Today's News and Commentary

About pharma

What do you do with expired or left over drugs (like opioids you no longer need for pain control)? Now Google has a national map to help you find a safe place for these medications.

Here is the site

Estimating the clinical cost of drug development for orphan versus non-orphan drugs: Orphan drugs (defined as having a limited application for a small patient population) get a number of protections in order to spur development. However, according to this research, they cost less to develop than their non-orphan counterparts. “The capitalized clinical costs per approved orphan drug and non-orphan drug were estimated to be $291 million and $412 million respectively.” Should health policy/law adjust for such differentials? What about a guaranteed profit margin (as was the case with the polio vaccine)?

Read the article

FDA head says federal government may take action if states don't adjust lax vaccine exemption laws: In the wake of the measles outbreak, some states have cut back or eliminated exemptions from vaccination. Still, “in 47 states, parents are exempted from vaccinating their children for religious reasons.” FDA head Scott Gottlieb, MD says the federal government will step in if states don’t tighten up on their policies.

Read the announcement

The fighter, the saint, and the odd man out: the executives who will defend pharma before Congress: This article profiles the seven pharma executives who will testify before the Senate Finance Committee next week. It is a fascinating read into a “who’s who” in this sector.

Read the article

Pfizer, Merck, J&J well-positioned for M&A and Biogen and BioMarin are prime targets: report: This article is a nice summary of a Morningstar report on what the pharma M&A activity might be this year and next.

Read the article

About medical devices

Abbott’s HBV Surface Antigen Test Earns CE Mark: Although the approval only applies to the EU, it can have very helpful public health implications in the US. People who go to walk-in, free clinics to check for STDs and HIV status can be lost to followup when tests are not provided on site. This 15 minute point of care test can capture more of those patients who can wait for the results.

Read the announcement

About insurance

CMS Improperly Paid Millions of Dollars for Skilled Nursing Facility Services When the Medicare 3-Day Inpatient Hospital Stay Requirement Was Not Met: Based on a sample of skilled nursing facilities (SNF) billing, the CMS Office of the Inspector General (OIG) estimates the agency erroneously paid $84 million over a 2 year period. The facilities billed for patients who were not hospitalized for 3 days prior to their stays. Many stakeholders have argued against this 3-day rule. In response, CMS will allow Accountable Care Organizations who apply for and are granted a waiver to circumvent this requirement. Medicare Advantage plans have always been free to admit patient directly to SNFs.

Read the OIG report

About the public’s health

Travel and Wait Times Are Longest for Health Care Services and Result in an Annual Opportunity Cost of $89 Billion: This report from Altarum found that wait times for healthcare services have not decreased over the past decade. Further, the actual encounter and waiting times are longer than any other service. The figure in the headline is an estimate of the opportunity cost of the waits and travel times for healthcare.

Read the study

Annual HHS Report: Prior to HHS Secretary Azar’s speech today about HHS activities and plans, the DHHS issued its annual report. There are too many items to even summarize but it is at least worth reading the executive summary.

Read the executive summary

Today's News and Commentary

About the public’s health

States Can Improve Residents’ Health and Reduce Healthcare Spending by Adopting Policies Outside of the Healthcare Sector, New Report Shows: Many non-medical measures have been recently implemented by private and public organizations in order to address the public’s health. This just-released study from the Trust for America’s Health “analyzes state action on 13 policies outside the healthcare sector that have a long-term impact on health and an evidence base showing their effectiveness. They include: tobacco and alcohol taxes, syringe access programs, universal pre-K and rapid rehousing laws, among others.” It’s a great blueprint for targeting actions that have positive returns on investments. Policy makers, TAKE NOTE!

Read the study 

50M gallons of polluted water pours daily from US mine sites: Where is the EPA? Some of these sites have irreparably harmed the environment. Will it take deaths to correct this travesty?

Read the story

Recommended composition of influenza virus vaccines for use in the 2019- 2020 northern hemisphere influenza season: In the midst of our current flu season, this WHO announcement is a reminder that public health officials are already trying to predict next year’s strain so that an effective vaccine can be prepared in time. In the meantime, researchers continue to work on a universal vaccine that would be effective against all strains.

Read the announcement

U.S. health spending to rise 5.5 percent per year over next decade: CMS: “U.S. health spending is expected to grow at an average rate of 5.5 percent every year from 2018 over the next decade and will reach nearly $6 trillion by 2027.” The economy had better grow to keep up with these expenses. Politicians advocate for so many new social programs but forget our growing financial responsibility in this sector.

Read more details

About pharma:

As politicians advocate for importation of drugs from abroad, we need to remember that the supply chain is not as safe outside the US. These two article in today’s news highlight that point.

Dr. Reddy’s Reports 11 Violations in FDA Inspection
WHO Warns of Falsified Leukemia Drug in Supply Chain

About healthcare IT

Is It Time for a Better Hospital ID Bracelet?: The typical hospital ID bracelet has small print prone to identification errors and is a germ reservoir. So say many critics of this iconic inpatient “jewelry.” Newer identifiers will be based on “stick-on” technology and/or bracelets that can act as locators and trackers of activity in recovering patients.

Read the article for more information.

Abbott and Novo Nordisk Enter Partnership to Provide Integrated Digital Solution to People with Diabetes Using Insulin: “Abbott  and Novo Nordisk today announced a non-exclusive partnership that will integrate insulin dose data from Novo Nordisk pre-filled and durable connected pens directly into the digital health tools compatible with the FreeStyle Libre system (FreeStyle LibreLink mobile app and LibreView cloud-based system).” The IT linkages are interesting but what makes this story noteworthy is the two companies cooperating to help patients better control their blood sugars.

Read the announcement

Arizona college student could die because she can't get copies of her medical records: What happens to electronic records when their holder goes bankrupt and access to them is tied up by by creditors? This Arizona college student is caught in such a situation as “creditors of bankrupt Florence Hospital at Anthem and Gilbert Hospital bicker over who should pay for access to them.” This problem has much wider implications as the government and other stakeholders are looking at interoperability options. One question to be decided is: where does the primary data reside?

Read the story

About insurance

Insurers, hospitals agree in telling CMS to keep 'silver-loading': When the federal subsidies for out of pocket expenses (so-called Cost Sharing Reductions) went away last year, Exchange plans compensated by raising their rates for the subsidized Silver-level plans (called “silver-loading”). CMS has issued a notice for comments on next year’s payment structure and many stakeholders want to maintain this current loading. Failing to do so, they claim, will cause financial destabilization of the market. If Republicans really want to harm the ACA, they will ignore these pleas.

Read the article

On Congress’ agenda is the problem of “surprise billing,” where a non-contracted healthcare provider bills for emergency care or provides services in a contracted facility. Several major healthcare organizations want their voices heard when the decisions are being made about this issue.

Read the joint statement

Read a report on this issue from the Brookings Institute

CVS shares tumble 8% as forecast takes a hit from investments in Aetna: On the heels a good 4th quarter report, the longer term outlook for CVS scared investors. Integration costs with Aetna, decrease business in Omnicare (its long term care pharma business) and cancellations by insurance companies that use CVS’s PBM services are contributing to the guarded outlook.

Read the details

Today's News and Commentary

About insurance

CMS can terminate private Medicare plans with poor Star Ratings again: After a pause, CMS has resumed its power to terminate Medicare Advantage and Part D plans that have poor ratings (at least 3 stars three years in a row). The “clock” starts with this year’s ratings which come out in the fall; so the soonest terminations will be in 2022.

Read the announcement

Anthem Study Finds More Employers Are Integrating Health Care Benefits Due to Better Health Outcomes, Lower Costs and More Satisfied Employees: Employers have traditionally separated health-related benefits, thus confusing employees. Now, Anthem’s latest edition of its biennial Integrated Health Care report found that “more than 71 percent of the 222 employers with 100+ employees surveyed are either actively integrating or considering integrating their medical, pharmacy, dental, vision and / or disability benefits under their employer’s health and wellness programs in the next five years due to the positive impact integration has on their employees. This represents an 11 percent increase from the study conducted in 2016.” As the title indicates, such an approach lowers costs and boosts employee satisfaction.

Read the announcement

Blue Cross and Blue Shield of Texas Joins Forces with Universities Statewide to Identify Solutions to Fragmentation and Costs in Healthcare: BCBS of Texas, a division of Chicago-based HCSC, announcement details about research projects it is funding with the state’s universities to improve healthcare. A couple examples: Rice University: Evaluate the impact of laws and public policies on health cost and outcomes. Tarleton State University: Examine fraud detection in health claims data.

Read the announcement

UnitedHealthcare expands digital data collection for Medicare beneficiaries: UnitedHealth has announced that it will expand use of its Navigate4Me software to gather data on seniors in its Medicare Advantage plans. Its success so far is exemplified by “a 14% reduction in hospitalizations and a 9% reduction in emergency room visits for people with congestive heart failure.”

Read about the program

About pharma

U.S. top court rejects Maryland bid to revive drug price-gouging law: The Supreme Court refused to hear an appeal by the state of Maryland of a decision finding its law to limit price increases for pharmaceuticals to be unconstitutional. The ruling was based on the prohibition of states to regulate interstate commerce.

Read the story

Democrats Introduce Price Gouging Bill: Continuing the theme of the above article, while states cannot pass laws regulating pharmaceutical pricing, Congress can. This announcement is the most recent of many at the federal level to contain pharmaceutical costs.

Read the article

Walgreens and CVS are redesigning their drugstores to focus more on health. Here's how they compare: I previously wrote about CVS’s plans to start HealthHUBs in their stores. Walgreens has now joined this trend. This article is a nice summary and comparison of both companies’ approaches to reinventing the “drugstore.”

Read the article

About medical education

Free tuition for first 5 graduating classes at Kaiser Permanente’s new medical school; NYU plans new school on Long Island: Kaiser Permanente is starting a new medical school. that will be tuition-free for its first five years. Recently, NYU also announced a free tuition program. Is free tuition or large scholarships a better use of money in higher education than building a new building? Perhaps the philanthropy model can be slowly changed?

Read the announcement

About the public’s health

Effect of low-sodium salt substitutes on blood pressure, detected hypertension, stroke and mortality:Is a low salt diet healthy? Answering this question has been controversial. This literature analysis gives a mixed response: Using low-sodium salt substitutes significantly lowers both systolic and diastolic blood pressure, but overall mortality was unchanged. The authors’ conclusion?: We need a long term randomized control study (of course) to find the answer.

Read the research

Today's News and Commentary

About pharma

Pfizer Questions Drug ‘Total Content’ in Biosimilar Guidance: As more biologics go “generic,” the question of similarity to the reference product has come up. Pfizer is asking for a definition of what “demonstrating that both products have the same total content of drug substance (in mass or units of activity)” actually means.

Read the article

Magellan Rx Management Medical Pharmacy Trend Report. Ninth Edition 2018: The report details costs for pharmaceuticals across the healthcare system. Of special note is that commercial costs are about $30 per member per month (PMPM)- a 68% increase over 5 years; Medicare is about $52 PMPM, or 22% five year increase; Medicaid is about $8.30, reflecting a 17% five year increase, though costs actually decreased in the last year. More than 90% of spending for all three groups are for specialty pharmaceuticals (such as biologics) that are administered to small percentages of patients. The overwhelming expenses for this latter category are not new. Unlike all other countries, the FDA does not use comparative effectiveness or other cost data in approving medications. Indeed it is prohibited from doing so.

Read the report

‘Everyone is at fault’: With insulin prices skyrocketing, there’s plenty of blame to go around: Speaking of the high cost of pharmaceuticals, this article is a very nice summary of the history and reasons behind the high prices for insulin.

Read the article

FDA Recognizes Polish, Slovenian Inspections: This article might seem strange, but I point it out to remind all that the FDA does not have the time or resources to inspect all foreign plants for Good Manufacturing Practices (GMPs). In undertaking cooperative action, the FDA has granted other jurisdictions the authority to inspect plants making products for the US market.

Read the announcement

About the public’s health

A Growing American Crisis: Who Will Care for the Baby Boomers? Our country has had a shortage of caretakers for our elderly for many years. Tasks are often provided by low wage/low skilled workers, many of whom are newly arrived immigrants. Some other countries (like Sweden) have professionalized this job category by providing training and a living wage for the work. Today, Elizabeth Warren announced a plan for universal childcare. Where does she think we are going to get adequately trained and compensated people for her program when we haven’t begun to address the issue of eldercare?

Read the baby boomer article

Read Senator Warren’s announcement

Association of Primary Care Physician Supply With Population Mortality in the United States, 2005-2015: The association between primary care availability and population health has long been assumed. This study quantifies the benefit: “In this epidemiological study of US population data, every 10 additional primary care physicians per 100 000 population was associated with a 51.5-day increase in life expectancy. However, from 2005 to 2015, the density of primary care physicians decreased from 46.6 to 41.4 per 100 000 population.” So what are we doing to make sure our supply of PCPs is adequate? We make them responsible for coordinating patient care (including all the paperwork, such a preauthorizations) and we pay them less than procedural specialists. We can do better.

Read the study

Today's News and Commentary

LIGHT NEWS IN CELEBRATION OF PRESIDENT’S DAY

About privacy and personal rights

With fitness trackers in the workplace, bosses can monitor your every step — and possibly more: What is your employer entitled to know when the company is concerned about your health and safety and is also paying most of your insurance premiums? This article provides an interesting look at this issue.

Read the article

Measles is back because states give parents too many ways to avoid vaccines: The question that has come up with the outbreak of measles (and other diseases) is: when do personal rights take a back seat to the public’s welfare. The first article is a nice summary of what is happening with the measles crisis. The second one is about Congressional action.

Read the article
Read what Congress is doing

About pharma

Hospitals are making a lot of money on outpatient drugs: The bottom line is that: “Depending on the drug and type of hospital, markups ranged on average from 3-7 times more than Medicare's average sale price. Markups were even higher for generic drugs.” With concerns over high pharma prices, add hospitals to manufacturers and PBMs as culprits.

Read the article

Today's News and Commentary

About insurance

Shift to medicare Advantage Ratchets Up Pressure on Hospitals: In the decades after the 1980s, hospitals needed to adjust to the rise in private managed care utilization and payment arrangements- starting with HMOs then PPOs and other variations. Despite the fact that Medicare managed care has been around since the mid 1980s, only recently have the numbers in the latest iteration (Medicare Advantage) started to reach significance. Some states have as many as 40% of beneficiaries in these plans. Now hospitals really need to adapt to the realities of doing business with these private insurers. This article is a nice summary of this issue.

Read the article

CMS launches new model for paying ambulance crews—even if they don't transport to the ER: CMS is launching alternate payment models to keep Medicare beneficiaries out of the hospital. One of these initiatives is paying EMTs to treat non-critically ill patients in their homes rather than transport them to the hospital regardless of their condition. This home treatment can be accomplished with the aid of telemedicine if needed.

Read the story

About science and health

Ribosomal DNA harbors an evolutionarily conserved clock of biological aging: How old is your body? Not chronologically, but how has it aged? There are a variety of online tools that ask about your habits, diet and weight; but they are just guesses at your true biological age. New discoveries have found a biological marker that is an accurate measure and possibly a modifiable target for aging: Ribosomal DNA. The article (particularly the abstract) is readable, even for those without a science background.

Read the research

About the public’s health

Breast surgeons say all breast cancer patients should be offered genetic testing: Commentary on this article is not about the specific recommendation but how we approach disease in this country. Instead of a targeted approach we tend to use a “shotgun.” For example, in the US we immunize everyone against influenza. In other countries only the highest risk populations or reservoirs of disease (like children) are vaccinated. How much more effective is our approach and at what cost?

Read the article

Survey: Flexibility, wellness key to employee retention: This article reports on what employees want in the workplace. The healthcare implication is summed up in the subtitle: “Forty-one percent of respondents in a recent survey say they’d take a 10 percent pay cut for a company that cared more about employee wellness.”

Read about the survey (Free site signup)

About healthcare IT

Tech companies see health data as a huge opportunity, but people don't trust them: It is obvious that the ability to access your medical records across the healthcare system regardless of provider type or geography is very important. But where should the actual information reside? One clue was provided by this recent study looking at whom people trust with their medical information. According to the survey, here are the willingness to share percentages:

  • My doctor 72%

  • My health insurer: 49%

  • My pharmacy: 47%

  • Research institution: 35%

  • Pharmaceutical company: 20%

  • Government organization: 12%

  • Tech company: 11%

So much for using Facebook/Google/Amazon to store your medical data.

Read the article

Surescript’s CEO Tom Skelton on efforts to take on high prescription drug prices, interoperability: Given all the proprietary IT systems, how will we achieve interoperability? The one organization that is a likely candidate to help is Surescripts- which has been processing e-prescriptions for a number of years and interfaces with all certified EMRs and insurers’ systems. This interview with the company’s CEO provides some insight into what Surescript can do to fix this major problem.

Read the article

Xcertia Releases New mHealth App Guidelines, Adding 3 Categories: Xcertia is a non-profit organization launched in 2016 by the Healthcare Information and Management Systems Society, American Medical Association, American Heart Association and the DHX Group. This article explains the mobile health (mHealth) app guidelines the organization has recently issued.

Read the article

 About pharma

New Government Funding Bill Provides FDA With Additional $269 Million: Now that the new budget is passed, the FDA is funded again- but now at a record level.

Read the story

Today's News and Commentary

About healthcare IT

DoD and VA still working out how to create single EHR: You would think the government is "on the same page" with all its information systems. But the Department of Defense and the VA have been using different, non-interoperable health information systems for years. These systems were supposed to be harmonized using the commercial Cerner system; however, they are still not integrated. This story updates this sad saga of government infighting and waste.

Read the story

Artificial Intelligence (AI) Health Outcomes Challenge: The Center for Medicare and medicaid Innovation (CMMI) has announced it will issue a “challenge” to develop AI solutions in healthcare. The details are not yet out but for those who want to keep track of this initiative, the website has a link.

Read the announcement
Read a story about the project

IBM Watson teams with Brigham, Vanderbilt on $50M AI research initiative: On a related note, “IBM Watson Health is making $50 million investment in healthcare artificial intelligence with the aim of exploring how the technology can be used to improve patient safety and health equity. The company announced a 10-year investment in collaboration with Brigham and Women’s Hospital…and Vanderbilt University Medical Center to research the use of AI to address major public health issues.”

Read the announcement

2019 HIMSS U.S. Leadership and Workforce Survey: What’s on the minds of information system professionals? This annual survey provides some of the answers. Top on the list are “Cybersecurity, Privacy, and Security” and “Improving Quality Outcomes Through Health Information and Technology.” (See page 8 for the list). Of note is that “Precision Medicine/Genomics” is second from the bottom.

Read the survey

About the public’s health

Large teams develop and small teams disrupt science and technology: As more large studies are being conducted in science, team characteristics are becoming more important. The authors of this fascinating study “analyse more than 65million papers, patents and software products that span the period 1954–2014, and demonstrate that across this period smaller teams have tended to disrupt science and technology with new ideas and opportunities, whereas larger teams have tended to develop existing ones.” The research gives hope to smaller groups working without the benefit of large organizations.

Read the research

Cancer statistics for African Americans, 2019: The American Cancer Society has issued its triennial report on this topic. The good news is that: “Overall cancer death rates declined faster in blacks than whites among both males (2.6% vs 1.6% per year) and females (1.5% vs 1.3% per year), largely driven by greater declines for cancers of the lung, colorectum, and prostate. Consequently, the excess risk of overall cancer death in blacks compared with whites dropped from 47% in 1990 to 19% in 2016 in men and from 19% in 1990 to 13% in 2016 in women. Moreover, the black‐white cancer disparity has been nearly eliminated in men <50 years and women ≥70 years.” Still, much needs to be done to fully remove inequities.

Read the report 

CVS introduces new concept store with more health care, less retail: Structures of delivery systems are changing. Typical pharmacies have consumer goods in the front and the pharmacy at the back. CVS is going to set up HealthHUBs in stores devoting more space for wellness, including room for yoga exercises. It is an interesting twist in retail models.

Read the story 

About health insurance

Push for Medicare buy-in picks up with '50 and over' bill: Some House and Senate Democrats have released a proposal to make Medicare available to those over 50 by being able to “buy in". LOTS of details need to be settled, though. Recall that “full” Medicare coverage (comparable to ACA exchange plans) requires Part A (“free” to current beneficiaries); Part B (which has an unlimited 20% coinsurance, income-determined premium, and a relatively small deductible); a supplemental plan to cover what A and B do not; and the Part D drug plan. Parts A, B and D are all subsidized by the federal government. Will individuals have to pay the full cost? Will the benefits be better and cheaper than buying an exchange plan? We need to wait and see.

Read the story

About quality

Weighing the Effects of Vertical Integration Versus Market Concentration on Hospital Quality: Research about the effects of industry consolidation in healthcare have been coming out for a number of years. In this latest study, research found: “Vertical integration [like physician practice acquisition] has a limited effect on a small subset of quality measures. Yet increased market concentration [like hospital mergers] is strongly associated with reduced quality across all 10 patient satisfaction measures.” The authors speculate that institutions are looking for increased efficiencies while individuals look for more time spent on caring. With consolidation and lessened competition, hospitals are not competing as much on patient satisfaction.

Read the research

Today's News and Commentary

“About pharma

Mylan's 'aggressive' generic Advair discount isn't as big as it looks: analysts: While generic introductions are not usually big news, when a very popular branded medication goes generic it can cause significant savings. The “analysts” in the title don’t think the savings will be as much as expected because of rebates and discounts from the branded manufacturer GSK. Still, it will be about 40%-off large volumes.

Read the announcement

Azar: HHS examining insurer policy requiring patients to start over on step therapy: One way the government plans to save money on Part D plans is by allowing them to institute step therapy for appropriate conditions, like hypertension and asthma. One “glitch” is when a patient changes plans and the insurer requires the steps to start over. HHS secretary Azar says his department will need to look into this inevitable problem.

Read the story (Subscription required)

A political ‘bomb’ over drug prices could threaten NAFTA 2.0: Who knew the new trade agreement could be held up over a healthcare issue? The problem is that the treaty would give branded drugs extra patent protection, thus lengthening the time prices could be kept high.

Read the story

FDA panel backs J&J’s ketamine-like depression drug: Physicians have been using the anesthetic ketamine off-label for treatment of depression for a while. Since it works by a different mechanism than existing drugs and acts much faster, it represents a whole new approach to treatment. While a panel approved the drug, asketamine, it still needs FDA approval. If it passes, it could become a blockbuster.

Read the story

Tea’s value as a cancer therapy is steeped in uncertainty: While not, strictly speaking a pharma story, people have been interested in the medicinal use of tea for centuries. This article from Nature is a good, scientific presentation of the topic.

Read the article

ICH Considers Harmonizing Generics Standards Across Borders: Standards for how closely generic drugs must adhere to their branded equivalents vary among countries. The International Council on Harmonization is now considering policies on standardization of these medications.

Read the story

About devices

U-Md. researchers develop smart fabric that automatically warms or cools you off: “Researchers from the University of Maryland say they have created a fabric that responds to its wearer, regulating the amount of heat that passes through the material.” While the article focuses on everyday use at home and in the office, imagine the healthcare uses to help patient temperature regulation, particularly in hospital and nursing home settings.

Read the article

Today's News and Commentary

About pharma

FDA launches tougher oversight of supplements: Many news outlets are reporting the FDA crackdown on the $40-$50billion per year dietary supplement industry. These items are regulated as food not drugs; however, they are making therapeutic claims and some contain non-listed medicinal ingredients.
Also, consumers must be aware that these supplements can have side effects and interact with prescription medications.

Read the article

A Flu Drug Was Called ‘Silver Bullet,’ but Some Doctors Prescribe Caution: Too good to be true? The anti-flu drug Xofluza was approved by the FDA last year for a one pill dosing. It has become the top seller in Japan, replacing Tamiflu. Physicians are now seeing resistant strains emerge. We need to see what happens in this country but can expect the same will happen with wider use.

Read the article

Catalyst Pharma sees net price of drug, once free, topping $300,000: Firdapse is used to treat a rare neuromuscular disorder-Eaton Myasthenic Syndrome (LEMS). The drug was provided free to patients by Jacobus Pharmaceuticals under the FDA compassionate use program. Catalyst bought the drug rights in 2012 and now has FDA approval for this indication as an orphan drug (which extends market exclusivity by seven years). The $300,000 annual price tag is an estimate that is net of discounts and rebates.
Next move will be up to Congress.

Read the story

About the public’s health

Tobacco use among children is increasing: According to a just-released report by the CDC: “E-cigarette use increased from 11.7% to 20.8% among high school students and from 3.3% to 4.9% among middle school students from 2017 to 2018. No change was found in the use of other tobacco products, including cigarettes, during this time.” This finding reverses the years-long decrease in tobacco use among this age group. Time to get serious about enforcement of age limits and the message that tobacco is not safe in any form.

Read the CDC study

HCCI’s Health Care Cost and Utilization Reports: The Health care Cost Institute has issued its annual report (for 2017) on costs and utilization. It provides some interesting insights by type of service and site of care. Overall, the record spending was due to increases in prices not utilization, which in some cases decreased. The report does not dig into the effect of new technology on the overall cost, which is part of the intensity of care.

Read the research


About healthcare IT

Salesforce rolls out new 'social determinant' tool for patients who need other kinds of help, like a ride to the doctor: There is a new entrant into the social determinants analytics space: Salesforce.com. According to the article: “Salesforce.com is rolling out a new tool as part of its Health Cloud platform to help hospitals and insurers spot environmental and social issues that can affect a person's health, like income or access to transportation, to connect patients with more services.”

Read the article

HHS Proposes Making EHRs More Portable: In an addendum to yesterday’s story about the ONC final rule, the regulations will also make it easier for patients to access and transfer their records.

Read the article

A Machine Gets High Marks for Diagnosing Sick Children: This interesting article from Scientific American draws on research done at Guangzhou Women and Children’s Medical Center reported in Nature Medicine (subscription required, but abstract is available). It is an interesting case study of the use of artificial intelligence to help physicians in the emergency room.

Read the article

Veritas Capital closes acquisition of Athenahealth, says combined company will have 'transformational impact': For those of you following the story, the Athenahealth deal has finally closed.

Read the story for the details and some history of the long journey.

VA teams with Apple to bring Health Records feature to veterans: The original announcement of the project was made in November. Now veterans will be able to access their medical records from VA facilities using the Health app on the iPhone.

Read the story

News from HIMSS: This week is the annual HIMSS conference.

Read some of the highlights so far and
Keep up with the conference

Value-based care is complicating provider revenue cycles:
Billing and collection used to be “simple” and require straightforward accounting systems. With the increase in “value-based” payments that can increase or decrease revenue depending on clinical performance, revenue cycle predictions and management are more complex. Information systems must now integrate both financial and clinical data sources. This article is a good thought piece on this topic.

Read the story

Today's News and Commentary

About health insurance

Republicans can’t wait to debate 'Medicare for all': Both parties are now saying “bring it on” and looking for “gotcha'“ moments. The Democrats think they have a winner in “Medicare for all” but Republicans are betting that when people see the cost and that (in some versions) they will lose the private coverage they now like, the debate will turn in their favor.

Read the article

Universal health care in California: $17 billion a year, says one estimate: Not all states are waiting for the federal government to solve their healthcare coverage problems. UC Berkeley health policy researchers (including former colleague Steve Shortell) presented a plan for covering all Californians. What is different from most plans is that they offer not only a cost for the proposal but also details on how to pay for it.

Read the article

Why UnitedHealthcare wants to expand diagnostic codes to the social determinants of health: You can’t measure something if you can’t capture the information. In order to capture and track social determinants of health, UnitedHealthcare has added diagnostic codes it wants its providers and other organizations to use. The article says the insurer is adding ICD10 codes but that is not correct- only the WHO can do that.

Read the article

Judge rejects Oscar’s request for injunction against Florida Blue in spat over broker agreements: Health insurer Oscar challenged the Florida Blue plan saying the latter’s exclusive arrangements with insurance brokers prevented its expansion in the state. The trial judge disagreed and cited Centene’s market share to show that a plan can build membership despite the Blue’s lock on the brokers. While this story seems to be local, it raises issues of anticompetitive behavior in a market with a dominant player.

Read the article

About pharma

UnitedHealthcare demands drug rebates even if pharma cuts list prices: analyst: A federal proposal to lower drug prices would mandate that rebates go to patients, not PBMs or payers. Instead of continuing the rebates, pharma manufacturers may lower prices in response. In anticipation of these possible changes, OPTUMRx (part of UnitedHealth Group) asked for seven quarters’ notice before a price drop and will apparently also be asking for some of its rebates to continue. It is not clear how all these changes will play out, so stay tuned.

Read the article

PCSK9 price-cut matchup is on, as Regeneron and Sanofi slash Praluent list tag 60%: In a price fight that is reminiscent of Hepatitis C treatments, companies are now lowering their prices for the very-expensive cholesterol-lowering PCSK9 drugs. According to the article: “ Repatha and Praleunt carried original list prices of a bit more than $14,000 a year. But drug pricing watchdogs at the Institute for Clinical and Economic Review (ICER) argued at the time that the PCSK9 inhibitors needed to bear prices of $5,404 to $7,735 to be cost-effective, drawing counterattack from Amgen and Regeneron.” Perhaps we now have a model of what competition does to extremely high cost medications.

Read the article

About quality

Effect of Financial Bonus Size, Loss Aversion, and Increased Social Pressure on Physician Pay-for-Performance: One of the considerations about methods to increase quality of care is changing the financial incentives of physicians. Behavioral economic studies have generally found loss aversion is the strongest motivator in financial decisions. However, in this small, “randomized clinical trial of 54 physicians and cohort study including 66 physicians and 8188 patients, increased bonus size was associated with improved quality relative to a comparison group, although adding increased social pressure and opportunities for loss aversion did not improve quality.” It is an interesting finding but the study needs to be done on larger scale, across different specialties and geographic areas.

Read the study

Cigna Value-Based Care Participation Tops 50%, Saving $600M:The movement to value-based care has been slow and statistics about its progress are often misleading. For Cigna, this reported milestone means: “More than 240 primary care organizations, more than 500 hospitals, and over 270 specialist programs in six areas of care are engaged in reimbursement through some type of pay-for-performance contract.” The figure we really need to see is that more than 50% of revenues for healthcare organizations are through pay-for-performance contracts.

Read the story

Hospital Mergers Improve Health? Evidence Shows the Opposite: There is nothing new in this article from today’s NY Times but it provides a nice summary of the evidence behind the increased prices and possibly adverse quality resulting from the continuation of hospital mergers.

Read the article

About healthcare IT

ONC unveils long-awaited information blocking rule: In response to requirements of the “Cures Act,” the ONC has issued its final rules, many of which are aimed at increasing interoperability of information systems. The one measure which this article highlights is preventing venders from blocking transmission of healthcare information from another vender’s system. Other measures include adopting of the United States Core Data for Interoperability (USCDI) as a standard and updating the electronic prescribing (e-Rx) SCRIPT standard.

Read the article
Read the Final Rule

About the public’s health

5 Things That Took Center Stage at AcademyHealth National Health Policy Conference: AcademyHealth is the association of academics who study healthcare. This article highlights the major issues they discussed at their annual meeting.

Read the article

The one graphic you need for accurate blood pressure reading: In a previous post I mentioned that blood pressure determination must be done properly to get a correct reading. For example: NO BLOOD PRESSURE READING OVER CLOTHING. This one page graphic demonstrates the correct procedure. Make sure if you are getting your pressure taken it uses these measures.

Read the article

A 5-Step Population Health InitiativeCould Reduce Your Asthma ED Admissions by Half:This article could also be listed in insurance, device or quality. It is a fascinating case study of how Dignity Health's innovation arm used “digital sensors from Propeller Health that slip over patients' inhalers and connect via wireless technology to their smartphone app and a clinician dashboard.” The result was a 57% reduction in ED-visits combined with hospitalizations. The article goes through important implementation steps, like having a physician champion.

Read the article

Today's News and Commentary

About the public’s health

The Lancet has published a special issue entitled: Advancing Women in Science, Medicine, And Public Health.

Americans have healthier hearts. We have a healthier budget, too: Policy makers often err when they say the aging population is a major source for increased healthcare expenses. That assumption is only partially true. Per capita healthcare costs for the elderly have been moderating for quite a while the numbers of those aging have increased. This article reports on research published in Health Affairs (Subscription required) that explains the cost moderation is due to more spending on “heart health.”

Read the article

About health insurance

HSAs still being used primarily for spending, not saving: How should you use your HSA? Save for a major, unexpected event or “pay as you go” for routine expenses"? This study shows 93% of funds are used for the latter. Is this use “correct?” It will depend on your individual circumstances. If you do not need the money, it grows tax free. On the other hand if you are in a high tax bracket, using pre-tax money whenever you can may make sense.

Read the results

PCPs, Psychiatrists Much Less Likely to Accept Medicaid:Access to care isn’t only about proximity and availability of resources, the resources must be affordable. One major problem with Medicaid is rates are so low that physicians may not accept patients who are beneficiaries. A study by the Medicaid and CHIP Payment and Access Commission (MACPAC) found that “across all types of providers, just 70.8 percent will see Medicaid patients, while 90 percent will accept privately insured individuals.” However, in a system that needs more primary care physicians to manages services, “only 68 percent of general practice or family physicians accepted new patients with Medicaid.”

Read the story

Unnecessary ED visits from chronically ill patients cost $8.3 billion: Even privately insured patients have continuity of care issues. This study from the Premier system explains the extent of these unnecessary visits and the medical conditions these patients are likely to have.

Read the article

About devices

FDA clears AI-based wearable device to monitor hospital patients: “Wearables” are one of the newer technologies that can help healthcare professionals monitor patients. One such previously reported device is the Apple watch that can report heart beat irregularities. This newly-approved device, which will be used in-hospital, goes one step further. “According to the vendor, the device monitors patients’ vital signs using proprietary algorithms that continuously analyze the data to help better predict their health trajectory and to enable clinicians to intervene earlier and improve outcomes.”

Read the article

New voices at patients’ bedsides: Amazon, Google, Microsoft, and Apple: Another emerging technology that is being applied to healthcare is “Voice User Interface” (VUI). This article is a nice summary of what the “big players” are doing in this space as applied to healthcare.

Read the article

Cleveland Clinic Innovations Top 10 Innovations for 2019: While not all devices, this annual top 10 list always contains thoughtful choices.

Read the list

About pharma

This Jagged Little Pill Could make Diabetes Easier to Treat: As gauged by media mentions, this one is the pharma story of the day. Proteins, like insulin, cannot be ingested because the acid and enzymes in the stomach break them down before they can be absorbed. Novo Nordisk partnered with MIT scientists to create a capsule with a small needle inside that will inject insulin after ingestion. It’s ground-breaking technology if it can be widely commercialized. Other uses could be for such items as immunizations.

Read the article

Dems unveil bill for Medicare to negotiate drug prices: Both major parties have been talking about ways to lower pharmaceutical costs. One method that has been discussed is direct contracting with manufacturers instead of going through PBMs (a tactic already underway by state governments in California and Massachusetts). The House Democrats have now unveiled their version of such action.

Read the article

J&J becomes first drugmaker to add prices to television ads: As previously reported, pharma companies are heeding the call to advertise prices in their media ads. Because of the complexity of pricing for different payers, firms decided to display website links in their TV advertising. J&J , however announced that it “will include both the list price of a product - the price before any rebates or discounts to insurers or pharmacy benefit managers - as well as potential out-of-pocket costs that patients will pay.”

Read the story

Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale: In the past couple years, the FDA has done a great job approving generics. However, of the 1600 approvals since January of 2017, 700 were still not on the market as of last month. This article explains the reasons for this delay, including branded manufacturers’ tactics to keep the competition off the market.

Read the article

About information systems

HHS' Office for Civil Rights reports $28.7M in payments for record HIPAA enforcement year: The Office of Civil Rights (OCR) is responsible for enforcing HIPAA regulations. Last year, the OCR settled 10 cases totaling a record $28.7 million in fines. This amount was largely due to the single largest settlement- a $16 million fine paid by Anthem for a 2015 data breach that involved nearly 79 million members.

Read the story

Today's News and Commentary

About pharma

Pharma CEOs enthuse about Trump's plan to shake up drug rebates: As previously reported, the Trump administration seeks to give drug rebates to patients, not payers or PBMs. We know what PBMs think, but what about pharma companies. Apparently they are in favor of the proposal.

Read what pharma companies are saying

About healthcare IT

Greenway Health to pay $57M to settle claims it falsified EHR certification: Whom can you trust? This health IT company agreed to settle charges it falsified EHR certification for meaningful use. eClinicalWorks paid a fine for the same infraction in 2017.

Read the story

Telemedicine’s challenge: Getting patients to click the app: Initial barriers to telemedicine use were due to the healthcare system, namely reimbursement and physician licensure for those who saw patients in different states. These problems are being rapidly resolved. Now we are left with patient attitudes to using this technology. For those who want more immediate access but in-person care, walk-in clinics are now widely available. Some people also prefer a regular primary care physician. Still, this form of communication is expected to grow rapidly.

Read the story

About health insurance

Health Insurance Coverage Eight Years After the ACA: This research by the Commonwealth Fund has some mixed news about insurance coverage. Among the results:

“45 percent of U.S. adults ages 19 to 64 are inadequately insured — nearly the same as in 2010 — though important shifts have taken place.
Compared to 2010, many fewer adults are uninsured today, and the duration of coverage gaps people experience has shortened significantly.
Despite actions by the Trump administration and Congress to weaken the ACA, the adult uninsured rate was 12.4 percent in 2018 in this survey, statistically unchanged from the last time we fielded the survey in 2016.”

Read the study

Prior authorization hurdles have led to serious adverse events: Physicians don’t like prior authorizations because it takes time and is frustrating. But what is the effect on patients of this process? This AMA-sponsored survey raises some serious concerns. For example, 28 percent of respondents report “the prior authorization process required by health insurers for certain drugs, tests and treatments have led to serious or life-threatening events for their patients.” This survey raises at least a couple questions: Which, if any, prior authorizations add value to the care process? What if we changed the financial incentives to make prior authorization unnecessary, e.g., capitated systems where providers are financial responsible for these orders?

Read the AMA announcement
Read the survey results

Today's News and Commentary

State of the Union

The President’s message last night had several references to healthcare related issues. He:
Called for increased funding for childhood cancer ($500 million over the next 10 years);
Proposed increase funding to eliminate HIV transmission;
Requested that health care entities increase price transparency to lower costs- especially in the pharma sector;
Reinforced his desire to eliminate“late term abortions;”
Expressed pride for eliminating the individual insurance mandate;
Stressed the importance of making sure insurance companies did not discriminate based on pre-existing conditions; and
Expressed pride in passage of the “Right to Try” law, which gives patients the ability to access non-FDA approved medications in cases where other treatments are not working.
Except for the funding of the first two initiatives, he did not offer any details about how goals would be pursued.
However, HHS Secretary Azar followed up with some details about the HIV reduction plans that include:
Identifying "geographic hotspots;"
Augmenting  existing programs, (like the Ryan White HIV/AIDS Program); and
Initiating new programs through community health centers that will increase access to screening and  PrEP prophylaxis medication.

Absent from the speech was the public health issue of gun violence, which Stacey Abrams addressed in the Democratic reply.

By the way, don’t forget to consult the fact checker in the Washington Post

About the public’s health

New disease surveillance tool helps detect any human virus: If a virus has a low concentration in blood samples, it can be difficult to diagnose a disease or carrier state. This new technique allows selective “catching” of genomic information to make earlier detection possible. “Short for ‘Compact Aggregation of Targets for Comprehensive Hybridization,’ CATCH allows users to design custom sets of probes to capture genetic material of any combination of microbial species, including viruses or even all forms of all viruses known to infect humans.”

Read the announcement

Younger than 100? Soon, you might not be able to smoke cigarettes in Hawaii: Hawaii was the first state to increase the legal age for smoking to twenty one. Now legislators are talking about gradually increasing this age by decades over the next few years until, in 2024, it reaches 100. Imagine a new ad campaign for “Senior Smokes?”

Read the story

Making OxyContin 'Tamper Proof' Helped Spread Hepatitis C: File this one under the law of unintended consequences. Given the opioid crisis, makers of OxyContin made the formulation harder to abuse. As a result, addicts have turned to using heroin and sharing their needles. This practice has caused a surge in Hepatitis C and HIV infections. Now we have another problem to fix.

Read the story

About pharma

Bipartisan group of lawmakers introduces bill to fight high drug prices: One way branded drug manufacturers slow generic companies from entering the market is by delays in providing them with the patented drug for FDA-required comparison studies. Senators on both sides of the aisle have recognized this problem and are promoting legislation to make it easier to obtain reference samples.

Read the story

Democrats bat away Trump's olive branch on drug pricing: Republicans have proposed several measures to control rising drug prices, including direct negotiation with pharma companies and indexing tied to prices in other countries. Democrats are skeptical about how serious their opponents are about these measures so they are offering some of their own. This article is a nice summary of where the two parties stand on this issue.

Read the article

OnYourRxSide: Continuing the theme of high drug prices, Pharmaceutical Benefit Managers (PBMs) launched an ad campaign to inform the public about how much value they deliver by making sure prices stay low. Recall that PBMs are the ones who get pharma company rebates.

Take a look at their site and make up your mind if you are convinced by the message.

Flip the Script: Drugmakers Blame Middlemen for Price Increases: One more on this topic. Pharma manufacturers have claimed they need higher prices to cover increasing costs of R&D to come up with new and better medications. Now they are changing their story. The real (?) reason for the increases, they claim, is the higher PBM and payer demands for rebates. Everyone seems to be pointing fingers at one another. Is there a free-market solution or does the federal government need to get involved?

Read the story

About healthcare IT

Google Tries to Patent Healthcare Deep Learning, EHR Analytics: The patent application is titled
”System and method for predicting and summarizing medical events from electronic health records.” It takes longitudinal EHR data and applies “deep learning” to predict healthcare events. Sounds like IBM’s Watson might have some competition.

Read the announcement

Read what else Google’s “Deep Mind” is doing

Today's News and Commentary

About the public’s health

Comparing Automated Office Blood Pressure Readings With Other Methods of Blood Pressure Measurement for Identifying Patients With Possible Hypertension: Physicians, nurses and their assistants are often hurried while caring for patients in the office setting. One part of the visit that is hurried is taking a blood pressure reading. This study found that automated readings are superior to those professionally obtained and “should replace the recording of blood pressure by nurses and physicians in routine clinical practice.” Caveat: Any reading must be done under the correct circumstances, like patient sitting at rest in a quiet room with arm resting on a level surface slightly bent. UNDER NO CIRCUMSTANCES SHOULD BLOOD PRESSURE BE OBTAINED OVER CLOTHING!

Read the research

About health insurance

Azar calls on hospitals to make list price information more useful: As previously reported, starting January 1 hospitals have been required to post their charges so patients can make informed choices about care. But since what patients will pay differ by insurance, the lists are meaningless. HHS secretary Azar is now calling on hospitals to help the public make more sense of these prices. But hospitals cannot know every patient’s insurance and even if they did, negotiated prices with payers are contractually confidential. Further, such knowledge will not help in cases of emergency.

Read the article

Hospital Prices Outgrew Physician Prices by Almost 20%: These findings, from data 2007-2014, were because: “Price growth in hospital-based procedures has been primarily driven by the facility side rather than the physician side.” Authors of the study, published in Health Affairs (Subscription required) suggest that: “Policy makers should consider a range of options to address hospital price growth, including antitrust enforcement, administered pricing, the use of reference pricing, and incentivizing referring physicians to make more cost-efficient referrals.” What is really curious is that they did not mention a currently debated plan for site neutrality in payment, i.e., paying hospital outpatient visits the same as physician office visits.

Read the summary and author interview

About pharma

Blood-Pressure Medicine Will Be First Product for New Generic Drug Venture: Hospital chain and Group Purchasing Organization Premier, Inc. launched a generic division called ProvideGx. This new company’s purpose is to provide scarce pharmaceuticals to its members. The first drug will be intravenous metoprolol, manufactured under contract by Baxter. ProvideGx joins CivicaRx, another generic company owned by hospitals to produce medications in short supply.

Read the article (Wall Street Journal, subscription required)

Today's News and Commentary

About pharma

‘De-integration’ of Sandoz from Novartis expected to include manufacturing cuts: This story exemplifies changes that have been occurring over years in the pharma sector. Merger, restructuring, divestiture/spinoff, etc. It is a great case study.

Read the article

Winners and losers under bold Trump plan to slash drug rebate deals: On the heals of last week’s story about federal initiatives to funnel drug rebates to patients instead of benefit managers, this article provides a nice analysis of the winners and losers with this new scheme.

Read the article

About health insurance

New Poll: Americans Are Focused on Health Care Affordability, Drug Costs, Protecting Pre-Existing Conditions in 2019: Results of this type of poll are not new, When you ask Americans if they are satisfied with their health plans, the large majority usually say yes. However, ask about the situation in the nation as a whole, and you get very different answers. In this insurance-industry sponsored poll, two thirds of Americans  “support the existing health care system over a government-run health care system” and 72% are “satisfied with their current health care coverage.” Those questioned said they want the government to focus on affordability (particularly pharmaceuticals) rather than coverage for all.

Read the study

About hospitals and health systems

Catholic Health Initiatives, Dignity Health combine to form CommonSpirit Health: These two systems have been talking about merging for more than 2 years. They finalized this effort on Friday. The resulting non- profit company will be called CommonSpirit Health, based in Chicago. The new company has 142 hospitals, 150,000 employees, nearly $30 billion in revenue and more than 700 care sites across 21 states.

Read the story

Prevalence of Malnutrition Risk and the Impact of Nutrition Risk on Hospital Outcomes: Results From nutritionDay in the U.S.: About half of hospitalized patients eat half their food. Poor nutrition in hospitals is linked to increased mortality. This study used data from the annual “nutrtionDay,”which was in November.

Read the study(Abstract available on this subscription site)
Read an article summarizing the findings

Today's News and Commentary

About pharma

Neuraminidase inhibition contributes to influenza A virus neutralization by anti-hemagglutinin stem antibodies: Don’t let the title put you off. Here’s what it’s about:
Influenza has two sites that help it invade normal cells: neuraminidase and hemagglutinin. Those proteins come in different forms are the” H and N” in designations for the annual strain of influenza, e.g., H1N1. Vaccines target the annually prevalent strain but it is always a guess. This research (in mice) showed that if antibodies are produced against a stable part of hemagglutinin and it is paired with a neuraminidase blocker (like Tamiflu), the virus’ invasive activity can be markedly curbed. Right now the antivirals shorten symptoms by a day. This treatment would be a real breakthrough.

Read the research(The article has a nice graphic that explains the science)

Celgene inks $1B deal for a preclinical epigenetic blood cancer drug from Canada: Sometimes methyl groups attach to a cell’s DNA and either turns on or off genes that may cause cancers to grow. Instead of attacking the DNA directly, this article highlights targeting at this “epigenetic” focus that is causing disease.

Read the announcement

Trump Targets Drug Middlemen With `Devastating' Rebate Plan: One way the Trump administration has proposed to deal with rising drug costs is by giving volume purchasing rebates back to patients instead of payers or their pharmaceutical benefit managers (PBMs). These latter entities claim costs of healthcare will go up if this change occurs. But what if, instead of rebates, the original prices are lower or the purchaser of the drugs demands value-based payment arrangements? Those actions would be game changers.

Read the article

About the public’s health

Heart Disease and Stroke Statistics— 2019 Update: A Report From the American Heart Association: This annual report has extensive data about cardiovascular (CV) disease, so a quick summary is not possible. Data and recommendations range from blood pressure control to adequate nutrition and sleep. Overall, 48% of Americans have some type of CV disease- 9% if you exclude high blood pressure. Some good news is that smoking rates continue to decline and people are somewhat more active. The bad news includes the high rate of obesity and higher 30 day and 1 year mortality rates for Medicare patients who were discharged under the new guidelines that look at 30 day readmission rates. “ The estimated direct costs of CVD and stroke increased from $103.5 billion in 1996 to 1997 to $213.8 billion in 2014 to 2015.”

Read the report

Trends in Pediatric Hospitalizations and Readmissions: 2010–2016: Again, good news and bad news. To summarize the conclusions of this research: “Pediatric admissions declined from 2010 to 2016 as 30-day readmission rates increased. The increase in readmission rates was associated with greater numbers of admissions for children with chronic conditions. Hospitals serving pediatric patients need to account for the rising complexity of pediatric admissions and develop strategies for reducing readmissions in this high-risk population.”

Read the research (Subscription required but you can read the abstract)

About health IT

Best of KLAS 2019 highlights Epic and Impact Advisors: Each year, KLAS issues its “best of” lists for IT companies. I am not promoting any of them but want to point out the diversity of systems that work best in certain settings and for specific purposes. What do you do if you have a large health system with different types of units? To assure interoperability, you need to go with an IT product that may only be '“good” in many areas rather than excellent overall.

Read the report

About health insurance

The Marketing of Short-Term Health Plans: Along with many other concerns (such as coverage), short term health plans have been found to mislead the public about their products. According to this study: “Consumers shopping online for health insurance will often find websites and brokers selling short-term plans as a replacement for ACA-compliant coverage. These websites and brokers often fail to provide consumers with the detailed plan information necessary to inform their purchase.” Unfortunately there are no protections against this kind of behavior.

Read the study

Today's News and Commentary

About diagnostics

C2N Diagnostics Receives Breakthrough Device Designation from U.S. FDA for Blood Test to Screen for Alzheimer’s Disease Risk: Testing for Alzheimer’s Disease has been very difficult because its cause has been debated. One fact is certain- there is an association with a protein (amyloid) accumulation in affected brain cells. PET scanning can pick up concentrations of this protein but it uses radiation and is expensive. The FDA has just approved a blood test to screen for amyloid in the blood. If a certain threshold is met, PET scanning can be considered. Here is the problem: Even if we can predict who is at risk for Alzheimer’s, the disease progresses at different rates in different people. Further, there is no treatment. Like other new tests, this one should be in great demand by older people who “just want to know.”

Read the announcement

Is Pap testing still needed after hysterectomy?: Years of research studies have proven that Pap smear screening should be routinely done every 3 years, assuming normal interval tests. Many women, however, still get Pap smears every six months- because that’s what their doctors tell them to do. Most egregious, however are that women who have had hysterectomies with removal of the cervix (for non-cancerous reasons) are still getting routine Pap smears. Those who still advocate for testing in this population claim vaginal cancer can still be detected. This article reviews the research and recommendations and is easily understandable for people with a medical background. It concludes :
”Pap testing to screen for vaginal cancer in women who have undergone hysterectomy for a benign indication is an example of more testing, not better care. Evidence is lacking to justify this test in women who are not at high risk of cervical cancer.”  

Read the review

Generex Subsidiary NuGenerex Diagnostics Announces CE-Mark Certification for its Rapid Point-of-Care Express II Syphilis Treponemal Assay: With a resurgence of syphilis and recommendation for routine screening in pregnancy, this point-of-care diagnostic should see wide adoption in obstetrician’s office when it is approved in the US. (CE-Mark Certification is for EU distribution).

Read the announcement

About the public’s health

Arsenic and Lead Are in Your Fruit Juice: What You Need to Know: For those of you with children and grandchildren, this article is a must-read. Consumer Reports published a study on commercially sold fruit juices- both in larger containers and juice packs, which are popular with children. Read this article for brands that you can safely buy and those you should avoid. By the way, they can be harmful to adults as well.

Read the article

A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy: This research was just published in the New England journal of Medicine but is available by the link below. Bottom line:
“E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support.” But use of e-cigarettes remains controversial. Two editorials comment on this issue. One recommends banning flavored nicotine delivery devices because of their increased addictive potential. The other notes that a ket finding of the research “is that among participants with sustained abstinence at 1 year, 63 of 79 (80%) in the e-cigarette group were still using e-cigarettes, whereas only 4 of 44 (9%) in the nicotine-replacement group were still using nicotine replacement. This differential pattern of long-term use raises concerns about the health consequences of long-term e-cigarette use.” 

Read the original research

AHRQ National Scorecard on Hospital-Acquired Conditions: Now some good news: “The National Scorecard on Rates of Hospital-Acquired Conditions, 2014 to 2017, the most recent report, shows that from 2014 to 2017 (preliminary data), HACs fell by 13 percent, saving about 20,500 lives and about $7.7 billion in healthcare costs.”

Read the full report

About pharma

House Dems launch probe of 'skyrocketing' insulin prices: Continuing yesterday’s post about rising insulin prices is this announcement of investigation of major insulin manufacturers.

Read the story

OxyContin Maker Explored Expansion Into “Attractive” Anti-Addiction Market: Purdue Pharma was considering playing both sides of this issue. A new definition for “Chutzpah?”

Read the investigative story

About health insurance

Deputy HHS Secretary Hargan Talks Stark Law, Kickbacks: The “Stark Laws” (there are more than one) were intended to prevent kickbacks for such things as referrals. Newer value-based models of care, however, require all parts of the care continuum to work together. Further, payment is often bundled. HHS has been talking about relaxing the rules in order to facilitate better care coordination. So far, many arrangements still fall into a gray area that requires signify by legal departments.

Read the article

New study aims to convince skeptical employers to embrace narrow networks: This article explains the cost advantages of narrow networks (“about 12% less to hospitals than PPO plans with broader networks”) and the pushback from employers who don’t like the limitation. The original article is by subscription only and is much more technical.

Read the report

2020 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter: This second call for comments deals with Medicare Advantage and Part D plans. It continues to propose allowances for the former plans to offer products and services that will help the overall health of members. Currently about 34% of all medicare beneficiaries belong to a Medicare Advantage plan, with projections that the proportion will grow to 42% in the next 10 years.

Read the announcement

University of Minnesota study finds ACA didn't shrink employer health coverage: One concern about the ACA was that it would encourage employers to drop employees from their sponsored plans— saving the company money and shifting the cost burden to employees and the federal government. This study finds that this fear was unwarranted.

Read the article

First Phase of New Association Health Plans Reveal Promising Trends: The non-ACA Exchange plans allowed by the Trump administration have caused public worry. Although premiums are cheaper than some Exchange products, the concern was they will reduce benefits and screen for pre-existing conditions. This report claims that these worries are unfounded and provides details about the structure and composition of these plans.

Read the article

Today's News and Commentary

About pharma

Harvard Study Finds Older Insulins Are Safe as Well as Cheaper: The big story in the popular press today is a report on research looking at costs and benefits of the “newer” (analog) insulins versus older synthetic human insulins. Bottom line: except for slight increase in low blood sugar at night, the older insulins are just as good clinically as the newer ones and at 50% lower cost. With analog insulin prices increasing so rapidly (see past posts), it is important to know there are options. It will be interesting to see how pharma companies refute the study. Note: In researching this news, I came across a JAMA article from 2003 that came to the same conclusion.

Read the article in Bloomberg
Read the editorial in JAMA (May need subscription)

Anthem moves up launch of its PBM to second quarter of 2019: Musical PBMs? Because of recent mergers and acquisitions, the PBM industry has had some major reshuffling. Cigna recently acquired Express Scripts, Anthem’s PBM. So Anthem is starting its own: IngenioRx. Watch the effect of this consolidation on free-standing PBMs like Walgreens. That company can survive on its retail business but the same may not be true for others.

Read the article

About the public’s health

Quality and Experience of Outpatient Care in the United States for Adults With or Without Primary Care: The message of this research is that patients who have primary care physicians do better than those without them. I am not sure why this research was done. This finding has been in the literature for decades. In fact, a recent NY Times article touted the primary care system in Cuba. It’s time to stop doing this kind of research and put the funding into making sure people have a regular source of care.

Read the research
Read the recent NY Times Article

CBO: Budget and Economic Outlook 2019-2029: The deficit outlook predicted by this study looks grim. “Over the 2020–2029 period, deficits are projected to average 4.4 percent of GDP, totaling $11.6 trillion. Such deficits would be significantly larger than the 2.9 percent of GDP that deficits averaged over the past 50 years.” A major reason for these deficits are mandatory spending through Medicare and Social Security. (Interesting to note that Medicare spending has exceeded that for Social Security since 1984.) For example, the Medicare Hospital Insurance (Part A) Trust Fund is due to be bankrupt by 2026. What is being done to correct this problem besides passing it to the next generation?

Read the CBO study

Today's News and Commentary

About healthcare IT

Medical devices are woefully insecure. These hospitals and manufacturers want to fix that: As the “internet of things” expands in healthcare, we need to be particularly aware of hacking medical products like pacemakers, pumps and diagnostic devices. They do not have the same regulatory requirements as traditional IT devices, like computers. A consortium of hospitals and manufacturers has issued a joint security plan to address this problem.

Read the article
Read the plan (Content starts on page 7)

New App Displays What Original Medicare Covers: Beneficiaries are often confused about what Medicare covers. This new app will help explain their benefits. We still need to see how CMS will announce this site to the general public.

Read the announcement

About insurance

HHS Sets New Priorities for Physician-Focused Payment Models: The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established criteria for physicians to bundle services to qualify as an Advanced Alternative Payment Model. This qualification permits exemption from some reporting requirements and sets up potentially more favorable payment models. This article is a nice review of recent HHS clarification of the application process. The government hopes to reduce annual avoidable events by 10% and costs by $10Billion.

Read the article

Medicare for all?: Many legislators and health policy advocates have been calling for a program that gives Medicare benefits to all. The explanation is vague because the details of these proposals are very different. They range from a true single payer system with elimination of private insurance to an option for those who cannot afford or access other options. Here are a series of articles that should give you an idea about this debate:
How to build a Medicare-for-all plan, explained by somebody who’s thought about it for 20 years It nicely frames the issue and provides a framework for analyzing proposals.
45% of the uninsured population is out of the ACA's reach: KFF report This article highlights the reason we need more options for healthcare insurance.
Harris backs 'Medicare-for-all' and eliminating private insurance as we know it: Kamala Harris announced her support for this proposal and would even favor eliminating private insurance.

Transparent Hospital Pricing Exposes Wild Fluctuation, Even Within Miles: As previously mentioned, since January 1, hospitals have been required by the federal government to post their charges. This article compares prices for various services among hospitals close to one another in both Oakland, CA and LA. It is interesting that each location’s listing has a Kaiser facility—care is essentially free there if the patient has a referral from a primary care physician; this fact highlights the uselessness of the federal requirement.

Read the article

About the public’s health

Coca-Cola emails reveal how soda industry tries to influence health officials: Industry often tries to influence public policy, particularly in the healthcare field. (Think tobacco and pharma, for examples.) This case documents how Coca-Cola tried to influence the CDC to make exercise the primary tool to combat obesity- thus taking pressure off sugar-filled drinks. This article nicely documents this effort.

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About pharma

AstraZeneca's latest value-based pact serves up Brilinta at generic-level copays: AstraZeneca has cut a deal with UPMC Health Plan regarding its “blood thinner” Brilinta. The drug will be priced like a generic, allowing lower out of pocket copays for patients and a lower price for the plan. Also, the price will be based on how well the drug performs (upward or downward payments). This scheme is part of a trend in pharma and elsewhere toward value-based payments.

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Today's News and Commentary

About pharma

Steep Climb In Benzodiazepine Prescribing By Primary Care Doctors: Are benzodiazepines (like Valium) the new opioids? The study found that from “2003 through 2015, the use of benzodiazepines in ambulatory care increased substantially from 3.8% to 7.4% of visits, including coprescribing with other sedating medications. Use among psychiatrists was stable (29.6% vs 30.2%) but increased among all other types of physicians, including primary care physicians (3.6% vs 7.5%), who as a group accounted for about half of all benzodiazepine visits.” These drugs are used for anxiety, insomnia and seizures; however, this research found that the biggest increase in prescriptions was for back pain and other types of chronic pain. Is this class of drugs replacing opioids? What is being done to make sure we don’t repeat the same mistakes?

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Use compulsory license and put ceiling to curb prices of patented medicines: Government panel: One way countries can get around international patent agreements is by declaring a public health emergency and using a “compulsory license” for drugs that will help address the crisis. The “loophole” was meant to help developing countries afford branded treatments in the face of epidemics. This article provides a recent example (India) of countries that stretch the purpose of these licenses to cover very expensive drugs to treat cancers and rare diseases.

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About the public’s health

Outbreak of Salmonella Infections Linked to Pet Hedgehogs: I didn’t know “this was a thing.” People who keep pet hedgehogs have been warned by the CDC to be very careful not to kiss or cuddle them, since many are infected with a salmonella species. Wash your hands after touching!

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CHOP opens first food pharmacy for patient families in West Philadelphia: The Children's Hospital of Philadelphia has opened a “food pharmacy” to provide neighborhood children with a food bank and nutritional counseling. Add this initiative to the others I have mentioned that document how hospitals are addressing social determinants of health.

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