Today's News and Commentary

About the public’s health

Planned Parenthood Refuses Federal Funds Over Abortion Restrictions: “Planned Parenthood said Monday that it would withdraw from the federal family planning program that provides birth control and other health services to poor women rather than comply with a new Trump administration rule that forbids referrals to doctors who can perform abortions. 
Planned Parenthood receives about $60 million annually through the federal program, known as Title X.”

Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: US Preventive Services Task Force Recommendation Statement: “The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing. (B recommendation) The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations. (D recommendation).” See, also, the accompanying editorial.

The economic case for prevention of population vitamin D deficiency: a modelling study using data from England and Wales: Researchers at the University of Birmingham calculated that adding vitamin D to wheat flour would prevent 10 million new cases of vitamin D deficiency in England and Wales over the next 90 years. The addition was extremely cost-effective; the combination of supplementation and fortification was £9.5 per QALY gained.

Flavonoid intake is associated with lower mortality in the Danish Diet Cancer and Health Cohort: The good news is that you can lower risk for mortality by eating foods you may like. “Results from our study indicate that for total flavonoid intake, risk of all-cause and CVD mortality was lower for flavonoid consumption until intakes of approximately 500 mg/d, after which higher intakes afforded no added benefit. This threshold was higher, approximately 1000 mg/d for cancer-related mortality. That the thresholds for each of the flavonoid subclasses approximately sum to the threshold for total flavonoid intake is consistent with the idea that all are important and afford added benefit. Interestingly, these threshold levels exist well within daily dietary achievable limits: one cup of tea, one apple, one orange, 100 g of blueberries, and 100 g of broccoli would provide most of the flavonoid subclasses and over 500 mg of total flavonoids. In this population it is likely that tea, chocolate, wine, apples, and pears were the main food sources of flavonoids.”

Self-sampling for human papillomavirus (HPV) testing: a systematic review and meta-analysis: Self-testing can increase compliance. “A growing evidence base, mainly from high-income countries and with significant heterogeneity, suggests HPV self-sampling can increase cervical cancer screening uptake compared with standard of care, with a marginal effect on linkage to clinical assessment/treatment.” Note that the evidence is from high income countries. There should be a business opportunity for more self-care products.

Business Roundtable Redefines the Purpose of a Corporation to Promote ‘An Economy That Serves All Americans’: This joint statement by many of the largest US firms changes the purpose of the corporation from maximizing shareholder value to stating: “Each of our stakeholders is essential.” Consider how this change will affect healthcare organizations.

About healthcare IT

First Survey of the Strategic Health Information Exchange Collaborative (SHIEC) Shows Health Information Exchanges (HIES) Provide Critical National Infrastructure: Ninety-two percent of the U.S. population is served by America’s health information exchanges (HIEs) who are members of the Strategic Health Information Exchange Collaborative (SHIEC). [See Chapter 8 of the text for more information about this initiative.]

Interoperability: Health data-sharing is lacking inside and outside of hospitals, survey says: Despite the “good news” in the above announcement, this article is another update about the lack of interoperability among data systems. This problem was reinforced by CMS Administrator Verma.

About healthcare insurance

Democrats back off once-fervent embrace of Medicare-for-all: This article explains why, “in recent months, amid polling that shows concern among voters about ending private insurance, several of the Democratic hopefuls have shifted their positions or their tone, moderating full-throated endorsement of Medicare-for-all and adopting ideas for allowing private insurance in some form.”

About healthcare quality and safety

CMS Announces Upcoming Enhancement of Overall Hospital Quality Star Ratings:”The Hospital Compare website’s Overall Hospital Quality Star Ratings rate hospital quality on a scale from one to five stars. CMS last updated the Star Ratings in February 2019, and has full confidence in their accuracy and reliability. Yet, to ensure the Star Ratings are as helpful as possible, CMS routinely refines the methodology used to calculate them. Today’s announcement means CMS plans to next update the Star Ratings in early 2020 according to the current methodology. CMS plans proposed rulemaking in 2020 to enhance the methodology and aims to finalize these rules prior to the release of the Star Ratings in calendar year 2021.” While CMS is to be praised for keeping the measures current and accurate, changing the criteria too often does not help quality improvement or the public’s understanding of the ratings. It takes time to make improvements and several years to evaluate the statistical significance of the outcomes of those efforts.

About pharma

AbbVie prices new rheumatoid arthritis drug at $59,000 a year: Last week Abbvie announced its successor to Humira for use in arthritis. “A four-week supply of Humira, the world’s best-selling medicine, has a list price of about $5,174, amounting to more than $60,000 for a year. However, the list price is not necessarily what patients actually pay as ‘out-of-pocket’ costs vary based on the duration of the treatment and individual healthcare plans…  The newly approved treatment, Rinvoq [upadacitinib] belongs to a class of medicines known as JAK inhibitors that block inflammation-causing enzymes called Janus kinases and will be available later this month… AbbVie said it planned to offer a co-pay card that could reduce out-of-pocket costs to $5 per month for eligible, commercially-insured patients, as well as a patient support program.”


Today's News and Commentary

About healthcare IT

Two of the country's largest HIEs team up to share data on Midwest patients: “Two of the largest health information exchanges in the country, Missouri Health Connection and the Kansas Health Information Network, have signed an agreement to enable providers to have access to 20 million patients' health records in Kansas, Missouri and some areas of surrounding Midwest states.” While this action is laudable the question remains why there need to be so many local efforts to integrate data bases when the federal government has been trying to launch The Trusted Exchange Framework and Common Agreement (TEFCA)- now in its second draft.

About health insurance

Development and Testing of Improved Models to Predict Payment Using Centers for Medicare & Medicaid Services Claims Data: “In this comparative effectiveness research study of risk models on 1 667 983 patients with 1 943 049 Medicare fee-for-service hospitalizations, use of present on admission codes and single diagnosis codes and separation of index admission codes from codes in the previous year improved models predicting payment that were compared with models based on Centers for Medicare & Medicaid Services grouped codes.” The study was done on data collected from July 1, 2013, through September 30, 2015, when ICD 9 codes were used. Such methodology would now need to be adapted using ICD 10 codes.

The ‘follow-up appointment’: This Washington Post article looks into medical debt for those living in rural areas. For example: “So far this year, Poplar Bluff Regional Medical Center has filed more than 1,100 lawsuits for unpaid bills in a rural corner of Southeast Missouri, where emergency medical care has become a standoff between hospitals and patients who are both going broke.”

Health Insurance Coverage Declined for Nonelderly Americans Between 2016 and 2017, Primarily in States That Did Not Expand Medicaid: “The uninsured rate climbed from 10.0 percent in 2016 to 10.2 percent in 2017, the first increase since 2013, after significant declines driven by the Affordable Care Act (ACA). This decline resulted in 700,000 more uninsured people in 2017 than in 2016.

The uninsured rate held stable in Medicaid expansion states at 7.6 percent, but increased from 13.7 percent to 14.3 percent in states that did not expand Medicaid.”

About public health

CDC, states investigating severe pulmonary disease among people who use e-cigarettes: Once again, vaping is not safe! According to the CDC: “94 possible cases of severe lung illness associated with vaping were reported in 14 states from June 28, 2019, to August 15, 2019.” What type of social media campaign will reduce vaping? Hint: scare tactics do not work.

Fast-Food Joints in the Neighborhood? Heart Attack Rates Likely to Go Up: This Australian study found that for “every additional fast-food outlet in a neighborhood, there were four additional heart attacks per 100,000 people each year…” Is there another role for zoning laws?

Nearly Half of U.S. Patients Keep Vital Secrets From Their Doctors: “Nearly half of U.S. patients don't tell their physicians about potentially life-threatening risks such as domestic violence, sexual assault, depression or thoughts of suicide, a new study finds.” How can we build trust between patients and their physicians? Perhaps we need more attention to strengthening relationships with a regular primary care physician instead of our current fragmented-care system.

Changes in Age Distribution of Obesity-Associated Cancers: Another reason to control the obesity epidemic in the young. These researchers found “there has been a shift of obesity-associated cancer burden to younger age groups and that interventions to reduce obesity and to implement individualized screening programs are needed.”

Impact of Carers’ Smoking Status on Childhood Obesity in the Growing up in Ireland Cohort Study: On a related theme…These findings of this Irish study “emphasize the health burden of childhood obesity that may be attributable to maternal smoking postnatally and through early childhood…”

Today's News and Commentary

About pharma

Another hit for Roche: UnitedHealthcare backs Amgen biosims over blockbuster oncology meds: Biosimilar drugs have been slow to make an impact on healthcare costs in the U.S. As a start to remedy this situation, “UnitedHealthcare (UNH) will put Amgen biosimilars of oncology meds Avastin and Herceptin first in line as preferred products in its commercial, community and Medicare Advantage plans starting Oct. 1… The two biosims, Mvasi and Kanjinti, launched in the U.S. in mid-July at a 15% discount off the original brands.” While the discount is not as much as traditional generics, it is a significant savings.

As specialty drug costs skyrocket, Anthem tests new idea for curbing 'shock' claims: Speaking about the high cost of specialty drugs, “Anthem is launching a new program in Kentucky that aims to work with providers to protect patients from ‘shock’ bills for these therapies. 
Anthem has teamed up with St. Elizabeth Healthcare, one of the state’s largest providers, as the first partner in the new program. In the model, the health system will absorb part of the cost of these services, discounting them by as much as 45%.” This project is a step short of the payer captitating the provider for such services.

Verma: CMS working 'fast and furious' on IPI drug pricing model, but doesn't say when it will be released: Earlier this year, The Trump administration announced its intention to lower drug costs by implementing an International Pricing Index (IPI) model- using prices outside the country as a guide to domestic costs. CMS administrator Verma has an update on this proposal, saying that “we are fast and furious” about getting the model done. When it will be implemented is not yet clear.

New drug disposal regulations to be implemented next week: “Starting Aug. 21, drugs like opioids and chemotherapies will need to be disposed of through proper channels rather than down the drain…” While the regulations are long overdue, compliance will be costly. For example Cleveland Clinic is expected to spend $500,000 per year to set up a complaint system. Perhaps manufacturers of those drugs can offer disposal solutions to customers as a “value-added” service.

About the public’s health

Without court action, Planned Parenthood says its health centers will withdraw from Title X over 'gag rule': “Planned Parenthood Wednesday notified the Ninth Circuit Court of Appeals that unless it steps in by Aug. 19 to block the Trump administration’s new Title X rule, its health centers will be forced out of the federal program in just days.” The previously reported rule bans Title X funding recipients from making referrals for abortion services.

New Look For Cigarettes? FDA Proposes Graphic Warnings On Packages And Ads: If you have seen packs of cigarettes in some other countries, you noticed the graphic “photo-realistic” images warning about the health risks of smoking. Such warnings were supposed to appear on American cigarette packs after passage of a law in 2009. Tobacco companies complained that such a requirement was a violation of their freedom of speech. As a result of an American Lung Association lawsuit against the FDA, “acting FDA commissioner Ned Sharpless told reporters that the 13 warnings the agency plans to plaster on cigarette packs, hew close to the factual dangers of smoking.” That decision is not yet a “done deal,” as tobacco companies are expected to sue. In any case, these messages would not appear at the soonest until 2021.

New York City Is Giving Out Prescriptions For Free Fruits And Vegetables: This article describes “New York City’s Pharmacy to Farm program, which provides extra money each month for fresh produce to people who receive Supplemental Nutrition Assistance Program (SNAP) benefits and are on medication for hypertension. One in five New Yorkers is on SNAP; one in four has high blood pressure.” As the program name explains, the benefits are distributed through a patient’s pharmacy.

For a decade, Francis Collins has shielded NIH—while making waves of his own: This article is a balanced, insightful look at the man running the NIH.

About healthcare quality and patient safety

CMS to require ACA plans to display star ratings for plans starting in 2020: “The Trump administration will require Affordable Care Act exchange plans to display their star ratings received for quality, in a move aimed at boosting transparency.” The requirement will apply to plans offered in the 2020 contract year and appear on such sites as Healthcare.gov.

About health insurance

American Medical Association leaves coalition fighting 'Medicare for All': “The AMA said it is leaving the industry group called the Partnership for America’s Health Care Future, which has been running ads against Medicare for All and public option proposals from the leading Democratic candidates for president. However, the doctors group’s CEO, Dr. James Madara, said in a statement that the AMA still opposes Medicare for All. It just wants to focus its energies on advocating for solutions, such as improving ObamaCare by making its subsidies for helping people afford coverage more generous.” 

Tracking the rise in premium contributions and cost-sharing for families with large employer coverage: The Kaiser Family Foundation has updated its employer-sponsored health insurance survey. Some of the highlights: “…the average family spent $4,706 on premiums and $3,020 on cost-sharing, for a combined cost of $7,726 in 2018. This represents an 18% increase in the health costs borne by employees and their families from five years earlier ($6,571 in 2013), outpacing the 8% increase in inflation and a 12% increase in workers’ wages over the same period.”


Today's News and Commentary

About pharma

FDA Plans Meeting on Real-World Evidence, Patient-Focused Drug Development: “The FDA has scheduled a Nov. 7 public meeting to discuss how to improve its drug development programs in the Office of New Drugs (OND) with the use of real-world evidence and an increase patient focus.”

U.S. FDA approves TB Alliance's treatment for drug-resistant tuberculosis: The FDA approved the non-profit TB Alliance’s triple drug regimen to treat multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB). The therapy is over 6 months versus the standard 2 year course- a significant improvement to aid compliance.

Top 10 all-star drugs in 2024: Humira's captain, but who else makes the roster?: The headline is a teaser for which drugs will reach the top of the sales charts in 5 years. As you read the list, contrast which are biologics and which are traditional “small molecules.”

Boehringer, MD Anderson build out 'virtual R&D center' for cancer research: This partnership is the most recent example of industry-medical center cooperation, in this case to develop oncology drugs.

Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018: “Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.”

About healthcare IT

VA releases tool for better integrating agency’s dozens of apps: “The VA’s new Launchpad app includes the ability to view and share electronic health records, book medical appointments, refill prescriptions, as well as communicate with the agency’s healthcare providers.”

About health insurance

Harvard Pilgrim Health Care, Tufts Health Plan to merge: This merger will give significant local market power to the new organization, which will “serve 2.4 million members in Massachusetts, Maine, Rhode Island, Connecticut and New Hampshire and would offer both employer-sponsored and government plans.”

Appeals court revives changes to Medicaid DSH payment rules: DSH [Disproportionate Share Hospital] payments are federal government subsidies to those facilities providing high volumes of care to Medicaid and uninsured patients. In 2017, CMS formalized a previous opinion that DSH payments should subtract third-party payments, such as those from private insurers and Medicare. That CMS decision prompted a group of children's hospitals to “ file a lawsuit claiming CMS overstepped its authority.” A federal judge ruled in favor of the hospitals, finding that the rule is inconsistent with the plain language of the Medicaid Act. CMS appealed the ruling, and the U.S. District Court of Appeals for the D.C. Circuit overturned the lower court's ruling. Will this decision be appealed by the plaintiffs and reach the Supreme Court? Many hospitals’ finances will depend on this critical decision.

As States Strive To Stabilize Insurance Marketplaces, Insurers Return: The Kaiser Family Foundation writes that since more states have implemented programs to stabilize their insurance markets (like premium subsidies and reinsurance programs), more private insurers will enter or return to them.

Will Increasing Primary Care Spending Alone Save Money?: Authors of this study point out that evidence for an affirmative answer to the title question is lacking. What they fail to point out are three important factors about primary care. First, many practitioners are not trained or inclined to deliver broad-based services. For example, many internists refer their diabetic patients to podiatrists to cut toenails when they could deliver the same service as part of routine office visits. Second, even if primary care physicians did deliver such services, they are also not trained or inclined to manage entire episodes of care. Finally, higher payments are needed to attract physicians to primary care specialties. Compare primary care physician income to other specialties and it is no wonder there is such shortage.

About healthcare quality and patient safety

Rating the Raters: An Evaluation of Publicly Reported Hospital Quality Rating Systems: Six experts in quality methodology graded four hospital quality rating reports. This is a landmark evaluation of the reported evaluating the reporters. Their findings? “There were no hospital quality rating systems meriting an A or A-. The highest grade received was a B by U.S. News. The CMS Star Ratings received a C. The lowest grades were for Leapfrog (C-) and Healthgrades (D+) (Table 3). We qualitatively agreed that the U.S. News rating system had the least chance of misclassifying hospital performance. There was considerable agreement in overall grade assignments among the six individuals who performed the ratings.” Read the study for details.

Today's News and Commentary

About health insurance

Large Employers Double Down on Efforts to Stem Rising U.S. Health Benefit Costs which are Expected to Top $15,000 per Employee in 2020: The National business Group on Health polled its members about how they will deal with the projected 5% increase in healthcare costs next year. “Employers identified implementing more virtual care solutions (51%) and a more focused strategy on high cost claims (39%) as their top initiatives for 2020. The survey also found that managing prescription drug benefit costs remains a high priority for employers in 2020.” Further, “ 49% of respondents plan to pursue an advanced primary care strategy in 2020, and another 26% are considering one by 2022…The number of employers offering full replacement consumer-directed health plans will shrink to 25% in 2020, down from 30% this year and 39% in 2018. Instead, employers will offer more plan choices like a preferred provider organization (PPO) plan.”

Use of Pharmacy Benefit Managers and Efforts to Manage Drug Expenditures and Utilization: The Government Accountability Office examined “the role of PBMs in the Part D program. This report examines, among other objectives, (1) the extent to which Part D plan sponsors use PBMs, (2) trends in rebates and other price concessions obtained by both PBMs and plan sponsors for Part D drugs, and (3) how PBMs earn revenue for services provided to Part D plans.” Among its findings: “PBMs primarily earned Part D revenue through a volume-based fee paid by plan sponsors based on PBM-processed claims; a per-member, per-month fee paid by plan sponsors; or a combination of the two. PBMs also earned revenue from the rebates they negotiated with manufacturers for Part D drugs, which accounted for $18 billion of the $26.7 billion in rebates in 2016. PBMs retained less than 1 percent of these rebates, passing the rest to plan sponsors. Plan sponsors in turn may use rebates to help offset the growth in drug costs, helping control premiums for beneficiaries.”

Where Tourism Brings Pricey Health Care, Locals Fight Back: Because local residents of this Colorado tourist town could not afford the local hospital’s charges, they created an alliance plan whereby members could obtain 30% discount off published charges. A related comment: purchasing power is an important tool to lower healthcare costs. That is why employer-sponsored insurance remains a viable option.

About the public’s health

Treating Parents for Tobacco Use in the Pediatric Setting: Improving care can be about the setting/context as much as the message. “In this trial, integrating screening and treatment for parental tobacco use in pediatric practices showed both immediate and long-term increases in treatment delivery, a decline in practice-level parental smoking prevalence, and an increase in cotinine-confirmed cessation, compared with usual care.”

Association of Intensive vs Standard Blood Pressure Control With Cerebral White Matter Lesions: What is an appropriate target for systolic (the “upper number”) blood pressure control? This research used brain imaging measures and concluded 120 was better than and older target of 140.

Public Comment on Draft Recommendation Statement and Draft Evidence Reviews: Screening for Illicit Drug Use, Including Nonmedical Use of Prescription Drugs: Many media outlets reported that the US Preventive Task Force recommended screening all adults for illicit drug use. The reporting was not quite correct, reinforcing that going to the original source is important. While “The Task Force found that clinicians should screen all adults for illicit drug use [and] More research is needed to make a recommendation for teens,” these were part of a draft recommendation statement open for comment until September 9.

Evaluation of the Cascade of Diabetes Care in the United States, 2005-2016: Control of blood sugars, lowering high cholesterol levels and blood pressure, and eliminating smoking are all important in mitigating the long term effect of diabetes. However, these researchers found that these factors have not improved significantly between 2005 and 2016. These gaps in care particularly affect “younger adults (18-44 years), women, and nonwhite individuals…” Another instance of knowing what to do but not doing it.

Roles of cyberbullying, sleep, and physical activity in mediating the effects of social media use on mental health and wellbeing among young people in England: a secondary analysis of longitudinal data: Adverse behavioral outcomes from excessive social media exposure is a recognized problem. Why it occurs and what to do about it are not always clear (other than cutting out use entirely). Researchers found that mental health “harms related to very frequent social media use in girls might be due to a combination of exposure to cyberbullying or displacement of sleep or physical activity, whereas other mechanisms appear to be operative in boys.” Clearly solutions need to be tailored, especially by gender.

Today's News and Commentary

About healthcare IT

AI, machine learning algorithms are susceptible to biased data: This article is more of a reminder. Medical research is often gender and race biased because of the composition of the studies’ populations. Therefore, algorithms and artificial intelligence programs based on that data will give biased results.

DoD, VA adopt single healthcare logistics information system: These two military branches announced they will use a single procurement and logistics system. Now if they could only harmonize their EMRs…

Wide Variety of Groups Support Standardizing Addresses in Electronic Health Records: Standardization of data formatting is essential for data mining, interoperability and patient matching. Many items are standardized, like diagnosis and treatment codes. But patient addresses are not entered in a uniform fashion. “For example, one system may use ‘Street’ in addresses, while others abbreviate it as ‘St.’” Major healthcare organizations are now calling for electronic health systems to use US Postal Service address standards.

About healthcare quality and safety

Emergency department monitor alarms rarely change clinical management: An observational study: The headline tells it all…there are so many alarms going off in the ED that staff don’t often pay attention to important signals, particularly because most of these alerts rarely change clinical management. The researchers call for changing alarm parameters and customizing settings.

About health insurance

Trends in Subsidized and Unsubsidized Enrollment: The ACA enrollment trends are tales of two populations:
”During two successive years of declining enrollment from 2016 to 2018, unsubsidized [emphasis added] enrollment declined by 2.5 million people, representing a 40 percent drop nationally. At the state level, the percent change in unsubsidized enrollment over this period ranged from a 0.4 percent drop in Rhode Island to a 91 percent drop in Iowa…

Since 2014, average monthly enrollment in the subsidized [emphasis added] portion of the market has grown substantially larger than in the unsubsidized market. The subsidized portion of the market was 122 percent larger than the unsubsidized portion in 2018, up from 61 percent larger in 2017.”

Healthcare industry groups warn final 'public charge' rule could impact immigrant health, drive up costs: This story was the most widely reported healthcare news today. The Trump administration finalized its “public charge” rule for immigration. Under that rule, “the Department of Homeland Security (DHS) could more easily reject green card or visa applications from people the agency deems likely to use public assistance programs such as Medicaid in the future.” If immigrants are not covered on Medicaid, some healthcare providers, like hospitals, would have to provide free care to them. The providers would, in turn need to charge more for private patients, with the costs being passed to the public in the form of higher insurance costs.

Hospital Price Increases for Inpatient Services Will Cost Consumers and Employers $250 Billion over the Next Decade: According to this UnitedHealthGroup study: “The annual cost of hospital inpatient services for privately insured individuals exceeded $200 billion in 2018 and is projected to exceed $350 billion in 2029…Between 2013 and 2017: Hospital prices for inpatient services increased 19 percent, about 4.5 percent per year; physician prices for inpatient services increased 10 percent, about 2.5 percent per year…”

About the public’s health

U.S. records 10 new cases of measles last week: Just a reminder that the outbreak is not over.

About pharma

FDA shatters generic drug approval record: The FDA has already approved more generics this year than all of last year, with two months to go in the current fiscal year. It is good news, but remember specialty drugs are driving pharmaceutical cost trends, and biosimilars are not being approved at a fast clip.

Humana calls Mallinckrodt's Acthar a 'billion-dollar golden goose' in $700M fraud lawsuit: In addition to existing federal action, Humana is now suing saying it “overpaid for Acthar by $700 million because of Mallinckrodt’s widespread campaign to stifle competition and pay doctors and patients to choose the pricey med…” The medication is a branded version of a long off-patent medication from Questcor, a company Mallinckrodt purchased. That company raised the price 85,000% (sic) from 2001-2017.

DNA Data Shared in Ways Patients May Find Surprising: This article is a great summary of what happens to your genetic data when you give it to your local hospital.

Today's News and Commentary

About health insurance

To Save Money, American Patients And Surgeons Meet In Cancun: This article is about self-insured businesses that fly their employees to “exotic locations” to have procedures performed in order to save money. This tactic has been tried on and off for decades. It can definitely save money and is safe- if nothing goes wrong.

Assessment of Out-of-Network Billing for Privately Insured Patients Receiving Care in In-Network Hospitals: This article details the increasing prevalence and cost of out-of-network billing for patients who were hospitalized or seen at the EDs at in-network hospitals between 2010 and 2016. “Of 5,457,981 inpatient admissions and 13,579 006 ED admissions… the percentage of ED visits with an out-of-network bill increased from 32.3% to 42.8%… during the study period, and the mean… potential financial responsibility for these bills increased from $220 ($420) to $628 ($865) ( all dollar values in 2018 US$). Similarly, the percentage of inpatient admissions with an out-of-network bill increased from 26.3% to 42.0%, and the mean… potential financial responsibility increased from $804 ($2456) to $2040 ($4967)…” Clearly this problem is growing in importance.

Medicare Plan Home Care Benefits Could Work: “Adding a mandatory home care benefit to all private Medicare plans [Medicare Advantage and well as Medicare supplements] sold in Minnesota could increase the plans’ premiums by about $20 per month — and cut the state’s spending on Medicaid nursing home benefits by about 21% by 2030.” It is an interesting way to reduce public long term care expenses.

About pharma

Amgen wins U.S. patent battle on arthritis drug Enbrel, thwarting Novartis: “U.S. District Judge Claire Cecchi in Newark, New Jersey, rejected arguments by Novartis’ Sandoz unit that the patents covering Enbrel’s active ingredient until 2029 should not have been granted because their concepts were already contained in previous patents.” Amgen will therefore be able to continue to charge branded prices for this drug.

Canada enacts drug price crackdown, in blow to pharmaceutical industry: In the biggest pharma reform since 1987, the Canadian government announced final regulations to lower drug prices by amounts expected to save Canadians C$13.2 billion ($10 billion) over the next ten years. Pharma companies may yet sue to block these regulations. Lower Canadian drug prices may further the arguments to import their drugs into this country.

About public health

Thermal Stabilization of Viral Vaccines in Low-Cost Sugar Films: This article describes a method to maintain vaccine efficacy for 2-3 months without previously required refrigeration. It is a real breakthrough in public health.

Today's News and Commentary

About healthcare IT

Healthineers sets plan to buy robotics firm Corindus for $1.1B: The point of this article is not so much about a large acquisition as to point out consolidation in the healthcare imaging and “peripherals” sectors. To me it is more of an IT story since there is a great need for interoperability and unified security systems among these devices.

Transitions hampered by info exchange between venues of care: Despite significant use of electronic data in hospital systems, transitions to long term- and post acute care sites are largely accomplished with manual processes. For example, “only 2 percent of long-term care providers are using IT-only strategies to coordinate care and transfer data. More than one-third of acute care providers are using manual processes to coordinate patient transitions with the long-term care community, and only 7 percent of that community is coordinating with acute care providers.” Undoubtedly many errors in care result from this lack of coordination and system interoperability.

HRSA grants $8.1M to help health centers boost IT use: The Health Resources and Services Administration will issue $8.1M in grants to improve the integration and delivery of health services. The grant will go to OCHIN, “one of the largest and most successful health information networks in the United States, serving more than 500 organizations nationwide with a full array of solutions to improve care for the nation’s most vulnerable patients.” OCHIN will distribute these funds to member health centers, which are obligated to serve all patients regardless of the ability to pay.

Hackers are going after medical devices — and manufacturers are helping them: It takes a thief to catch a thief…This article explains how manufacturers of medical devices are hiring “hundreds of ethical hackers” to help them identify security vulnerabilities in their products.

Study shows Apple devices in combo with apps could identify dementia: Drug maker Eli Lilly sponsored research to differentiate normal participants from those with mild signs of Alzheimer’s Disease using an iPhone and digital apps. If there is a difference, the researchers hoped they could detect the disease sooner. There were, in fact, differences, including:  “People with symptoms tended to have slower typing than health volunteers, and received fewer text messages in total.”

About health insurance

Insurance Coverage Saves Lives:This article summarizes that data showing how lack of insurance contributes to excess deaths.

A look at network participation in TRICARE’s PPO plans: TRICARE provides health benefits to more than nine million active duty and retired military members and their families. This article summarizes research from Health Affairs (Subscription- only access). “Nationally, about 67% of general practice physicians accept TRICARE, compared to about 95% that accept private plans, 86% that take Medicare and 65% that accept Medicaid…on patient-reported measures, such as perceived access to specialty care and satisfaction with their physician, TRICARE members were in line with those in private plans.” 

Financial Performance of Medicare Advantage, Individual, and Group Health Insurance Markets: Medicare Advantage plans have been more profitable (based on individual member gross margins) than individual or group plans from 2006-2018. This study details this finding and also raises the issue of what it means under some Medicare for All proposals that would allow private plans to administer Medicare benefits.

About pharma

CVS slows store expansion plans, cuts pace by a third:This week CVS announced it will only open 100 new stores this year and 50 next year; it has opened 300 per year in the past. The company will concentrate, instead, on redesigning its existing stores around the HealthHUB concept (see previous blogs). This week Walgreens also announced it is closing 200 stores. It appears we have reached the market saturation of chain drug stores.

With importation on tap, Grassley urges FDA to inspect foreign drug plants 'unannounced': As previously reported, many foreign drug manufacturing plants are inspected by FDA teams after much advanced notice. This process has led to record falsification and special preparation for the survey that does not reflect usual procedures. Sen. Chuck Grassley has now requested that the FDA’s inspections be unannounced.

Trump Team Hits Brakes On Law That Would Curb Unneeded Medicare CT Scans, MRIs: Many people are familiar with pre-authorization requirements that private insurance plans have for such high cost services as MRIs and PET scans. In 2014, Congress passed the Protecting Access to Medicare Act (PAMA) , which “established a new program to increase the rate of appropriate advanced diagnostic imaging services provided to Medicare beneficiaries. Examples of such advanced imaging services include: computed tomography (CT); positron emission tomography (PET); nuclear medicine; and magnetic resonance imaging (MRI).” This program was to start in 2018 but was delayed by the Trump administration until 2020. According to this report, “the Centers for Medicare & Medicaid Services has slated next year as a ‘testing’ period, which means even if a physician doesn't check the guidelines, Medicare will still pay for the scan. CMS also said it won't decide until 2022 or 2023 when exactly physician penalties will begin. Critics worry the delays come at a steep cost: Medicare is continuing to pay for millions of unnecessary exams, and patients are being subjected to radiation for no medical benefit.” While proposals for Medicare for All tout lower administrative costs of a public system, they do not mention that private insurance companies are paying for necessary activities (like these reviews) that Medicare does not.

Today's News and Commentary

About pharma

CMS: Medicare will begin to cover CAR T-cell therapies in some facilities: “Medicare will cover the therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications, officials said. In addition, Medicare will cover the FDA-approved therapies for off-label uses that are recommended by CMS'-approved compendia.”

CEO confirms Novartis knew about data issues before FDA approval of Zolgensma:  Continuing the Novartis Zolgensma story, CEO Vas Narasimhan said that the company first received the allegations of data manipulation in mid-March. The FDA approved the drug May 24. He explained: "We made the decision to progress our quality investigation prior to informing FDA and other regulatory authorities so that we could provide the best information and technical analysis, which we did promptly on completion on June 28." Undoubtedly more will come out in the near future.

What's behind the surge of prescriptions for risky, expensive medications? Millions from drugmakers: This article is a really good in-depth explanation of the biologic medication sector and the questionable marketing techniques that have contributed to its growth. Check here for a closely related story.

About health insurance

The Potential Impact of a Medicare Public Option on U.S. Rural Hospitals and Communities: Many hospitals rely on relatively higher private insurance payments to stay solvent. If a “Medicare for All” option is implemented, all providers would receive payments according to a (lower) Medicare fee schedule. What would the impact be of that payment change? According to this Navigant analysis: “offering a government insurance program reimbursing at Medicare rates as a public option on the health insurance exchanges created by the Affordable Care Act (ACA) could place as many as 55% of rural hospitals, or 1,037 hospitals across 46 states, at high risk of closure. The rural hospitals at high risk represent more than 63,000 staffed beds and 420,000 employees…”

Doctors Argue Plans To Remedy Surprise Medical Bills Will ‘Shred’ The Safety Net: On the other handPhysicians for Fair Coverage is a “coalition formed by large companies — firms such as US Acute Care Solutions, U.S. Anesthesia Partners and US Radiology Specialists — that serve as corporate umbrellas for medical practices.” This organization is running a $1.2 million ad campaign that claims Congress’ solution to end surprise billing will reduce payments and result in shredding the safety net for vulnerable patients. The Kaiser Family Foundation thoroughly investigated this claim and found it to be “False.” It reminds me of the Upton Sinclair quotation: It is difficult to get a man to understand something, when his salary depends upon his not understanding it!

Wisconsin Governor Credits Health Reinsurance Plan for Drop in Premium Rates: This is the most recent report of the effect on premiums of state reinsurance plans. (Previously reported was Colorado’s experience.) Wisconsin Governor Tony Evers said the program will lower rates by an average of 3.2%, rather than face a projected 9% increase.

About the public’s health

Three hospitals team up on $3m plan to help low-income families pay the rent: This type of program is not new, just the latest example of hospitals providing low-income housing to local residents.

Aligning Payment And Prevention To Drive Antibiotic Innovation For Medicare Beneficiaries: This article, by CMS Administrator Verma, discusses the health policy/payment changes that need to be enacted in order to address the problem of antibiotic resistance (AMR).
“Specifically, the agency has finalized the following changes to foster antibiotic innovation and secure beneficiaries’ access to these medications:

  1. Develop an alternative pathway for New Technology Add-On Payments (NTAPs) without the “substantial clinical improvement” (SCI) criterion and increase the value of these payments from 50 percent to 75 percent for Qualified Infectious Disease Products (QIDPs)

  2. Adjust severity levels for AMR within clinically-relevant DRGs

  3. Explore policy changes in rulemaking beyond IPPS [Inpatient Prospective Payment System] to scale hospital stewardship programs to enhance patient safety”

The Best Probiotics: Vitamins and other nutrients are best obtained through diet rather than supplements. For example, the best probiotic may be the apple, which has an average of about 100 million bacteria. These bacteria are of many different species—far more diverse than store-bought supplements. The one problem is that 90% are in the core, which we most often do not eat.

Plant‐Based Diets Are Associated With a Lower Risk of Incident Cardiovascular Disease, Cardiovascular Disease Mortality, and All‐Cause Mortality in a General Population of Middle‐Aged Adults: Speaking of diets…the headline tells the research’s results.

About healthcare IT

Predictive analytics in health care: how can we know it works?: The main message of this article is that algorithms should be open to scrutiny to make sure they are valid. Too often private companies, like health plans, employ “black boxes” for uses like utilization review. Such lack of transparency can hurt not only patients but the companies using these potentially flawed tools. Here is a related article on this subject.

Today's News and Commentary

About healthcare IT

DirectTrust hits milestone of 1B messages exchanged; developing instant messaging standard: “DirectTrust is a collaborative non-profit association of 121 health IT and health care provider organizations to support secure, interoperable health information exchange via the Direct message protocols. DirectTrust has created a ‘trust framework’ that extends use of Direct exchange to over 106,000 health care organizations and 1,582,373 Direct addresses/accounts. This trust framework supports both provider-to-provider Direct exchange and bi-directional exchange between consumers/patients and their providers.” Messages over this secure interchange just passed the 1 billion mark. [See Chapter 8 of the text for a fuller explanation of Direct Trust.]

32M patient records breached in 2019: The number of patient record breaches this year has already doubled the number that occurred infall of 2018. The article gives some examples of large offenders.

Industry Voices—Removing ban on nationwide unique patient identifier would save lives, money: The reason patients do not have unique identifiers (as do all other healthcare stakeholders) is concern over privacy/threat of breaches. Despite the number of breaches, IT experts claim that the unique identifier will aid interoperability and reduce “wrong patient” errors.

About healthcare insurance

What Explains Support for or Opposition to Medicare for All? This recent Urban Institute survey demonstrates how complex opinions are about “Medicare for All.” Support (or opposition) varies by such factors as political party membership, age and which version of the program is presented (such as single payer or option for enrollment).

Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration: CMS announced that: “After careful consideration, the Centers for Medicare & Medicaid Services (CMS) is discontinuing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration because of the rates of low participation. CMS will not be accepting applications for MAQI for 2019.” This option would have exempted qualified providers from being subject to the Merit-Based Incentive Payment System (“MIPS”) if they participated “to a sufficient degree in certain payment arrangements with Medicare Advantage Organizations…” [See Chapter 9 of the text for a fuller explanation of these programs.]

About healthcare quality and patients safety

UI Hospitals has 'healthy appetite' for improving low marks from patients: The article’s point is that the University of Iowa Hospitals and Clinics (UIHC) was working to improve its patient satisfaction scores. The other message is that patient satisfaction does not always correlate with measures of care quality. “UIHC fell below the state average on all but one of 10 patient satisfaction measures… It fell below the national averages in all but three categories.But despite low scores elsewhere, UIHC ranked above the state and national averages in the percentage of patients who said they’d recommends it to family and friends. UIHC earned four stars in that.” Most marketers would take the latter measure as a sign of organizational success.

Why Are These Medical Instruments So Tough to Sterilize?: Duodenoscopes are used to look at the upper gastrointestinal tract. But they are very hard to sterilize and have caused a large number of infections when reused.

About pharma

U.S. judge expresses support for novel opioid settlement talks framework: When the tobacco settlements were paid, states got all the money and rarely shared it with counties or municipalities. This time, the latter entities want some of the compensation. To that end, U.S. District Judge Dan Polster in Cleveland will allow a proposal that “calls for creating a class of up to 3,000 counties and 30,000 cities, towns and villages that could vote on whether to accept any settlement the plaintiffs reach with defendants in the opioid litigation.”

Today's News and Commentary

About pharma

FDA ready to crack down as Novartis reveals manipulated Zolgensma data: BREAKING NEWS Today, Novartis revealed that it manipulated data in its drug application for the gene therapy drug  Zolgensma. You will recall that, at $2.125million, it is the most expensive treatment on the market for any condition. The FDA is still deciding what to do with its already-granted approval.

Drug industry urges Canada to act early on U.S. import plan: Innovative Medicines Canada (IMC), their equivalent of our PhRMA, has issued recommendations to the Canadian government to prevent shortages in that country that would result from American importation of pharmaceuticals.

Pentagon eyeing Chinese production of tainted 'sartan' API as trade war grows: Active Pharmaceutical Ingredients (APIs) are the basic materials that make up pharmaceuticals. Most of these agents, as well as the raw materials that go into their manufacture, are produced abroad- particularly in China. A Chinese manufacturer of “sartan” drugs, used in antihypertensives, has been found to be supplying contaminated ingredients. The Pentagon has gotten involved because many active duty military are taking these medications. The situation may get worse (even without such tainting) if the trade war between our countries heats up even further.

Drug Price Forecast : This report is Vizient’s annual research on drug prices. Out of many findings is that their client’s pharma costs will continue to rise (by about 5%) and 90% of the top drugs (by spending) will be biologics. The obvious importance of development of more biosimilars is highlighted.

About the public’s health

Screening for Pancreatic Cancer US Preventive Services Task Force Reaffirmation Recommendation Statement: “The USPSTF found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves disease-specific morbidity or mortality, or all-cause mortality.” Early detection of this disease should be a top priority of cancer research.

2019’s Best & Worst States for Health Care: The annual WalletHub state rankings are out and Minnesota is on top. Composite scores are comprised of cost, access and outcome scores. Read the article to find out where your state ranks. Is there consistency among the three metrics?

About healthcare IT

Telemedicine May Boost Unnecessary Antibiotic Prescribing in Kids: One reason for this finding is that: “Getting an antibiotic prescription… was the strongest single predictor of satisfaction, and a physician's antibiotic prescribing rate was highly correlated with their overall satisfaction ratings…” Should we measure patient satisfaction for those visits if it leads to worse clinical behavior?

About health insurance

TRICARE families report worse access to care than commercially insured, uninsured: study: This article summarizes a report in Health Affairs (which is available only by subscription). The research compares access for beneficiaries covered by TRICARE (insurance for families of active military) with private and other public insurance plans. The headline tells the story.

Patients’ preferences over care settings for minor illnesses and injuries (Be patient, the site loads slowly): How do patients make choices about where to obtain care? Do financial considerations play a part? This research found that:

“Out‐of‐pocket costs and wait time had minimal impact on patient's preference for site of care. Choices were driven primarily by the clinical scenario and patient characteristics. For chronic conditions and children's well‐visits, the doctor's office was the preferred choice by a strong majority, but for most acute conditions, either the ER (for high severity) or urgent care clinics (for lower severity) were preferred to the office setting, particularly among younger patients and those with less education.” The authors concluded that the “low impact of out‐of‐pocket costs suggests that insurers interested in encouraging increased utilization of alternatives would need to consider substantial changes to benefit structure.”

Today's News and Commentary

About medical devices

3D bioprinting of collagen to rebuild components of the human heart: This article is a fascinating look at the use of collagen in 3D bio printing. It raises many possibilities for replacements of body parts other than for the heart.

About healthcare IT

NIST guidance aims to help providers secure IoT tools: As previously reported, peripheral devices (“Internet of Things” or IoT) have major security concerns. The National Institute of Standards and Technology has issued guidance aims to address these potential problems. This article summarizes the suggestions. For more information, check the NIST/IoT website.

Anthem, Humana along with Apple and Google testing API for patient access to claims data: As previously reported, CMS is launching a new version of its Blue Button link that will enable beneficiaries to check on their claims. The private equivalent also announced this functionality; it comes from the CARIN Alliance, “led by distinguished risk-bearing providers, payers, consumers, pharmaceutical companies, consumer platform companies, health IT companies, and consumer-advocates who are working collaboratively with other stakeholders in government to overcome barriers in advancing consumer-directed exchange across the U.S.” The lead management is from Leavitt Partners.

About the public’s health

Teens Are Getting Hooked on Leftover Prescription Meds: This article summarizes two studies published in the Journal of the American Academy of Child and Adolescent Psychiatry. “…the first one involved more than 18,000 high school seniors. It found that about 11% of them said they misused prescription drugs in the past year, and of those, 44% had multiple sources for the drugs.More than 70% of teens who got prescription drugs from multiple sources had a substance use disorder -- prescription medications, other drugs and alcohol -- within the previous year.”

“The second study, involving nearly 104,000 12- to 17-year-olds, found that the most common sources of prescription drugs were: getting them free from friends and relatives, physician prescriptions for opioids, and buying stimulants and tranquilizers illegally.”

Natural American Spirit's pro-environment packaging and perceptions of reduced-harm cigarettes: Public perception about two brands of cigarettes (both manufactured by Reynolds American) were assessed. Natural American Spirit [NAS] has pro-environmental packaging and Pall Mall does not. “Consistently on all measures, NAS cigarettes were rated as less harmful for oneself, others, and the environment relative to Pall Mall (p's < .001). Though Reynolds American manufactures both brands, participants rated the company behind NAS as more socially responsible than the company behind Pall Mall.” Authors concluded: “Stricter government regulations on the use of pro-environment terms in marketing that imply modified risk is needed.”

De Blasio Administration Launches NYC Care in the Bronx, Key Component of Mayor's Guaranteed Health Care Commitment: As previously reported, NY City announced it would provide “quality and affordable health care for hundreds of thousands of New Yorkers who are not eligible for insurance or who cannot afford it.” Last week, the first program was launched in the Bronx and will offer residents “access to a dedicated primary care provider, …preventive care and routine screenings, …access to specialty care services, [the ability to] make appointments and navigate their health care needs through a new 24/7 customer service center. New Yorkers will also get access to affordable medications day or night.”

About health insurance

Cigna Plans Big Medicare Advantage Expansion: This article is another example of how Medicare Advantage is continuing to expand. “…the insurer plans to enter 37 new counties with such HMO offerings for what executives said will be a 14% increase in the company’s Medicare Advantage footprint, pending regulatory approvals.”

Financial Costs and Burden Related to Decisions for Breast Cancer Surgery: We often think that the costs of care mainly affect poor, minority and uninsured patients. In this study, most of the subjects “were white (90%), were insured privately (70%) or by Medicare (25%), were college educated (78%), and reported household incomes of more than $74,000 (56%).” Researchers found that among “the highest incomes, 65% of women were fiscally unprepared, reporting higher-than-expected (26%) treatment costs.”
The costs of care need to be discussed with all patients regardless of their perceived ability to afford treatment.

Charity becomes a lifeline even for Americans with health insurance as deductibles soar: Continuing the theme of costs of care, this article is a great summary of how families are coping with these expenses by seeking charitable subsidies from a variety of sources. The problem is often that they are underinsured and need help meeting the rising annual out-or-pocket expenses, particularly deductibles.

The Use Of Vendors In Medicare Part B Drug Payment: The Medicare Part B drug benefit pays physicians 6% over average national sales price. Thus, revenue can be maximized by administering the most expensive effective medications. The pricing scheme is the only mechanism Medicare has for controlling Part B expenditures. Part D, on the other hand, is handled by private companies which have a variety of non-price mechanisms for controlling costs, e.g., step therapy, prior authorization, etc. This article is a nice summary of how the federal government is looking at adopting Part D procedures to control Part B expenses.

Military Health Systems: This topic is the subject of a special issue of Health Affairs (Most articles require a subscription).

About pharma

Johnson & Johnson scores latest talc trial win as case count reaches 15,500: This article is the latest update in legal proceedings against J&J for damages alleged to have occurred from asbestos in its talc-based baby powder.

Drugmakers master rolling out their own generics to stifle competition: This story provides another example of how pharma brands can effectively extend their patents by producing their own generics.

Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers [ARBs]: ACE inhibitors (ACEIs) and ARBs are equally effective, for example, to lower blood pressure. Because ACEIs were on the market first, they are all generic. These authors found that by “maximizing generic substitution and therapeutic interchange, Medicare could have saved approximately $676 million (89.6%) in 2016 and 2017 of the total $754 million spent on these brand-name ACEIs and ARBs during those 2 years ($537 million in 2016 and $203 million in 2017),excluding possible manufacturer rebates.” Imagine what such a program could save for other classes of medications.

About healthcare quality and patient safety

CMS delays funding renewal for quality improvement organizations: “The 13 quality improvement organizations that are part of CMS' Quality Innovation Network are halting operations and laying off staff as they wait for the agency to renew their multimillion-dollar contract. The $960 million contract, which ended in mid-July, wasn't renewed and won't be until sometime between September and November, according to a CMS memo to the organizations last month.”

Today's News and Commentary

About the public’s health

Binge Drinking Among Older Adults in the United States, 2015 to 2017: Binge drinking is defined as five or more drinks on the same occasion for men and four or more drinks on the same occasion for women. In this research sample of 10 927 respondents over age 65, 10.6% “were estimated to be current binge drinkers. Binge drinkers were more likely to be male, have a higher prevalence of current tobacco and/or cannabis use, and have a lower prevalence of two or more chronic diseases compared to nonbinge drinkers… the prevalence of binge drinking was higher among non‐Hispanic African Americans than whites…, tobacco users…, cannabis users …, and those who visited the ED in the past year.” The importance of this research is that the prevalence is larger than expected and interventions can be directed at certain populations.

Iceland cuts teen drinking with curfews, youth centers: At the other end of the population age group, teen drinking and drug use were huge problems in Iceland. “In 1999, when thousands of teenagers would gather in downtown Reykjavik every weekend, surveys showed 56% of Icelandic 16-year-olds drank alcohol and about as many had tried smoking. Years later, Iceland has the lowest rates for drinking and smoking among the 35 countries measured in the 2015 European School Survey Project on Alcohol and Other Drugs.” The Icelandic Centre for Social Research and Analysis accomplished this improvement by developing town-financed venues where teens can meet, instituting curfews and keeping “young people busy and parents engaged without talking much about drugs or alcohol. That stands in sharp contrast to other anti-abuse programs, which try to sway teenagers with school lectures and scary, disgusting ads showing smokers’ rotten lungs or eggs in a frying pan to represent an intoxicated brain.” The program has been successfully copied in many other countries ranging from Finland to Chile.

Association of Region and Hospital and Patient Characteristics With Use of High-Intensity Statins After Myocardial Infarction Among Medicare Beneficiaries: This research is a good example of geographic disparities in healthcare. The authors studied use of statins as secondary prevention for cardiovascular disease and found: “In models considering region and beneficiary and hospital characteristics, region was the strongest correlate of high-intensity statin use, with 66% higher use in New England than in the West South Central region.”

Whole genome sequencing revealed new molecular characteristics in multidrug resistant staphylococci recovered from high frequency touched surfaces in London: The headline speaks for itself and highlights the importance of hand handwashing.

Scientists are making human-monkey hybrids in China: “The Spanish-born biologist Juan Carlos Izpisúa Belmonte, who operates a lab at the Salk Institute in California, has been working working with monkey researchers in China to perform the disturbing research. Their objective is to create ‘human-animal chimeras,’ in this case monkey embryos to which human cells are added…The idea behind the research is to fashion animals that possess organs, like a kidney or liver, made up entirely of human cells. Such animals could be used as sources of organs for transplantation.” In addition to technical issues, a discussion of the ethics of this process is important. Additionally, will such engineered organs be allowed in this country if the process that produces them is illegal?

Performing different kinds of physical exercise differentially attenuates the genetic effects on obesity measures: Evidence from 18,424 Taiwan Biobank participants: This article is fascinating. The authors split the cause of obesity between individual behavior (overeating and sedentary) and genetically induced. Treatment of the former is straightforward. But will the same measures work on the genetic variety? The answer is a bit complex. “Regular jogging blunted the genetic effects on BMI [body mass index], BFP [body fat percentage], and HC [hip circumference]. Mountain climbing, walking, exercise walking, international standard dancing, and a longer practice of yoga also attenuated the genetic effects on BMI…Exercises such as cycling, stretching exercise, swimming, dance dance revolution, and qigong were not found to modify the genetic effects on any obesity measure.” Overall, jogging was best. One caveat: this study was done on a population of Han Chinese.

About pharma

Mylan reaches $30 million settlement in SEC's EpiPen probe: Mylan classified its branded EpiPen as a generic product so it could minimize government rebates. In 2017, the company finalized a $465 million settlement with the Justice Department. This latest, related settlement was with the SEC. I wonder how much Mylan thought it would make by misclassifying the EpiPen and if it was, a priori, worth a business risk of about half a billion dollars.

FDA drug approvals are up 11%: “The FDA accepted 137 new drug approvals (NDAs) and biologics license applications (BLAs) in 2018, up 11% from 2017 and 36% from 2012 to 2017, according to a new report. In 2017, the FDA approved 122 drugs, compared to 101 over the previous five-year period.”

GlaxoSmithKline, Pfizer complete formation of consumer healthcare joint venture: This joint venture is the latest variation on business unit restructuring in the pharma industry.

About healthcare quality/safety

Analysis of Human Performance Deficiencies Associated With Surgical Adverse Events: While perfection in any endeavor is impossible, continuing improvements require knowledge of the sources of error. Some errors are in the design of systems and require work flow or technical changes. Others are due to human error. This study found that human performance deficiencies “were identified in more than half of adverse events, most commonly associated with cognitive error in the execution of care.” Use of these findings are discussed with respect to frameworks for change.

Association of US News and World Report Top Ranking for Gastroenterology and Gastrointestinal Operation With Patient Outcomes in Abdominal Procedures: “In this administrative database study of 51 869 abdominal operations, the annual case volume was 397 at top-ranked hospitals compared with 114 at nonranked hospitals. No statistically significant differences in serious morbidity or in-hospital mortality were found between these cohorts.” This article is a comment on the volume-quality relationship. In the past it was found that hospital and/or physician volume could determine the quality of the outcome. One unstated interpretation of this research could be that physician volumes were more important than hospital volumes. Volumes per surgeon at these facilities was not studied.

About health insurance

Medicare proposes outpatient hip replacements: Medicare already pays for knee replacements on a same-day basis (that is, no hospital admission). Now it is proposing the same coverage for hip replacements. This proposal is a great opportunity to think about the financial impact on independent physicians and hospitals. Although hospitals have been moving to same-day surgeries and investments in surgicenters for years, this procedure has been mostly done as an inpatient.

Today's News and Commentary

About pharma

Would Trump's new drug-imports plan do much to prices—or to pharma?: Yesterday, CMS announced two pathways that would allow drug importation with the aim of lowering costs. On further reflection, it may not have such a large impact. First, “…many of pharma's most costly products—biologics such as AbbVie's Humira; IV drugs, a category that would include many pricey cancer treatments; and inhaled products, such as respiratory therapies from GlaxoSmithKline and AstraZeneca, are all excluded. So are meds that require Risk Evaluation and Mitigation Strategies at the FDA—a group that comprises many expensive and newer drugs, such as multiple sclerosis treatments.” Next, the second pathway that allows drug manufacturers to import medications does not compel them to do so- particularly if it is not in their best interest. Finally, we need to realize that not all drugs are cheaper abroad. Certainly, generics are much cheaper in the US than in the countries from which we would import drugs. We will need to see how much these pathways are used and whether it is worth the effort for interested stakeholders.

About healthcare IT

Unbounded—Parent-Physician Communication in the Era of Portal Messaging: While patient portals can increase accessibility of care, for physicians it can represent another “time sink” for uncompensated care. In addition to phone calls, this pediatric study states that “the average pediatrician currently answers approximately 10 patient portal messages a day, and this number is expected to grow.” The authors opine that one reason the number of messages will grow is that the bar is much lower for messaging than phone calls. This article is a balanced presentation of this issue.

About healthcare insurance

Health Plans Are Riding The Medicare Wave:This survey of insurance executives shows how bullish they are about growing their Medicare Advantage businesses. 92% say they plan to grow that product faster that their traditional Medicare offerings. The survey cites the growth of the Medicare-eligible population and value-based results as reasons for this growth.

HHS approves Colorado's waiver to set up ACA reinsurance program: Colorado became the eighth state to get a waiver that “enables the federal government to use ‘pass-through’ money that it would have spent on ACA tax credits to help fund the reinsurance program.” By offering health plans reinsurance for claims above $30,000 (with a cap of $400,000), premiums can be lowered. According to CMS, “the waiver is expected to lower premiums in the state by 16% in 2020, and enrollment could increase by nearly 3% because of the lower premiums…”

Democrat’s Proposals: Here are a couple good articles summarizing last night’s “round 2” of Democratic debates: The messy health care discussion at the second Democratic debate, explained and Biden and Harris put health care plans to test on Democratic debate stage. Bottom line is that the debate focuses mainly on two candidates. Harris has her version of “Medicare for All” and Biden wants to make the ACA better.

About the public’s health

Poorer U.S. patients less likely to get blood pressure controlled: A reminder that economic disparities are an independent factor in receipt of appropriate care. The headline speaks for itself.

Trump administration tightens opioid prescriptions for feds: The Federal Employee Health Benefits Program will change its coverage of opioids in view of widespread abuses. “Under the new policy, the initial prescription will be for a 7-day supply, instead of up to 30 days.”

Nutrient deficiencies in rice grown under higher carbon dioxide could elevate health risks for tens of millions: This article raises a “new” concern about global warming due to rising CO2 levels. “In the past decade both laboratory and free-air studies have shown that crops of many dietary staples, including wheat, barley, rice, potatoes, and soybeans, develop lower concentrations of iron, zinc, protein, and other nutrients crucial to human health when they are grown under elevated levels of carbon dioxide… Now a recent study in the AGU journal GeoHealth finds declines in B-vitamin concentrations in rice grown under elevated CO2 concentrations may increase the future health risks of large numbers of people around the globe.”

Today's News and Commentary

About health insurance

Democratic debate was a boxing match over Medicare-for-all: This review of last night’s Democratic debates (round 1 of 2) did not have any real policy surprises. The differences among candidates became more focused. This article from the Washington Post is the best summary I have read.

Fiscal Year 2020 Payment and Policy changes for Medicare Skilled Nursing Facilities: This announcement was part of a number of payment and policy changes CMS issued yesterday, This one concerns funding and revised quality measures for skilled nursing facilities. The good news is that:” CMS projects aggregate payments to SNFs will increase by $851 million, or 2.4 percent, for FY 2020 compared to FY 2019.”

Humana raises 2019 guidance as Medicare Advantage enrollment grows: This article is not so much about Humana as the prospects for continued growth for Medicare Advantage plans.

Trump Administration Drives Down Drug Costs for Seniors: The announcement is blatantly self-serving, but the message is good: “Over the past three years, average Part D basic premiums have decreased by 13.5 percent, from $34.70 in 2017 to a projected $30 in 2020, saving beneficiaries about $1.9 billion in premium costs over that time.” The announcement, however, does not include information about trends in out-of-pocket expenses.

About healthcare IT

Rite Aid launches telehealth service through in-store kiosks:”In partnership with telehealth company InTouch Health, Rite Aid will begin offering a virtual service that connects customers with clinicians via its RediClinic Express kiosks located in retail stores.” Awareness about telehealth options is a major reason for its low usage. Perhaps this opportunity will also publicize what telehealth is.

In ongoing feud with PillPack, Surescripts bars ReMy Health from using its patient data: Amazon owns PillPack and Surescripts (which manages about 80% of U.S. prescriptions) is owned by CVS Health and pharmacy benefit manager Express Scripts. By Surescripts withholding patient data from its competitor, the latter’s business model can be severely impeded. This action raises a continuing concern about antitrust activity that the FTC is currently investigating.

CMS pilot taps FHIR to give clinicians access to claims data: The more generic story in many outlets was the capability by clinicians to access claims data. This article looks into the technology a bit deeper than others do.

About pharma

Exclusive: Two powerful Canadian provinces argued against federal drug price crackdown: American pharma companies claim that controlling their prices will impede their ability to research and develop new products. At the same time, policy makers correctly claim we have the highest branded drug prices in the world and point to Canada as an example we should emulate. Well…”Ontario and Quebec, have privately expressed concerns with a federal government plan to slash the price of patented drugs, arguing that such regulatory changes could hurt investment in life sciences.”

Congress seeks briefing on potential threat to U.S. heparin supply: The specifics of the article are less important than the illustration of how fragile our pharma supply chain can be. The “blood thinner” heparin is made from ingredients originating in pig intestines. “…60 percent of the crude heparin used to make finished heparin in the United states is sourced from China,” where there is an outbreak of African swine fever.

A Massive U.S. Drug Price-Fixing Probe Has Hit Major Roadblocks (from Bloomberg, limited free access): Federal and state actions against generic manufacturers’ alleged price-fixing collusion began in September 2016 with an FBI raid on Mylan. Since then, the investigations have faced a number of roadblocks. This article is a comprehensive update on this story.

How a Big Pharma Lawsuit Could Succeed Where Big Tobacco Failed: This article provides some history behind the $246 billion settlement from Big Tobacco in the ’90s and how many states misused the payouts for purposes other than public health. The message is how settlements from the opioid lawsuits can be put to better use.

HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs: HHS announced plans for two pathways to allow states to import drugs. According to the government statement released today:
The first pathway would be through a notice of proposed rulemaking (NPRM) whereby HHS and FDA would rely on the authority under current federal law “to authorize pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval.”

The second mechanism is through guidance, whereby the “FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries…. To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the U.S.”

About the public’s health

Lyme disease: Lyme disease may be 3 times higher than previous estimates in the UK (perhaps also in the US). It is timely that the FDA has just approved four diagnostic tests with new indications for diagnosing Lyme disease.

For Mortality, Busting the Myth of 10 000 Steps per Day: You should exercise; but you may not need to do 10,000 steps a day. This research on women found that benefits start at 4400 steps, increasing with further activity and leveling off at 7500 steps.

Today's News and Commentary

About healthcare quality and patient safety

The Best Hospitals 2019-20 Honor Roll: This year’s US News rankings have just been published.

Medical-device reprocessing saved providers $470 million last year: Usually reprocessing single- use devices is a red flag for quality/safety concerns. This article explains how they can be safely reused at a substantial cost savings.

About pharma

Drug companies to pay $70 million for delaying cheaper generics, California attorney general says: The FTC has been challenging branded drug manufacturers who pay generic companies to withhold their products during the period when the latter have marketing exclusivity. This case is unusual because a state is taking action against such a practice.

In A 1st, Doctors In U.S. Use CRISPR Tool To Treat Patient With Genetic Disorder: A patient received cells that were genetically altered using the CRISPER tool. The treatment was to correct her sickle cell disease.

About health insurance

CMS proposes hospitals post online negotiated rates with payers: CMS has issued a proposed rule to require hospitals to post online their list prices and a payer-specific negotiated prices for 300 common shoppable services, such as lab tests or certain clinical services. After accepting comments, the measure is set to start January 1, 2020. Failure to comply will result in penalties of $300 per day.
Comments: Will patients who go to a facility dictated by their insurance bother to look at the prices? Will patients who need emergency care look up the prices? Will this measure have any impact on “surprise billing?” Is $300 per day a sufficient penalty for not revealing confidential negotiated fees? What if payers offer to compensate hospitals for the penalty to keep the prices confidential?

Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2020: CMS has issued its proposed policies for comment that concern next year’s Medicare physician payments and quality provisions.

Trump Administration’s Patients over Paperwork Delivers for Doctors: In a related publication, CMS published measures '‘aimed at reducing burden, recognizing clinicians for the time they spend with patients, removing unnecessary measures and making it easier for them to be on the path towards value-based care.” The administration claims these new regulations will save 2.3 million hours per year.

Hurry up and wait: Docs say insurers increasingly interfere: This article highlights how utilization reviewers determine what tests/treatments are done by withholding payments.
Comment: If providers assumed financial risk for services would we have this problem?

About healthcare IT

Google Translate accurate enough to convert medical research into English: Review articles in the US are usually limited to studies published in English. This research showed that Google Translate is accurate enough to expand these reviews to other languages.

Today's News and Commentary

About health insurance

Governors weigh health care plans as they await court ruling: The headline is self explanatory. Governors gathered in Salt Lake city and discussed what would happen if the courts find the ACA is invalid.

2019 Wellness & Wealth Report: This inaugural report from Lively, Inc. found that healthcare benefits are the most important factor for employees- surpassing competitive salaries and 401 (k) plans.

Despite calls to start over, US health system covers 90%: This story was in a number of media today. Some spun it positively and others said “only 90%” of the population is covered. This article also points out that the adequacy of coverage is also important, as American face higher out of pocket costs.

Trump administration rejects Utah request for partial Medicaid funding: As previously reported, Utah and some other states were considering a partial expansion of Medicaid- more than current limits but not quite up to ACA expansion requirements. The Trump administration turned down the state’s request, setting this option aside.

Judge strikes down New Hampshire Medicaid work requirements program: Some states have tried to add work requirements to receive Medicaid benefits. This court decision is the latest (after Kentucky and Arkansas) striking down this condition for participation.

Aetna enlists AI to settle health insurance claims: Claims payments can get very complicated. This article explains how “Aetna allocates 50 employees to read notes about payment, deductible, and extraneous fee explanations in each contract, calculate pricing and update the claim. And with Aetna handling 2.4 million contracts per year, the process takes weeks to months, and often results in incorrect payment for claims.” The solution to this complex, often personnel-intensive process is use of artificial intelligence. This article is a nice summary of this use for AI.

HHS' OIG: CMS must review how MSSP overhaul is affecting ACO care: The HHS’ Office of the Inspector General interviewed 20 high performing Accountable Care Organizations to find out their secrets for success. Among the findings were the presence of care coordinators. But the one shortcoming was lack of a mechanism to share best practices with other ACOs.

Legislation introduced to back state Medicaid programs in addressing social determinants: Addressing social determinants of disease can reduce overall costs. But until legislation is passed, theses measures are not part of Medicaid funding. The model for expansion is what CMS allows Medicare Advantage plans to provide to their members.

About pharma

Restrictions on $2 Million Drug Highlight Challenge for Gene Therapies (Wall Street Journal, subscription may be required): The article deals with the specifics of Novartis’ gene therapy Zolgensma, which costs $2.1 million. The principles apply to other extremely expensive, life-saving or life-altering therapies.

Pfizer close to merging off-patent drug business with Mylan: report: This story was the top healthcare “business news” today and is the latest in the pharma sector’s ongoing restructuring.

NIH issues strict new requirements for fetal tissue research funding(Washington Post, subscription may be required) “In a notice spelling out the rule changes, NIH says that all grant applications and renewals for research relying on tissue collected from elective abortions must provide a detailed justification, documenting why no alternative methods could accomplish the same research goals. This and other changes for scientists at universities and other institutions take effect in two months.”

About healthcare IT

VA to spend $4.9B maintaining EHR over next decade as it rolls out Cerner replacement: This article is the latest on the VA EHR fiasco which is way over budget and time projections. The VA estimates that while it is rolling out its $10 billion Cerner system over the next 10 years, it will need $4.9 billion to maintain its legacy system, which has “130 versions or instances…across 1,500 sites.”

VUMC pilot to use voice commands to retrieve EHR data: It is often cumbersome to navigate an EHR. This pilot study at Vanderbilt will use voice commands to expedite searches.

HHS Awards Nearly $42 Million to Expand Health Information Technology In Health Centers Nationwide: “HHS, through the Health Resources and Services Administration (HRSA) awarded almost $42 million in funding to 49 Health Center Controlled Networks (HCCNs). These awards will enable the HCCNs to support 1,183 federally-funded health centers across all 50 states, the District of Columbia and Puerto Rico to expand the use of health information technology (health IT)…HCCNs are groups of health centers collaborating to improve operational and clinical practices by making technology easier for providers and patients to use, increasing the security of patient information and using data to improve patient care.”

Today's News and Commentary

About the public’s health

Association of Racial Bias With Burnout Among Resident Physicians: Physician burnout has been blamed for clinical errors and personnel shortages due to early retirement. This article explains another problem resulting from burnout- racial bias among resident physicians. The authors speculate that burnout may thus be contributing to healthcare disparities.

Juul went into a ninth-grade classroom and called its device 'totally safe,' teens testify:This story was reported in a number of media outlets. At the same time Juul has been promoting its programs to restrict its products to potential underage users, according to these stories it paid schools to do presentations on the safety of vaping. The stories are really disturbing.

Yale Employees Test Their Workplace Wellness Program In The Courts: Yale instituted a workplace wellness program to reduce healthcare costs. Participation is “voluntary,” but non compliance will trigger a financial penalty deducted from paychecks. Employees have filed a class action lawsuit against this program. Perhaps Yale should have increased costs for health benefits for all and provided reductions for those who participated in healthy activities?

About healthcare quality and safety

Modernizing the HCAHPS Survey: The Federation of American Hospitals conducted a survey about the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) that is administered to Medicare patients after hospital care. The organization points out a number of problems with the current version: Response rates are falling; the survey could do better to provide patients with comparable data; the topics need to be updated (for example to include questions related to efficiency and team-work of the care team); more research is needed on additional factors that influence patient experience; and  health literacy level needs to be made more appropriate for the surveyed population.

The top recommendations were: Add a digital mode of delivery to patients; shorten the survey; make revisions “in light of today’s shift to value-based care, changes in health care delivery, improvements in technology, and evolving patient priorities; reframe the care transitions and discharge planning sections of the HCAHPS survey; and periodically re-evaluate the HCAHPS survey.”

About pharma

Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies (From the Journal of General Internal Medicine- subscription required): Unlike other countries, the US does not have a central technology evaluation entity that looks at cost-effectiveness. This research compares FDA-approved drugs with those from Australia, Canada, and England, which do have cost-effectiveness review. Medicare spending from 2011-2016 was then calculated for the drugs that were used in this country but not approved in the other three. The results were: “Medicare spending totaled $3.7B, $17.8B, and $2.1B on drugs and biologics not recommended nor covered in only Australia, Canada, and England, respectively… $2.8B on those not recommended nor covered by any two countries, and $0 by all three countries. Between 2011 and 2015, Medicare beneficiaries filled 43.4M prescriptions for the not recommended nor covered drugs and biologics, spending $2.8B out-of-pocket …” The recommendation to apply cost-benefit standards seems obvious but it is currently illegal here.

Trump gives boost to state drug import plans: As previously reported, several states (Vermont, Florida, Colorado and Maine) passed laws allowing foreign drug importation to lower costs. But this action is illegal unless it gets federal approval. Now HHS Secretary Azar has changed his stance on this issue and will support ordering drugs, mainly from Canada.

FDA Agrees to Accept Inspections for All 28 EU Member States: One of the objections to drug importation is the spotty oversight of manufacturing in other countries. The US has been working with other nations to deem their supervisory authorities acceptable for imported drugs. Now, the “FDA has agreed to recognize inspections by all 28 EU member states under the U.S.-EU's mutual recognition agreement (MRA) for GMP [Good Manufacturing Practices] inspections.”

Senate panel advances bipartisan bill to lower drug prices amid GOP blowbackThis bipartisan bill is the one Senators Grassley and Widen have been crafting. One of the controversial parts of the bill is provision that limits drug price increases for Medicare Part D; drug companies would have to repay revenue if their prices rise faster than inflation. Many Republicans see this measure as a free market constraint. Democrats are crafting their own bills which may go even further than this one. Further, the industry trade group, Pharmaceutical Research and Manufacturers of America (PhRMA), has continued to lobby against this Senate bill. In any case, nothing further will be done before the August recess.

Today's News and Commentary

About health insurance

A look at people who have persistently high spending on health care: This study from Kaiser draws on three year’s experience with its membership. There are many good lessons from this research, but, in summary, the conclusion was: “Those with persistently high spending, while few in number, are some of the most expensive users of care – the 1.3% of enrollees with high spending in each of three consecutive years (2015-2017) had an average spending in 2017 of almost $88,000, accounting for 19.5% of overall spending that year. The predictability and extent of their spending suggest that any efforts to reduce the total costs of care and improve health system quality must focus heavily on this group of people.” High cost patients had significantly increased expenses for inpatient, outpatient and pharmaceuticals, so case management looking at the entire episodes of care need to be implemented. HIV infection, cystic fibrosis and multiple sclerosis were, by far, the three costliest conditions.

Senate will not vote on bipartisan health costs bill before leaving for August: The headline says it all.

About the public’s health

Births in the United States, 2018:This annual report from the CDC reveals that birth rates fell to an all-time low in the US. The rates declined for non-Hispanic white, non-Hispanic black, and Hispanic women. The teen birth rate also declined ( by 7%) from 2017 to 2018.

New Texas anti-abortion group vies for family planning funds: In a new twist on federal withholding of Title X funds: “A new faith-based, anti-abortion health group in Texas is suing HHS for the right to receive federal family planning funds — another sign such groups are moving aggressively to win some of the backing that long went to organizations like Planned Parenthood.”

About healthcare IT

Fitbits and other wearables may not accurately track heart rates in people of color: “In short: Skin with more melanin blocks green light [used by the sensors in the wearables], making it harder to get an accurate reading. The darker your skin is, the harder it gets.”

Today's News and Commentary

About pharma

Sanofi grabs nonprescription rights to Roche's Tamiflu, aiming for Rx-to-OTC switch: The title explains the article’s contents. Sanofi seeks to get FDA approval to make the influenza drug Tamiflu available over the counter.

Senators announce bipartisan proposal to lower drug prices: There is bipartisan support in the Senate Finance Committee for a proposal to keep drug prices down “by forcing pharmaceutical companies to pay rebates to Medicare if they raise prices of drugs more than the rate of inflation. Those rebates would be equal to the difference between the price increases and the inflation rate.The proposal also includes a cap on out-of-pocket costs for drugs covered under Medicare’s Part D, which is for self-administered prescription drugs, as well as changes to the program’s Part B, which covers physician-administered drugs….The senators said the proposal would save taxpayers $100 billion from the Medicare and Medicaid programs. Beneficiaries would save $27 billion in out-of-pocket costs.” The proposal has White House support but still has a long way to go before becoming law.

Drugmakers shell out record amount lobbying Congress(Financial Times subscription required): The industry lobbying group Pharmaceutical Research and Manufacturers of America spent a record $16.1 million in lobbying in the first half of 2019. The article cites the above proposed legislation as one reason for the stepped up activity.

More biosimilar drugs are coming to market. Yesterday the FDA approved the second biosimilar for Rituxan. Also approved was a biosimilar for Humira.

Implanted drug could someday prevent HIV infection: A number of news outlets reported on a matchstick-sized implant that could offer continuous protection against HIV infection for at least a year. While apparently effective, running randomized controlled trials could prove to be ethically difficult.

Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes: What happens when insurers deny coverage for very expensive medication? In the case of these costly cholesterol-lowing agents: “Individuals in the rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort. Rejection, abandonment, and disparities related to PCSK9i prescriptions are related to higher cardiovascular outcome rates.” Perhaps the payers need to change criteria for coverage.

Latest generic drug deal puts hospital-owned Civica Rx ahead of schedule: This article is an update on Civica, a generic pharma company formed last year by hospitals who wanted to lower their pharma costs and relieve some of their drug shortages. “More than 30 health systems are Civica members, representing 900 U.S. hospitals and 30% of U.S. licensed beds.”

About the public’s health

Trump proposal would push 3 million Americans off food stamps: The title tells it all. Obviously there are healthcare implications to this action.

Worldwide recall launched for textured breast implants linked to rare cancer: This morning Allergan announced a breast implant recall.

About healthcare IT

IBM Watson Health's new manager talks about returning to basics, doubling down: There are a number of uses for artificial intelligence (AI) in healthcare settings (see below). IBM’s Watson has realized it cannot be all things to all stakeholders. Instead, it has decided to focus on clinical care. In the past year it gave up the healthcare management sector and is not enrolling new pharma clients.

Hand hygiene compliance surveillance with time series anomaly detection: Use of Artificial Intelligence-aided time series methods provided “more interpretable views of anomalous data compared to traditional statistical process control charts.” As well, individual patterns could be detected for more focused interventions.

Deep Learning to Assess Long-term Mortality From Chest Radiographs: Using AI in this study, “the deep learning CXR-risk score stratified the risk of long-term mortality based on a single chest radiograph. Individuals at high risk of mortality may benefit from prevention, screening, and lifestyle interventions.”

AmeriHealth Caritas' Inclusion of Community Health-Based Services Reduces Emergency Room Utilization: “An analysis of data compiled by AmeriHealth Caritas' clinical and health care analytics teams indicates that high-risk Medicaid members who receive community-based services, with an emphasis on screening for and addressing the social determinants of health, experience a reduction in hospitalization rates.” The program resulted in decreases of : 26.3% in inpatient admissions; 27.2% in inpatient days; 9.7 % in emergency department visits; 22% in potentially preventable admissions; and 12% in potentially preventable emergency department visits.

Wellness culture's obsession with Fitbits, 23andMe and data isn't necessarily making us healthier: Is more data always better when one desires to improve health? Not always, as this article explains.

Cost of a Data Breach Report 2019: (Registration is free for the full report) This annual report comes from IBM Security. The average cost of all data breaches is $3.9 million; but healthcare breaches are the most expensive at an average of $6.45 million. All breaches cost an average of $150 per record; healthcare breaches average $429.

DataSpii: The catastrophic data leak via browser extensions: On a related note, this report explains the data leaks that can occur from using browser extensions.