Today's News and Commentary

About pharma

“Inactive” ingredients in oral medications: If you’ve noticed the labels on back of pill bottles that list active and inactive ingredients, most likely you’ve ignored the latter list. This research may make you think twice about doing that: “A majority of medications contain ingredients that could cause adverse reactions, underscoring the need to maximize the tolerability and safety of medications and their inactive ingredients.”

Read the research (Subscription required)

Reducing the burden of tuberculosis treatment-Drug delivery system would allow patients to switch from daily to monthly doses: One reason chronic medications fail is patient compliance. A new device from MIT is a wire on which “beads” of antibiotics are strung and is placed in the stomach. The beads dissolve over a month after which the wire is removed and another “dose” is placed.

Read about this fascinating medication delivery system

Senate Bill Would Address ‘Patent Thicket’ Critics Say Stymies Biosimilars: A bipartisan Senate bill would require pharma companies to disclose all applicable patents that are being used to protect their biologic drugs. The aim is to help generic companies understand sooner what these protections are so they can develop biosimilars sooner.

Read the announcement

Effect of Potential Policy Change to Part D Generic Tiering on Patient Cost Sharing and Part D Plan Costs: Medicare Part D plans are allowed to place generic drugs in a “non-preferred” tier in their formularies. As a result, CMS is considering requiring these plans to place generics in the lowest tier. A study by Avalere calculated that if this tier change occurrs in 2019, it could save Medicare beneficiaries $4.1 billion. This one is a “no brainer;” only question is what is taking CMS so long to make the change (other than lobbyists)?

Read the study

Cutbacks by some doctors halved new opioid prescriptions over 5 years: The campaign to reduce opioid prescriptions is working. “The rate of first-time opioid prescriptions declined 54 percent between 2012 and 2017 in the U.S., largely because many doctors stopped prescribing the painkillers.” Further, for those who are receiving opioids, the prescriptions are have a shorter duration.

Read the article

 About the public’s health

U.N. warns of millions of premature deaths by 2050 due to environmental damage: Adding to yesterday’s environmental warning, this 740-page UN report was “compiled over six years by 250 scientists from 70 nations.” It concluded that human activities causing pollution could be devastating from both health and economic standpoints. The harm from air pollution alone (vehicle emissions, industrial waste, as well as burning fuels such as wood, coal and kerosene for cooking, heating and lighting) “was resulting in around 7 million deaths annually…costing around $5 trillion in welfare losses.” Additional costs in life and wealth occur from other sources, like water pollution. And yet, we have climate change/pollution deniers…

Read about the study

About insurance

State-Run Reinsurance Programs Reduce ACA Premiums by 19.9% on Average: Seven states decided to offer their own reinsurance programs for ACA Exchange plans. Yesterday, Avalere released a study that such programs reduced premiums by 6% to 43.4%.

Read about these programs and other benefits

Key Democrat announces investigation into 'junk' healthcare plans backed by Trump: Yesterday, House Committee on Energy and Commerce Chairman Frank Pallone, D-N.J., announced an investigation into short term health insurance plans- what they are calling “junk plans.” The concern is that, although the premiums are less costly than ACA Exchange plans the benefits may be much worse and the out of pocket expenses may be much higher in the long run.

Read the announcement

Today's News and Commentary

About quality and safety

Claims Data Signals & Solutions to Reduce Risks and Improve Patient Safety: This study (prepared by medical liability insurer Coverys) offers reasons for malpractice suits against primary care physicians. By far the single greatest cause was diagnostic error, accounting for 46% of the claims and 68% of indemnity payments. About half of the diagnostic errors were cancer-related. The study also has suggestions for mitigating these risks.

Read the report

2019 Top 10 Patient Safety Concerns: This report from the ECRI provides a list of top patient safety concerns. Following on the above article, the #1 concern is “Diagnostic Stewardship and Test Result Management Using EHRs.”

Read the report

Patient Outcomes After Hospital Discharge to Home With Home Health Care vs to a Skilled Nursing Facility: All things equal, which is better, discharging to home or a skilled nursing facility? After adjustment for proximity of the two options, the authors of the study found that: “Among Medicare beneficiaries eligible for postacute care at home or in a skilled nursing facility, discharge to home with home health care was associated with higher rates of readmission, no detectable differences in mortality or functional outcomes, and lower Medicare payments.”

Read the research (Subscription required, but abstract is available)

About health insurance

The Impact of Medicare-X Choice on Coverage, Healthcare Use and Hospitals: The American Hospital Association and Federation of American Hospitals issued a report on the effect Medicare buy-in would have on healthcare costs and hospital finances. Among the conclusions: “Nationally, healthcare spending would be reduced by $1.2 trillion (7%) over the 10-year period from 2024 to 2033, with spending for hospital services being cut by $774 billion -accounting for almost two-thirds of the total spending reduction.”

Since Medicare payment rates are a lot lower than commercial plans, and since these rates would affect hospitals the most, the findings are not surprising.

Read the full report

UnitedHealthcare Will Expand a Drug Discount Program Aimed at Lowering Consumer Costs: United’s pharmaceutical benefits management (PBM) subsidiary (OptumRx) announced that it will require all new employer-sponsored plans to pass along drug company rebates to their members. This action is in line with Medicare Part D proposals being floated by CMS.

Read the story (From the NY Times but appears to be open access)

Pharmacy benefit managers next up to testify in US Senate hearings on drug pricing: Speaking of drug prices, on the heels of recent Congressional testimony by big pharma execs, PBMs are set to appear on April 3.

Read the story

HHS Secretary Azar defends proposed cuts to Medicare hospital payments: Part of the President’s budget calls for reduction in hospital payments. This article reviews both what Democrats say the budget does and what Secretary Azar says will happen. You can see a recording of his defense and make up your own mind.

Read the article and see his defense

About the public’s health

FDA rolls out vaping policy to make it harder for minors to buy flavored products: Outgoing FDA Commissioner Scott Gottlieb continued his assault on tobacco products- this time issuing proposed rules for controlling flavored tobacco products delivered by electronic devices (vaping). The rules would limit sales of fruity and kid-friendly vaping products to stores that bar minors or have separate adult-only sections; online sellers would have to enhance their age verification processes and cut bulk sales.

Read the article
Read the FDA Draft Guidance

Cardiovascular disease burden from ambient air pollution in Europe reassessed using novel hazard ratio functions: This research concludes that: “The annual excess mortality rate from ambient air pollution in Europe is 790 000…Between 40% and 80% are due to cardiovascular events, which dominate health outcomes… We estimate that air pollution reduces the mean life expectancy in Europe by about 2.2 years with an annual, attributable per capita mortality rate in Europe of 133/100 000 per year.” To put these numbers in perspective, the mortality rates are higher than tobacco use. Seems like air pollution has become the #1 public health problem.

Read the research

Today's News and Commentary

BREAKING NEWS:

National Cancer Institute director Ned Sharpless to become acting FDA head
Read the announcement

About pharma

FDA approves Pfizer's biosimilar to Roche's Herceptin: Biosimilar drugs are coming into increased use. They are expected to lower costs by about 20% (far less than non-organic medications). This biosimilar will have a big impact on costs because of the frequency with which it is used.

Read the announcement

MAP4K4 Inhibition Promotes Survival of Human Stem Cell-Derived Cardiomyocytes and Reduces Infarct Size In Vivo: Interesting molecular science article. Briefly, these investigators found that a certain gene produces a toxic protein when heart cells are stressed (like in a heart attack). Blocking expression of the gene can save heart cells and lead to a greater functional status after healing. Though the research was in a mouse model it has great promise for future human trials.

Read the research

FDA launches Request to Connect website:According to the website, the form : ” is intended for use by individual patients, caregivers, advocates, patient groups, and health professionals to encourage understanding and participation in FDA's regulatory work. This form is not for use by industry stakeholders. Requests may be related to a drug, biologic, device or a combination thereof.”

Request information from the FDA


About insurance

The Many Varieties of Universal Coverage: Confused about all the new proposals for health reform- especially those calling themselves “Medicare for all?” This interactive graphic from the Commonwealth Fund provides a really good explanation about these plans.

Read the article

10 critical facts about the TPE program: This article is a really good summary about the Targeted Probe and Educate program- CMS’ audit procedure. Originally designed to help providers reduce rejected claims, it is really a sampling of bills and the medical records to back them up. This process can be conducted annually even if no problems are uncovered. If there are problems…well, read the article.

Read the article

About the public’s health

Trump proposes big cuts to health programs for poor, elderly and disabled: The White House budget is out and it has a number of healthcare provisions- ranging from the opioid crisis to controlling drug costs to Medicaid funding. The overarching message is: “The 2020 Budget requests $87.1 billion for HHS, a 12-percent decrease from the 2019 estimated level. The Budget proposes $1,248.8 billion in net mandatory health savings, reducing longer-term deficits.” This article is a nice summary of these proposed changes.

Read the article
Read the budget statement (Start on page 39)

Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial: Human papilloma virus (HPV) is responsible for cervical cancer.; so screening for HPV has been replacing Pap smears in some settings. This study showed that self- obtained specimens were as good as clinician-obtained specimens in picking up higher grades of cancerous changes in women infected with HPV. While these self-obtained specimens are not a replacement for medical care, they would be very helpful in screening programs in places where such care is not readily available.

Read the research

Health Literacy and Income Mediate Racial/Ethnic Asthma Disparities: Many factors account for health disparities. This study “suggests racial/ethnic differences in several asthma outcomes are largely due to effects of health literacy and income. Interventions to improve racial/ethnic asthma disparities should target health literacy and income barriers.”

Read the research

VA Secretary Robert Wilkie announces precision medicine testing initiative with Sanford Health: Veterans will have a no-cost option to obtain genetic testing so their healthcare can be tailored to those results. “Veterans will access the test at their local VA facility, and Sanford Health will process the tests at its South Dakota-based Imagenetics facility.” Why Sanford? Because that’s where former VA Secretary Shulkin landed after he was fired.

Read the story

About healthcare IT

How to ensure business associate agreements protect all parties: As mentioned yesterday, significant IT breaches are coming through business associates. This article is a reminder of and a good summary about the importance of business associate agreements and their part in security.

Read the article

With lessons learned from computers, a new platform could help boost production of lifesaving biological therapies: What happens in a cell when a manufactured sequence of DNA is introduced, for examples, to help the cell produce immunity to infection or manufacture a protein missing in its host? Microsoft announced a partnership with Princeton University and two British biotech companies to develop a platform to more rapidly answer such questions. According to the company: “Microsoft’s Azure cloud infrastructure and machine learning tools can quickly analyze experimental data and improve models that predict how cells will react when a particular sequence of DNA is introduced. That could help users zero in on the best conditions for engineering a lifesaving drug, or bacteria that fix dyes onto textiles through a non-toxic process.” The venture is called Station B.

Read the announcement

Today's News and Commentary

About devices

Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial: This research could change the way glaucoma is treated. Traditionally, a patient administers medicated drops to the eyes when there is a buildup of pressure (glaucoma). This study concludes that a single laser treatment does just as well as a lifetime of medication. It goes so far to conclude that: “Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice.”

Read the research

Senators Introduce Bipartisan Bill to Repeal Device Tax: “Sens. Pat Toomey (R-Penn.) and Amy Klobuchar (D-Minn.) have introduced legislation that would end the nationwide medical device tax. The 2.3 percent medical device excise tax — a tax paid whenever a purchase is made — became active in 2013. In July 2018, the House voted to permanently repeal the tax, with 283 members of Congress voicing their support for revocation.” With this tax gone and others on hold- where will the money come from to fund the ACA?

Read the announcement

About the public’s health

Chile’s sugary food fight echoes around the world:Taxing unhealthy products is the best way to lower consumption. The soft drink industry in this country has successfully fought against such measures for sugary drinks- claiming that the taxes infringe on people’s choice about what to eat. Five years ago, Chile imposed an 18% tax on sugared drinks. Two years ago the government targeted kid-friendly marketing of such products. “A new law limits cartoon food packaging, stops schools selling unhealthy foods, restricts TV adverts, bans promotional toys and mandates large black cigarette-style warning labels on foods high in salt, saturated fat, sugar and calories.” The result? “New labels have cut the likelihood of people choosing sugary breakfast cereals by 11 per cent and sugary juices by almost 24 per cent… Monthly consumption of targeted sugary drinks fell by almost 22 per cent after the tax started in 2014.” These changes were implemented because of the same health problems we face in America- obesity and diabetes. Where is our government’s political will to stand up to these lobbies in the interest of the public’s health?

Read this story (Subscription required- Financial Times )

About healthcare IT

Doctor on Video Screen Told a Man He Was Near Death, Leaving Relatives Aghast: A machine was rolled into the critically ill patient’s room where a physician on the devices’ screen asked him and his family about end of life measures. This story is about the lack of human touch with telemedicine.

Read the story (From the NY Times but appears to be open access)

Taking the Best Care of Our Members: Oscar 2018: In contrast to the above telemedicine article, health plan Oscar’s members have a very high use of telemedicine and other online services, and they appreciate the experience. This information is from their annual report so the data is self-reported.

Read the report

Apps step up to the plate with diet and DNA-tailored advice: This article discusses two apps. The first is a customized diet using the “nudge” behavioral motivation. The second is grocery store-based. The customer provides a saliva sample that is analyzed within 15 minutes. The results are used to provide a customized diet based on the individual’s DNA results.

Read the article (Subscription required- Financial Times )

Data breach may have exposed the personal, medical information of 600,000 in Michigan: While data breaches are, unfortunately, no longer big news, this one (and another, smaller, one at Rush Medical Center in Chicago last week) highlight that business associates are increasingly to blame.

Read the story

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Software Application for Contraception: Since this announcement is about software I put in in then IT section. The FDA has changed software apps for contraception from Class III to Class II devices. The reasoning is that: “We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.” It is interesting to follow the FDA’s reasoning as it tries to understand and regulate healthcare apps.

Read the final rule


About pharma
Patients and Insurers Accuse Genentech of Exploiting Cancer Patients: The class action lawsuit accuses the Roche subsidiary of Genentech of furnishing vials with more medication than can be used in a single treatment. The extra cannot be used because the potency expires. The problem is that patients/insurers are charged for the full amount of the drug. These practices especially apply to the commonly used (and expensive) drugs Rituxan (rituximab) and Avastin (bevacizumab).
Read the story

About insurance

Anthem Won’t Mimic UnitedHealth’s Doctor Buying Binge: Many hospitals and insurance companies are buying doctor practices. Anthem, however says it would rather develop partnership arrangements. Sounds like it’s back to the 1980s and 90s with IPA and network models.

Read the story

Iowa court: Medicaid can cover sex reassignment surgery: The Iowa Supreme Court upheld a lower court’s ruling that “the state cannot deny two transgender women Medicaid coverage for sex reassignment surgery.” Not too long ago, two conditions were specifically excluded from virtually all health insurance policies- cosmetic surgery and sexual reassignment surgery. We have come a long way.

Read the story

Child Enrollment in Public Health Programs Fell by 600K Last Year: Good news or bad news? We don’t know. Some explain that this finding is due to higher employment, and thus private coverage through parents’ employers . Other worry about an increase in the number of uninsured. The truth may depend on circumstance in each state.

For details, read the research report

Study: High-deductible health plans aren't making members better healthcare consumers: This article reviews two studies in the March issue of Health Affairs (subscription access only). One looks at consumer behavior for those with a High Deductible Health Plan (HDHP). These plans are supposed to make patients more cost-conscious since the first dollar payments for care are coming from their own savings. However, the study found that only about 40% “were saving for future healthcare costs. Other behaviors were even less common: just a quarter of those surveyed had spoken with a doctor about price, and about 14% had compared prices.” Other studies on HDHP members have shown higher rates of cost-seeking behavior but the figures are certainly more than plans with higher out of pocket coverage. The second study raises another concern with these plans- delay of care; in this case for breast cancer diagnosis and treatment.

Read the summary article

Evaluating an episode-based payment system for post-acute care: One of the most costly and variable expenses for Medicare is post-acute care. To get a better handle on these costs, MedPAC is discussing changing the payment basis for these episodes of care.

Read the MedPAC discussion

Today's News and Commentary

About the public’s health

Grape or grain but never the twain? A randomized controlled multiarm matched-triplet crossover trial of beer and wine: To start your weekend…Now research has proven it doesn’t matter if you drink wine before beer, or vice versa- as long as you drink responsibly.

Read the research (if you need to be convinced)

About insurance

Why Consumers ChooseShort-Term Health Insurance: This survey by eHealth delves into who buys short term policies, why they make this choice and how they use their benefits. It is an interesting read, One big surprise is that people ages 55-64 are more likely to buy these policies than those in younger age groups. The reason is premium affordability- which is a tradeoff for coverage.

Read the survey results

Trump Administration Weighs Publicizing Secret Rates Hospitals and Doctors Negotiate With Insurers: As of January 1, hospitals are required to disclose their “list prices.” But these figures are meaningless because the vast majority of payments are according to contractual rates (or mandates in the cases of Medicare and Medicaid). The next step in federal calls for hospital price transparency is to have them reveal their contractual pricing with insurance companies. Still, individuals will be left to figure out what they will owe given the terms of their insurance policies. What is really needed is a calculator for patients with specific insurance policies to know what they will end up paying if they get care from a specific provider.

Read the article (Wall St Journal but appears to be open access)

About pharma

Two Medicare payment strategies to improve price competition and value for Part B drugs: Reference pricing and binding arbitration: MedPAC has joined the call to look for ways to reduce Part B drug spending by calling for its Commissioners to comment about reference pricing and binding arbitration at its full meeting the month.

Read the meeting brief

EMA Shuts Down London Office for Move to Amsterdam: In advance of the impending Brexit, the European Medicines Agency has completed its planned London office closing and is opening in Amsterdam.

Read the announcement

Johnson & Johnson, ViiV report positive data for once-monthly injectable HIV regimen combining Edurant, cabotegravir: HIV treatments have been complex cocktails of drugs, initially requiring multiple daily doses. If this regimen proves successful it would be a truly disruptive innovation. This treatment would not only be more convenient but also enhance monitoring of non-compliant patients.

Read the article

New target for chronic pain relief confirmed by scientists-Scientists observe drug target that can reduce pain when activated: New research from the University of Hiroshima gives hope for a novel pain control mechanism." “Previous research had shown that activating a type of cell receptor (REV-ERBs) that sends chemical signals inside the cell to block the production of certain genes regulates pain-causing and inflammatory molecules inside the body.” Turning on this gene in mice lowered pain. It is not clear if therapies would be stand-alone or used to reduce use of other drugs.

Read the research

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's steps on naming of biological medicines to balance competition and safety for patients receiving these products: The FDA is trying to balance the need for information about which drugs are biosimilars against an implication that they are inferior to the original branded medication. This announcement explains changes in how medications will be named to accomplish both purposes.

Read the announcement

About devices

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices: READ THIS STORY. The essence of the report is that: “The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.”

Read the story

Today's News and Commentary

About pharma

Good News: Opioid Prescribing Fell. The Bad? Pain Patients Suffer, Doctors Say: The pendulum seems to be swinging back. First we did not treat pain adequately. Then came the call to treat pain control as a “vital sign,” which led to over treatment and the opioid epidemic. Now that we are beginning to control opioid overuse, physicians are saying our zeal is causing under-treatment.

Read the article (NY Times but appears to be open-access)

J&J prices ketamine-like depression treatment at $590-$885 for two doses: To amend a previous story, J&J has announced the price for its new anti-depression drug Spravato.

Read the announcement

Office of Generic Drugs- 2018 Annual Report: While this report was issued about a week ago, it is noteworthy to recall the accomplishments on the heels of Commissioner Gottlieb’s resignation. Among the milestones are approval or tentative approval of 1,021 Abbreviated New Drug Applications (ANDAs) and publication of more than 250 new or revised guidances, product- specific guidances (PSGs), and manuals of policies and procedures (MAPPs) for stakeholders.

Read the report

Louisiana's 'Netflix' deal for hepatitis C drugs wins bids from AbbVie, Gilead and Merck: As previously reported, Louisiana was considering a “subscription price” for pharmaceuticals as a way to control costs- like Netflix. Now the state has moved forward and is accepting bids for drugs that treat hepatitis C.

Read the article

About healthcare IT

6 top challenges to successful data integration: This short explanation is a good summary of barriers to data integration. For example: “Each organization has a unique set of APIs, and 47 percent of survey respondents pointed to integrating all these sources as their most challenging task.”

Read the article

Lawmakers voice concerns about VA’s plans for Cerner EHR: The integration of VA and DoD information systems as well as upgrading for both will take another 10 years and $16.1 billion. Congress is now concerned about that timeline and cost. Further, with new VA initiatives to expand care options in the private sector, it appears the new system may not be interoperable with non-governmental provider sites.

Read the article

2019 CIO Survey Report: This survey was conducted by Grant Thornton and the results were sorted by industry sector. One key finding for the healthcare/life science sector was that the top problem for Chief Information Officers is conflicting priorities among stakeholders. This finding is no surprise, particularly in hospitals systems where different departments not only have different information needs but their financial metrics are different and can come into conflict.

Read the report

About the public’s health

Federal judge in Boston sets timeline for FDA to produce graphic cigarette warnings:”A federal judge in Boston has ordered the US Food and Drug Administration to create mandated colorful graphic health warnings on cigarette packs and advertising products by mid-March of next year.” If you ever find yourself in a Canadian airport and go to a duty-free shop that sells cigarettes you will see what these packages might look like.

Read the article

Even with measles outbreaks across the US, at least 20 states have proposed anti-vaccination bills: Given population mobility, we need a national immunization policy that will protect the whole country. Think about federal regulation of interstate commerce as an example.

Read the article

Industry Voices—Six keys to focusing on social determinants with the biggest economic impact: This article provides a short, useful list of best cost-effective strategies for implementation of programs to address the social determinants of health.

Read the article

WHO unveils sweeping reforms in drive towards “triple billion” targets: In order to accomplish its five year strategic “triple billion plan,” the WHO announced a major reorganization. The strategy calls for: “one billion more people benefitting from universal health coverage (UHC); one billion more people better protected from health emergencies; and one billion more people enjoying better health and well-being.” The four pillar structure will deal with Programmes, Emergencies, External Relations and Governance, and Business Operations. All will be supported by the Division of the Chief Scientist at WHO Headquarters in Geneva “to strengthen WHO’s core scientific work and ensure the quality and consistency of WHO’s norms and standards.”

Read the announcement

About insurance

The Atul Gawande health care company finally has a name: Haven: The health care company formed in January, 2018 by Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. finally has a name and website. It is called Haven and it will focus on “improving access to primary care, lowering prescription drug costs, and making insurance benefits easier to understand.” While initially focusing on the 1.2 million employees of its founders, the venture is expected to expand its practices more widely once it gets going (and is successful).

Read the story

Why judge’s ruling against UnitedHealth could be turning point for mental health parity: U.S. Chief Magistrate  Joseph C. Spero of the U.S. District Court in Northern California ruled that United Behavioral Health (UnitedHealth’s behavioral health subsidiary) unlawfully used internal policies to discriminate against patients with these needs order to cut costs. Federal law mandates that behavioral health benefits are on parity with other benefits. The decision in this class action suit is expected to be appealed.

Read the story

Trump Administration Looks to Jump Start Interstate Health-Insurance Sales: The Trump administration has discussed this initiative before. Somehow it has the idea that if cross-state products were offered it would lower insurance costs. I think the policy makers forgot that healthcare is delivered locally and costs reflect that fact. A policy sold in Oregon (where costs are relatively cheap) will not cost less if the customer lives and receives health services in the expensive Miami area.

Read the article (Wall St Journal but appears to be open access)

Today's News and Commentary

About pharma

Today’s top story is the resignation of FDA Commissioner Scott Gottlieb, MD. Regardless of political affiliation, most healthcare experts agree he was a bright spot in the current administration. Dr. Gottlieb has been praised for, among other actions, promotion of expedited generic approvals and fighting tobacco use- especially flavored cigarettes. He has been commuting between the DC area and his family in Connecticut and cites family time as his reason for leaving. A replacement has not been named.

The Real Price of Medications- A survey of variations in prescription drug prices:This report by the U.S. PIRG Education Fund found huge variations in drug prices among pharmacies. (As examples, see the graphic in the article.) Patients should not assume that they are getting best prices if they are go to a pharmacy contracted with their health plan.

Read the report

FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression: I previously reported that an FDA committee approved Esketamine for treatment of depression. Now the drug has been approved by the full FDA for use in very controlled circumstances under physician supervision. Its potential is to rapidly treat depression when other medications have failed or in addition to other medications.

Read the story

The Orphan Drug Act Revisited: This opinion piece is a thoughtful review of why we have the Orphan Drug Act and why it needs to be changed. Briefly, rare diseases, which were the intended targets of the drugs developed under this law, were defined by organ system. With increasing knowledge of genetic and molecular mechanisms of disease, many commonalities are being identified- making rarity no longer a reliable criterion for granting orphan status.

Read the article (From JAMA but appears to be open access)

About the public’s health

Dietary Reference Intakes for Sodium and Potassium (2019)-National Academy of Sciences Engineering Medicine): Sodium intake guidelines have been controversial for many years. People sensitive to sodium can get or worsen high blood pressure and heart failure. So what is a reasonable intake if you do not know if you will be adversely harmed? This study recommends 2300 mg/day or less. To put this number into perspective, the average US consumption is 3400mg/day. The report also calls on commercial food companies to lower sodium content in their products; most dietary salt comes from prepared food not from added salt at home.

Read the full study (Free signup required)

Staph infections can kill-More prevention in healthcare & communities needed: The CDC issued this report noting that staph infections (particularly MRSA) are still the cause of significant mortality. Recommendations for control are cited.

Read the announcement

Unconventional natural gas development and hospitalizations: evidence from Pennsylvania, United States, 2003–2014: This research found that long term exposure to fracking was associated with higher rates of genital and urinary problems ( like urinary tract infections, kidney infections, and kidney stones) and skin conditions( such as cellulitis and abscesses). The greater the density of drilling, the higher the incidence. Add these findings to other environmental concerns for this drilling technique.

Read the research

About insurance

How Affordable are 2019 ACA Premiums for Middle-Income People?: Subsidies for ACA exchange premiums are for those who make up to 400% of the federal poverty level. But what about those above that figure? Premiums can vary dramatically by age group and location. Research by the Kaiser Family Foundation found that: “while there seems to be a consensus that individual market premiums are out of reach for some middle-class people ineligible for ACA subsidies, there is little consensus around what to do about it.”

Read the research

Medicare Advantage insurers to CMS: Rethink expanding use of encounter data in risk adjustment: Among other factors, CMS adjusts Medicare Advantage payments based on the severity of illness of the beneficiaries. About 25% of this risk adjustment is based on claims data and CMS want to increase the contribution to 50%. Insurers are pushing back, citing inaccuracies and gaps in such sources.
One wonders how insurers are making accurate payments if the claims data is so poor.

Read the story

About healthcare IT

UPMC files federal trademark registration for cloud solution: UPMC has developed what it calls its “healthcare operating system (hcOS).” It is described as a three layer cake: “We ingest the data out of clinical systems as the base layer and get it into the cloud…The middle layer is a set of tools or processing that can handle things like governance, security, identity management, privacy, harmonization and indexing on top of the data. And, the third layer is natural language processing and artificial intelligence.” It is built using the Health Level 7 Fast Healthcare Interoperability Resources (FHIR) standard. For those into IT terminology this product is a PaaS (platform as a service).

Read the article

Today's News and Commentary

About healthcare IT

UPMC cuts hospital readmission rates with ML [Machine Learning] algorithm: Interesting article on the use of ML to effectively decrease readmissions by identifying at-risk patients. The results: “…the ML algorithm identifies patients at highest risk of re-hospitalization within seven and 30 days of discharge. To date, re-hospitalizations have been reduced by about 50 percent.” The article has a dashboard graphic that illustrates important features of the algorithm.

Read the article

Microsoft built a bot to match patients to clinical trials: Microsoft's lab in Israel has developed user-friendly software to match patients with clinical trials. Patients can enter their information and the app will ask further questions if needed. The business model is for drug companies to buy the product to help them recruit patients for their studies.

Read the article

Amazon gives AI to Harvard hospital for efficiency gains: Beth Israel Deaconess Medical Center in Boston already uses Amazon’s cloud service to store its data. Now Amazon is giving the medical center a grant to develop Artificial Intelligence to help with some routine functions, like more efficient operating room scheduling.

Read the article

‘Wired into the walls’: Voice-recognition system promises to automate data entry during office visits: One of the most burdensome tasks facing medical professionals is documentation of the patient visit. Some practitioners use “medical scribes.” The device described in this article is made by Nuance, the parent company of Dragon dictation software. Patient-physician conversations are transcribed live and aided by a locator when movement of either occurs. Having personally used Dragon for medical dictation, I can attest to its accuracy once it learns your voice and to spell technical terms. However, the transcription will still need to be reviewed since substitutions do occur.

Read the article

IQVIA debuts research platform to de-ID links between genomic and clinical data: One problem in gathering data for research is protection of patient confidentiality. IQVIA has developed a platform that de-identifies patient data while preserving clinical and genetic data.

Read how this task is accomplished

What Your Doctor Isn’t Allowed to Tell You:
Despite the promise of healthcare IT, systems do make mistakes that create errors in care. The theme of this article is: “Badly designed electronic records can be hazardous to your health, but a gag clause protects the makers.The problem is that some EHR vendors have such overwhelming market power that they insert gag clauses into their contracts with hospitals, ostensibly to protect their intellectual property.” The author calls for banning these gag clauses in order to help healthcare providers freely exchange information about functionality.

Read the article (From the Wall Street Journal, but appears to have open access)

How Banner Health Network is managing interoperability with 30-plus EHRs: Interoperability continues to be a problem, especially within healthcare systems that are expected to have freely flowing information. Phoenix-area Banner Health Network is successfully using software to link internally disparate EMRs.

Read the story

About hospitals

IBM Watson Health Announces 100 Top Hospitals:2019 Study Finds Top-Performing U.S. Hospitals Provide Better Care at Lower Cost and Higher Profit Margins than Peers Evaluated in the Study: This “top” list was formerly the Truven Health Analytics 100 Top Hospitals. Each “top hospital” ranking has its own methodology. Read this list and see if you agree with its evaluation.

Read the rankings

Speech: Remarks by Administrator Seema Verma at the Federation of American Hospitals 2019 Public Policy Conference: This speech was delivered yesterday. While Verma covered many topics (the full address is included in the link), the one part on which the media is focusing is the “Stark” laws. The laws in question (named after the now-retired Fortney “Pete” Stark, D-CA) were directed at hospitals providing financial incentives to physicians in return for referrals. With increasing prevalence of bundling and cooperative relationships like ACOs, the federal government is realizing that the laws need to be changed or “safe harbors” for the relationships need to be more clearly defined.

Read the address

About the public’s health

New funding models for health urgently needed, experts warn: The G20 Health and Development Partnership — a coalition of business, academic and non-governmental organisations- issued a report today that says disease and antimicrobial resistance pose a bigger threat to the world’s economy than global warming. Governments need to take responsibility for these problems and new methods of financing must be implemented.

Read a summary article
Read the full report

Big Pharma Gave Money To Patient Advocacy Groups Opposing Medicare Changes: For-profit entities, especially “big pharma” are influencing the lobbying efforts of nonprofits by making large donations. The Kaiser Family Foundation has a website called Pre$cription For Power that is a resource for such information.

Read the article

About insurance

Paying Patients To Switch: Impact Of A Rewards Program On Choice Of Providers, Prices, And Utilization: We know that patients who have to pay more out of pocket use fewer services. This study is the “other side of the coin.” Patients who used lower-cost, preferred providers got money back for doing so. The results: “For 131 elective services, patients who received care from a designated lower-price provider received a check ranging from $25 to $500, depending on the provider’s price and service. In the first twelve months of the program we found a 2.1 percent reduction in prices paid for services targeted by the rewards program. The reductions in price resulted in savings of $2.3 million, or roughly $8 per person, per year. These effects were primarily seen in magnetic resonance imaging and ultrasounds, with no observed price reduction among surgical procedures.”

Read the research (Subscription required)
Read an open access summary

Today's News and Commentary

About pharma

BREAKING NEWS

Drugmaker Lilly to Launch a Half-Price, Generic Version of Its Top-Selling Insulin: While Congress presses pharma companies to lower costs, and specifically allow importation of generic insulin, Lilly announced this morning that it would launch the generic Insulin Lispro at half the price of the Humalog branded version. This article is one of many published in the past few hours on this topic. Expect widespread print coverage tomorrow.

Read the announcement

Marketplace Pulse: Cost-Sharing for Drugs Rises Sharply at Higher Tiers: One way insurance companies have been able to maintain profitability is by increasingly shifting costs to patients (and providers). This study from the Robert Wood Johnson Foundation documents this shift for pharmaceuticals. Among the study’s findings: “The median co-insurance is 40 percent, not insignificant when the average monthly cost of a specialty drug can exceed $5,000. In the small group market, less than one-third of silver plans have this design, and the median co-insurance is somewhat lower at 30 percent.” The article has some helpful graphics to demonstrate the market conditions.

Read the research

Drug Companies and Doctors Battle Over the Future of Fecal Transplants: A side effect of antibiotic use can be diarrhea due to overgrowth of the bacterium C. Difficile in the intestine. Traditional treatments have been use of additional, different antibiotics. In the past few years, researchers found that delivery of normal fecal bacteria to the colon works as well as the antibiotics and has the advantage of repopulating the flora. Now that the latter therapy has proved itself, the FDA is facing the question of how to regulate it. Is it a drug, a device, or something else?

Read the article

The Side Effects of Million-Dollar Drugs: The article focuses on Luxturna, a gene therapy for a form of blindness affecting about 2000 people in the US. The article also summarizes the gene therapy efforts for other conditions and the extraordinary costs of this type of therapy.

Read the article (Subscription required)
Read a recent industry-sponsored summary about this topic

About the public’s health

Sugary drink tax tied to drop in soda consumption: Despite efforts at behavioral therapy and education programs, the best way to discourage unhealthy consumption is to tax the offending product. This method has worked very well with respect to tobacco. Lately, despite vigorous industry opposition, it has proven effective in lowering consumption of sugary drinks. Last year’s imposition and repeal of such a tax in Cook County, IL is evidence of the political difficulties of such a measure.

Read the article

About devices

FDA Seeks to Build Risk-Benefit Database for Robotically-Assisted Surgical Devices: On the heels of last week’s announcement that robotic surgeries are not always better than their traditional counterparts, the FDA has made this announcement.

Read the artcle

Mammalian Near-Infrared Image Vision through Injectable and Self-Powered Retinal Nanoantennae: This article is fascinating- it explains research using nanoparticles injected into mouse eyes that bind to receptors and enable the animals to see the infrared spectrum. If the concept proves valid in humans, it can help colorblindness. Imagine other implications as well.

Read the research

About healthcare IT

Moody's: Hospitals among industries with highest risk of exposure to cyberthreats: The bond-rating firm, Moody’s, is concerned about any financial liability companies and sectors may have that will affect credit status. This recent report cites hospitals as having among the highest threats to cybersecurity. One reason for this vulnerability is the need for interoperability.

Read the article (The original study requires a paid subscription)

About insurance

U.S. seeks to cut dialysis costs with more home care versus clinics: Medicare’s End Stage Renal Dialysis Program costs about $114 billion annually. Many patients have their treatments in dialysis centers when care can be provided with equal effectiveness and lower cost at home. CMS is now interested in increasing earlier treatments, home care options and access to transplantation in order to lower overall costs.

Read the article

Reducing Individual Market Premiums to Expand Access to Coverage and Care: In its March 2019 Issue Brief, the BCBS Association describes the high cost of individual policies on the ACA exchanges. Three solutions are explained to address this problem:
1. Revise federal assistance to help more people afford coverage
2. Enact policies to lower costs and remove financial barriers to accessing care
3. Improve outreach to encourage people to obtain and maintain insurance
If these measure seem familiar…remember when cereal assistance helped with out of pocket expenses and “navigators” helped people understand and signup for plans?

Read the Issue Brief

About healthcare quality

Medicare Trims Payments To 800 Hospitals, Citing Patient Safety Incidents: “Eight hundred hospitals will be paid less by Medicare this year because of high rates of infections and patient injuries, federal records show.
The number is the highest since the federal government five years ago launched the Hospital Acquired Conditions (HAC) Reduction Program, created by the Affordable Care Act. Under the program, 1,756 hospitals have been penalized at least once… This year, 110 hospitals are being punished for the fifth straight time.”

Read the article
Check if “your” hospital is on this list

About hospitals and health systems

Updated Physician Practice Acquisition Study: National and Regional Changes in Physician Employment 2012-2018: The trend for hospital-employed physicians has grown rapidly, but in the past year seems to have leveled off. This is a very interesting study of you want to “look at the numbers.”

Read the report

Today's News and Commentary

About healthcare quality

I’m a Journalist. Apparently, I’m Also One of America’s “Top Doctors.”: Today’s news starts with an amusing article by Marshall Allen, a non-physician healthcare reporter for ProPublica, who was named one of America’s “Top Doctors.” The story looks into the for-profit world of “best” lists for physicians in healthcare. Not in the article, but how accurate is that Yelp rating?

Read the story

CMS has just released its hospital star (quality) rankings-updating 2017 evaluations. You can look up specific hospitals on the “hospital compare” website. A number of hospitals and organizations have complained that these ranking do not adjust for severity of illness or social factors. One article that analyzed these concerns was from the Chicago Tribune, which detailed the drop in quality scores for a number of academic institutions in the Chicago area. In reply to critics, CMS asked for comments about the process.

About pharma

FDA warns Canadian drug distributor about sending ‘unsafe’ drugs to U.S.: In looking for less expensive medications, not all sources from abroad are safe and effective. According to the article: “The FDA urged U.S. consumers ‘not to use any medicines from CanaRx,’ which supplies drugs to employees of about 500 cities and counties, and private-sector employers seeking discounts on drug prices.”

Read the article
Read the FDA letter

Bill would allow lower priced insulin to be imported: Despite the above concerns, “ U.S. Rep. Peter Welch of Vermont introduced legislation on Thursday that would allow for the importation of low cost insulin from Canada and other countries for people with diabetes.”

Read the article

About healthcare insurance

GOP senator: Legislation combating surprise medical bills could come in March: The latest Congressional initiative to address surprise medical bills could be introduced this month.

Read the article

H.R.1398 - To delay the reimposition of the annual fee on health insurance providers until after 2021: One of the sources of funding for the ACA is a tax (fee) on healthcare insurers. Congress delayed this source of funding hoping that if insurers did not have to pay the tax they would lower premiums. There is now a bipartisan bill that would further delay reimposition of this tax.

Read the bill
Read an article about the proposal

How Much Will Medicare for All Cost?: As previously reported, the “Medicare for all” proposal does not have a definitive funding source (or price tag). The Committee for a Responsible Federal Budget writes that similar proposals would cost $28-32 trillion dollars over a decade. This interesting article also provides estimates from different sources about the cost for such plans. Where will we get the money?

Read the article

About devices

Guardant’s blood test outperforms standard tissue biopsy in landmark NSCLC study: One of the latest impactful technologies is so-called “liquid biopsies,” where blood is analyzed for cancer. This article reports that, by several measures, this new tool is better than the standard tissue biopsy.

Read the article

Genetic test to detect antimicrobial resistance developed:
Antibiotic resistance is traditionally determined by growing the bacterium and placing a disc containing an antibiotic amid the growing culture. Lab techs then observe whether the disc kills the bacteria. A rapid test for assessing resistance has now been developed that relies on detecting the genes responsible for resistance. The new test is not only accurate but much faster than the older method (10 minutes versus days).

Read the article

FDA warns against using surgical robots for breast cancer surgery: Just because it is new doesn’t mean it is better. The FDA is warning that the use of robotic surgery for breast and other cancer surgeries does give as good results as more traditional methods.

Read the article

About the public’s health

Hawaii Tops U.S. in Wellbeing for Record 7th Time: The new Gallup poll is out and again Hawaii is on top.

Read the poll results

Today's News and Commentary

After yesterday, today was a light healthcare news day.

About insurance

Azar touts funding HSAs with Obamacare subsidies: HHS Secretary Azar gave a talk about the options opening up for health insurance. They include: funding Health Savings Accounts (HSAs) with ACA premium subsidies for those enrolling in the individual market; expanding plan coverage (such as for essential medications) before patients need to use HSA money; eliminating rebates to the PBMs in the Medicare Part D market; and expanding “association health plans.”

Read the article
Read another article covering a different slant on the speech

Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, January–September 2018: The National Center for Health Statistics released its most recent health insurance coverage report.The overall findings: “In the first 9 months of 2018, 29.7 million persons of all ages (9.2%) were uninsured at the time of interview—not significantly different from 2017, but 18.9 million fewer persons than in 2010.” The coverage varied by age: of adults aged 18–64, 13.0% were uninsured; among children aged 0–17 years, 4.9% were uninsured.

Read the report

Claims Denials and Appeals in ACA Marketplace Plans: This study by the Kaiser family foundation found that: “across issuers with complete data, 19% of in-network claims were denied by issuers in 2017, with denial rates for specific issuers varying significantly around this average, from less than 1% to more than 40%. We also find that consumers rarely appeal claims denials to their issuers, and when they do, issuers typically uphold their original decision. Healthcare.gov consumers appealed less than one-half of one percent of denied claims, and issuers overturned 14% of appealed denials.” Claims denials also varied by state. For example, in Kentucky the rate was 40.7% while in Oregon it was 7.6%. The research speculates on the possible reasons for these denials but is not clear.

Read the research

Today's News and Commentary

About pharma

The big news from yesterday was the testimony of drug execs about why prices are high and what can be done about the problem. In short, they said prices were high because of R&D costs. When confronted with the fact that prices are lower in other countries, they said those countries have price controls. When asked if they would lower prices if the rebate system were changed they gave a qualified yes. But, of course, they said blame should be placed on Pharmaceutical Benefit Managers (so-called middle men) and insurance companies who demand the rebates. In sum, nothing new and we will see if anything but posturing will come from this meeting. Of the many articles summarizing exactly what happened, I think the two below are best.

The Health 202: Congress could have been tougher on drug executives
Big Pharma grilled on the Hill: International pricing, AbbVie CEO's bonus and bye-bye rebates

GOP lawmaker says panel to investigate drug company gaming of patent system: On a related issue is this announcement about looking at patent gaming to prolong profitability. For example, Abbvie has more than 100 patents on its top seller Humira.

Read the announcement

About devices

FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies: The title explains the content of the announcement. This launch presents an outstanding opportunity for medical diagnostic companies to create useful and profitable products.

Read the announcement

About insurance

U.S. House Democrats introduce sweeping 'Medicare for All' bill: House of Representative “Progressives” have offered their version of “Medicare for All.” Unlike some of the buy-in proposals making Medicare available for all, this one would create a true single payer system. Two features make this bill improbable for both passage and success: a 2 year implementation timeline and, according to the article, it “does not include new or increased taxes or other additional revenues to pay for the healthcare overhaul.” Lead sponsor Pramila Jayapal said possible ways to pay for the bill include “a tax on millionaires and billionaires, employer premiums and closing tax loopholes for the wealthy.” Does she think that is anywhere near enough money when the current Medicare system has less than 10 years solvency left?

Read the article

About hospitals

New Survey Shows Physicians Are Key Revenue Generators for Hospitals: A new survey by Merritt Hawkins finds that, on average, physicians bring in $2,378,727 per year for hospitals. This figure “includes both net inpatient and outpatient revenue derived from hospital admissions, tests, treatments, prescriptions, and procedures performed or ordered by physicians.” Of course there is a large spread. “Full-time cardiovascular surgeons generate an average of $3,697,916 a year…[while] family physicians generate an average of $2,111,931 in net revenue annually for their affiliated hospitals.”

Read the survey results

Today's news and Commentary

About pharma

As mentioned last week, today is the day major pharmaceutical company executives will testify before Congress about price increases. More on this event tomorrow when all the testimony has been given.

FDA Approves More Generic Drugs, but Competition Still Lags: Speaking of increase prices, this study by the Pew Charitable Trusts looked at what happened to generics after Congress passed the Generic Drug User Fee Amendments (GDUFA) in 2012. Some highlights:

  • More drugs were approved than before the law but the speed of approval has not increased.

  • “Costs generally decline most significantly once second and third generics enter the market, but versions after the third generic usually reduce prices less effectively.”

  • “…more than 500 brand drugs still lack competition, even though there are no patent protections or periods of exclusivity that would prevent the approval of competing generic versions.3 These “sole source” products are most at risk for price spikes.”

    This study is a really good review of the generics field.

    Read the research

CRISPR Therapeutics and Vertex Announce Progress in Clinical Development Programs for the Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001: This announcement is an important milestone: the first company-sponsored use of a CRISPR/Cas9 therapy in a clinical trial. This gene-editing technique will be used to treat patients with beta thalassemia and sickle cell disease.

Read the announcement

Antibiotic resistance: using a cultural contexts of health approach to address a global health challenge: This monograph from the WHO presents a fascinating analysis of how addressing cultural factors is essential for attacking healthcare problems- in this case antibiotic resistance. The analysis makes the case for this approach thusly:
”Any attempt to reduce inappropriate uses of antibiotics and reduce the risks of resistance requires systematic understanding of the histories and cultures of medicine uses, structural issues surrounding health and health care, and an appreciation of cultures of risk.”

This approach can be used at the organizational as well as the societal level.
Read the monograph 

French Patients Refusing Generic Drugs to Face Reduced Reimbursement:The point of including this article is that the US has lots of price control mechanisms in place, but the prices themselves are so high these measures are not making a significant impact. French President Macron has just announced a new “health transformation strategy” that will be phased in over the next few years. The purpose is to increase organizational efficiency and reduce costs. Starting next year, patients who refuse generic drugs or substitutions without a valid medical reason will have higher out-of-pocket costs for those prescriptions. This practice is, of course, not new in the US; but since 2013 in France 80 percent of brand-name drugs were substituted for generics.

Read the announcement

About hospitals

A comparison of scheduling, work hours, overtime and work preferences across four cohorts of newly licensed registered nurses: This article reviews the items in the title. The study found that: ”New nurses are predominantly scheduled for 12‐hour shifts and nearly half work weekly overtime, trends that have remained relatively stable over the past ten years.” The concern is overwork leading to errors- a topic addressed by residency rules limiting physician trainees from working more than 80 hour weeks.

Read the study

Hospitals' all-payer margins climb in 2017 even as Medicare margins slump: Bad news and good news from MedPAC. Average hospital margins for Medicare were negative 9.9% in 2017, the lowest in at least a decade. The good news is that aggregate all-payer margins climbed to 7.1% in 2017; by comparison, it was 6.3% in 2010. These data support the contention that private insurance is subsidizing Medicare.

Read the article (Basic subscription required)

About healthcare IT

Assessing the Use of Google Translate for Spanish and Chinese Translations of Emergency Department Discharge Instructions: Hospitals need to deal with an increasing number of patients whose primary language is not English. Yet translators are not always available. How good are online translations, like Google Translate (GT)? Researchers studied “100 sets of patient instructions contained 647 sentences. Overall, 594 (92%) and 522 (81%) sentences were accurately translated into Spanish and Chinese, respectively, by GT.” Not bad. It does raise the question of accuracy for other languages. Also, how critical are the errors in the non-accurate parts of the translation?

Read the research (Subscription required)

Catholic Health merges IT to enable use of social determinant of health data: Catholic Health has incorporated what it calls the “Total Health Roadmap” into its IT capabilities for primary care physicians. This roadmap includes “a range of physical, social and psychological issues, such as availability of food and safe housing, transportation, quality child care, access to behavioral health treatment, and more.” The purpose is to prospectively identify social determinants of health that will affect a patient’s care.

Read the article

Today's News and Commentary

About the public’s health

Trends in Human Papillomavirus Vaccine Types 16 and 18 in Cervical Precancers, 2008–2014: HPV vaccinations are working to reduce incidence and spread of the two most common cancer-causing strains. According to this research: “From 2008–2014, the proportion of HPV16/18-positive CIN2+ declined, with the greatest declines in vaccinated women; declines in unvaccinated women suggest herd protection.”

Read the research

Trump steps up attack on Planned Parenthood: In a rule issued Friday, the Trump administration issued new rules making clinics ineligible for Title X Family Planning funds unless they are physically and financially separate from abortion providers. This ruling hits Planned Parenthood especially hard. Undoubtedly these changes will be challenged in the courts.

Read the article

Chemicals in e-cig flavors could harm respiratory tract: Flavoring chemicals that have been regarded as safe were found to be harmful when inhaled. In recent lab experiments, “diacetyl - a chemical with a butter-like smell - and its ‘chemical cousin’ 2,3-pentanedione” were found to cause genetic damage in the cells that line the respiratory track. This study adds further evidence that e-cigarettes are not safe.

Read the article

These Are the World's Healthiest Nations:The Bloomberg Healthiest Country Index is now out. Spain took the #1 spot from Italy, which is now #2. The US is down one spot at 36- one below Costa Rica and six below Cuba. Health systems, as well as healthy practices like diet, are factors the study cites for these findings.

Read the report

Association of Physician Organization–Affiliated Political Action Committee Contributions With US House of Representatives and Senate Candidates’ Stances on Firearm Regulation: The simple (though disturbing) conclusion of this research is that for the 2016 election: “Physician organization–affiliated PACs included in this study donated more funds to more US House of Representatives and Senate candidates who oppose firearm safety policies than to candidates in support of such policies.” The reasons for PAC donations are complex and include candidate stances on insurance issues and other public health matters. Still, this issue should be high on the priority of the mix of important topics that determine support.

Read the study

About pharma

Roche nears $5-billion deal to acquire Spark Therapeutics: report: In the latest case of pharma M&A, Roche will spend a reported $4.3 billion to purchase gene therapy company Spark Therapeutics.

Read the announcement

GE to sell its biopharma business to Danaher for $21.4B: The above announcement was all over the news today: but in a much even bigger deal, GE is selling its biopharma business as part of a restructuring plan.

Read the article

Novartis gene therapy would be cost effective up to $900,000: U.S. group: The Institute for Clinical and Economic Review (ICER) calculated that Novartis’ gene therapy for muscular dystrophy would be cost effective not only at the target price of $900,000 but also up to $5million. These findings raise many questions about how much is available to spend on healthcare. It is unlikely countries with national budgets for healthcare (everyone but the US) would pay so much. We will need to see how this pricing plays out in the public and private sectors.

Read the article

Senators Introduce Bill to Prevent Using Native American Tribes to Shield Patents: Last year, Allergan cut a deal with the St. Regis Mohawk tribe to protect its patent on Restasis. The legal theory is that native tribes have their own sovereign immunity that gives them special status with respect to patents. Several Republican senators have introduced a bill to take such legal maneuvers off the table.

Read the article

About human resources

Changes in Burnout and Satisfaction With Work-Life Integration in Physicians and the General US Working Population Between 2011 and 2017: Physician shortages are due to both supply and demand problems. On the supply side, physicians have either been leaving practice or cutting back due to “burnout.” The good news is: “Burnout and satisfaction with work-life integration among US physicians improved between 2014 and 2017, with burnout currently near 2011 levels.” The bad new is physicians are “at increased risk for burnout (odds ratio, 1.39; 95% CI, 1.26-1.54; P<.001) and [are] less likely to be satisfied with work-life integration (odds ratio, 0.77; 95% CI, 0.70-0.85; P<.001) than other working US adults.”

Read the research

Healthcare Executives See a Mixed Outlook: Physicians are the toughest recruits for healthcare organizations but nurses, other healthcare professionals, as well as administrators are also in short supply.

Read the study from JP Morgan

About healthcare IT

Data error exposes patient information: In the latest case of large data breaches, the University of Washington (UW Medicine) announced that a vulnerability in their system exposed Protected Health Information of about 974,000 individual patients.

Read the announcement

Epic Systems Remains Top Overall Software Suite in KLAS Rankings: The annual KLAS rankings are out for software systems. While Epic Systems remains best overall, each category has its own best product.

Read the article
Read the rankings (signup required)

About healthcare quality

Health plan solutions can help improve patient care, but will providers adopt them?: Physicians trust heath plans only a bit more than pharma companies (which have the lowest low scores). Yet plans need their cooperation to improve patient quality outcomes. What can be done?
A recently released Deloitte survey said that compliance and cooperation are fostered if the plans offer providers assistance, like help with care coordination and chronic care management. Also, providers would like certain benefits in return for their participation, including reduced preauthorizations and preferred status in the plan’s network.

Read the study

Factors Associated With High-Quality Guidelines for the Pharmacologic Management of Chronic Diseases in Primary Care: This article points out the need for clinical research to make sure what we do is evidence-based. The authors of this literature review found that clinical practice guidelines (CPGs) in primary care “are of widely variable quality, with less than 25% of included CPGs rated as high quality. “

Read the research

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.”

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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?

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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.

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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.

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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.

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‘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.

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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.

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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.

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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.

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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.

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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.

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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.

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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?

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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.

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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.

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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.

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 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.

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