Today's News and Commentary

About the public’s health

Meeting Individual Social Needs Falls Short Of Addressing Social Determinants Of Health: On the continuing theme of addressing social determinants of health, this article is a nice summary that defines terms and gives examples of initiatives.
Read the article

Kaiser Permanente Unveils Housing Program to Address SDOH: Picking up on the theme of the previous article, this one provides an in-depth explanation of what Kaiser is doing in Oakland to address homelessness.
Read the article

Appropriateness of outpatient antibiotic prescribing among privately insured US patients: ICD-10-CM based cross sectional study: Inappropriate prescription of antibiotics is a major problem that has led to increased pharmaceutical costs and emergence of drug-resistant bacteria. How big a problem is it? According to this study: “Among all outpatient antibiotic prescription fills by the cohort, 12.8% were appropriate, 35.5% were potentially appropriate, 23.2% were inappropriate, and 28.5% were not associated with a recent diagnosis code.” But the data was gathered using diagnosis codes. The accuracy of coding is notoriously poor; for examples: coding the wrong precise code, but listing a related diagnosis because it is quicker to retrieve; coding a more severe diagnosis to justify treatment and possible higher billing codes; or forgetting to add a diagnostic code when the patient was seen for more than one reason. Read the study and draw your own conclusions about its accuracy.
Read the study

Medscape National Physician Burnout, Depression & Suicide Report 2019: Given the shortage of physicians in many specialties and geographic areas, it is important to retain those we have. Yet the stresses of practice can be overwhelming. According to this survey, “burnout has been defined as long-term, unresolvable job stress that leads to exhaustion and feeling overwhelmed, cynical, detached from the job, and lacking a sense of personal accomplishment.” 44% of surveyed physicians reported having those feelings with another 15% reported feeling depressed. The results varied by specialty, ranging from a high of 54% for urology to a low of 28% for public health and preventive medicine.

Read the report for more details on reasons for burnout and what physicians are doing about it

About information technology

Apple is in talks with private Medicare plans about bringing its watch to at-risk seniors: The watch can now detect changes in heart rhythm (such as atrial fibrillation) and falls. It can also tally the number of steps the wearer takes. Are these benefits worth the cost ($399)? Should the watches be given to all seniors or be available only for those at high risk? When does the information capability violate privacy? What happens when insurance companies require members to wear this or similar devices as a condition of insurance (or incur a large penalty/increased premium for not doing so)?
Read the article

About pharma

The FDA has five weeks till money runs out for approving new drugs:Pharma companies may be hard hit if the budget crisis is not resolved. The FDA has stretched its resources but only has five weeks of funding left to review new drug applications (NDAs). The patent protections, however, continue to run- meaning the lost revenue by delayed approval could be substantial.

Read the article

Forget to take your medication? A new digital pill will alert you — and your doctor: Patients do not always take their medications. Reasons vary from high costs to being unable to open the bottle. This technology targets patients who do not take their medication- leaving the reasons to be determined. After they are ingested, pills containing sensors will transmit to a receiver on the abdomen. The receiver will then transmit via a mobile app to the physician.

Read the article

About insurance

Medicare Advantage industry sees slower growth for 2019: Despite “slower growth,” Medicare Advantage plans added 1.4 million more members in the past year. Now about 22.4 million beneficiaries belong to these private plans. The article has more details about growth and who the major players are.

Read the article

Today's News and Commentary

About pharma

Gottlieb Says User Fees Will Pay for Post-Market Surveillance Amid Shutdown: As previously mentioned, the budget impasse has affected FDA activities. One activity not mentioned is the so-called Phase IV studies, i.e., post-marketing surveillance for adverse drug problems. Since there is not money available for this important activity, FDA Commissioner says the user fees (normally used for drug approvals) will be diverted for this purpose.

Read the announcement

Rising Drug Prices Said to Strain Hospitals, Force Budget Cuts: I have commented on the issue in previous posts, but this article summarizes a recent NORC survey of 4200 hospitals. The two main problems are rising costs and shortages. The article also highlights that the increased costs are forcing some hospitals to cut back on expenses for key functions, like staffing.

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Fragile pharmaceutical supply chain increases costs, compromises care: On the same theme as the above article, this one also draws on the NORC study but focuses more on the shortages and how hospitals are “massaging” the supply chain to alleviate the problem.

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Walmart Could Leave CVS Caremark Pharmacy Networks Amid Dispute: CVS Caremark is a pharmaceutical benefit manager (PBM) that uses Walmart pharmacies as outlets. (It also uses CVS pharmacies). The two are now set to split as early as February. According to the article, the reasons are in dispute but one is that Walmart is raising its fees for filling prescriptions. The Walmart outlets are a small part of the CVS PBM but it will be interesting to see if these giant companies can come to terms.

Read the article
About information technology

Approaches and Challenges to Electronically Matching Patients’ Records across Providers: This report is from the Government Accountability Office. Everyone agrees on the benefits of being able to link patient medical records from a variety of sources and also agrees that computer system interoperability problems impede that effort. One issue being avoided is using a single patient identifier to help with this linkage. The single identifier was part of the HIPAA data standardization but was removed over privacy concerns. There is good reason for this concern given the large numbers of people involved in data breaches. Until security issues are largely resolved and the public feels comfortable, patient information will probably not flow seemlessly.

Read the GAO report
Read a commentary

2019 Interoperability Standards Advisory: Continuing the theme of interoperability, the Office of the National Coordinator has issued standards for nomenclature. This document is very technical but is worth a cursory look-through to get an idea of the extent of what interoperable data needs to look like. It also highlights that data sets are overseen by different organizations.

Read the report

About insurance

Optum breaks $100B in revenue for the first time, boosting UnitedHealth's growth in 2018: Somehow I think this headline should read “tail wags dog.” United Health Group started out as an insurance company- now called United Healthcare. It added another division (now called Optum) to furnish support services for health insurance companies- including banking for Health Savings Accounts, actuarial services and analytics. This year Optum broke $100B in revenue for the first time and accounted for a significant portion of its parent’s profitability.

Read the announcement

Today's News and Commentary

About the public’s Health

Ten threats to global health in 2019: This list from the WHO ranges from the very specific (Dengue) to general system issues (weak primary care systems). Perhaps these threats will provide opportunities for entrepreneurs.

Read about the list

Seven in 10 Maintain Negative View of U.S. Healthcare System: In the latest Gallup poll, 70% of those surveys said the US healthcare system was in crisis or had major problems. Of not is that this figure has been largely unchanged for the past 14 years. A surprising finding is that despite Republican calls to dismantle the ACA and Democratic attempts to protect it, 84% of democrats have a negative view of the system while only 56% of Republicans share that opinion. Of course peoples’ opinions about “the system” have always been at odds with their personal experiences.

Read the study

CVS pledges $100 million for community health programs: On the heels of its purchase of Aetna, CVS is launching Building Healthier Communities “ to improve access to affordable health care, manage health challenges like chronic conditions and opioids and partner with communities.” CVS has been very proactive about health initiatives- recall the company removed cigarettes from its stores for health reasons.

Read the announcement 

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FDA resuming some food inspections halted by shutdown: As previously reported, because of the budget impasse, the FDA stopped inspecting domestic food plants. The agency announced that it will resume inspections for such “high risk” items as cheeses, produce and infant formula.

Read the announcement

About pharma

Want to win over payers, pharma? Forget the 'me-too' drugs, CSL chief says:The title of the article says it all: be innovative if you want payers to support your R&D pipeline. One tactic not mentioned is to ask payers what they need for their members.

Read the interview

Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: Platelet inhibitors (like Plavix) are used to prevent recurring heart attacks and strokes. These medicines can be costly, however. In this study, investigators found that use of coupons to help with expenses “increased persistence with a guideline-recommended therapy but did not improve clinical outcomes at 1 year.” Pharma marketers claim coupons increase affordability so patients will fill their prescriptions and improve their health. We need to see a longer term effect of coupons before the practice is stopped for lack of healthcare improvement evidence.

Read about the study

Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs:One way the federal government has tried to save Medicare from going bankrupt is by playing a shell game- shifting benefits from one part to another. The latest is a proposal to shift some Medicare Part B pharmaceutical costs to Part D. Drugs now under Part B include those administered in a physician’s office (like chemotherapy or immune system modulating medications); they are subject to a 20% coinsurance covered by supplemental insurance policies. Part D is the self-administered drug program purchased by Medicare beneficiaries and subject to different types of out of pocket expenses, depending on the plan.
This study’s results say that the government will save money by making these changes but they may cost patients more. The authors call for changes where both CMS and patients benefit.

Read the study

Today's News and Commentary

About pharma

Ohio Passes Law Allowing EpiPen Alternatives: While the specifics of this article are not important, the overall issue is: whether pharmacists can substitute medications with or without permission of the prescribing physician in order to save money. Different jurisdictions in the US (and other countries) have different laws with respect to this action. Do you know what is allowed where you live?

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Italian Agency Hits Chinese Heparin Manufacturer for GMP Violations: This article is another reminder that India and China are the world’s leading sources for raw materials that go into pharmaceutical manufacturing. China was the source of the heparin contamination that hit Baxter several years ago.

Read the announcement

About hospitals

Hospitals' solution to surprise out-of-network bills: Make physicians go in-network: Patients ending up in hospitals that are contracted with their health plan often receive bills from physicians who have not signed such agreements. The problem is that many hospitals have not insisted that physicians who practice full time in the institution sign up with the same plans as the do. These physicians include practitioners in pathology, radiology, anesthesiology, and emergency medicine. Now some hospitals are finally catching on and requiring such arrangements.

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Memorial Sloan Kettering Curbs Executives’ Ties to Industry After Conflict-of-Interest Scandals: What happens when a hospital executive (particularly a physician) is a highly compensated board member of a healthcare company and a conflict of interest arises from those dual roles? This situation unfolded in the past few weeks at Memorial Sloan Kettering. This new policy addresses the outside activities.

Read more about this story and hospital policy

Just looking for a problem? That's Providence St. Joseph's strategy for its new $150M venture fund:Since at least the 1980s, hospitals diversified their services and investments in an attempt to capture additional revenue. These investments ranged from real estate to starting their own health insurance companies. Now one hospital has started its own venture fund.

Read the story

About insurance

Judge pauses appeal of ObamaCare ruling, cites government shutdown: Democratic state attorneys general, the House of Representatives, and the Executive Branch are all appealing the ruling that would invalidate the ACA. On Friday, the U.S. Court of Appeals for the 5th Circuit granted a pause in the appeals process because of the government slowdown from the budget impasse.

Read the story

Medicaid is reducing poverty over time, study finds: Is Medicaid having an impact on poverty levels or is it just providing health coverage for its recipients? The study, published in Health Affairs, showed that Medicaid expansion reduced the rate of poverty among states who chose to expand the program under the ACA by 0.917 percentage points, or by 690,000 people. The reduction in poverty of that number of people provides another reason for program expansion.

Read the article summary

Trump Administration Plans Effort to Let States Remodel Medicaid: The Trump administration is again considering replacing current Medicaid payments with block grants. This scheme was part of the Republican’s failed attempt to repeal the ACA in 2017. Details of how the system would be implemented and its payments calculated are not yet clear. Funding would need to be approved by the House, so chances of significant overhauls are slim.

Read the article

V.A. Seeks to Redirect Billions of Dollars Into Private Care: This article was on the front page of yesterday’s New York Times. It is a well-done summary of the very long-standing debate about whether care for veterans should be privatized or stay in VA facilities. The current debate started when the last Congress passed the “Mission Act.” Its purpose was to increase access to medical care for veterans who lived far from a VA facility. Now, the current administration is trying to expand the private access to more veterans, regardless of their proximity to care. Proponents of this change will face a very powerful veterans lobby.

Read the article

Today's News and Commentary

About insurance

Senator Ben Cardin seeks to expand Medicare to include dental benefits: Medicare does not pay for dental benefits; nor does any private health insurance plan (unless problems are due to trauma or medical conditions). Recognizing that dental care is important for proper nutrition and overall health, from where is the money for these services coming? The proposal claims it will pay for itself in longterm savings. We have heard that one before.
Read the announcement

About information technology

Annual Update on the Adoption of a Nationwide System for the Electronic Use and Exchange of Health Information: The Office of the National Coordinator has submitted to Congress its annual report. Briefly, it says interoperability is still a problem and “we’re working on it.” The news here is that there is nothing new or groundbreaking that will finally have a significant impact on interoperability.

Read the report

Walgreens Tests Digital Cooler Doors With Cameras to Target You With Ads: Although this technology is geared to purchasers of soft drinks from the drugstore coolers, it raises issues about what else is being monitored. For example, if you go to a Walgreens and pick up a prescription, then get a drink from the cooler, are those two purchases linked? Read the article and think about other privacy issues as your preferences are tracked in a pharmacy.

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AI approach outperformed human experts in identifying cervical precancer: A NIH-developed algorithm does better than physicians in visually identifying precancerous cervical disease after acetic acid application. This visual inspection can link to the algorithm via cell phone/camera, so it can be used in areas remote from medical care. Obviously, medical followup must be available if an abnormality is found.

Read the announcement

About the public’s health

Total Fertility Rates by State and Race and Hispanic Origin: United States, 2017: This annual CDC document reveals that the US has its lowest birthrate since 1978. However, average statistics are not valuable because of the large geographic and racial differences. (The report has maps showing these divisions by state.) This document is an important planning source for healthcare professionals ranging from those in public health to marketing managers.

Read the report

About pharma

Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs: File this one under “old wine in new bottles.” Louisiana’s plan is to pay pharmaceutical companies a subscription fee in return for access to medications when needed by patients. This model was named after Netflix because of the subscription financing. More than 25 years ago, managed care organizations paid Pharmaceutical Benefit Management (PBM) companies a per member per month fee in return for unlimited pharmaceutical use. Many arrangements had upper and lower limits to the deals whereby PBM profits and losses were limited. It is nice to see that one more good idea from the past has been rediscovered.

Read the article

Today's News and Commentary

About the public’s health

Antibiotic Prescribing for Children in United States Emergency Departments: 2009–2014: This study found that when children go to a non-pediatric ER, they are more likely to receive inappropriate antibiotics. What to do with such information? Increase pediatric ERs or enhance training of all ER physicians to prescribe appropriately?

Read the original article

Social Determinants of Health Key to Value-Based Purchasing Success: I have previously written about the importance of considering social determinants in caring for individuals and populations. This article is a nice overview of this topic and highlights the need to incorporate social determinant dimensions when designing and evaluating value-based services.

Read the article

Associations of Income Volatility With Incident Cardiovascular Disease and All-Cause Mortality in a US Cohort: 1990 to 2015: Associations between health and wealth, as well as socioeconomic status are well-known. This study takes those concepts a step further. The volatility of income also plays a role, increasing morbidity and mortality by nearly twofold.

Read the original article

Government shutdown: In addition a previous blog entry about the effect of the shutdown, add two more problems. FDA Commissioner Gottlieb has resorted to Tweets to communicate important messages, such as drug recalls. Further, according to the Washington Post, the FDA, “which oversees 80 percent of the food supply, has suspended all routine inspections of domestic food-processing facilities…” The irony is that imported food will still be examined. So much for encouraging purchase of American products.

About pharma

Partisan stances remain on how to lower drug costs: Today Sen. Bernie Sanders is set to announce the liberal Democratic plan for reducing drug prices. Measures are expected to include: pegging prices agains international benchmarks; CMS contracting directly with pharma manufacturers to get best prices (rather than relying on on private Medicare Part D plans to do so); and allowing Americans to import “safe” drugs from other countries. On the other side of Congress, Republican Senator Chick Grassley (who is chair of the senate finance committee) has come out against direct negotiations with manufacturers.
These two opposing stances on drug company negotiations have been going on since passage of the Medicare Modernization Act (MMA) in 2005, which created the Part D program. Democrats have always favored federal purchasing while Republicans have defended the ability of “free markets” to control prices. If Democrats gain control of both chambers and the White House in 2020 we may see their wish become reality.

Read about the Sanders proposal

Read about the Grassley statement

Prescription Drug Pricing: An Overview of the Legal, Regulatory, and Market Environment: Continuing the above theme, this paper, from the American Enterprise Institute, is an excellent topical review.

Read the monograph

‘Marketers are having a field day’: Patients stuck in corporate fight against generic drugs: In a Washington Post front-page story today, reporters tell how drug companies are spreading stories that generic biologically-derived drugs are inferior to the branded versions. In an interview, FDA Commissioner Scott Gottlieb said: “I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of unbranded biologic drugs… The messages “can potentially undermine consumer confidence in biosimilars in ways that are untrue.’’
Of course, the motive is profit. How much is the difference if the generics are used? According to the article, “savings to the U.S. health-care system that have been estimated at $54 billion to more than $200 billion over 10 years.”

Read this in-depth article

Novartis puts AI on the job to help reps say the right things to the right doctors: Continuing a theme of marketing, Novartis’ pharma CEO Paul Hudson announced at this week’s annual JP Morgan conference that the company is using artificial intelligence in its marketing efforts, but in a novel way. The AI
will help drug reps  “plan better, move better and make sure when they show up to see a healthcare professional, they are talking about the things that the healthcare professional is absolutely interested in…” Perhaps in addition to educating themselves about their products, salespeople will have to bone up on certain sports or esoteric hobbies that interest their customers.

Read the article

New strategy may curtail spread of antibiotic resistance: Antibiotic resistance has become a huge health problem worldwide. This phenomenon relies on bacterial ability to share genes in small packages (called plasmids) that confer the protection. If the plasmids can be modified so they cannot be spread among bacteria, resistance can be reduced. This article explains what researchers at Washington University are doing in this area of research. It could create a new category of antibacterial agents that would be used with traditional antibiotics.

Read the announcement
Read the original article (Subscription required but the abstract is available)

Today's News and Commentary

About pharma

Medical Marketing in the United States, 1997-2016: This article is a nice review about how much medical marketing has grown in the US, despite restrictions on direct physician marketing practices. According to the research:
”From 1997 through 2016, spending on medical marketing of drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 to $29.9 billion. The most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016. DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies.” Sadly, one of the authors, Dr. Lisa Schwartz recently died.

Read the original study 
If you cannot access the original, read the Kaiser Health News comments

Drugmaker Eli Lilly to start publishing list prices of drugs: In October, members of the trade group PhRMA agreed to post prices for advertised drugs. But the prices are so different among pharmacies and insurance plans that it would be impossible to give the information in a short commercial message. (Recall that side effects must also be given.) So companies are going to give website addresses and toll-free numbers where patients can get an idea of what the medication might cost. Lilly has touted itself as the first company to comply with this industry guideline by making prices about its diabetes treatment Trulicity available.

Read the article

Prescription Drug Costs Driven By Manufacturer Price Hikes, Not Innovation: Recall that expenses are driven by price, volume and intensity (in this case, innovation). The study quoted in this article from Health Affairs(Subscription required) concluded that: “The rising costs of generic and specialty drugs were mostly driven by new product entry, whereas the rising costs of brand-name drugs were due to existing drug price inflation.” It should be noted that drug costs will be higher if enough people who should be taking medication were doing so- particularly for diabetes and high blood pressure.

Read the commentary article

New California governor tackles drug prices in first act: New California Governor Gavin Newsom has already started to shake up the healthcare landscape. He announced that instead of using managed care models, the state would act as purchaser for all 13 million Medicaid recipients. Additionally, his executive order creates a mechanism allowing “private companies and other governmental agencies to participate in the process of negotiating drug prices with pharmaceutical companies.” The entity would be the biggest single purchaser of pharmaceuticals in the US. (Read below about what is happening with insurance in California.)

Read the article

About information technology

Rush working with AT&T to be the first 5G-enabled U.S. hospital: The latest push in technology is implementation of 5G-enabled equipment that will greatly increase speeds of transmission. This technology can help in the healthcare field by, among other activities, enhancing telemedicine and device communication capabilities. The joint venture should be carefully followed to assess the future of this advance on healthcare delivery.

Read the article


About the public’s health

Facts & Figures 2019: US Cancer Death Rate has Dropped 27% in 25 Years: Now some good news. The reasons for this drop are not only increases in early detection and treatment, but reductions in smoking. But like many other health statistics, the results show benefits are uneven in the population.

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Prevalence of and Factors Associated With Patient Nondisclosure of Medically Relevant Information to Clinicians: Technology and delivery systems will not help healthcare if patients lack trust. This article looks at what patients withhold and why. “ …most participants reported withholding at least 1 of 7 types of medically relevant information, especially when they disagreed with the clinician’s recommendations or misunderstood the clinician’s instructions. The most commonly reported reasons for not disclosing information included not wanting to be judged or hear how harmful their behavior is.” In one of the two studies reviewed in this article those most likely to withhold information were female, younger, or had worse self-rated health. An association was not found for: those who have a chronic illness; with educational level : or with race.

Read the original article
Read the popular media version

About insurance

Announcements about insurance expansions: As Republicans have tried to dismantle the ACA, Democratic jurisdictions have come up with their own plans to extend benefits to the uninsured. These efforts now include California, Washington State and NY City.

Read the article about NY City
Read the article about California
Read more about the Washington announcement

Today's News and Commentary

This week is the 37th annual JP Morgan Healthcare conference, a large meeting about the healthcare industry.

For updates and keynote addresses see this website

About pharma

FDA plans to create a new office to leverage cutting-edge science: The FDA will be launching a new 52-person group, called the Office of Drug Evaluation Science (ODES). It will be part of “the Office of New Drugs, which is itself part of the FDA’s Center for Drug Evaluation and Research [CDER}, which oversees the approval of new medicines.” Its tasks will include a cloud-based, standardized reporting mechanism for drug development and approval applications as well as patient reporting of side effects.

Read about the announcement

All seven of the FDA’s recent commissioners agree it should be independent — but not on how to accomplish it: The FDA is part of the Department of Health and Human Services (DHHS). Both the DHHS Secretary and FDA Commissioner are political appointees. The seven recent FDA commissioners recount how they faced political pressures in their job and call for an independent agency. While the likelihood of independence is slim, this important agency must be able to make decisions based on science rather than politics.

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Live Attenuated Influenza Vaccine: Will the Phoenix Rise Again? Every year, pharma companies try to anticipate the viral strains that will cause illness in the upcoming flu season. This projection allows for manufacture of appropriate vaccines. Many different vaccine versions are available. One of the differences among products is between the inactivated injected vaccine and the live attenuated version that is inhaled through the nose. Last year, the CDC did not recommend the inhaled version because it lacked effectiveness. For this flu season it is back on the approved list. This article (an editorial about the subject in Pediatrics) highlights the importance of annual evaluation of these vaccines. While I do not endorse one product over another, it has always been OK to get an inactivated form. The choice is yours in consultation with your physician. By the way, research is still ongoing for a “universal” flu vaccine that will not depend on the seasonal strain.

Read the article

Report: Drug prices drive up insurance premium costs: Yesterday I reported the California study about specialty pharmaceuticals causing rapid rise in drug prices. I mentioned that the situation was similar in other states. Coincidentally, this article verifies that assertion for Vermonters. “Using average wholesale prices as of January 2018, the care board found that prescription drugs accounted for $81.65 in monthly premium charges per consumer. That’s up 11.4 percent from the previous year.” Again, specialty pharmaceutical were largely responsible for those figures.

Read the article

Life, Death and Insulin: This article is a great piece of investigative journalism and commentary from the Washington Post. It summarizes what happens to diabetics when they can no longer afford their insulin. The problem is that the price of this essential medication has been rising rapidly. It raises the issue of what has been called value-based pharmaceutical benefits. Some advocate that life saving or sustaining medications should be available at no cost to patients. Other medications with less critical value should have graduated out of pocket spending requirements. Other countries (like Italy ) already tier their medication payments in such a fashion. Unfortunately this country does not even allow cost-effectiveness to be a criterion for drug approval. We have a long way to go before we are philosophically ready for value based payments.

Read the article

IPO bonanza as biotechs get in while the iron’s hot (or before it cools): For years, many viewed biotech companies as a separate industry from large pharma. Industry experts, however, knew they were just part of the business’ s spectrum. With more acquisitions, this expert opinion is becoming more obvious. Further, the recent stock market downturn has not seemed to dampen IPO interest. This article highlights some of the current and upcoming activities in this field.

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How Takeda's $62 Billion Shire Deal Reshapes Pharma World: Continuing the theme of large acquisitions was this announcement yesterday. The article is a nice summary of what is happening in the field and the new list of the biggest players..

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Measuring the return from pharmaceutical innovation 2018: One reason for the mergers and acquisitions is that R&D productivity had markedly declined and companies are looking outside for new products. This annual Deloitte report quantifies this problem: “R&D returns have declined to 1.9 percent, down from 10.1 percent in 2010—the lowest level in nine years. Returns have been impacted by the growing cost of bringing a drug to market which now stands at $2,168 million – almost double the $1,188 million recorded in 2010.” Are the benefits of these combinations sustainable or are they short-term fixes?

Read the report

Civica Rx adds 12 more health systems, including NYU Langone, Memorial Hermann: To combat rising pharmaceutical costs, last year some hospitals got together to form a generic drug company called Civica Rx. The number of participants is now up to 750. Read this summary of where this venture is now.

Read the article

Court Rejects Trump’s Cuts in Payments for Prescription Drugs: In 2005 the Medicare Modernization Act changed the way outpatient pharmaceuticals were paid- from an Average Wholesale Price basis to 106% of the drug’s national average sales price. Providers (such as hospitals and Federally Qualified Health Centers) who care for uninsured and large proportions of Medicaid patients can purchase pharmaceuticals from manufacturers at a large discount and bill insurers at retail rates under what is called the 340B plan. Last year the Trump administration unilaterally cut 340B payments from 106% to 77.5% of average sales price. Washington DC federal district court judge Rudolph Contreras ruled that this cut overstepped executive authority. According to the article: Under the Medicare law, Judge Contreras said, federal officials have the power to “adjust” reimbursement rates. But, he said, they abused that power and “fundamentally altered the statutory scheme established by Congress for determining” reimbursement rates. [HHS Secretary] Azar “may either collect the data necessary to set payment rates based on acquisition costs, or he may raise his disagreement with Congress,” but he may not circumvent the mandate of Congress… The government had acknowledged that it did not know the precise amount of the difference between what hospitals were paying for the drugs and what Medicare was reimbursing them.

“The court is still considering how to compensate hospitals for the money lost, estimated at $1.6 billion for last year.”

Read the article

About the public’s health

Medicaid plans cover doctor visits, hospital care—and now GEDs:Picking up on a theme I have mentioned before- social determinants of health- this article highlights another way insurers can help their members. “AmeriHealth Caritas, a Philadelphia-based insurer with 2 million Medicaid members in Pennsylvania and five other states, helps connect members with nonprofit groups providing GED test preparation classes, offers telephone coaching to keep members on track and pays the testing fees.” Maybe the model can be expanded.

Read the story

About quality

Association of Extending Hospital Length of Stay With Reduced Pediatric Hospital Readmissions: Readmission rates are a measure of hospital quality of care. This retrospective study looks at the association between length of stay and readmission rates for pediatric patients across diagnoses. Only 6 diagnoses were found to have higher 15 day readmissions with shorter initial hospital stays. However, the authors concluded that: “the number of additional hospital bed-days and costs needed to avoid 1 readmission may neither be reasonable nor cost-effective to pursue.” For example, for newborns with high bilirubin,  “134 additional hospital bed-days and $104 000 were required to prevent 1 readmission.” Their final recommendation was: “efforts to avoid readmissions should focus on other aspects of hospital discharge care.”

Read the original article (Subscription required)
Read a media summary

Two-Year Evaluation of Mandatory Bundled Payments for Joint Replacement: Continuing the theme of cost/quality issues, this study looked at the Medicare program, which requires bundled payments for hip and knee replacement surgeries. The good news is that in the first two years of this initiative, “there was a modest reduction in spending per hip- or knee-replacement episode, without an increase in rates of complications.”

Read the study

Today's News and Commentary

About marketing:

2019 Healthcare Consumer Trends Report: Healthcare providers are increasingly focused on patient perceptions when designing products and services. This thoughtful report has some interesting insights, especially: “51.3% of patients say that convenient, easy access to care is the most important factor in their decision-making. Convenience matters more than brand reputation (39.8%), more than quality of care (34.6%), more than the interpersonal conduct of doctors and nurses (44.2%)—even more than insurance coverage (46.4%). In fact, 80% of patients say that they select providers based on convenience factors alone”. Do patients assume providers are interchangeable with respect to quality?

Read the report

About insurance

The $9 Billion Upcharge: How Insurers Kept Extra Cash From Medicare: In this front page Wall Street Journal article, the authors document the systematic overestimation of expenses when companies involved in Medicare Part D (drug benefit) submit their bids to CMS. These bids include administrative expenses as well as profits. If expenses turn out lower than estimates, the companies keep a portion of the overage. They are at risk for some of the losses should they occur. However, so far the industry has reaped $9 billion extra. This article does a great job of investigative journalism and explains the process very well. One further piece of data not in the article: Future Medicare Part D liabilities are more than those for Social Security.

Read the article(Subscription required- but worth finding the article)

About the public’s health

Prevalence and Severity of Food Allergies Among US Adults: Ask adults if they have a food allergy and about one in five will answer yes. But only about 11% of the population truly has a true allergy. The article claims this misinformation causes unnecessary lifestyle restrictions and possible adverse nutritional consequences. Authors call for better documentation of these allergies through testing.

Read the article

Health advocates say schizophrenia should be reclassified as a brain disease: Other than the specific recommendation in the title, this article highlights the importance of definitions and framing in healthcare. How we define and classify a disease determines (among other things) how research is done, how treatment is funded and who provides the care. For example, epilepsy is caused by “electrical” phenomenon in the brain and is considered a neurological disease treated by neurologists. Schizophrenia is a “chemical” disease in the brain considered to be a psychiatric disease treated by psychiatrists. These differences are the result of tradition…with modern understanding should we change the models?

Read the article

About devices

The FDA is still letting doctors implant untested devices into our bodies: This article highlights the problems with medical devices that the FDA approves based on older technology- 510(k) process. The problem is that these devices may be truly new and have unanticipated adverse effects or are based on outmoded treatments. The overarching issue, however, is the FDA’s bringing products to market as soon as possible so they can benefit patients versus assuring their safety. This is a great summary of this problem.

Read the article

About pharma

5 Things About the Orphan Drug Act: January 4 was the 36th anniversary of passage of the Orphan Drug Act. The purpose of this legislation was to give pharma companies financial incentives to develop drugs for “rare” diseases. One problem is that drugs can be used for more than one reason. If only one is an orphan indication, the manufacturer receives benefit for all uses. This article summarizes where we are now with the results of the Act.

Read the article

Johns Hopkins, Bristol-Myers must face $1 billion syphilis infections suit: In 2010 a professor at Wellesley College discovered that in the 1940s, experiments were conducted in Guatemala on patients with syphilis to test penicillin’s effectiveness. These experiments were echos of the Tuskegee Study, in which African American men were observed for progression of their syphilis long after penicillin was available. The court decision says that the trial may progress to the discovery phase.

Read the article

Insurers blame specialty drug costs for rising premiums. This report from California shows why: This study from California reflects a national trend: “Specialty drugs made up about 3% of prescriptions in California in 2017 but accounted for more than half of the prescription drug spending that year.. insurers reported that per member per month [pmpm] drug spending reached about $81 last year, or about 16.5% of premiums in 2017…” Specialty drugs (like biologicals) are driving the pharma cost trend. Without the ability to approve drugs based on cost/benefit criteria, these costs will continue to rapidly rise. To put these costs into another perspective, the pmpm spending in many cases is more than what is paid to primary care physicians in capitated arrangements.

Read the article

Today's News and Commentary

About healthcare professionals

4 Physician Assistant Trends to Watch in 2019: The US faces uneven physician shortages: by specialty and geography. One way we are attempting to address this problem is by using what used to be called “physician extenders,” such as nurse practitioners and physician assistants. One of the areas of need is primary care. Yet only about 20% of physician assistants are in family medicine and general practice. As this growing field saturates, we will see if these professionals help fill the specialty shortage needs. It is unclear how they will address the geographic problem.

Read the article

Dealmaking stayed hot in 2018, with a focus on physician practices: Most of the healthcare deals last year focused on hospital, insurance and pharma mergers/acquisitions. Physician practices were also a hotbed of activity. Purchasers ranged from hospitals systems to insurance companies to private equity firms. This article provides a good overview of this trend, which is on track to continue in the coming years.

Read the article

About insurance

House Democrats plan to hold hearings on Medicare for All: Liberal Democrats have been talking about this program for sometime. Now, new (returning) House Speaker Pelosi has given her endorsement to the idea of holding hearings on the matter. No one disagrees that everyone should have health insurance. The problem is when they realistically come up with the costs of an open-ended system that is based on volume of services rendered and with no consideration of evaluations of the benefits of new technology. By the way, future liability for Medicare is $29.2 trillion and Social Security is $19.8 Trillion. Neither are “funded,” meaning it is a future promise without the current money to deliver.

Read the article

Final Healthcare.gov enrollment numbers show drop due to cancellations: While analysis about the details is a couple months away, CMS says ACA exchange enrollment was down 4% from the previous year- about 2.1 million new customers and about 6.3 million renewals. As mentioned in a previous blog, it is unknown whether these figures are good or bad news. Are people opting out of insurance entirely or signing up for short term coverage, or are more people covered by employer-sponsored plans due to increased employment? Wait until March to find out.

Read the announcement

DOJ Reclaimed $2.5 Billion from Healthcare-Related False Claims Cases in Fiscal 2018: Healthcare fraud continues as an important added expense of our healthcare system. It is one more result of the fact that we largely pay by volume rather than value. As a thought experiment, think about how you would commit fraud in a capitated system.

Read the announcement

House Democrats vote to defend ACA in court — and jam Republicans: Continuing yesterday’s post about the House’s intent to join in the appeal over the ACA, representatives voted to make the action official.

Read the story


About hospitals

AHA data show hospitals' outpatient revenue nearing inpatient:The gap between hospital inpatient and outpatient revenue has narrowed over a number of years. Those figures are now closer than ever. There are many reasons for this trend: inpatient revenues have decreased or been flat as outpatient revenues (particularly diagnostics) have grown rapidly. Further, technology had allowed more procedures to be done on a same-day basis. According to The American Hospital Association's 2019 Hospital Statistics report (which analyzes 2017 data), “hospitals' net outpatient revenue was $472 billion and inpatient revenue totaled nearly $498 billion… creating a ratio of 95%, up from 83% in 2013." Many people expect outpatient revenue to surge past inpatient revenue in the near future. Is the core function of inpatient services now intensive care?

Read the story [Subscription required]


Hospitals See Opportunity in Bringing Care Facilities to Patients: Many hospitals and healthcare systems have expanded through merger and acquisition. But what if the hospital has a market niche that precludes such tactics? Past examples have included the Mayo Clinic and Cleveland Clinic expansions to other locales. This article focuses on the Hospital for Special Surgery (HSS) in NY City. In contrast to the general capabilities of the Mayo and Cleveland Clinics, the HSS’s expertise is orthopedic care. This article analyzes its strategy to open facilities in other markets. It is an interesting move since “6% of patients who visit the primary Upper East Side Hospital for Special Surgery campus come from the immediate neighborhood. Some 94% of patients who are seen by the hospital drive in or fly to the hospital.”

Read the article

About pharma

The 20 most expensive pharmacy drugs in 2018, featuring names big and small: Enough has been said about the high cost of branded pharmaceuticals. This article gives you the facts about the 20 therapies that topped the list.

Read the article

About information technology

Most U.S. patients not using online medical portals: Healthcare providers rely on patient portals as a secure method of communication. Despite this feature being a requirement for “meaningful use” of electronic records, most patients are not using this method to connect with healthcare providers. According to this article, which draws on research published in Health Affairs [Subscription required]: “Overall, 63 percent of survey participants reported not using a patient portal during the past year, and 60 percent reported not having been offered access to a portal. Nonusers were more likely to be men, aged 65 or older, to be unemployed, live in a rural location, have public insurance through Medicaid, have a high school diploma or less education and to lack a regular doctor. Similar characteristics, as well as being non-white, were seen among people who said they weren’t offered access to a patient portal.”
This article also brings to mind many studies about how an overwhelming percent of people now prefer to use online tools to access medical care and communicate with providers. If available, the methodology description of those studies will reveal that they generally rely on….yes, online surveys.

Read the article describing the research

Today's News and Commentary

About pharma

Bristol-Myers bulks up cancer portfolio with $74 billion Celgene deal: The new year is only three days old and a blockbuster acquisition has been announced. You can read the details about what the companies said were strategic reasons for the purchase. Historically these combinations have made financial sense because of the economies of scale gained by the business functions of each company. Products lose patent rights and economies of scale do not apply to R&D… So what is the attraction of megamergers/acquisitions other than “short term” revenue enhancement?

Read the announcement


About the public’s health

How the government shutdown affects health programs: As previously noted, because HHS and VA programs had been funded, the budget impasse has left governmental healthcare programs largely unaffected. Now that the the problem is dragging on, it is worthwhile to look at the areas where healthcare is affected because lack of financing :
Insuring food safety falls under the FDA, but a large part of that effort is funded by the Agriculture Department.
HHS oversees The Indian Health Service, but funding comes from the Interior Department.
”The Department of Homeland Security’s Office of Health Affairs assesses threats posed by infectious diseases, pandemics and biological and chemical attacks.”
The Environmental Protection Agency is likewise on the list of Departments whose funding is being withheld.

Read the article

Sex differences in GBM revealed by analysis of patient imaging, transcriptome, and survival data:
STOP and read!
I know this article seems really esoteric (it comes from Science Translational Medicine) but I include it to highlight a problem. By and large, clinical research has under-represented women. It was originally assumed that what was found true in men also applied to women. Many studies have shown the incorrectness of this supposition. Hormonal differences have been given as the cause of this variance. However, according to the study’s authors: “Sex differences play a role in patient outcomes, and… in the case of the brain tumor glioblastoma, these go beyond hormonal influences and appear to be intrinsic to the tumor cells themselves… the sex of the patient correlates not only with prognosis but also with responses to different treatments, suggesting that it may be an important factor to consider when optimizing the therapeutic regimen for each patient.” With the increased focus on individualized medical treatment, the patient’s sex must also be considered a biological variant.

Read the article

How far Americans live from the closest hospital differs by community type: The focus on costs and quality (including patient experience) often overshadows the problems with access to healthcare. This study highlights the access problems faced by those living in rural areas. Note the figures are averages, so many people face longer distances to get to care. Remember that not all access issues involve transportation- for example, scheduling delays also contribute to this problem.

About Information technology

Health Industry Cybersecurity Practices:Managing Threats and Protecting Patients: HHS has made cyber security a top priority for the coming year. As a result of The Cybersecurity Act of 2015 (CSA) (Public Law 114-113), a task force was convened that looked at this growing problem. This document is the culmination of this effort. It is an excellent summary and resource.

Read the task force report

11 best practices for protecting connected medical devices:This article draws on the above report to highlight the issue of peripheral device vulnerability. Diagnostic equipment as well as implantable electronics (like pacemakers) are more easily hackable than, for example, electronic records. We need to pay more attention to this oft-overlooked security exposure.

Read the list with brief explanations

HL7 Releases FHIR Version 4.0 for Healthcare Interoperability:Other than security, the biggest IT problem is interoperability. HL7 is supposed to be a platform for aiding seamless communication among different IT systems. but there are several versions of this product. One advance is Fast Healthcare Interoperability Resources (FHIR). This version claims to be a large step forward in enabling this connectivity. The reading gets technical very quickly but at some point a cursory knowledge for all healthcare management professionals is necessary.

Read the announcement

Read more about FHIR 4.0


About pharma

Aurobindo Pharma USA recalls 80 lots of blood pressure drug from America:The specifics of this article are less important than the overall message. Last year a number of drugs were pulled from the US market because of impurities. This announcement highlights the fact that a large majority of chemicals used in manufacturing of pharmaceuticals for the US market come from India and China. Further, there are large numbers of generic medicines sourced from abroad. The FDA does not have the resources to inspect all these foreign plants and so relies on local enforcement- which is often inadequate.. Until local authorities can be trusted and rapid analytic devices are developed for use at point of inspection, this perennial problem will inevitably recur.

Read the article

FDA says certain antibiotics could rupture main artery:In the mid 1980s, the quinolones came on the market as a new class of antibiotics. Use rapidly increased for such conditions as urinary tract infections and community acquired pneumonias. As early as 1983, an association between quinolone use and Achilles tendon rupture was reported. Recognition of this problem has been growing as use of this class of drugs has continued to increase. In 2008, the FDA mandated that all these products have a black-box warning. Now it appears that connective tissue in general is at risk— aortic ruptures or tears have been associated with quinolone use. The obvious message: no drug is always safe and use must include consideration of risk/benefit tradeoffs and informed patient participation in decision making.

Read the article

Give it to us straight, doctors tell pharma advertisers—but being funny is OK, too: Have you ever read an advertisement or seen a commercial on TV and asked yourself either: What was that about? or Why don’t I understand the message? The problem of understandability is also prevalent in pharma advertising. According to a recent study: “More than one-third (39%) of doctors said they are sometimes confused by messaging, and another 35% reported being overwhelmed on occasion by the language used in the ads.” Despite all the regulatory requirements advertisers face, 76% of doctors recommend the Keep It Simple strategy. Humor helps as well.

Read about the study

About quality

Merit-based Incentive Payment System (MIPS):As providers enter another year of Quality Payment Program requirements, this link provides a great resource for understanding and complying with the MIPS.

Connect to the resource

About insurance

House Democrats seek authorization to intervene in ACA lawsuit:The Democrats in the House of Representatives have crafted rules giving that body the authority to participate in appeal of the recent ACA ruling in Texas. If it passes, they will join Democratic state attorneys general in that effort.

Read the announcement

Today's News and Commentary

About information technology

In Screening for Suicide Risk, Facebook Takes On Tricky Public Health Role: This article reminded me of Dave Eggers’ book The Circle (published in 2013). It was about a tech company (like Facebook) that slowly invades everyone’s personal loves. It is a very believable dystopian vision of how our lives could come under a microscope. This NY Times piece explains how Facebook software identifies potential suicides and calls local police to intervene. It raises several questions: Is this software a medical device (which would require FDA approval)? How accurate is it? For example, how many people were incorrectly identified as suicide risks and taken for medical care unnecessarily? What is the next condition Facebook identifies that it will report to the police? One can see the potential benefit of identifying drunken selfies before the imbiber starts to drive. What about a future in which posts about binge eating lead to interventions to prevent obesity and diabetes?

Read the article

About the public’s health

NYC pharmacies can’t sell cigarettes starting Jan. 1: It has been almost five years since CVS announced it would not sell cigarettes in any of its stores. Starting yesterday, NY city pharmacies (including stores containing pharmacies- like supermarkets) cannot sell cigarettes. Store owners are worried that the reduced traffic will be very bad for business. Remember when restauranteurs gave the same argument when smoking bans went into effect for public places? Who has noticed that restaurants are less crowded? Kudos to the NYC Health Department!

Read the announcement

About pharma

Drugmakers Raise Prices on Hundreds of Medicine: As previously reported here, after apparent rapprochement with Congress earlier in 2018, more than” three dozen drugmakers raised the prices on hundreds of medicines in the U.S. on Tuesday… The average increase was 6.3%…” The issue of rising drug prices will be one where Democrats and Republicans can agree and may be the target for both parties for an early bipartisan win. We will need to see how strong the Pharmaceutical Research and Manufacturing Association (PhRMA) lobby is.

Read the report

In another record year for pharma TV ads, spending soars to $3.7B in 2018: In anticipation of price increases, drug companies increased their spending on TV ads. Since ethical restrictions and enhanced reporting of physician marketing expenses went into effect a few years ago, these companies have had more money to spend on Direct to Consumer ( DTC) advertising. How this spending will translate into increased sales is yet to be determined, especially in light of stricter health plan formulary controls.

Read the article

Special Report—2 years after sluggish 2016, new drug approvals hit their stride in 2018:
By the FDA’s count, it approved 59 NMEs [New Molecular Entities] in 2018, topping its previous record of 53 in 1996.” This effort appears to be due to increased efficiencies and somewhat relaxed approval standard for treatments for rare diseases. It is not known what percentage of applications are approved since the FDA does not report such statistics.

Read more details about these approvals

About insurance

ACA mandate gone, but a few states still require coverage: The individual obligation to have health insurance (mandate) has been linked to prohibiting insurance companies from discriminating based on preexisting conditions. If people can sign up whenever they want and insurance companies cannot screen applicants, those firm will go out of business. Since the federal mandate is gone as of yesterday, some states are imposing their own in order to maintain the market integrity for preexisting condition exclusions for insurance coverage.

Read the article.

Today's News and Commentary

Another slow news day in anticipation of New Year’s Eve.

Wishing all of you a happy and healthy New Year.

HealthcareInsights will return on January 2.

About insurance:

Obamacare, Ruled Invalid by Federal Judge, Will Remain in Effect During Appeal: Judge O’Connor, who ruled the ACA invalid, issued a stay on Saturday- meaning the law’s provisions will remain in place pending appeal by 16 (Democratic) state attorneys general. It is unclear if or how the federal government will participate in the appeal since it agreed with the judge’s opinion about the individual mandate but said it was severable from the rest of the law. The political issue remains that the Republicans don’t want to be seen as participating in removal of insurance guarantees for people with preexisting conditions.

Read the article

About research methods:

The Proposal to Lower P Value Thresholds to .005: As we head into the new year and propose resolutions for improvement, I thought this article from April would be useful. For those of you who do research or rely on “p-values” to interpret studies’ statistical significance, the author states:” the proposed reduction in the level for declaring statistical significance may dismiss mostly noise with relatively little loss of valuable information. “ He also provides other suggestions for tightening criteria.

Read the article

About the public’s health:

The Physical Activity Guidelines for Americans: Also on the theme of new year resolutions, increasing exercise is on many people’s list. This article from HHS is one of the most complete I have seen on this topic. It not only gives the health benefits of physical activity, but also how to fulfill recommendations.

Read the recommendations

About healthcare marketing:

Consumerism: The Role of Patient Experience in Brand Management and Patient Acquisition: This study by Press Ganey highlights the changing expectations of healthcare consumers as more Millennials enter survey pools. As many polls have indicated, Millennials are more experience oriented than their predecessors. A major take-away of this study is that: “Patient experience is five times more likely to influence brand loyalty than other marketing strategies.” [Emphasis in thee original]. A corollary might be that reputation alone will not carry your organization, you need to deliver on your promises.

Read the study

Today's News

About the public’s health:

Changing Epidemiology of Herpes Zoster After Vaccine Adoption in the U.S.: This study looked at the effect of varicella vaccine introduction in 1996 in the US. Two questions required answers: 1. Did the vaccine reduce childhood chicken pox and 2. Did this reduction in childhood disease lead to fewer cases of shingles in older adults? The answer to the first question is: “Among children, the incidence of herpes zoster declined in all age groups by 70% to 80%.” The answer to the second question is mixed: “Among adults age 35 and older, herpes zoster [shingles] incidence increased steadily through ages 50-55 without any clear accelerations or decelerations, whereas the rise in shingles incidence for older individuals has slowed since adoption of the herpes zoster vaccine program.” The takeaway is that we need research looking at the long-term effects of vaccines in adults- prevention in children is good, but what about their lifelong protection against those diseases?

Read the summary article (Free signup for site)

Read the original article

Patient Attitudes Toward Individualized Recommendations to Stop Low-Value Colorectal Cancer Screening:
In this research, Veterans Administration patients were asked: “If you personally had serious health problems that were likely to shorten your life and your doctor did not think screening would be of much benefit based on the calculator, how comfortable would you be with not getting any more screening colonoscopies?” The overall results were that: “many veterans have strong preferences against screening cessation even when given detailed information about why the benefit may be low.” The article details factors that positively and negatively affect the probability of agreement with the statement. Two caveats must be considered. One is demographics: those surveyed were overwhelmingly white males. Perhaps more importantly is the insurance status of this population. Because this study was in the VA system, the costs were largely covered. These types of studies need a price sensitivity component to be truly worthwhile.

Read the original research

BD Completes Molecular Portfolio For GI Infection With New Viral Panel: While this article could have been classified as tech news, the public health implications convinced me to place it here. The FDA approved this device that can, in 3.5 hours, distinguish among five viruses that cause gastroenteritis (norovirus, rotavirus, adenovirus, human astrovirus and sapovirus). Rapid identification of the cause of outbreaks can help containment efforts. The cost of this device is not clear or whether it can be used at the point of care (like a pediatrician’s office).

Read the announcement

Fight Against Superbugs at an Inflection Point in Science and Innovation: Drug resistant bacteria pose an ever-increasing public health problem. This article is a nice summary of what the FDA is doing to help address this issue- ranging from expedited approvals to supervision of safety for newly introduced medications. It is based on a talk that FDA Commissioner Dr. Scott Gottlieb gave at the Pew Charitable Trusts.

Read the article.

About quality:

Hospital readmission reduction program linked to heart failure, pneumonia deaths: Starting in 2012, CMS penalized hospitals for higher than expected Medicare readmissions for pneumonia, heart failure (HF) and acute myocardial infarction (AMI- heart attack). Readmission for these and other conditions added to the list resulted in $2billion in penalties to date. But what were the health outcomes of this program? This study seeks to answer this question by analyzing the effect of the Hospital Readmissions Reduction Program (HRRP) on 30 day post-discharge mortality for the original three illnesses.. Briefly, the research showed: “Among Medicare beneficiaries, the HRRP was significantly associated with an increase in 30-day postdischarge mortality after hospitalization for HF and pneumonia, but not for AMI.” As far as site of care, the “overall increase in mortality among patients with HF and pneumonia was mainly related to outcomes among patients who were not readmitted but died within 30 days of discharge. “ The increased rates were small (less than 0.5%) but statistically significant. These findings should still cause concern because we don’t always understand the unintended consequences of seemingly logical legislation to lower costs or improve quality. The results are also disturbing because the exact reasons for these findings are not known.

Read the announcement

Read the original article

About pharma:

A Chinese alternative medicine empire is under fire after doctors say it gave jujube tea to a 4-year old cancer patient: Regulation of drugs in the category called: “alternative and complementary medications” has been problematic for the FDA. The operative question is “When is a substance a drug” and not, for example, a nutritional supplement? Some other countries (like Singapore) regulate what is sometimes called Traditional Chinese Medicine- by and large, the FDA does not regulate them. This article highlights what happens when loosely regulated companies can market their products to the public.

Read the article

Federal judge says HHS overstepped authority in cutting 340B payments: The 340B program allows hospitals and other entities with poorer populations (such as those who are uninsured or on Medicaid) to buy pharmaceuticals from the manufacturer at a discount over prevailing true wholesale rates and charge payers their full retail prices. The “profit” here is from enhanced cost reductions not increased pricing. Since last year, the federal government has been trying to reduce payments to providers participating in the 340B program. Today, saying that HHS overstepped its authority, a federal judge issued an injunction stopping these cuts.

Read the announcement

About insurance:

Tracking Medicaid Expansion: As the year closes, it is worthwhile to track where things stand with respect to Medicaid. In addition to new expansion states (such as Virginia and Maine), there are now six states with job requirements and another ten pending approval.

See the map of what is happening nationally

The Hidden System That Explains How Your Doctor Makes Referrals: This article is from the front page of today’s Wall Street Journal print edition. It explains how, once a hospital buys a physician’s practice, it keeps track of where referral services go, i.e., if they stay in-system or not. This is an excellent explanation of contractual issues, pressures and cost differences between office procedures and the much more expensive facility-based services.

Read the article

Today's News

About the public’s health:

10 Notable Health Care Events of 2018: At this time of year everyone is publishing a ‘best of” or “most notable“ list. This list is from the Commonwealth Fund and it does a good job capturing this year’s top healthcare stories. While the topics range from legal challenges to the opioid crisis, all these issues affect the public’s health. What’s on your list?

Read the list and comments

Public Comment for Healthy People 2030: Every ten years, HHS launches a “Healthy People” campaign that outlines the country’s public health goals during that coming decade. HHS has just issued a call for comments on the next iteration of this ongoing project. This document will frame governmental initiatives through several administrations. Since all sectors of the healthcare field can be affected, it is important that everyone is familiar with its contents- not only for organizational strategy but for a concern for the public’s health.

Read the request for comments and a brief explanation of the initiative

America’s Health Rankings: Health Foundation’s 2018 Annual Report:
This report has some details about factors contributing to health (such as obesity, suicide and childhood poverty) but also some overall state rankings. At the top are Hawaii, Massachusetts and Connecticut. At the bottom are Louisiana, Mississippi and Alabama. What is implicit in this report is that there is no “nation’s health. ” There are such large state and regional differences that a national average (as reported in international rankings) is meaningless- except to highlight the disparities themselves.

Link to the Executive Summary as well as full report

CDPHP, St. Catherine's team up to house the homeless: I include this article as another example of insurance company or provider initiatives to address social issues affecting health. In this example, in Albany, NY, the Capital District Physicians' Health Plan is teaming up with St. Catherine's Center for Children to provide housing for the homeless. President Trump said he did not know what the late President George HW Bush meant by a “thousand points of light.” He should read this article.

Read the article

Sanofi's pediatric hexavalent vaccine approved by U.S. FDA: This announcement could also have been under a pharma heading; but the potential for improving the public’s health is profound. The vaccine, called Vaxelis, was developed in partnership with Merck and is designed for children aged 6 weeks to 4 years old. The vaccine covers: diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and haemophilus influenza type B. While this single shot should make vaccination more convenient (and hopefully lead to higher rates of compliance), presumably children will need to return to complete the course for Hepatitis B. This formulation is to come to market in 2020.

Read the announcement

Trump signs into law maternal mortality prevention legislation: Earlier this month, Congress passed The Preventing Maternal Deaths Act to address rising maternal mortality rates. The Act authorizes “$58 million for each fiscal year from 2019 through 2023 [to] support 33 existing states with maternal mortality review committees (MMRCs) and assist the remaining 17 states [to] develop them, as well as to standardize data collection across the country.” The measure is now law.

Read the article

About insurance:

Hospital prices are about to go public: In April, CMS announced its plan to require hospitals to post their charges. This January 1 hospitals will start complying. Many indicate they will post their
chargemasters on their websites. One caution is that these charges are a “wish list” of what hospitals would like to collect; they do not reflect what Medicare, Medicaid or contracted private insurers actually pay them. Even though the usefulness is limited, it is hard to oppose such measures because they are politically popular and explaining how they would really help the public (or not) is difficult.

Read the article

Booker Calls for Greater Transparency in Medicaid Drug Coverage Decisions: Last July, The Center for Public Integrity wrote about how drug companies are influencing physicians and their office staffs to prescribe products to Medicaid beneficiaries. Now, Senator Cory Booker (D-NJ) is calling for more transparency about how Medicaid drug coverage decisions are made. Recall that while all states provide medication coverage to this population, it is optional for them to do so and they have wide discretion in designing this benefit. It is not clear how Senator Booker’s plan would address influences at the physician office level.

Read the announcement

About quality:

Psychiatric Hospitals With Safety Violations Still Get Accreditation: On the front page of today’s print edition, the Wall Street Journal continues its series of articles criticizing the Joint Commission (JC) for not withholding accreditation for underperforming hospitals. This time, the focus is on psychiatric hospitals. The article is best summarized by its opening paragraph: “More than 100 psychiatric hospitals have remained fully accredited by the nation’s major hospital watchdog despite serious safety violations that include lapses linked to the death, abuse or sexual assault of patients, a database investigation by The Wall Street Journal has found.” The JC is authorized by CMS and private entities to accredit hospitals (and other healthcare organizations) using standardized criteria that are in line with Medicare’s “conditions of participation.” The operative question here is: when does identification of problems change from opportunities for improvement to immediate dangers for patients?

Read the article (subscription required)

About information technology:

New Tennessee Law Opens Up Telemedicine Across State Lines: Physicians must be licensed in the state where the patient resides. Functionally, it means that doctors are visiting patients not vice versa. This article provides a reminder about the Interstate Medical Licensure Compact, which facilitates cross-state medical licensure.

Read the example from this state

Today's News

About costs of care:

Estimated Nonreimbursed Costs for Care Coordination for Children With Medical Complexity: While children with complex medical conditions are rare ( <1% of the pediatric patients), they account for more than a third of health care costs for this sector. Many specialists are involved in their care, but the cost for coordinating services falls on their primary care provider- the general pediatrician. This study “tracked time spent in practicably measured nonbilled care coordination efforts” and found that “ the adjusted median estimated cost of documented activities ranged from $145 to $210” per child per month. Similar financial burdens fall on primary care internists and family medicine physicians. In other words, those earning the lowest income in medical practice bear the highest unreimbursed costs of coordinating care. Quantifying these amounts highlights the need to better balance payments to cognitive and procedural specialists.

Read the article

About insurance:

Consumer Engagement in Health Care: Findings From the 2018 EBRI/Greenwald & Associates Consumer Engagement in Health Care Survey: High deductible health plans are supposed to make patients more cost sensitive- encouraging them to shop for healthcare based on cost and quality. This study shows that persons who enroll in such plans do, indeed, engage more with their care decisions. However, the the population enrolling in these plans “ have higher income and higher education than those enrolled in more traditional health coverage;… are more likely than enrollees with more traditional health coverage to be employed full-time; and… were more likely than enrollees in more traditional health coverage to report being in very good health.” As with many other healthcare studies, sorting out the direction of causality is important before meaningful interpretation can be made.

Read the study

About information technology:

Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier: In an effort to simplify reporting requirements, HHS issued a proposed rule that would eliminate the HIPAA requirement for providers to list the patent’s health plan identifiers. The complaints about this requirement centered on the fact that providers gather insurance data by payer not specific health plan of that payer. The proposed rule is open for commentary but I cannot see who would oppose it.

Read the proposed rule in the Federal Register

Read a summary article

Feasibility of Reidentifying Individuals in Large National Physical Activity Data Sets From Which Protected Health Information Has Been Removed With Use of Machine Learning: Just when you thought HIPAA was protecting your identity… This study analyzed physical activity data gathered from accelerometers and reported to the National Health and Nutrition Examination Survey (NHANES). Data was de-identified with traditional methods. Using machine learning, one algorithm “successfully reidentified the demographic and 20-minute aggregated PA data of 4478 adults (94.9%) and 2120 children (87.4%).” While this study was focused on one type of data,  it calls attention to the ability to re-identify individuals using increasingly sophisticated software and the need for better “data scrubbing.”

Read the article

About quality:

Variation in the Quality of Head and Neck Cancer Care in the United States: While this article is very specific in focus, its results highlight a more general topic in quality studies: volume-quality linkages. For many conditions, high institutional and/or physical volume predict better outcomes (such as lower mortality). But this association does not always hold. This study demonstrates a wide variation in quality among hospitals with different volume and other characteristics , such as academic and system affiliations as well as geographic locations. The reasons for these variations are to clear and the authors call for better identification of high performance centers based on as yet to be identified criteria.

Read the research (Subscription required)

Long-Term Survivorship Care After Cancer Treatment - Summary of a 2017 National Cancer Policy Forum Workshop: Speaking of cancer, the good news is that many diseases are now either curable or treatable, turning a death sentence into a chronic condition. But what happens to “survivors?” Providers of care tend to look at these patients as successes and then move on to others who need treatment. The results of this 2017 workshop were published in this month’s Journal of the National Cancer Institute. It provides an excellent summary of all dimensions of caring for these patients.

Read the article

About the public’s health:

Screening for Syphilis Infection in Pregnant Women: This article is not from today’s news but made a top story list for the year. It is a reminder that we need to stay vigilant about re-emerging health threats. At one time, every US jurisdiction required a syphilis test to obtain a marriage license. Now none do. But syphilis has returned as a public health problem: ”After a steady decline from 2008 to 2012, cases of congenital syphilis markedly increased from 2012 to 2106, from 8.4 to 15.7 cases per 100 000 live births (an increase of 87%). At the same time, national rates of syphilis increased among women of reproductive age.” As a result, the US Preventive Task Force now issues its highest (A) recommendation that all pregnant women be screened early in pregnancy for this disease.

Read the recommendation

Today's News

Slow news day before the holiday, so just a few items.

There will not be a blog post tomorrow, but will resume Wednesday.

Merry Christmas.

About healthcare IT:

Willy Wonka and the Medical Software Factory: This article about Epic was in the business section of the NY Times this weekend. It is an interesting insight into the firm’s culture. For example: “The company’s dress code is that when visitors are on campus, wear clothes.”

Read the article

About pharma:
This past year was a record for generic approvals by the FDA. Included in the list were
biogenerics/biosimilars. These two articles summarize the field for the past year and future prospects.

The Key Biosimilars Developments of 2018

Top Trends In The Biopharmaceutical Industry And Bioprocessing For 2019

The Cost of Not Taking Our Medicine: The Complex Causes and Effects of Low Medication Adherence: Pharma companies are trying very hard to gain market share by getting new patients to try their products. However, they may be better served by focusing on existing patients and making sure they fill and refill their medications. “One study confirms that up to half of all prescribed medications are not taken as prescribed and some 20% to 30% of all persistent medication prescriptions are never filled.” Imagine the lost revenue from this non-compliance. Further, the healthcare system pays because of the adverse health effects of untreated diseases.

Read this well-done review of this problem

Today's News

About insurance:

CMS releases 2020 Medicare Advantage risk adjustment payment model: CMS pays Medicare Advantage plans based on a number of factors, including an individual’s severity of illness. These calculations are often made one by one, or sometimes paired (as with diabetes and heart failure). Starting in 2020, CMS will phase in a new risk-adjusted payment method that counts the number of these conditions in the calculation. It is an attempt to make payments more accurate and comprehensive.

Read the announcement

CMS finalizes ACO overhaul, shortening pathway for financial risk: Accountable Care Organizations are most often paid on a fee for service basis, with limited downside liability for over-utilization, lower quality or patient complaints about care. ACOs were supposed to transition to a more risk-based arrangement, but few have done so. CMS is now forcing their hand by shortening the time they have to convert to the higher risk scheme.

Read the details

Administrative, network costs doomed New York City health plan startups: This finding is no surprise and highlights that nothing is new in healthcare systems. This article opines about why 2 of the 3 recent NY City health plan startups failed: high administrative costs as membership grew and “rental” of a provider network. I believe that the reason Oscar is left standing is because it was better capitalized, allowing it to sustain early costs- not because they are better administered or had a better delivery model. But you decide.

Read the story

Health law’s fines are not the big stick everybody thought: As previously reported, we won’t know for a while exactly how many people signed up for the insurances exchanges. However, this article points out that the penalty for not having insurance was not a significant sign-up inducement. In other words, now that the penalty is gone, people did not drop coverage. This finding flies in the face of the logic of Judge O’Conner in deciding that the fine (tax) was an essential element of the ACA.

Read the article

About pharma:

Judge: Most Claims Can Proceed in Remicade Antitrust Claims:Continuing this week’s bad news for J&J (see yesterday’s blog), a judge has ruled that antitrust claims can proceed against the company for blocking biogeneric competition with its Remicaid product.

Read the announcement

Exclusive: Big Pharma returning to U.S. price hikes in January after pause: After bowing to governmental pressure (at all levels) to hold down costs for their products, nearly 30 pharma companies have announce price increases for next year. This information comes from mandatory filings in California before such increases can occur. It will be interesting to see how the Trump administration deals with this change of heart.

Read the announcement

Outgoing GOP chairman urges colleagues to oppose Trump drug pricing proposal:Speaking of federal initiatives to lower drug costs, seems like the tactics are not embraced by all- even in the same party. Outgoing Senate Finance Committee Chairman Orrin Hatch ( R-Utah) wrote a letter to his Republican colleagues urging them to oppose the President’s proposal to index American pharmaceutical prices to an international market basket.

Read the story

About quality:

Mixed Messages to Consumers From Medicare: Hospital Compare Grades Versus Value-Based Payment Penalty: Medicare has two ways to recognize hospital quality (or lack of it). One is the grade it gives hospitals on the hospital compare website. The other is the bonus or penalty based on the quality of care. However, this research study shows that the two are not congruous. For example: “Of 120 (4.1%) hospitals graded as ‘better’ than the national rate for HF [heart failure], none were scored as having excessive HF readmissions and 50% were penalized.” The inconsistencies are confusing for hospitals but also for the public as these penalties are often the subject of news reports. We need consistent and easily understood quality measures to aid in care seeking decisions- how will the government correct this problem?

Read the study

Doctors with bad records can often still practice on patients. Here’s what needs to happen to fix this:In 1986, Congress created the National Practitioner Data Bank which is a centralized, national repository of all information about physician disciplinary actions. Before issuing a medical license, granting hospital privileges or hiring a practitioner, the decision maker is supposed to consult the Data Bank. But this procedure is not always followed. This article provides a great explanation of this issue, starting with three fundamental problems: “The system can be gamed, so not all problem doctors appear on the list; state medical boards don’t always check the data bank; and the information is off limits to those who are most at risk: patients” Sometimes having laws and organizations in place are not enough- the work actually must be done.
Read the article

New Organization Says It Is Improving Presentation of Clinical Guidelines: On July 16 of this year, AHRQ’s National Guideline Clearinghouse (NGC) was closed due to lack of funding. Shortly thereafter, ECRI Institute said it would take over the NGC’s function (originally for a fee but then changed its mind and is now free). Now, a non-profit organization, The Alliance for the Implementation of Clinical Practice Guidelines (AiCPG) is offering free guideline searches, including those archived from the NGC.

Read the announcement

Lives lost, Organs wasted: The allocation of organs for transplant is a process that still needs much reform. Logistical problems as well as geographic inequities are two major problems. This article provides some personal experiences as well as a factual presentation of this important issue.

Read the story

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Today's News

About devices:

J&J Agrees to $400 Million Settlement Over Faulty Hip Replacements: Not a good couple weeks for J&J. In addition to the court’s upholding of a $4.7 billion verdict in a case regarding asbestos contamination of its Baby Powder, the company is now facing settlement payments from faulty hip replacements. More claims go to trial next month.

Read the announcement

The public’s health:

What Is the Status of Women’s Health and Health Care in the U.S. Compared to Ten Other Countries?: The Commonwealth Fund just issued this paper and the results are mixed. For example: “Women in the U.S. have the highest rate of maternal mortality because of complications from pregnancy or childbirth, as well as among the highest rates of caesarean sections.” However, women in the US have among the highest breast cancer screening and lowest breast cancer mortality rates in the world. Of course, these positive results are attained at very high financial costs.

Read the study

The Major Causes of Death in Children and Adolescents in the United States: While this country spends many millions of dollars on disease treatments for children and adolescents, over all ages in this group about 61% of deaths are due to injuries- especially from auto accidents and firearms. What are we doing to address these problems?

Read the article (you may be able to signup for limited monthly access)

US adults aren’t getting taller, but still putting on pounds: The obesity data continues to get worse.
The latest CDC study came to some of the following conclusions:

—The average woman in the early 1960s was 5 feet, 3 inches and 140 pounds. Now, women are a half-inch taller and about 30 pounds heavier, on average.

—In the last decade, the average weight of men rose about 2 pounds, to 198. For women, it rose 6 pounds, to nearly 171.

—Men have 40.3-inch waistlines, on average; women’s waistlines are 38.7 inches. Over the past 15 years those dimensions are increases of about 1.5 and 2.5 inches, respectively.

Read the article

Nevada and Idaho Are the Nation’s Fastest-Growing States: The title of this Census Bureau announcement is a lesson in political spin. The upbeat presentation buries the fact that the overall US population grew by 0.62%- the lowest rate since 1937. Reasons for this finding include lower birth rates, higher death rates and reduced immigration. The latter cause has kept growth up and population aging down. As the population ages we will not only need more caregivers, but also people who work and pay taxes, particularly into the Medicare program.

Read the report


About insurance:
Cigna-Express Scripts clears final state approval, set to close on Thursday: After clearing many regulatory hurdles, the $67 billion merger is due to close today.

Read more about the completion of the deal

Cleveland Clinic Florida, Wellstar Health System among first to join Humana's value-based care program: In April, Humana announced its National Hospital Incentive Program, which will determine payments to physicians and hospitals based in criteria developed by the Joint Commission- especially looking at outcomes rather than volume of services. Humana is finally implementing this program at two well-regarded southern medical centers. Currently only a minority of care is delivered under value-based arrangements. Hopefully, this announcement heralds more efforts on the private sector to move from “volume to value.”

Read the announcement

Senate GOP blocks bid to intervene in ObamaCare case: In addition to the Justice Department, Congress can participate in the appeal of last week’s court decision that declared the ACA unconstitutional. Republican senators blocked the Democratic resolution for intervention on behalf of the law. House Democrats vow to join the fight once they take control next month.

Read the article

4.3M people sign up for healthcare in final week of ACA enrollment: “So far, 8.5 million people signed up for coverage, down about 3.4% compared to 8.8 million people the same time last year.” However, we won’t know the true numbers for a few months. As mentioned in a previous post, a number of reasons may favorably explain this drop, e.g., higher employment (exchange members changing to employers’ coverage) and Medicaid expansions. In Virginia alone, recent Medicaid expansion signed up about 100,000 former exchange enrollees.

Read the announcement

New Jersey health systems and insurers pitch in on Housing First programs: While this article is not, strictly speaking, about insurance, it is a program geared to frequent users of healthcare services. Housing for the homeless has been one strategy that insurers and health systems are implementing to improve community health and reduce healthcare costs. This New Jersey program is a great example of what can be done by partnerships among healthcare stakeholders.

Read about this program

About pharma:

Pennsylvania Auditor Calls for Flat Fees for PBMs: Continuing the theme of transparency for charges by Pharmaceutical Benefit Managers, this flat fee is the latest governmental recommendation. We will need to see how all the proposals shake out, but it appears they will not go away until the issue is resolved.

Read the announcement

Gottlieb: FDA Will Increase Inspections of Stem Cell Facilities: Despite last year’s announcement of closer supervision of stem cell facilities, unauthorized use and contamination persist. For example, today the CDC announced a bacterial outbreak due to stem cell injections. This enhanced oversight should not be confused with recent federal restrictions on stem cell research.

Read the announcement

'Bad drug' lawsuit ads hurt doc-patient relationships and need regulation, says industry coalition: This survey is the latest documentation that when lawyers advertise on TV about injuries from taking a drug, a significant number of people who benefit from the medication stop taking it- causing more harm. In this study, 58% of healthcare providers “said they’ve had patients who stopped taking their prescribed drugs after viewing drug-injury lawsuit ads.” Some legal regulation of these ads is being proposed, such as statements about not stopping medication without advise of a personal physician; however, that measure may not be enough. We have yet to see a proper balance between making people aware of their legal rights while protecting them from harmful scare tactics.

Read about the survey

Generic drug firms seek gag order in price-fixing case: Recall from a previous post that more than a dozen generic manufacturers are being investigated for price fixing. These companies are now asking a federal court in Philadelphia to issue a gag order on the investigation. So much for transparency.

Read the article

About information technology:

Methods Used to Enable Interoperability among U.S. Non-Federal Acute Care Hospitals in 2017: Despite the year in the title, this report was just issued by the Office of the National Coordinator detailing how hospitals transmitted and received records, especially from entities outside their own networks. While slow progress in interoperability is occurring, the following statistics are telling in how far we have yet to go: “About seven in 10 hospitals sent (66 percent) or received (73 percent) summary of care records using mail or fax in 2017.”

Read the entire report

Walgreens, Verily to work on projects to improve health outcomes: The drugstore giant and Alphabet subsidiary are joining to deploy technology that includes “sensors and software that can be used to help prevent, manage, screen and diagnose disease. The companies have a shared goal of scaling deployment at Walgreens retail locations. The companies plan to begin work on a medication adherence project that will deploy devices and other approaches designed to improve patient compliance with prescription orders.” Tis venture is yet anther creative collaboration between different sectors of the healthcare field.

Read the full announcement

Today's News

About medical devices:

House Committee Introduces Five-Year Medical Device Tax Delay: I do not usually write about pending legislation or announcements about individuals making proposals. However, this article is a reminder that the medical device industry has a special place in the healthcare field. This sector was the only significant one that lobbied against passage of the ACA and has continue to challenge it. As a result, devices were hit with the highest taxes- 2.3%. By comparison, other sectors were assessed flat amounts lower than that percentage. The continued lobbying seems to have paid off. “The 2.3 percent tax has been subject to several moratoria since its passage in the Affordable Care Act in 2010, including a two-year delay extension as part of a continuing resolution in early 2018. The new bill would extend the delay until December 31, 2024.”

Read the announcement

GE Files Confidentially for Health IPO, Buoying Stock: In its continuing effort to restructure after a significant slump in market value, the conglomerate seeks to shed its healthcare business in an IPO. The new enterprise value, including debt, could be about $65-70 billion.

Read the story

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety: The FDA has encouraged development of innovative devices that are significant improvements over those on the market or are new breakthroughs. Now, it finalized its guidance to promote devices that are not better per se, but improve safety. The initiative is called the Safer Technologies Program, or STeP.

Read the statement about this program

About pharma:

Pfizer, Glaxo to Create Over-the-Counter Drug Giant: Many pharma companies used to sell consumer products, like toothpaste, mouthwash and chewing gum. In more recent years, they have narrowed their focus to medications. Now companies are refining their offerings further to branded pharmaceuticals and vaccines. Continuing this trend, drug giants Pfizer and Glaxo are creating the world’s largest over-the-counter medicines business,, which last year had combined sales of $12.7 billion.

Read the article

Read the announcement

Cleveland Clinic, Kaiser Permanente throw support behind proposal to require prices in TV drug ads: While transparency in healthcare costs is obviously beneficial, it ceases to have value when it obfuscates more than it enlightens. Drug prices vary widely due to factors such as insurance coverage, the pharmacy where the prescription is filled, and geography. Also, the price does not take into account the total cost of care. For example, some medications are more expensive but are less likely to require add-on drugs to achieve a therapeutic effect. Further, some drugs require less monitoring with office visits or lab tests and are thus cheaper overall than less costly alternatives. Adding a ”your costs may vary” statement to the ads is not honest or helpful. Let’s reveal true costs only when they are known.
Read the article

Embracing the future of work to unlock R&D productivity:
This ninth annual study by the Deloitte Centre for Health Solutions has some bad news fo biopharma companies. Analysis of 12 large cap firms found that R&D returns " declined to 1.9 per cent, down from 10.1 per cent in 2010 - the lowest level in nine years.” Reasons for this decline are both reduced sales and higher expenses. It now costs $2.17 billion to bring a drug to market.

Read the full report:

About hospitals:

Adverse Events and Patient Outcomes Among Hospitalized Children Cared for by General Pediatricians vs Hospitalists: Do hospitalists provide higher quality and more efficient care than the primary care physicians they replace in the inpatient setting? Many studies question the overall value of this relatively new specialty. But those studies were done looking at adult patients. If children are hospitalized, they can be much sicker than adults This study looks at pediatric hospitalists and comes to the conclusion that: “General pediatrician and hospitalist inpatient care had similar length of stay, total costs, and readmission rates. However, AEs [adverse events] differed between hospitalists and general pediatricians, with device-related AEs more common among hospitalists, which may be associated with hospitalists’ fewer years in practice.”

Read the study or
If you cannot connect to the above link, read a summary here

Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information: About a year after the Wall Street Journal reported that The Joint Commission did not remove accreditation from hospitals with significant quality problems, CMS has issued a request for information asking about conflicts of interest for accrediting organizations who also provide consulting services . “This request for information (RFI) seeks public comment regarding the appropriateness of the practices of some Medicare-approved Accrediting Organizations (AOs) to provide fee-based consultative services for Medicare-participating providers and suppliers as part of their business model. We wish to determine whether AO practices of consulting with the same facilities which they accredit under their CMS approval could create actual or perceived conflicts of interest between the accreditation and consultative entities.”

Read the RFI and
More background about the request

About insurance:

I read 1,182 emergency room bills this year. Here’s what I learned: Sarah Kliff has been writing on Vox about the crazy emergency room bills that readers have sent and she has investigated. [She was a guest speaker at Northwestern recently and I had a chance to meet her. Hear her if you can.] This article summarizes her findings and is well-worth reading. It epitomizes many of the problems with our healthcare system and should make you angry. Think about what you can do about them. For starters, if you think the bill is outrageous or erroneous and cannot get a resolution form the providers of care, file a complaint with a state agency, such as the department of insurance. That action also gets the insurance company involved and often leads to accomodations.

Read the article

A Path to Incremental Health Care Reform: Improving Affordability, Expanding Coverage, and Containing Costs: This Urban Institute policy study recommends four “scenarios” to achieve the article title’s goals.:
“Scenario 1: Restore 2016 ACA policies. Reinstate the ACA’s individual mandate penalties and cost-sharing reductions and prohibit the expanded availability of short- term, limited-duration (STLD) plans.
Scenario 2: Expand Medicaid eligibility in all remaining states….
Scenario 3: Improve marketplace financial assistance…
Scenario 4: Reduce nongroup market premiums and out- of-pocket costs. Cap provider payment rates paid by insurers in nongroup insurance markets at levels somewhat above Medicare levels.”
However, these measure are not all cost-saving. Implementing Scenario 1 will reduce the number of uninsured by 2.2 million and reduce federal spending by $11.4 billion. If all four measures are put in place 12.2 million more people would be insured, but at an increased federal cost of $119.2billion.

Read the policy statement

Characteristics of Physicians Excluded From US Medicare and State Public Insurance Programs for Fraud, Health Crimes, or Unlawful Prescribing of Controlled Substances: One of the major causes of waste and diminished quality is the category of “fraud and abuse.” This study examines the prevalence among physicians and identifies characteristics of those more likely to engage in these activities:
” In this cross-sectional study assessing all physician exclusions from 2007 to 2017, the number of physician exclusions grew by 20% per year (equivalent to 48 additional exclusions per year) to encompass approximately 0.3% of US physicians in 2017. Exclusions were more common in the West and Southeast census regions, and male physicians, physicians with osteopathic training, older physicians, and physicians in specific specialties (eg, family medicine, psychiatry, internal medicine, anesthesiology, surgery, and obstetrics/gynecology) were more likely to be excluded.” Despite these findings, claims reviews, not physician characteristics will be the principle way these problems are discovered.

Read the study.
If you cannot access this study, read more about it here.

December 2018 Health Sector Economic Indicators Briefs: The Healthcare Price Index growth has finally dipped below the inflation rate: 1.5% versus 2.0%, respectively. The study by Altarum also showed that the national health spending growth estimate for 2017 was down from 4.7% to 3.9%.

Read the report

The public’s health:

Christmas, national holidays, sport events, and time factors as triggers of acute myocardial infarction: SWEDEHEART observational study 1998-2013: Relax, it’s Christmas! In this multi-year Swedish study, researchers found the highest risk for heart attack was at Christmas- even greater than major sporting events like the World Cup. Maybe the Swedes are not so “chill” after all. Happy Holidays!

Read the full study

Advance Care Planning in Older Adults With Multiple Chronic Conditions Undergoing High-Risk: Years after recognition of this problem, advanced directives are still underutilized. This study is one of many updating the need for this important documentation. I am quoting some conclusions since this article may only be available to subscribers of the journal. “Among a cohort of 393 older adults with multiple chronic conditions who are undergoing high-risk surgery, 101 (25.7%) had preoperative ACP documentation, including only 17 of 55 decedents (30.9%). Yet in a prior study, 52% of surgeons self-reported having had preoperative ACP discussions. High-risk populations in this study, including patients 85 years and older, those with dementia, and those with greater health care use, were more likely to have ACP documentation.”

Read the study

Nearly 40,000 People Died From Guns in U.S. Last Year, Highest in 50 Years: Res ipsa loquitur.

Read the article