an essential medicine for all countries to buy, but it has been unaffordable in much of the world, with a price tag of about $20,000 (£15,000) per patient…With the drug now out of patent, the WHO has approved a biosimilar version – a cheap copy – of the monoclonal antibody made by a company in the Netherlands…The price will be 65% lower than Herceptin itself, which at about $9,000 is still a burden for lower income countries.”

CMS updates drug dashboards to increase pricing transparency: “The dashboards focus on average spending per dosage for prescription drugs paid for by Medicare Parts B and D as well as Medicaid. They also track the change in average spending per dosage over time, display the name of each drug's manufacturer and show information on drug uses and clinical indications…
The data showed that in 2018, total gross spending on prescription drugs was $168.1 billion in Medicare Part D, $33.3 billion in Medicare Part B, and $66.4 billion in Medicaid. 
The proportion of prescription drugs with a unit price increase went down from 2017 to 2018 in both the Medicare Part B program and in Medicaid. In the Medicare Part D program, the proportion of prescription drugs with a unit price increase remained steady from 2017 to 2018.”
To check the data go to this CMS website.  

How Patients Feel About Cancer Drug Development: This survey of more than a thousand people found, among other opinions, that:
88% would share their healthcare data if it helped develop therapies faster for treating cancer.
82% believe patients should be compensated for sharing health data, suggesting potential for profit-sharing in drug development.
69% would want a share of the profit if their or a family member’s data was used to help develop a new cancer drug.
Read the study for more insights.

Cigna’s Express Scripts And Big Blue Cross PBM In Major Deal To Tame Drug Costs: “Cigna’s Express Scripts pharmacy benefit management unit and a PBM owned by 18 Blue Cross and Blue Shield plans [Prime Therapeutics] have joined forces to tame drug costs for a massive client list that covers 100 million people…The collaboration will allow Prime’s member Blue Cross health plans to gain leverage through Express Scripts’ buying clout and large pharmacy network.”

About the public’s health

Plasma metabolite biomarkers of boiled and filtered coffee intake and their association with type 2 diabetes risk: Good news for some coffee drinkers. 2 cups of filtered coffee per day reduces risk for Type 2 diabetes. The reduction does not occur for less consumption of filtered coffee or for boiled coffee (like percolated).

Biocompatible near-infrared quantum dots delivered to the skin by microneedle patches record vaccination: The researchers developed a vaccine delivery system with dissolvable microneedles that imbed patterns of near-infrared light-emitting microparticles to the skin. The microparticles encode the vaccination information, including administration date, and can be read with a modified smartphone.

About healthcare IT

Identifying Potential Patient Safety Issues From the Federal Electronic Health Record Surveillance Program: [Full access to this JAMA article by subscription]“…findings begin to estimate the extent of vendor lack of adherence to certification standards and the potential for patient harm, with 3.7% of total product IDs having a nonconformity issue that could be a contributing factor to a patient harm event.” For example, one error gave a medication dose 10 times what was recommended. Clearly manual oversight is needed.

Artificial Intelligence in Healthcare: Excellent monograph from the National Academy of Medicine covering this important and emerging topic..

Today's News and Commentary

About pharma

Novartis plans giveaway of world's most expensive drug: “Novartis plans to give away up to 100 doses annually of Zolgensma, its $2.1 million spinal muscular atrophy treatment, under a new managed-access program.” Patients must meet certain clinical criteria, but the constraining factor is that the drug must not be approved in the country where the patient resides.

FDA Issues Draft Guidance for Developing Hemorrhoids Treatments: The story is not specifically about hemorrhoids, but it emphasizes the FDA’s desire to include more patient reported outcomes in evaluating treatments.

About the public’s health

Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity: This research suggests “with high predictive accuracy that by 2030 nearly 1 in 2 adults will have obesity… and the prevalence will be higher than 50% in 29 states and not below 35% in any state. Nearly 1 in 4 adults is projected to have severe obesity by 2030… and the prevalence will be higher than 25% in 25 states.”

About health insurance

Medicaid, CHIP enrollment decline for 2nd straight year: “Enrollment in Medicaid and the Children's Health Insurance Program (CHIP) declined nationally for the second year in a row, with a 2.6% decrease over the past two years, according to a new report. 
The Medicaid and CHIP Payment and Access Commission (MACPAC) released its annual look at enrollment, spending, benefits and service use for Medicaid and CHIP. The group found that Medicaid and CHIP enrollment dropped in 34 states and the District of Columbia. 
This trend was felt in both states that expanded Medicaid and those that did not.”

Democrats want a 2020 Supreme Court hearing on the lawsuit that could upend Obamacare: A really good summary (and expert comments) of yesterday’s story about the Appellate Court’s decision that the individual mandate is unconstitutional.

About healthcare IT

Blue Button 2.0 API Update: According to CMS, Blue Button 2.0 is a “developer-friendly, standards-based API that enables Medicare beneficiaries to connect their claims data to the applications, services and research programs they trust.”
“On December 4th, a third-party application partner reported a data anomaly with the Blue Button 2.0 API (BB2.0). CMS verified the anomaly and immediately suspended access to the production environment. We discovered a bug in the BB2.0 codebase which may be causing certain beneficiary protected health information to be inadvertently shared with another beneficiary or the wrong BB2.0 application.”
See the website for the impacted applications.

Hospital execs say they are getting flooded with requests for your health data: This article is a nice review of the opportunities for hospitals to profit by supplying clinical data to companies.

Today's News and Commentary

IMPORTANT BREAKING STORY

Appeals court strikes down individual mandate in ACA case, but punts on severability: “In a blow to the ACA, federal appeals judges have ruled 2-1 that the landmark healthcare law's individual mandate is unconstitutional but punted on the question of whether that mandate can be excised from the remainder of the law…’The individual mandate is unconstitutional because it can no longer be read as a tax, and there is no other constitutional provision that justifies this exercise of congressional power,’ they wrote in their opinion (PDF).” I predict that the lower court will find the whole law is now invalid. The ruling will be appealed to the Supreme Court, where Chief Justice Roberts (who wrote the original opinion on the law) is still in charge. But the composition of the court is now Republican-leaning. The outcome is uncertain.

About pharma

US Unveils Proposed Rules to Allow Some Canadian Drug Imports: ‘The FDA and HHS will unveil a plan Wednesday to allow certain prescription drug imports from Canada—but one that leaves out, for now, many specialty medications and other therapies for chronic disease that cost patients the most. [Exclusions are controlled substances, biologics and intravenously injected drugs.] Through a Notice of Proposed Rulemaking and a draft guidance for industry, the FDA will seek request for comment on 2 pathways. One would allow states to submit proposals to the FDA to allow the importation of small molecule brand-name medicines sold at retail pharmacies— typically ones that have rebates attached to them…
the other… is draft guidance for industry, which would let manufacturers import the same versions of FDA-approved drugs they now sell in foreign countries. Under this pathway, drugmakers would use a new National Drug Code (NDC) and sell these drugs in the United States at cheaper prices.”

Lawmakers try to find next opportunity to tackle drug prices, surprise billing after setback: Both those initiatives will be pushed back to at least this coming May.

Lawmakers expand definition of biologics in year-end spending bill: Another proposed inclusion in the budget compromise: A “provision would change the definition of biologic drugs to include ‘chemically synthesized polypeptides,’ which includes such drugs as Novo Dordisk's diabetes medication Victoza and Eli Lilly's osteoporosis drug, Forteo. 

Biologic drugs, which are made from living cells, get 12 years of market exclusivity, while ‘small molecule’ drugs get five years. The policy change would give more drugs longer periods of market exclusivity, which would give larger profits to drugmakers and force consumers to wait longer to get cheaper generic versions…” The provision would only apply to new drugs approved after the law passes.
Clearly the pharma industry remains very powerful.

About the public’s health

Trump Administration Proposes New Rules to Increase Accountability and Availability of the Organ Supply: This enhancement would be accomplished by reducing financial barriers by expanding “the scope of reimbursable expenses for living donors to include lost wages, and childcare and eldercare expenses for those donors who lack other forms of financial support,” and updating the criteria for Organ Procurement Organization (OPO) Conditions for Coverage. The question is: are the factors these solutions are aimed at fixing the ones that are responsible for delayed transplantations?

Weekly U.S. Influenza Surveillance Report: The CDC reports we are now into the flu season. The overall hospitalization rate is about the same as previous seasons while the mortality rate thus far is lower.

US permits sale of cigarettes with 95% less nicotine: “The Food and Drug Administration will allow 22nd Century Group to begin selling the first low-nicotine cigarettes reviewed by federal health regulators. The products contain roughly 95% less nicotine than standard cigarettes, according to the FDA…Regulators stressed that their ruling does not mean the new products are safer than regular cigarettes. The agency noted there are no safe tobacco products. Cigarettes cause cancer, lung disease, stroke and a number of other deadly diseases.” The question here is whether smokers will smoke more cigarettes to get the same amount of nicotine and thus be worse off than if they smoked traditional cigarettes.

About health insurance

In medical billing, fraudulent charges weirdly pass as legal: This story is by the Kaiser Health News Editor-in Chief and details from personal experience charges that she believes are mostly legal but unethical. Great discussion piece.

Hospitals avoid $4B payment cut — for now: Yet another measure in the budget bill: a temporary delay in cuts to Medicaid Disproportionate Share Hospitals payments.