Today's News and Commentary

About the public’s health

Liver transplant rules spark open conflict among transplant centers: As previously reported, federally sponsored allocation methods for organ transplants have been changing. Undersupplied, populated areas complained that they don’t have enough organs. Relatively underpopulated areas (which are better-supplied) say they will be discriminated against if their available organs go elsewhere. Atlanta federal court judge Amy Totenberg said she will allow a lawsuit to go forward by those claiming to be adversely affected by the new rules.

Read the story (Washington Post but appears to be open access)

Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake: This research explains the science of why junk food is bad for you. Subjects were presented with identical diets were with respect to calories, sugar, fat, fiber, and macronutrients. One diet was “ultra processed” and the other was a healthier offering. In addition to the presented diets, subjects were free to eat other foods without caloric restriction. Results showed the ultra processed diet (junk food) led to about 500 calories more per day than the healthier diet, with a significant increase in weight gain. The healthier diet also led to weight loss.
Reasons for these findings? The glucose tolerance between groups was not changed but “the appetite-suppressing hormone PYY increased during the unprocessed diet as compared with both the ultra-processed diet and baseline. Also, the hunger hormone ghrelin was decreased during the unprocessed diet compared to baseline.” Other researchers have been investigating obesity treatments using PYY and ghrelin. This study may lend some scientific credence to those investigations.

Read the research

Fostering Productive Health Care Cost Conversations: Sharing Lessons Learned and Best Practices: This themed issue of the Annals of Internal Medicine has articles about how physicians can conduct cost of care conversations with patients.

Link to the articles (Open access)

About pharma

Trump administration backs off Medicare drug pricing rule: “Under current law, private Medicare health plans are required to cover all or ‘substantially all’ drugs in six ‘protected”’classes, such as HIV treatments, antidepressants, drugs to treat epileptic seizures, and cancer drugs, regardless of cost.
Last fall, the administration proposed allowing health plans to exclude protected drugs with price increases that are greater than inflation, as well as certain new drug formulations that were not a ‘significant innovation’ over the original product.” Yesterday, CMS Administrator Seema Verma said that, based on feedback, the agency is withdrawing the proposal.

Read the story

White House, Congress considering killing Part D rebate rule, creating spending cap: In a related story about Medicare drug costs, the White House and Congress are considering abandoning a policy of rebates going to patients in favor of a spending cap.

Read the story

Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses: CMS issued final rules to address lowering drug costs. Among the rules are: the requirement to include “negotiated drug pricing information and lower cost alternatives in the Part D Explanation of Benefits beginning on 01/01/2021”; the requirement that Part D plans provide access to a Real Time Benefit Tool to be integrated into clinicians’ electronic prescribing or electronic health records systems no later than 01/01/21; and “certain new requirements for when MA [Medicare Advantage] plans may apply step therapy as a utilization management tool for Part B drugs.”

Read the rule:

Are pharmaceutical companies making progress when it comes to global health?: The Access to Medicine Foundation issued this report looking at how pharma companies are responding to the healthcare needs of developing countries. Among the findings: “…several pharmaceutical companies are now doing business in new, inclusive ways that aim to reach people on very low incomes. Seven companies are running a total of ten inclusive business models, eight of which are being expanded. Plus, 17 companies now set measurable targets related to access to medicine, up from eight in 2010. Yet, only some companies (9) are tackling the risks of unethical sales behaviour by changing sales bonuses. Fewer companies (4) have consistently supported international trade agreements designed to ensure the poorest people can benefit from medical innovation.” 

Read the report

AAM Rejects FDA’s Updated Biosimilar Naming Policy: As recently reported, manufacturers of branded biological drugs want the FDA to come up with a suffix for the product’s name that will identify it as the “original.” Predictably, “the Association for Accessible Medicines (AAM) and its Biosimilars Council is urging the FDA to scrap its proposed suffix-based naming policy for biological products because it would act as ‘a barrier to biosimilars access.’”

Read the story

Gilead schemed with J&J, Bristol-Myers to keep their HIV combo monopoly, lawsuit claims: It seems there is an epidemic of anticompetitive behaviors among pharma companies. On the heels of the recently reported Teva case, Gilead and others have been charged with monopolistic practices regarding a key component in an HIV treatment combination.

Read the story

Dems push bill on health care, drug prices through House: Along with five Republican votes, House Democrats passed a bill to address high drug prices. However, the bill also has provisions to rescind Executive Orders intended to dismantle the ACA, like allowing short-term plans to compete with those on the exchanges. Because of that addition, senate Republicans say it is DOA.

Read the story

Today's News and Commentary

Yesterday was the 100th issue of this blog.
Thanks to those whose encouragement and interest have kept it going.

About antitrust

FTC commissioner: Panel outmatched by healthcare's merger mania: This article summarizes comments by FTC Commissioner Rebecca Kelly about current antitrust prosecution problems. She says the Commission is understaffed and underfunded. Further, the McCarran-Ferguson Act is impeding investigation of insurance company mergers, since the data gathering in that sector requires Congressional action.

Read the article

DOJ sides with Oscar Health in ongoing spat with Florida Blue over broker agreements: Last November, Oscar health sued the Florida Blues plan, claiming that the latter’s broker agreements prevented competitors from expanding into the local ACA exchanges. The presiding judge, citing the McCarran-Ferguson Act, was not convinced of Oscar’s argument. Now the DOJ has stepped in to encourage the trial to proceed.

Read the story

Novartis may be close to settling a kickback case on the eve of a trial: After six years of sparring with the DOJ over charges that it offered lavish gifts to physicians to encourage prescription of its products, Novartis is rumored to be settling this whistleblower suit for $1 billion.

Read the story

Civica Rx and Xellia Pharmaceuticals Join Forces to Reduce Chronic Drug Shortages: Civica Rx, the hospital consortium formed to combat drug shortages for its owners, signed a contract with Xellia Pharmaceuticals of Denmark to “manufacture essential antibiotics, including Vancomycin and Daptomycin…” This contract is the first definitive agreement the organizations has made.

Read the announcement

The Death of Antibiotics: We’re Running Out of Effective Drugs to Fight Off an Army of Superbugs: This article is a good summary of the problem of antibiotic resistance. One startling statistic: The World Health Organization predicts that worldwide death rates from drug-resistant microbes will climb from the current 700,000 per year to 10 million by 2050. At that point, they will have surpassed cancer, heart disease and diabetes to become the main cause of death in the human race.”

Read the article 

CMS cracks down on spread pricing by pharmacy benefit managers [PBMs]: As part of its continuing scrutiny of PBMs, CMS is now looking into their practice of “spread pricing.”

Spread pricing occurs when health plans contract with a pharmacy benefit manager to manage their prescription drug benefits, and PBMs keep a portion of the amount paid to them by the health plans for prescription drugs, instead of passing the full payments on to pharmacies. 

The spread is the amount between what the health plan pays the PBM and the amount the PBM reimburses the pharmacy for a beneficiary's prescription.”

The reason CMS is involved is that spread pricing is especially of concern for Medicaid and CHIP plans.

Read the story

About healthcare IT

Express Scripts Simplifies Digital Health Technology Marketplace for Consumers and Payers: “The new formulary will help payers ensure the safety, effectiveness and usability of digital health technology tools made available to their members. Available in 2020, the digital health formulary will be a curated list of technology- and software-enabled applications and devices that help patients prevent, manage or treat a medical condition.”

Read the announcement

Forescout Releases Inaugural Device Cloud Research Based on Leading Device Intelligence: Among the findings of this report is that “71 percent of Windows devices within these healthcare deployments are running Windows 7, Windows 2008 or Windows Mobile, with Microsoft support planned to expire on January 14, 2020. Running unsupported operating systems poses a risk that may expose vulnerabilities and has the potential to impact regulatory compliance.”

Read the report

Erasing the Affordable Care Act: Using Government Web Censorship to Undermine the Law: This report from the Sunlight Foundation documents the federal actions to delete web content regarding the ACA. “The Web Integrity Project has documented 26 instances of ACA censorship — including excised words, removed links, altered paragraphs, and removed pages — on HHS websites.” If you want to get an idea of what was done, check Table 1 starting on page 15. For example, authorities removed HealthCare.gov from the header of CMS.gov.

Read the report

About the public’s health

Alabama governor invokes God in banning nearly all abortions: If left standing, this new Alabama law would outlaw abortion except in cases the mother’s life is in danger. Rape and incest are not exceptions. A woman who obtains an abortions would not be prosecuted but physicians performing the procedure could get up to 99 years in prison. The expectation is that the law will be challenged in court. Supporters of the law hope the case will be taken to the Supreme Court where Roe v. Wade will be overturned.

Read the story

States with the worst anti-abortion laws also have the worst infant mortality rates: The article’s title speaks for itself.

Read the story

North Carolina sues Juul, setting up a fresh legal fight for the embattled e-cigarette company: In the first state action against e-cigarettes, the North Carolina Attorney General filed a lawsuit against Juul Labs, alleging that the company caused consumer addiction by “deceptively downplaying the potency and danger of the nicotine” and employed advertising campaigns that targeted people under the legal smoking age. In addition to the FDA prohibition on the sale of fruit or candy flavors in stores, North Carolina’s would also remove mint. Further, the state seeks to prohibit online sales that are not tobacco or menthol flavors.

Read the story

Federal judge orders FDA to start regulating e-cigarettes: In a related story, a federal judge in Maryland ordered the Food and Drug Administration (FDA) to “speed up its reviews of thousands of electronic cigarettes currently on the market…" The order was given as a result of a lawsuit filed last year by the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and other public health groups.

Read the story

About healthcare quality

Walmart Charts New Course By Steering Workers To High-Quality Imaging Centers: Walmart will financially incentivize its employees to use one of 800 high quality imaging centers when CT or MRI scans are needed. The company said that because of incorrect diagnoses from those studies “about half of the company’s workers who went to the Mayo Clinic and other specialized hospitals for back surgery in the past few years turned out not to need those operations. They were either misdiagnosed by their doctor or needed only non-surgical treatment.”

Read the story

About health insurance

White House Wants Patients to Know Health-Care Prices Up Front: In February the White House floated a proposal that would make providers’ negotiated fees public. Now it also wants payers to publish these proprietary figures. Patients would still have to know what their plan’s terms are with respect to out of pocket costs.

Read the story (Wall Street Journal but appears to be open access)

Today's News and Commentary

About pharma

Pfizer Recommends Suffixes for Biosimilar Reference Products: Suffixes on biologicals indicate the type of molecule. The most well known is “-mab” which stands for monoclonal antibody. Pfizer is now asking the FDA to add a new class of suffixes for reference compounds for biosimilars. Such a change may give the “original” product a marketing edge the manufacturer can use to exploit. Imagine a direct to consumer campaign that asks patients to “look for ‘xyz’ at the end of your drug name to make sure you are getting an original product.”

Read the article

AbbVie wraps up all Humira-related patent litigation in US after reaching deal with Boehringer Ingelheim over biosimilar: Speaking of biologics, in 2017 Boehringer Ingelheim got FDA approval for a generic version of AbbVie’s blockbuster Humira. However, litigation has prevented its launch. The companies just settled— the biosimilar will not be available until 2023. Remember this story when you read about Congressional action to lower drug prices.

Read the story

About the public’s health

UK turns to Asia for nurses to cover staff shortages: What does Brexit have to do with American healthcare? The UK has heavily depended on other EU countries to supply physicians and nurses to staff its National Health Service. With Brexit’s visa uncertainties, the country is relying more and more on recruiting nurses from Asia- particularly the Philippines and India. The problem is the US also relies on Philippine nurses. Such diversions of potential staff have not been figured into our needs projections. We will need to see what these global issues do to our nursing capabilities.

Read the story (Financial Times requires subscription)

This doctor posted online in favor of immunization. Then vaccine opponents targeted her: This story is about an internist who posted her encouragement for immunization and was blasted on social media with negative personal reviews ( by people who were not her patients). The anti-vexers have now gotten mean. Let’s hope violence is not next.

Read the story

Twitter launches tool to combat vaccine misinformation: On the same theme, Twitter has now provided a pop-up link when someone enters a term like “vaccine.” It directs the searcher to credible sources of information like the Department of Health and Human Services's (HHS) website about vaccines.

Read the story

Why the Government Pays Billions to People Who Claim Injury by Vaccines: The federal Vaccine Injury Compensation Program was established in 1986 to compensate persons who were harmed from vaccinations. The harm payments were designed to indemnify against manufacturing problems and very rare side effects caused by the vaccines. The story of this program is very interesting and has public health implications.

Read the story

Association of a Beverage Tax on Sugar-Sweetened and Artificially Sweetened Beverages With Changes in Beverage Prices and Sales at Chain Retailers in a Large Urban Setting: Philadelphia imposed an excise tax of 1.5 cents per ounce on sugar-sweetened and artificially sweetened beverages in 2017. Over the next year, “volume sales of taxed beverages in Philadelphia decreased by 1.3 billion ounces after tax implementation (51%), but sales in Pennsylvania border zip codes increased by 308.2 million ounces, partially offsetting the decrease in Philadelphia’s volume sales by 24.4%…In contrast to Mexico and Berkeley findings [two other places that imposed such taxes],  there were no statistically significant increases in nontaxed beverage sales, suggesting consumers were not substituting with these drinks in Philadelphia.” This study is additional proof that increased taxes on unhealthy products reduce consumption.

Read the research

Births: Provisional Data for 2018: CDC’s National Center for Vital Statistics just released birth data for 2018. The trend of lower numbers and rates continues (with few exceptions) since 1991. This demographic information has a profound effect on funding for Medicare and Social Security, which are paid by current workers for current beneficiaries. We will need to look for sources other than population growth for relief of these rapidly depleting funds.

Read the report

About healthcare quality

The Leapfrog Group announced results of its 2018 hospital comparisons: This announcement was picked up by many media- even non-healthcare ones. People can look up the quality scores (A to F) of the 2600 surveyed hospitals. Among the findings:
”Patients at “D” and “F” hospitals face a 92% greater risk of avoidable death
Patients at “C” hospitals on average face an 88% greater risk of avoidable death
Patients at “B” hospitals on average face a 35% greater risk of avoidable death…
If all hospitals had an avoidable death rate equivalent to ‘A’ hospitals, 50,000 lives would have been saved…”

Read the report and look for a hospital close to you

The Joint Commission enters next generation of quality measurement, offers accredited hospitals real-time quality metrics: Over the last two years, The Joint Commission has implemented electronic clinical quality measure (eCQM) reporting with a Direct Data Submission Platform (DDSP). The DSSP is now continuously available, i.e., not just for periodic reporting purposes. This connectivity allows “providers to measure and improve performance in near realtime without additional outside vendors.”

Read the announcement

Today's News and Commentary

About health insurance

U.S. judge calls hearing on merger of CVS and Aetna: court filing: The CVS-Aetna deal has closed, but Judge Richard Leon of the U.S. District Court for the District of Columbia scheduled June 3 to hear arguments that the merger is anticompetitive. The hearing, which is to last a maximum of three days, is not expected to undo the merger.

Read the announcement

Maryland Gov. Larry Hogan Signs 1st-In-Nation Measure To Help Uninsured: “The new law will create a box for people to check on state income tax returns. If a taxpayer checks the box, the state’s health care exchange will see if the person qualifies, based on information in the tax return. Those who qualify for Medicaid will be enrolled automatically. The exchange will reach out to people who qualify for private coverage.” The government is proactively helping those in need? How unusual!

Read the story
New York’s 2014 Law to Protect Consumers from Surprise Out-of-Network Bills Mostly Working as Intended: Results of a Case Study:
Surprise medical bills have gotten the attention of Congress and the White House. In March 2014, the New York legislature passed the Emergency Services and Balance Billing Law (“Surprise Billing” law), which went into effect in March 2015. With this law, the state has come up with a successful program that may be a model for national initiatives. In its baseball-style arbitration: “Each party to the dispute (the payer and the physician) must submit to the arbiter their best offer. The arbiter must choose one of the two offers without compromising between the two sides. This encourages the parties to submit reasonable bids.” While not a panacea, the results are encouraging: a 34 percent drop in out-of-network billing since the law was in effect, with 57 percent of cases resolved. Decisions have been roughly evenly split between providers and payers.

Read the report

About the public’s health

How Public Health Outreach Ended A 1990s Measles Outbreak And What's Different Now: The measles epidemic is not over and is expected to spread. This article is a reminder that the past outbreak is very different than the current one. From 1989-1991 there was a funding problem causing low income children not to be immunized. With attention to funding and fundamental public health measures in a cooperative community, the problem was successfully addressed. The current problem is due to uncooperative parents who are misinformed about immunizations. Perhaps what we need is more PR/persuasive advertising than classical public health measures.

Read the story

The fate of rural and inner city hospitals: Two recent articles highlight the problems of rural and inner city hospitals. Both were local stories that provide lessons for similar institutions across the country.

Who’s going to take care of these people? As emergencies rise across rural America, a hospital fights for its life (From the Washington Post but appears to be open access)
Medical center's traumas illustrate struggle of all Medicaid-dependent hospitals (From Crain’s Chicago Business but appears to be open access)

About healthcare technology

Stem Cell Treatments Flourish With Little Evidence That They Work: Stem cell therapies have the potential to treat many illnesses. But their use in orthopedic conditions has not been shown to be definitively effective. Since infusions of stem cells (and platelets) into joints is not FDA regulated, these treatments are being administered without regulatory review of efficacy or safety. Caveat emptor.

Read the story

Health Canada Aligns with FDA Guidance for 3D printed Medical Devices: This article is a reminder of the medical uses of 3D printing and some of the companies in this sector.

Read the article
Read what the FDA says about 3D printed devices

Today's News and Commentary

About pharma

U.S. states accuse Teva, other drugmakers, of price-fixing: Today’s top story is in all news media: Teva apparently led a conspiracy (with 19 other drug manufacturers) “to divide up the market for drugs to avoid competing and, in some cases, conspire to either prevent prices from dropping or to raise them…” 44 states filed a lawsuit on Friday in the U.S. District Court in Connecticut.

Read the story

Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry: Biosimilars are the equivalent of generic drugs for biological compounds. Definition and handling of generic drugs are straightforward; but because biologicals are more complex, their evaluation has not been clear. The FDA issued this document (called a “nonbonding recommendation”) for evaluating these drugs. The guidance is expected to help biosimilar manufacturers gain easier approvals.

Read the document

CBO Says Bill to Curb Pay-for-Delay Would Cut the Deficit by $613 Million Over 10 Years: On a related note, Senators Amy Klobuchar, D-Minnesota, and Chuck Grassley, R-Iowa. are cosponsoring a bill that would prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time (a practice called pay-for-delay). If the bill passes, the Congressional Budget Office (CBO) says because of cheaper drugs and higher fees it will reduce the deficit by $613 million by 2029.

Read the story

Delivery Might Be Key to Gene Therapy’s Orphan Status, CBER Official Says: The FDA says it is open to granting orphan drug status to an established genetic therapy if the mode of delivery is different than the other treatment.

Read the story

Lessons from UnitedHealthcare's [UHC] stalled plan to get oncologists to prescribe generics: In an attempt to encourage oncologists to use generic medications, UHC offered a voluntary program to pay these physicians a higher rate for these drugs. Bottom line: it did not have any notable impacts on prescribing rates or spending. Two possibilities for this failure: 1) the extra payment was still not enough to compensate for gains from using more expensive medications and 2) this payer was one of many, so overall habits did not change from a focused, voluntary program. The solution would be for the insurer to buy the drugs from the manufacturer or wholesaler and supply them to the oncologist. As usual, this process is not new— just waiting for someone to “rediscover it.”

Read the story (The research is in Health Affairs but it only available by subscription)


About health insurance

Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, 2018: This governmental study provides a wealth of information about health insurance coverage. Among the findings:

“In 2018, 30.4 million persons of all ages (9.4%) were uninsured at the time of interview—not significantly different from 2017, but 18.2 million fewer persons than in 2010…

Among adults aged 18–64, 68.9% (136.6 million) were covered by private health insurance plans at the time of interview in 2018. This includes 4.2% (8.4 million) covered by private health insurance plans obtained through the Health Insurance Marketplace or state- based exchanges.

The percentage of persons under age 65 with private health insurance enrolled in a high-deductible health plan increased from 43.7% in 2017 to 45.8% in 2018.”

Read the report

DOJ asks Supreme Court to toss payers' suits seeking $12B in risk corridor payments: The federal government enticed insurance plans to participate in ACA exchanges by providing some time-limited financial guarantees. One of the guarantees was implementation of risk corridors: If a plan made more than a certain profit it would  pay the government; if the plan lost more than a target, the government would subsidize that loss. This scheme was designed to be budget neutral. What happened was there were not a lot of profitable plans to subsidize the ones who lost money. (Recall the problems signing up healthy people and erroneous actuarial assumptions about the covered populations.) Insurers appealed earlier court decisions, claiming they are owed $12 billion in risk corridor payments. The Justice Department is asking the Supreme Court to deny the appeals.

Read the story

Washington to offer first ‘public option’ insurance in US: “Washington is set to become the first state to enter the private health insurance market with a universally available public option.

A set of tiered public plans will cover standard services and are expected to be up to 10% cheaper than comparable private insurance, thanks in part to savings from a cap on rates paid to providers. But unlike existing government-managed plans, Washington’s public plans are set to be available to all residents regardless of income by 2021.”

Read the story

Bob Menendez proposes bill to help NJ save Obamacare insurance gains: Other states, like NJ, Pennsylvania, New Mexico, Nevada, Oregon and Minnesota are also considering public exchanges.

Read the article

Today's News and Commentary

IN MEMORIUM
NY Times reporter Robert Pear was an insightful investigator and commentator about health issues.
His death was announced in a number of outlets but, fittingly, here is what the NY Times had to say:
Robert Pear, Authoritative Times Reporter on Health Care, Dies at 69

About the public’s health

Juul’s ‘switch’ campaign for smokers draws new scrutiny: Vaping company Juul has been under attack for marketing to teenagers. In a strategic shift, it is now encouraging current cigarette smokers to switch to its product.

Read the story

It’s time to stop murder by counterfeit medicine: This article reviews a very serious global problem- counterfeit medication. WHO estimates that about 10% of medications world-wide are fake. Other estimates put the figure in some countries at 50%. As some in this country are promoting importation from abroad to lower our pharma costs, we should keep this problem in mind.

Read the story

Inactivated polio vaccine now introduced worldwide: This article is really an announcement. With the addition of Zimbabwe and Mongolia, every country has and endorses this polio vaccine. The problem now is getting it to all those who need it and preventing violence against those who administer it.

Read the announcement

Is Conference Room Air Making You Dumber?: Finally, some scientific evidence that those long meetings will not help make better decisions. As the meeting goes on and on, the accumulated carbon dioxide in the room reduces decision-making capabilities. I suppose you could open the windows, but it would be better to be more efficient in the first place.

Read the article

Coca-Cola gained control over health research in return for funding, health journal says:According to this report in Politico: “"Using Freedom of Information Act requests, researchers at the University of Cambridge identified more than 87,000 pages of documents that included five agreements between Coca-Cola and universities in the U.S. and Canada. The provisions gave Coca-Cola the right to review research in advance of the publications. It also was allowed to have control over data and disclosure of any study results.

The universities involved were Louisiana State University, University of South Carolina, University of Toronto and University of Washington.

Despite having the power to prevent publication, the researchers of the study didn’t find any hard evidence Coca-Cola exercised that right. However, the FOIA documents collected included several redactions, making a final conclusion difficult.” Do you still wonder how proposals for taxes on sugar drinks are defeated?

Read the article
Read the original research

Increase in Hepatitis A Virus Infections — United States, 2013–2018: With all the recent focus on measles, we often forget that other preventable viral infections are also on the rise. This article from the CDC calls on greater attention to immunizations for vulnerable populations.

Read the report


About pharma

Pharma companies, PBMs play blame game over drug prices at hearing: The arguing continues as Congressional committees try to get to the bottom of why drug prices are so high. At the House Energy and Commerce Committee’s Subcommittee on Health, PBMs claimed that eliminating rebates would raise premiums for individuals while drug companies said it would help them lower their prices. The article is a nice update on this ongoing issue.

Read the story or
Watch the testimony (WARNING- it’s more than 6 hours)

Most European Academic Centers Fail to Report Trials, Study Finds:The reason this story is important US news is that our regulators are considering accepting European studies for drug approvals here. If many trials are not reported, it raises concerns about that proposal.

Read the story

Medicine Use and Spending in the U.S.: This study from IQVIA found: “Spending on all U.S. medicines increased 4.5% to $344 billion on a net price basis, despite lower price growth, due to higher patient use of new and protected brands…There were 5.8 billion prescriptions dispensed in 2018, up 2.7% from 2017 when adjusted for prescription duration. More than two-thirds of total prescriptions last year were for chronic conditions, which are increasingly filled with 90-day prescriptions…”

Read the report

Drugmakers Urge FDA to Add PBPK Modeling to Food Effects Guidance:”Leading drugmakers are calling on the FDA to include the use of physiologically-based pharmacokinetic (PBPK) modeling in its draft guidance on assessing the effects of food on drugs...” The reason this story is “news” is that rules are usually imposed on industries, not originated with requests from those being regulated.

Read the story

About health insurance

Democrats launch health-care law rescue in face of Trump’s threat of repeal: Yesterday the House Democrats passed a bill that would block HHS state waivers for insurance plans meant to skirt the ACA’s regulations.

Read the story (Washington Post but appears to be open access)

About quality

Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial: This article highlights that we need to constantly reevaluate the evidence about accepted treatments. The research looks at a well-established procedure (gall bladder removal) and compares usual care with surgery only after certain more restricted criteria are used. While the clinical outcomes were the same in both groups, the latter had many fewer operations.

Read the research

About healthcare IT

2019 Data Breach Investigations Report (DBIR): Verizon just published its annual report on data breaches by industry. For healthcare, the main threat was from internal sources. However: “This is the second straight year that ransomware incidents were over 70 percent of all malware outbreaks” in this sector.

Read the report (Healthcare starts on page 44)

To Philips, the future means selling more than a better MRI machine: It might seem strange that this story is listed under IT. Phillips has announced its intention to expand from just a medical equipment company into artificial intelligence to integrate care across a continuum of services. According to its CEO, Jeroen Tas: “The whole theme around precision diagnosis is no longer about building the best MRI or CT scanner—it’s really about fusing the information you get from these modalities, and creating profiles or models of the disease that allows for a very precise selection of the right-fit therapy.”

Read the story

About health insurance

Prices Paid to Hospitals by Private Health Plans Are High Relative to Medicare and Vary Widely: This research from RAND was reported in many news outlets today. Among its findings:

“On average, case mix–adjusted hospital prices were 241 percent of Medicare prices in 2017…Relative prices for hospital outpatient services were 293 percent of Medicare rates on average…”

“Reducing hospital prices to Medicare rates over the 2015–2017 period would have reduced health care spending by approximately $7.7 billion for the employers included in this study.”

It is common knowledge that private insurance payments subsidize public programs. This study provides the amount of that subsidy. and also how much hospitals would lose if Medicare for All is implemented and adopts Medicare payment methods.

Read the report

Today's News and Commentary

About the public’s health

Assessment of Use, Specificity, and Readability of Written Clinical Informed Consent Forms for Patients With Cancer Undergoing Radiotherapy: “This nationwide study of informed consent practices for cancer treatment with radiotherapy demonstrates that while all US academic radiotherapy departments use written consent forms, it is rare for templates to meet the recommended readability levels for patient materials.” This article is a reminder about communication with patients at the appropriate level of education and literacy.

Read the abstract

Walmart, Sam's Club raise age to buy tobacco to 21; won't sell flavored nicotine to minors: The title is self-explanatory. Walgreens also recently raised its tobacco purchase age to 21. But they still do not match CVS, which stopped selling tobacco products because of health concerns.

Read the story

About healthcare technology

Natera Earns Breakthrough Device Designation for Tumor DNA Test: This technology uses genetic markers from the patient’s tumor to check for recurrence by detecting those markers in serial blood samples after treatment. It is a real breakthrough technology because it can detect the recurrence much sooner than other methods.

Read the announcement
Read about the test

Genetically Modified Viruses Help Save A Patient With A 'Superbug' Infection: Knowledge about bacteriophages antedates the antibiotic era. These organisms are viruses with special affinity for bacteria (as opposed to, for example, human cells). Once infected with the phage, the bacteria dies. By administration of special phages, a 17 year old woman has been successfully treated for a drug resistant infection after lung transplant. Until better antibiotics are found, this therapy may be the only hope for such patients.

Read the story

About quality

Physician groups voice frustrations with Quality Payment Program: Yesterday, representatives from the American College of Surgeons, American Academy of Family Practice and the American Medical Association testified before a Senate committee hearing their feed back about the MACRA quality programs. The organizations criticized the relevance of criteria and cumbersome reporting process. As well, they wanted an update on meaningful use IT criteria in the face of increasing interoperability requirements.

Read the article

MACRA, 2 years later: 9 ways to make it better: Following in the above article, this one summarizes the testimony of AMA president Barbara McAneny, MD about measures to improve MACRA.

Read the article

How Johns Hopkins researchers found a way to curb excessive skin cancer surgery: One way to treat skin cancer is to shave off the growth level by level- called Mohs micrographic surgery (MMS). Researchers noted that surgeons “are paid based on the number of stages performed per tumor, ‘creating a perverse incentive… to use an excessive number of staged resections to remove a lesion.’ …In other words, they may cut too much during surgery, quite possibly, because they'll get paid more to do it.” If physicians were provided data on their relative performance, however, 83% of surgeons who were identified as outliers improved their MMS behavior- a sustainable change. The study extrapolated Medicare savings from such an intervention at $11million per year. This research is another case of the benefit of peer data dissemination.

Read the story 

About pharma

Americans' Prescription Med Use Is Declining:This just-released study from the National Center for Health Statistics (part of the CDC) showed, among other findings, that:

  • In 2015–2016, 45.8% of the U.S. population used prescription drugs in the past 30 days.

  • Prescription drug use increased with age, from 18.0% of children under age 12 years to 85.0% of adults aged 60 and over.

  • Prescription drug use was highest among non-Hispanic white persons followed by non-Hispanic black persons, and lowest among non-Hispanic Asian and Hispanic persons.

  • The most commonly used types of drugs included bronchodilators for ages 0–11 years, central nervous system stimulants for ages 12–19, antidepressants for ages 20–59, and lipid-lowering drugs for ages 60 and over.

  • The percentage of the U.S. population that used prescription drugs decreased over the preceding decade. This finding reversed an previously upward trend.

Read the study results

Covance: Why biosimilars could be large piece of the drug price puzzle: This article is an interesting review of biosilmilar drugs (biologic generics). One factor impeding their adoption is that the branded versions provide such large rebates that in order to save money from these discounted versions, a health plan will have to drive large volumes to them.

Read the article

Today's News and Commentary

About pharma

In a crafty move, FDA may have found a way to dampen controversy over a $375,000 rare-disease drug: Here’s what competition can do. Earlier this year the FDA approved Firdapse, a drug manufactured by Catalyst to treat adult Lambert-Eaton myasthenic syndrome ( a muscle weakness disease). Since it was an orphan drug, it was also granted 7 years of market exclusivity. Because of its unique status, the company announced a $375,000 price tag. However, the FDA just approved the same drug, this one made by Jacobus Pharmaceuticals, called Ruzurgi. The difference is the latter approval was for children with the same condition. Once approved, either drug can be used to treat people of all ages. While Ruzurgi’s price has yet to be announced, Catalyst stock dropped 44% in anticipation of price competition.

Read the story

Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency:The final rules about advertising drug prices on television have been issued. If the wholesale acquisition cost is $35 or more per month, the advertisement must contain the statement: “ “The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.” The terms take effect 60 days after publication in The Federal Register.

Read the rule

Alphabet's GV leads funding in gene editing company Verve Therapeutics: Continuing a trend to cross-sector involvement, Alphabet Inc’s venture capital arm (GV) “led a $58.5 million investment to launch Verve Therapeutics, a new biotech focused on developing therapies that edit the human genome to treat heart diseases…Verve plans to target adults at risk of coronary artery disease, the leading cause of death worldwide, by editing their genes to mirror those of people whose naturally occurring genes have been associated with a lower risk of heart disease and heart attacks.” How much would you pay for such a treatment?

Read the announcement

Judge tells HHS to revisit 340B after ruling cuts 'unlawful': The 340B program allows certain hospitals and other healthcare providers to buy discount drugs from the manufacturers in order to provide them to Medicaid or free-care patients. These providers could then charge Medicare and Medicaid up to 6% over the average national sales price of drugs. Recently, CMS cut rates to to 22.5% less than the average sales price— a change that would result in a $1.6 billion payment reduction. In a lawsuit by multiple hospital entities challenging this reduction, DC District Court Judge Rudolph Contreras ruled it was unlawful. This decision was a truly big win for eligible providers. Now we will have to wait for the appeal.

Read the story

Study: Payers, PBMs hinder drug access for autoimmune patients: Researchers at Emory University graded insurance companies for their coverage of autoimmune drugs to treat Crohn’s disease, multiple sclerosis, psoriasis, psoriatic arthritis and rheumatoid arthritis. They found that: “86% of Medicare Advantage plans received an F for coverage of autoimmune drugs and 48% of private insurers received an F. Within private insurers, another 50% of companies rated a C and not one received an A.” Since these drugs are very expensive treatments, it is reasonable to recommend step therapy if all medicines in a class are equally effective but vary in price. However, imposing high out of pocket payments for patients as a cost reduction strategy makes no sense, since these drugs are not discretionary purchases.

Read about the study

About healthcare IT

Feds Want To Show Health Care Costs On Your Phone, But That Could Take Years: In a related story to the tv advertising rule above, HHS is proposing regulations in anticipation of consumers’ ability to price compare healthcare services on the phone. For example, such comparisons will likely have disclaimers about variance by insurance.

Read the article

Lawmakers call for delay in implementing interoperability rules: CMS has been pushing for IT interoperability implementation. But yesterday, Sen. Lamar Alexander, R-Tenn. (chair of the Senate Health, Education, Labor and Pensions ((HELP)) Committee) called for a delay of two new rules. He cited provider and payer costs and and the ability to comply with the rules in a relatively short amount of time.

Read the article

FDA clears first AI-powered mobile app to catch heart murmurs: Prior artificial intelligence healthcare apps have been geared to voice recognition, input of lab data, or recording patient information (like pulse or EKG readings). This one listens for heart murmurs. Is the stethoscope on its way out?

Read the story

Allscripts' Practice Fusion receives grand jury subpoena related to EHR certification, anti-kickback concerns: Allscripts recently bought Practice Fusion, knowing it had engaged in some questionable practices. In return for a deeply discounted price of $100million, as opposed to more than $1billion, Allscripts said it would assume all future liabilities. Now that contingency has come. In its latest SEC filing, Allscripts reported: “ In March 2019, Practice Fusion received a grand jury subpoena in connection with a related criminal investigation. The document and information requests received by Practice Fusion relate to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services’ Electronic Health Record Incentive Program and Practice Fusion’s compliance with the Anti-Kickback Statute and HIPAA as it relates to certain business practices engaged in by Practice Fusion.” The article also mentions past problems at Greenway and eClinicalworks.

Read the story

About the public’s health

Prediabetes puts your health at risk, but reversing it is "very doable," experts say: The main message is not new (diet and exercise can help stave off diabetes for those on the cusp of the disease). However, the statistics are very disturbing: “According to the Centers for Disease Control and Prevention, more than 1 out of 3 adults in the United States — approximately 84 million people — have prediabetes . Yet, 90 percent of those affected do not know they have it.” How many people would change their behavior if they knew they were prediabetic?

Read the article

Vital Signs: Pregnancy-Related Deaths, United States, 2011–2015, and Strategies for Prevention, 13 States, 2013–2017:Speaking of prevention, the CDC found that 60% of pregnancy-related deaths are preventable. Causes vary by when the death occurred after delivery.

Read the article for details

Strengthening national health security and preparedness helps build a culture of health: The 2019 Robert Wood Johnson Foundation health preparedness index shows continued improvement, but overall the U.S. scores only 6.7/10. Domain scores range from a high of 8.3 for Health Security Surveillance to a low of 4.9 for Healthcare Delivery. (The latter measure has not statistically improved in the past few years.)

Read the report

U.S. Library of Medicine Digital Collections: This new website has 906 video presentations on health-related topics. It is a fascinating historical archive. For example, on the first page is an audio recording with accompanying photos of President Roosevelt’s speech dedicating the National Institute {not Institutes at that time] of Health on October 31, 1940.

Connect to the site

About health insurance

Kaiser Permanente building infrastructure to 'connect the dots' for social determinants: This article is a nice review of what Kaiser Permanente is doing to address social determinants of healthcare for its members.

Read the story

Do People Who Sign Up for Medicare Advantage Plans Have Lower Medicare Spending? This research from the Kaiser Family Foundation showed that Medicare Advantage (MA) plan members had lower costs than traditional Medicare beneficiaries the year before they switched to a MA plan. The conclusion was that CMS payments to MA plans may be too high.
The better health of HMO members (Medicare or commercial plans) is not a new finding. What has been shown in the past is that for patients matched by health status, the HMO plan provided the same quality of care at a lower price. Further, MA payments are health status adjusted. Recently, CMS allowed MA plans to offer enhanced services that traditional Medicare does not cover.
More analysis needs to be done on this issue before making any payment policy changes.

Read the research

Individual Insurance Market Performance in 2018: Insurance company performance under the ACA was very rocky over the first few years. This research shows that finances are now on a stronger footing. Specifically, “individual market insurers saw better financial performance in 2018 than in all the earlier years of the ACA and returned to, or even exceeded, pre-ACA levels of profitability.” The Medical Loss Ratio has declined from a peak of 103% in 2015 to 70% last year. It is expected plans will need to rebate $800 million to subscribers for going under the 80% individual/small group target.

Read the report 

Today's News and Commentary

About pharma

Using External Reference Pricing In Medicare Part D To Reduce Drug Price Differentials With Other Countries: CMS and the White House have been floating the idea of using reference pricing for Medicare Part D drugs to save money. The idea would be to peg our prices to what other countries pay. This study looks at the impact of such a plan.
The research compared price differences between the US and the UK, Japan, and Ontario (Canada) for “single-source brand-name drugs that had been on the market for at least three years.” The authors found that prices “averaged 3.2–4.1 times higher in the US after rebates were considered. The price differential for individual drugs varied from 1.3 to 70.1. The longer a drug remained on the market, the greater the differential. The estimated savings to Medicare Part D of adopting the average price of drugs in the reference countries was $72.9 billion in 2018.”
Of course pharma will come back and say the reduced payments will cut into R&D, which will affect our country’s leadership in innovation.

Read the research (Health Affairs requires a subscription; abstract is available)
Read a related article

A $2 Million Drug Is About to Hit the Market: Novartis has set the price of its gene therapy drug Zolgensma (to treat spinal muscular atrophy) at $2million. This price would make it the most expensive treatment ever. Since the treatment is for infants, analysis includes lifetime economic benefits. The article discusses high cost therapies, with attention to genetic interventions.

Read the story (Wall Street Journal -may need a subscription)

Drug-resistant tuberculosis reversed in lab: This story could be one of the biggest pharma/public health announcements of the year. Researchers identified a compound that would impair the TB bacterium’s ability to form a coating that makes it resistant to drug treatment. The compound (called C10) makes the organism susceptible to even first line drugs like isoniazid (the oldest anti-TB medication).

Read the announcement

Trump directs Azar to work on Florida drug import plan: As previously reported, Florida has passed legislation allowing Canadian drug imports to lower healthcare costs in the state. The obstacle would be FDA approval since the practice, as planned, is illegal. Now the President has instructed HHS Secretary Azar to help the state with its initiative. The law goes into effect July 1.

Read the article


About healthcare IT

NIH launches beta version of Data Browser for PMI cohort: The National Institutes of Health is conducting a Precision Medicine Initiative called All of Us. The purpose of the program is to gather very large data bases of individual health statistics that can be used for research to inform precision medicine decisions. The beta version of the first round of data was launched yesterday. The disease-specific information is very sparse now and is mainly frequency of conditions by sex- which is skewed toward female participation. The other topics include such issues as healthcare literacy and self-reported health status.

Until the number get very large, one still has to be careful of self-selection bias in the reporting.

Read the announcement

Medtronic’s iPad-Based Pacemaker Programmer Receives FDA Clearance: This Bluetooth-enabled cardiac implant device allows programing and data downloads using the Apple iPad.
Sounds great…what about hackability?

Read the announcement

About the public’s health

Trump May Redefine Poverty, Cutting Americans From Welfare Rolls: One way to reduce welfare benefits is redefine who is eligible. This article is about lowering income targets for welfare eligibility. The issue of Medicaid coverage is not discussed but certainly is of concern if this measure is implemented.

Read the article

The measles epidemic continues
Three related article on this topic.
Federal health officials dispute connection between measles outbreak, 'conscience rule': Some have claimed states will not be able to enforce elimination of religious exemptions for vaccination because of the “conscience rule” issued last week. However, an unidentified HHS official stated: “The final rule only provides enforcement mechanisms for Federal conscience and anti-discrimination laws that Congress has enacted. It does not create new substantive conscience protections.” Apparently the states can act as they wish in this regard.

Poll: 72 percent say parents should be required to vaccinate their children: This NBC News/Wall Street Journal poll is very discouraging. 72% is nowhere near enough support to achieve herd immunity.

Number of US measles cases continues to climb, now with 764 reported: The results speak for themselves.

Today's News and Commentary

Last Thursday and Friday the site had some technical problems which are now corrected. The news stories for those dates are below today’s news.

About healthcare technology

FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices: As reported last month, the FDA had an alternative reporting system that allowed device manufacturers to avoid revealing problems to the public. Now the agency announced it will discontinue that option and publicly disclose the past information.

Read the article

Biomarker for chronic fatigue syndrome identified:Chronic fatigue syndrome is an ill-defined condition characterized by such features as exhaustion, sensitivity to light, and unexplained aches and pains. It is estimated that at least 2 million people are affected in the US. Diagnosis has been based on the cluster of symptoms and negative results of tests used to detect other diseases. Now Stanford University scientists have found a way to make the diagnosis with 100% accuracy. The technique measures the ability of a patient’s plasma and immune cells to withstand stress in the form of an electric current. This diagnostic test is also being used to assess treatments.

Read the announcement

About the public’s health

San Francisco sues Trump administration over new 'conscience' rule: San Francisco has initiated a lawsuit in response to the federal rule issued last week allowing professionals to refuse care as a matter of conscience. This action will probably not be the last one challenging the rule.

Read the story

Healthcare leaders look at the past, present and future of consolidation: This article is a nice summary of the current status of physician practice-healthcare system consolidation.

Read the story

Employed physicians now outnumber independent doctors: The title explains it all.

Read the article

About pharma

GoodRx Quarterly Report: Q1 2019: Among the findings in this study:

  1. During the first quarter of 2019, the average list price, the price set by the manufacturer, for all brand and generic drugs increased by 2.9%.

  2. Over 500 brand name medications saw a list price increase in January, 2019.

  3. The 20 most expensive medications in the US all cost more than $25,000 for a monthly

    supply.

  4. Prices for drugs in New York, Los Angeles and San Francisco were as much as 17%

    higher than the national average during Q1.

Read the study and further details

About health insurance

Lower Health Care Spending and Use for People with Chronic Conditions in Consumer-Directed Health Plans [CDHPs]: This research found that :
”Across all four service categories, spending per person was lower for CDHP enrollees than non-CDHP enrollees in all years studied. In 2016:

 Inpatient: 13% lower spending ($110 per person).
 Outpatient: 7% lower ($99 per person).
 Professional services: 8% lower spending ($139 per person).
 Prescription drugs: 26% lower gross spending ($306 per person).”

The reductions in service costs were due to utilization.

‘Prescription drugs had the largest difference in gross spending and use between CDHP enrollees and non-CDHP enrollees – across all chronic condition sub-populations.
Prescription drugs was also the only category of services for which CDHP enrollees and non-CDHP enrollees had a bigger difference in their gross spending than in their service use.'‘

Unlike other similar studies, this one did not look at the health outcomes for the reduced utilization. Out of pocket costs can go up to exorbitant levels and lower costs. But if the result is poor health, someone will need to pay in the long run.

Read the research

About healthcare quality

Assessing the Quality of Public Reporting of US Physician Performance: CMS’s Physician Compare website is supposed to furnish clinical data so patients and their families can make more informed choices about from whom to seek care. However:

“In this study, 76.7% of clinicians had no performance data on Physician Compare, 99.7% had no clinician-level performance data, and among clinicians with data, performance reflected only a few measures and the quality performance was generally high. As currently configured, Physician Compare fell short of its goal of providing information that is widely useful to patients and their caregivers for choosing clinicians.”

Read the research



Today's News and Commentary

About the public’s health

U.S. health agency finalizes conscience and religious freedom rule: Today’s top story, carried by almost all news media, is HHS finalizing a rule that allows “health providers and entities to opt out of providing, participating in, paying for or referring for healthcare services that they have personal or religious objections to.” In addition to abortion and birth control (including sterilization), this rule could affect treatment of gay, lesbian and transgender people. The rule has been strongly opposed by organizations such as the AMA.

Read the story

About pharma

PhRMA Says ‘Status Quo Must Change’ on Diabetes Prices: PhRMA President and CEO Stephen J. Ubl announced: “America’s biopharmaceutical companies are committed to addressing patient affordability challenges and to changing the incentives in the supply chain so that more of the $166 billion on rebates and discounts given to middlemen help lower patients’ costs at the pharmacy counter.” We will see…

Read the announcement

Budget office: $177B in added costs from Trump drug plan: The Congressional Budget Office  estimates that giving medication rebates to patients instead of insurers (or pharmaceutical benefits managers) will cost taxpayers $177 billion over 10 years. The reason is that insurance premiums include expectations of the rebates; without them, the premiums would go up. Some individuals will come out ahead- their rebates will be more than their premium increases. But since 75% of Part D premiums are federally subsidized, the public will end up footing most of the bill.

Read about the analysis

About health insurance

CBO: 7 million more uninsured after ObamaCare mandate repeal: The Congressional Budget Office estimates that in 10 years the number of uninsured people will be 35 million, or 13 percent of people under age 65. 

“The CBO said the increase in the uninsured is the result of the elimination of the mandate penalty, rising health insurance premiums and more people enrolling in plans that don’t meet the CBO’s definition of health insurance, such as short-term plans.”

Read the article

Kaiser Family Foundation / LA Times Survey Of Adults With Employer-Sponsored Health Insurance: This survey found that overall, “most people with employer-sponsored insurance (ESI) are generally satisfied with their health plans;” however,  40% report that “their family has had either problems paying medical bills or difficulty affording premiums or out-of-pocket medical costs, and about half say someone in their household skipped or postponed some type of medical care or prescription drugs in the past year because of the cost. Seventeen percent say they’ve had to make what they feel are difficult sacrifices in order to pay health care or insurance costs; for some, the sacrifices they report making are extreme.”

Read the study

About healthcare technology

Speech: Remarks by [CMS] Administrator Seema Verma at the Medical Device Manufacturers Association Annual MeetingAdministrator Seema Verma at the Medical Device Manufacturers Association Annual Meeting:  In her address to the trade group for medical devices, Verma outlined several initiatives to help speed innovative technologies to market. The one measure that was new was a more frequent coding change cycle for technology. Since codes are needed for payment, increasing their issuance to quarterly from annually would enable sooner technology introduction.

Read the speech

Today's News and Commentary

About health insurance

House Democrats introduce moderate Medicare expansion plan: Yesterday, House Reps. Rosa DeLauro (D-Conn.) and Jan Schakowsky (D-Ill.), along with 16 cosponsors endorsed a plan called The Medicare for America Act. “All U.S. residents would be eligible for the expanded Medicare plans, but newborns, the uninsured and anyone receiving coverage through Medicaid, Medicare, ObamaCare or the Children’s Health Insurance Program (CHIP) would automatically be enrolled.” Unlike Medicare for All, individuals could to keep their employer-sponsored health insurance. The only declared presidential candidate supporting this proposal is Beto O’Rourke (D-Texas).

Read the article

Trump Administration Files Formal Request to Strike Down All of Obamacare: Yesterday I reported that the President was encouraging a bipartisan effort to save the ACA. Yesterday, his administration came down hard on the law recommending the Justice Department support its repeal in toto. “In filing the brief, the administration abandoned an earlier position — that some portions of the law, including the provision allowing states to expand their Medicaid programs, should stand.” In a tweet last month the President said: a replacement plan “will be on full display during the Election as a much better & less expensive alternative to Obamacare.”

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

As Retiree Health-Care Bills Mount, Some States Have a Solution: Stop Paying: States are looking more closely at their retiree healthcare costs, since they are rapidly rising unfunded liabilities. Some are eliminating retiree health insurance benefits for new hires while looking for ways to trim current expenses.

Read the story (Wall Street Journal but appears to be open access)

The CBO analyzed what it would take to shift to a single-payer system. Here are 5 takeaways: Yesterday, the CBO issued a report on its take of a single payer system (like Medicare for All). There wasn’t much new that hasn’t been discussed concerning the forms such a program could take. Also, no budget/tax estimates were offered. The article does give a nice summary of this report.

Read the article

Taking action and providing states options to minimize economic burden created by the ACA: In another case of mixed signals by the Trump administration, CMS Administrator Verma solicited requests for information (RFIs) from the states to develop insurance programs as alternatives to ACA exchanges. She announced: “Through this RFI, CMS—along with the Department of the Treasury—are asking for more ideas for new programs and waiver concepts for states to consider under a State Relief and Empowerment Waiver plan. Our hope is that these additional waiver concepts will foster further discussion and spur innovative thinking among states that drive toward real solutions to improve access to affordable coverage for all Americans.” The alternatives would be implemented under “Section 1332 waivers.”

Read the announcement


About the public’s health

Texas SNAP recipients may face ban on junk food and sugary drinks: In an effort to stem obesity, the Texas legislature will take up a bill that “would ban people from using food stamps to pay for energy drinks, candy and other junk foods.” Such legislation has failed to pass elsewhere.

Read the story(Washington Post but appears to be open access)

About healthcare IT

How Successful Are Healthcare Organizations With Clinical Analytics?:HIMSS Analytics surveyed 110 senior healthcare leaders about their organizations’s use of clinical analytics. The overall findings were:

—90% of respondents report using analytics in clinical areas.

—Only 28.4% of respondents are using analytics for effectiveness of care projects, 21.6% are using for population health, and 10.8% are using for chronic care management.

—Among healthcare organizations that have not yet deployed analytics but plan to do so, only 31.8% say population health will be a top focus area. 59.1% say effectiveness of care will be a top focus area.

In addition, the survey revealed that healthcare leaders rate clinical staff (physicians and nurses)the lowest among five categories of stakeholders on their ability to drive decisions throughtheir use of analytics.

Read the report

About pharma

Antibiotic resistance: the small Indian biotech hoping to solve a big problem: This article is really about the lack of development of new antibiotics as the global bacterial resistance problem becomes worse. So different models need to be developed to correct this problem. For example, Lord Jim O’Neill, former Treasury minister for both David Cameron and Theresa May told an event at the Wellcome Trust last month that the failure of the pharmaceutical sector to develop new antibiotics meant that it was time for the industry to be turned into some kind of "government funded utility".

Read the story

Fixing a ‘market failure’: To develop new antibiotics, upend the incentive structure, experts urge: On the same theme but with an American spin, policy makers here are also looking at governmental involvement in antibiotic development.

Read the article

Legislature approves Canadian drug import bill, other health reforms: The Florida legislature approved two measures to lower pharmaceutical costs: the Canadian Prescription Drug Importation Program in the Agency for Health Care Administration and the International Prescription Drug Importation Program in the Department of Business and Professional Regulation. (The Canadian Prescription Drug Importation Program would be for state health-care programs, while the international program would be for all state residents.) The state still needs FDA approval for the program since it is illegal without a waiver.

Read the story

Today's News and Commentary

About pharma

Whistleblowers: Company at heart of 97 000 percent drug price hike bribed doctors to boost sales: Companies that dramatically raise prices can’t always succeed on their own. This article highlights a whistleblower’s claim that Mallinckrodt's Questcor Pharmaceuticals unit bribed doctors and their staffs to increase sales of HP Acthar Gel- used to treat a rare infant seizure disorder. The price was hiked to $39,000.

Read the story

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines: The FDA will require boxed warnings (its strongest caution) for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist). The reason for this change is “several reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. These complex sleep behaviors may include sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove.” I do not expect much change in prescribing of these medications since the side effects have been known for quite awhile. Also, stock prices of the companies should not be affected- Ambien and Sonata are available with generics and Lunesta’s parent corporation Sumitomo Dainippon Pharma Co. Ltd.has not dipped after the announcement

Read the announcement

Oklahoma high court nullifies medical abortion restrictions: Following the Kansas Supreme Court decision allowing abortion as a human right under its constitution, another “middle America” state’s high court ruled that “a state law restricting access to drug-induced abortions is unconstitutional.” This example is another instance of state action that may challenge federal initiatives on this issue.

Read the article

Maryland Takes Step Toward Capping Drug Prices: A bill waiting for the governor’s signature would create a panel to review drug prices for governmental entities and set caps if needed. Other states, like California, have only required advance notification of price hikes.

Read the story (Wall Street Journal but appears to be open access)

House Judiciary Unanimously Passes Bipartisan Bills to Lower Prescription Drug Prices: Meanwhile, at the federal level, the House Judiciary Committee passed four bipartisan bills to lower prescription drug prices. Measures in these bills include strengthening the Federal Trade Commission’s (FTC) “ability to challenge anticompetitive pay-for-delay agreements in court;” prohibiting big pharmaceutical companies “from engaging in anti-competitive conduct to prevent generic versions of prescription drugs from entering the marketplace;” curbing “the abuse of the Food and Drug Administration (FDA) citizen petition process and expand access to prescription drugs by reducing incentives for branded pharmaceutical companies to interfere with the regulatory approval of generics and biosimilars that compete with their own products;” and requiring that “the Federal Trade Commission (FTC) conduct a study on the state of competition in the drug supply chain. This study would focus on whether pharmacy benefit managers, or PBMs, have engaged in any anti-competitive practices, such as steering patients to pharmacies for anti-competitive purposes, giving such pharmacies more favorable rates than it offers to competing pharmacies, or using its market power to depress the use of lower-cost prescription drugs.”

Read the announcement

US drugmakers buoyed by growth in China and new products: This article documents how much Chinese sales (and to some degree sales in developing nations) are significantly contributing to US drug manufacturers’ profitability.

Read the article (Financial Times- subscription required)

Payment policy for prescription drugs under Medicare Part B and Part D: James Mathews, Ph.D., executive director of the Medicare Payment Advisory Commission (MedPAC) testified yesterday before the House Subcommittee on Health of the Committee on Energy and Commerce about MedPAC’s recommendations to control drug spending. This written testimony starts with a really good summery of how Medicare Parts B and D pay for drugs. See Figure 1 for the evolution (and display of complexity) of the Part D actuarial formula. He then discusses rising costs for both parts. If you already know these facts, start on page 17 with the recommendations. Among the recommendations are:

For Part B: Reducing the payment rate from 106 percent to 103 percent of wholesale acquisition cost for new single-source Part B drugs that initially lack Average Sales Price (ASP) data and for existing drugs that lack ASP data; requiring manufacturers to pay the Medicare program a rebate when the ASP for a drug grows at a rate in excess of an inflation benchmark; and grouping an originator biologic and its biosimilars into the same billing code to maximize price competition.

For Part D: Giving sponsors greater flexibility to use formulary tools, like removing protected status from two of the six drug classes in which plan sponsors must now cover all drugs on their formularies (antidepressants and immunosuppressants for transplant rejection), streamlining the process for formulary changes, requiring prescribers to provide supporting justifications with more clinical rigor when applying for exceptions, and permitting plan sponsors to use selected tools to manage specialty drug use; excluding manufacturer discounts on brand-name drugs from counting as enrollees’ true out of pocket spending (for meeting deductible and annuals maximums); and reducing government reinsurance while increasing capitated payments.

Read the statement

About healthcare IT

Epic, Cerner growing EHR market share with increased hospital consolidation: KLAS: “Among hospitals with 500 or more beds, Epic has a 58% market share and Cerner now has 27% of the market.” What is interesting about the growth in market share is that much of it has come through mergers an acquisitions among customers.

Read the story

How FHIR 4 will drive interoperability progress in healthcare: While not really news, this article is a nice summary of where the industry is with respect to FHIR and interoperability. It does get a bit technical for those not familiar with IT terminology.

Read the article

As Artificial Intelligence Moves Into Medicine, The Human Touch Could Be A Casualty: An interesting article from NPR that looks at the interface between humans and Artificial Intelligence with respect to patient care.

Read the article

About health insurance

Trump urges Dem senator to revive bipartisan ObamaCare talks: This story is really strange. At a White House meeting yesterday, President Trump encouraged Senator Patty Murray (D-Wash) to resume her efforts to get bipartisan support to fix the ACA. In 2017 and 2018 she worked with Senator Lamar Alexander (R-Tenn) to craft a compromise proposal. According to the story: “Murray replied that she had been told the White House would veto the measure. Trump replied that he never said that and encouraged Murray and Alexander to resume their efforts, a Democratic source said.” I am not sure how this request fits into the “repeal and replace before 2020” strategy the President previously announced.

Read the story

Today's News and Commentary

About the public’s health

House panel proposes $2 billion increase for NIH: The House Appropriations Committee has recommended a $2 billion increase in the NIH’s funding. The President wanted a $5 billion cut. The part of this increase to watch is $25 million for firearm injury prevention research. “The Centers for Disease Control and Prevention [CDC] would also receive $25 million, the first funding since Congress passed a 1996 law banning CDC from advocating for gun control.” After giving the NRA strong support at its annual meeting this past week, the President may be hard pressed to agree to the entire funding package.

Read the story

Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report: Physicians and patients have long wondered about the “best” diet for diabetic patients. Is it low carb, low fat, high protein, some combination? The answer is that the presumption of “one best diet” is incorrect. This article is a consensus statement from the American Diabetes Association advocating for individualized diets. It updates 2014 recommendations.

Read the policy paper

The Economic Value of Education for Longer Lives and Reduced Disability: It has long been known that higher levels of education (independent of health knowledge)are associated with better health. How much this benefit is worth had not been calculated. This research developed an economic model showing how powerful education is in its effect on health. In monetary terms: “The value of education for longer, healthier lives may surpass the value for earnings.”

Read the research for the numbers and theory

FDA clears Philip Morris’s heat-not-burn IQOS tobacco device for sale: The FDA has approved for sale a Philip Morris device (IQOS) that heats but does not burn tobacco. The agency says: “the products produce fewer or lower levels of some toxins than combustible cigarettes.” It will still have restrictions on sales and a health warning.

Read the article


About health insurance

The Health 202: Medicare-for-all champions might not hear what they want at first Hill hearing today: This morning the House of Representatives held a hearing on Medicare-for-all. Not everyone has the same idea of what this program would mean and not all Democrats are supportive. This article is a great summary of this morning’s event. While healthcare is (and will be) an important issue, it is difficult for the public to sort out who is advocating for what plan. Left-leaning Democrats want a single payer system; right-leaning Republicans want to abolish the ACA but have yet to put forth a comprehensive program of their own; centrists of both parties are either watching or advocating for fixes to the ACA. The public is split on its desires (see the article below).

Read the article

'Obamacare' Still Earns a Split Decision From Americans: In its most recent poll on the subject, Gallup found support for the ACA at 50% and disapproval at 48%. The ratings were strongly along party lines.

Read the poll

Why Vermont’s single-payer effort failed and what Democrats can learn from it: This article is a great explanation of what went wrong on Vermont’s road to a single payer system. It worth a read for anyone interested in health policy. The bottom line: according to Vermont Governor Shumlin: “What I learned the hard way is it isn’t just about reforming the broken payment system. Public financing will not work until you get costs under control.”

Read the article

Why Don't More Medicaid Insurers Sell Plans in ACA Marketplaces?:The Urban Institute and RWJ Foundation conducted a research study that asked insurers the question in the headline. The answers came down to the predictability and ease of Medicaid participation versus the higher administrative costs and unpredictability with exchange participation.

Read the the report(See the pdf link to the right of where the article starts)

About pharma

ViiV Healthcare seeks US approval of long-acting, injectable HIV treatment: Treatments for HIV infections have come a long way from complicated multiple daily dose regimens. The latest innovation is this FDA filing for once a month injections. The same company announced a once-daily pill last week.

Read the announcement

Should Drug Prices Be Disclosed in Ads Targeted Directly to Consumers?: This piece is from today’s Wall St. Journal supplemental section on healthcare issues. It presents two experts, each stating the case for her opposing opinion.

Read the article (May require subscription)

AbbVie, Washington state strike subscription payment deal for hepatitis C treatments: Joining Louisiana, Washington state has contracted for however many hepatitis C treatments it needs in exchange for one monthly “subscription” price.

Read the story

Today's News and Commentary

About the public’s health

Religious Objections to the Measles Vaccine? Get the Shots, Faith Leaders Say: Other than baseless pseudoscientific claims, a leading reason parents do not vaccinate their children is religious objection. This article does a great job explaining this religious belief and debunks it using Jewish, Muslim and Catholic authorities as sources. After reading this article it would be hard for anyone to still claim religious reasons for not vaccinating their children.

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

Kansas Supreme Court rules state constitution protects abortion rights, a decision that could lead to challenges in other states: On Friday, the Kansas Supreme court ruled 6 to 1 that the state’s constitution protects the right “to control one’s own body, to assert bodily integrity, and to exercise self-determination. This right allows a woman to make her own decisions regarding her body, health, family formation and family life — decisions that can include whether to continue a pregnancy.” This ruling may be template for other states that want to insulate themselves from federal efforts to ban such procedures.

Read the story (Washington Post but appears to be open access)

No Time to Wait: Securing the Future from Drug-Resistant Infections: The WHO just published this document detailing the global harms from drug-resistant infections and measures that must be put in place to prevent the situation from worsening. See Figure 1 for a helpful graphic of the situation. Very strong language in the report- but it is needed.

Read the report

High-Sensitivity Troponin I and Incident Coronary Events, Stroke, Heart Failure Hospitalization, and Mortality in the ARIC Study: Troponin assays have been used for many years to assess acute heart attacks. In more recent years, the test has been improved by using high sensitivity versions. This large study found that a high sensitivity version (hs-TnI) can also be used to predict cardiovascular events (like heart attack and stroke) years before they occur.

Read the research

5-year versus risk-category-specific screening intervals for cardiovascular disease prevention: a cohort study: Speaking of cardiovascular screening, this study assessed the frequency of recommended followups in patients with cardiovascular disease. It found that the usual 5 year interval (based on expert opinion, not research) was too frequent for some and inadequate for others. A customized approach is detailed.

Read the research

When It's Time For A Mammogram, Should You Ask For 3D?: This report from NPR was published yesterday and aired this morning. It discussed the superiority of 3D mammography over the older 2D version and recommends this technique if available.

Read the article

For Obese People, Commuting by Car Can Be a Killer: Study: Another reason to use public transportation. This news release about research conducted in the UK found: “Compared to people of normal weight who walked or cycled to work (active commuters), those who were obese and commuted by car had a 32% higher risk of early death from any cause; twice the risk of dying from heart disease; and a 59% higher risk for non-fatal heart disease.”

Read the press release

In Washington, Juul Vows to Curb Youth Vaping. Its Lobbying in States Runs Counter to That Pledge; Juul has said it doesn’t market to teens and is against vaping in that age group. This NY Times investigative article says otherwise: “The company’s 80-plus lobbyists in 50 states are fighting proposals to ban flavored e-cigarette pods, which are big draws for teenagers; pushing legislation that includes provisions denying local governments the right to adopt strict vaping controls; and working to make sure that bills to discourage youth vaping do not have stringent enforcement measures.”

Read the story

Genetic and Early-Life Environmental Influences on Dental Caries Risk: A Twin Study: Genetics or environment? In the case of dental caries (cavities) it’s environmental influences that can begin as early as the prenatal period. This finding is good news because factors leading to caries can be modified.

Read the research

About pharma

FDA approves expanded label for Regeneron/Sanofi's cholesterol drug: Praluent is in a class of drugs called PCSK9 inhibitors, which can powerfully lower LDL cholesterol. It came out in 2015 as an adjunct to statin therapy for high risk patients with high cholesterol that was not controllable by other means. Now the FDA has expanded its indication to “ to reduce the overall risk of major adverse cardiovascular events, “ which include heart attacks, ischemic strokes and unstable chest pains requiring hospitalization. Of note is that the price will now be $5,850 a year, down from more than $14,000 a year, when it was first approved in 2015; the reduction is due to price competition from Amgen’s Repatha.

 Read the article

Synthetic and living micropropellers for convection-enhanced nanoparticle transport: Nanoparticles have great potential to deliver medication to targeted sites, especially tumors. One technique to get the particles where they are needed is use of magnets. This research documents using both synthetic magnets in nanomachines as well as natural magnetic properties of bacteria.

Read the research

About healthcare IT

Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties: HHS has just issued revised monetary penalties for HIPAA violations. The previous penalties were assessed by the type of occurrence without regard to the severity of breach, mitigating circumstances or what the provider did to prevent it. Now the penalties for the lowest categories (like “no knowledge”) have been lowered to as low as $100 per infraction. (See page 7 for a chart of penalties.)

Read the announcement

About health insurance

Department of Labor appeals ruling against 'Trumpcare' plans: The Department of Labor will take the federal government’s lead in appealing the court decision that association health plans are invalid.

Read the article

Today's News and Commentary

About healthcare quality

CMS nursing home star ratings overhaul sees 37% of skilled nursing facilities losing 1 or more stars: Ratings of nursing facilities have been rising over the years, so CMS decided to reset its criteria. This revision resulted in a downgrade of one or more “stars” for 37% of these facilities. As the article points out, this change comes at a time when hospitals are choosing their “after care” partners for participation in global payments.

Read the article

About health insurance

Anthem’s Social Determinants Benefits Package Boosts Medicare Enrollment: This year CMS started to allow Medicare Advantage plans to offer expanded benefits like transportation to and from medical visits, healthy meals, and personal care at home. This expansion is paying off for Anthem, which reported a 14% jump in Medicare Advantage enrollment.

Read the story

Speech: Remarks by Administrator Seema Verma at the National Association of Accountable Care Organizations (NAACOS) Spring 2019 Conference: READ THIS SPEECH! CMS administrator Verma does a great job outlining changes that need to be made to improve our healthcare system.

Examples:
”… safeguards put in place under the Stark Law limit providers’ ability to make referrals or coordinate care in innovative ways.  Therefore, we are undergoing a top-to-bottom review of Stark Law regulations to ensure that they are encouraging, rather than hindering, the move to value.”

“We are also combing through and pruning our quality measure sets, so that clinicians can focus on a smaller set of more impactful measures – last year we reduced measures by 20%.”

“To encourage adoption, CMS is promoting multi-payer alignment.  Adoption will increase when providers don’t have different models for different payers.  We want to work with private sector groups to synchronize our models with those in private plans where possible. “

“CMS is striving to set consistent and fair benchmarks.  We factor in a number of important questions, including:  How do we create a level playing field so that provider performance is fairly evaluated?  How do we factor in risk adjustment, so there is not an incentive to cherry-pick healthy patients and so we can strengthen the incentive to take on the most complex patients?  And finally, how do we reward good performers without creating a race to the bottom, where your benchmark always gets harder as your performance improves?”

One statement that the media has highlighted above all others is:

“Looking forward, you can expect that some of the models we have under development will be mandatory.”
In other words, CMS will be making some of its value-based programs mandatory.

Read the speech

Humana, Doctor on Demand launch virtual primary care health plan; This program is not your usual telemedicine linkup; it is part of a structured health plan that Humana is offering with Doctor on Demand and is called On Hand. This virtual primary care model will have lower premiums and no “office” copays for calls. Members will get a kit that includes a blood pressure cuff, thermometer and log to help convey data to the physician. Other in-network virtual services will also be available.

Read the article

Association insurance pushes on despite court ruling: Despite a court ruling last month that challenges the legality of association health plans, many people are still enrolled in them. This article updates what is happening with this insurance product.

Read the article

About the public’s health

Consumption of Alcohol Beverages and Binge Drinking Among Pregnant Women Aged 18–44 Years — United States, 2015–2017:Alcohol consumption during pregnancy can lead to serious problems for the newborn- called fetal alcohol syndrome. Since the occurrence is idiosyncratic, no level of alcohol consumption is “safe” during pregnancy. This CDC report found that: “Analysis of 2015–2017 Behavioral Risk Factor Surveillance System data found that 11.5% of pregnant women reported current drinking, and 3.9% reported binge drinking during the past 30 days.” Clearly we still have a problem.

Read the report

Americans Are Among the Most Stressed People in the World, Poll Finds: Emotions can have a profound effect on health- especially stress. This article summarizes mainly the US results from the 2019 Gallup Global Emotions study. We are not only stressed , but we are more stressed than any time in the past decade. Not surprisingly, stress doesn’t always correlate with politics or wealth. For example the countries that reported the highest “positive feelings” tend to be South/Central American; highest overall were Paraguay and Panama.

Read the summary article(NY Times but appears to be open access)
Read the full report (Click the link)

About pharma

Questions about BMS-Celgene integration plans? Obviously. Answers? Not so much: This interview with Bristol-Myers Squibb CEO Giovanni Caforio explains the company’s strategy after the Celgene acquisition. One overall message is that R&D will still be pursued with each original company’s agenda.

Read the interview

WHO Invites Comments on Drug Shelf Life Policies: Drug shelf life policies are extremely important because many poorer countries cannot afford to throw out costly medications. The WHO is soliciting comments to formulate a policy about this issue.

Read the article

About healthcare technology

FDA clears first device treatment for childhood ADHD: A prescribed, external trigeminal nerve (forehead and face) stimulation device has been approved by the FDA for treatment of unmedicated childhood ADHD.

Read about the product

Molecular subtyping reveals immune alterations associated with progression of bronchial premalignant lesions: Researchers have found four molecular subtypes of bronchial pre malignant cells from high risk smokers. These changes can reliably identify those at high risk. But all that can be done now is intensify surveillance; preemptive interventions are not yet available.

Read the research

CMS Plots to Increase Breakthrough Device Payments; Among other criteria for CMS to consider payment for a “breakthrough device” is evidence that it represents a “substantial clinical improvement.” But comparative studies may not be available at the time the innovation is launched. CMS has said it will waive this requirement for two years while the manufacturer gathers more data.

Read the announcement

About healthcare IT

Nearly half of U.S. doctors say they are anxious about using AI-powered software: survey: This article provides a nice summary of an international Medscape survey about physician attitudes toward using Artificial Intelligence in clinical practice. American physicians are more skeptical than their European counterparts and many feel the technology is still too much in its infancy to be reliable.

Read about the survey

Today's News and Commentary

About healthcare IT

Federal Trade Commission, Plaintiff, v. Surescripts, LLC: This is the story of the day. Surescripts may be the only truly interoperable functionality in the IT space. It checks patient insurance eligibility and allows physicians to prescribe electronically. The FTC filed this suit claiming Surescripts engaged in anticompetitive behavior (such as predatory pricing) to keep its monopoly. The government is asking for cessation of this behavior and “grant other such equitable relief, including equitable monetary relief, as the Court finds necessary to redress and prevent recurrence of Defendants’ violations.”

Read the brief

Poor Usability of Electronic Health Records Can Lead to Drug Errors, Jeopardizing Pediatric Patients: This report from the Pew Trusts documents the harms to pediatric patients from electronic record dysfunctions. The paper details twelve different area and opportunities for improvement. Examples include: Patient received drug overdose due to entry of wrong weight; Display problems with automatic medication holds caused missed dose: and Hidden medication order settings contributed to a lapse in care.

Read the study

About health insurance

Poll: Majority of Americans want laws protecting them from surprise medical bills: If you ask Americans what they want next from their health insurance, it is lower drug costs and protection from surprise medical bills. ACA repeal and “Medicare for all” got fewer than a third response rate as a high priority.

Read the article

Three New Opportunities to Test Innovative Models of Integrated Care for Individuals Dually Eligible for Medicaid and Medicare: CMS Administrator Verma announced federal efforts to reduce costs for those eligible for both Medicare and Medicaid (dual eligibles). According to Verma: “ dually eligible individuals have accounted for 20 percent of Medicare enrollees, yet 34 percent of Medicare spending. The same individuals have accounted for 15 percent of Medicaid enrollees and 33 percent of Medicaid spending.”
Her proposal calls for three types of programs: capitation model, shared fee for service, and state-specific innovations. Of note is that from their earliest days, Medicare HMOs enrolled dual eligibles. Also, the shared fee for service is like the Medicare Shared Savings Plans currently in operation. Further, states have long been able to apply for waivers for Medicaid beneficiaries and others. I do not understand what is new. Why add to the bureaucracy when expansion of current programs would solve the same problems?

Read the CMS announcement

We’re investigating how insurance gaps endanger mothers. This is why.: This article points out the growing maternal mortality rate weeks after delivery, when many mothers lose their Medicaid eligibility. The mortality is due to untreated chronic conditions.

Read the story

Moody's: Insurers like Centene, Molina better positioned to weather economic downturn than in 2008: This article summarizes a recent Moody’s report on resilience of the healthcare sector in the event of a recession. A couple sample points: companies like Centene and Molina will be fine because of their positions participating in ACA exchanges where the unemployed would be eligible for subsidized enrollment; hospitals, on the other hand, would see an unfavorable change in payer mix and increase in uncompensated care.

Read the article (The original report requires subscription)

About the public’s health

The Impact of Chronic Underfunding on America’s Public Health System: Trends, Risks, and Recommendations, 2019: This report from the Trust for America’s Health documents underfunding for public health measures. For example, “the CDC’s budget fell by 10 percent over the past decade (FY 2010-19), after adjusting for inflation.” An additional $4.5 billion is required to bring this system to where it needs to be. The study also documents the high degree of public support for more funding.

Read the report

Antibiotic use linked to greater risk of heart attack and stroke in women: Another reason to be cautious about antibiotic use. The “researchers found that women who used antibiotics for periods of two months or longer in late adulthood were 32% more likely to develop cardiovascular disease than women who did not use antibiotics. Women who took antibiotics for longer than two months in middle age had a 28% increased risk compared to women who did not…The most common reasons for antibiotic use were respiratory infections, urinary tract infections and dental problems.”

Read the article

The State of the Air 2019: In its 20th annual report, the American Lung association reports that air quality is getting worse. Currently: “More than four in 10 Americans, approximately 43.3 percent of the population, live in counties that have monitored unhealthy ozone and/or particle pollution. The number of people exposed to unhealthy air increased to nearly 141.1 million. “ You can also look up the air quality where you live.
For example, I live near two adjacent counties, both of which got an “F” rating for ozone.

Read the report

About pharma

New PhRMA Report Shows More Than 160 Medicines in Development for Diabetes and Related Conditions:Finally some good news. Pharma companies have been working a lot on medications for rare diseases that can be sold at high prices. This article documents the research for a very common disease.

Read the article

Gilead defied a government HIV patent. The Justice Department has opened a review.: Gilead holds the patent for Truvada as a treatment for HIV infection. But the drug can also be used to prevent infection (Truvada for PrEP). The Justice Department claims the patent for the latter use belongs to the federal government because it was developed at the CDC. The issue is that Gilead is not paying the government royalties for its preventive use.

Read the story

Today's News and Commentary

About pharma

Pharma Lobby Nears Spending Records With Drug Prices Under Fire: With all the governmental talk about lowering drug prices, the pharma lobby is spending record amounts on lobbying ($9.91 million in the first quarter).

Read the article

About the public’s health

Hospitals sue over new national liver transplant policy: The United Network for Organ Sharing, a non profit organization that works with the federal government to fairly allocate organs for transplant, announced new criteria would be starting April 30. The criteria change the geographic distribution currently in place. Several hospitals and patients have sued, claiming the new system is unfair, particularly to those in rural areas and in some states (like Georgia and Alabama).

Read the article

Federal judge will enjoin family-planning physician gag rule: ”U.S. District Judge Michael J. McShane said Tuesday he will issue a temporary injunction against the Trump administration’s gag rule dictating what physicians can and cannot say about family planning to their patients in the Title X program.”
The gag rule would prohibit family planning funds from going to organizations that provide abortions or refer patients to organizations who do.

Read the story

Scientists Dig Into Hard Questions About The Fluorinated Pollutants Known As PFAS:This story from NPR concerns one of those ubiquitous classes of chemicals about which scientists know relatively little about the health effects.

Read the story

WHO recommends one-hour maximum screen time per day for under-5s: And no time for those under one year!

Read the article

The Forgotten Middle: Many Middle-Income Seniors Will Have Insufficient Resources For Housing And Health Care: This article from Health Affairs has limited access; but the message in the abstract is clear: “We project that by 2029 there will be 14.4 million middle-income seniors, 60 percent of whom will have mobility limitations and 20 percent of whom will have high health care and functional needs. While many of these seniors will likely need the level of care provided in seniors housing, we project that 54 percent of seniors will not have sufficient financial resources to pay for it. This gap suggests a role for public policy and the private sector in meeting future long-term care and housing needs for middle-income seniors.”

Read the abstract

Walgreens, Rite Aid set minimum age to sell tobacco products at 21 years: This action is an improvement but still not as good as CVS, which does not sell tobacco products.

Read the announcement

Popular e-cigarette products contaminated with bacterial and fungal toxins, study finds: In another tobacco-related story, the headline provides another reason not to smoke.

Read the article

Trump poised to roll back transgender health protections: “A proposed rule from the Department of Health and Human Services (HHS) that’s expected in the coming days would make it easier for doctors, hospitals and insurance companies to deny care or coverage to transgender patients, as well as women who have had abortions.” The ACLU says it will challenge the rule if it is issued.

Read the article

New Findings Confirm Predictions on Physician Shortage: This latest study continues other recent ones that document physician shortages. Many reasons exist including, physician retirements, growing populations and geographic maldistribution of providers.

Read the findings

About healthcare IT

Telehealth initiatives are expanding at the state, as well as national level, with laws and programs to enable this technology. Here are two examples in Arizona and South Carolina.

About health insurance

Verma Seeks to Clarify Commitment to Preexisting Condition Protections: Short term health plans are meant to provide a cheaper alternative to ACA exchange plans by limiting benefits. The concern is whether they would also exclude preexisting conditions. CMS administrator Verma offered reassurances that federal waivers for these types of plans would not be granted unless they guaranteed “that people with pre-existing conditions continue to have access to coverage that is at least as comprehensive and as affordable as it is today.” This position is stricter than that of the White House, so we will still need to see how it all plays out.

Read the article

About healthcare financing

Global Healthcare Private Equity and Corporate M&A Report 2019: This report from Bain & Co. reports that “disclosed deal values surged almost 50%, to $63.1 billion, topping last year’s level of $42.6 billion, and deal count rose to 316 in 2018 from 265 in 2017. “ Activity was all across the healthcare sector.

“Corporate buyers also jumped in with enthusiasm, pushing corporate M&A in healthcare to a record $435 billion in 2018, surpassing the previous high of $432 billion in 2015.”

Read the full report

Today's News and Commentary

About health insurance

U.S. health officials unveil experiment to overhaul primary care: CMS announced the outlines of several programs that would augment primary care physicians’ responsibilities for the cost and quality of care. Along with the added responsibility is the potential to gain extra payments (or incur losses). One of these models is meant to replace the Next Generation ACO plans.

Read the article (A number of media outlets carried this story today; I think this version is among the best)
Read the CMS announcement

2019 Annual Report of the Boards of Trustees of the Federal Hospital Insurance [HI] and Federal Supplementary Medical Insurance Trust Funds: This report is the annual assessment of the Medicare program. Lots to digest but the “bottom line” is:
”The estimated depletion date for the HI trust fund is 2026, the same as in last year’s report. As in past years, the Trustees have determined that the fund is not adequately financed over the next 10 years. HI income is projected to be lower than last year’s estimates due to lower payroll taxes and lower income from the taxation of Social Security benefits. HI expenditures are projected to be slightly higher than last year’s estimates because of higher-than-projected 2018 spending and higher projected provider payment updates, factors that are mostly offset by the effect of lower assumed utilization of skilled nursing facility services.

In 2018, HI expenditures exceeded income by $1.6 billion. The Trustees project deficits in all future years until the trust fund becomes depleted in 2026.”

Read the report

About healthcare IT

Assessment of the Data Sharing and Privacy Practices of Smartphone Apps for Depression and Smoking Cessation: While apps can help users with their healthcare problems, they are often not secure and do not reveal how they share information with other entities. “In this cross-sectional study of 36 top-ranked apps for depression and smoking cessation available in public app stores, 29 transmitted data to services provided by Facebook or Google, but only 12 accurately disclosed this in a privacy policy.” Here is an opportunity for government to enact and enforce privacy requirements.

Read the research

How patients can turn their medical data into money: Following on the above research, this article discusses platforms where patients can not only keep ownership of their personal medical data but also monetize it. (For example, see Hugo Health)

Read the article (Financial Times- subscription required)

Speech‐based markers for posttraumatic stress disorder in US veterans: Speech recognition technology has moved way beyond asking for songs or ordering takeout food. Many diagnostic tools are being developed that rely on analysis of voice patterns. This article provides one example.

Read the research

Free App to Help Patients Ask Appropriate Questions: The Agency for Healthcare Research and Quality (AHRQ) recently launched a free mobile app to help patients better prepare for medical visits.

Read about the app

About the public’s health

IBM Watson Health Names Nation's Top Health Systems: Another list is out, this time from IBM Watson. According to the report, the hospitals provide better care at lower cost than peer organizations.

Read the report

Association Between Receipt of a Medically Tailored Meal Program and Health Care Use: If patients receive any advice about diet, it is usually general and formulaic. This research showed that customized meals can produce better results: “Participation in a medically tailored meals program appears to be associated with fewer hospital and skilled nursing admissions and less overall medical spending.”

Read the research

Humana’s Bold Goal Program: In 2015 Humana launched its Bold Goal program in seven communities. The aim was to reduce “unhealthy days” by addressing social determinants of health. Some initiatives were successful and others were not. It is still an interesting program and worth reading about it.

Read the 2019 report

About pharma

The Changing Landscape of Research and Development: This report from IQVIA, based on 2018 data, has a number of interesting findings. Among them:
—It takes a median of 13.6 years from first patent filing to launch of a successful “new active substance.”
—”The companies bringing these drugs to the market are changing, with the role of emerging biopharma (EBP) companies growing. EBP companies patented almost two-thirds of new drugs launched in 2018 and registered 47% of them, while large pharma companies patented only one-quarter…Emerging biopharma companies now account for over 70% of the total late stage R&D pipeline.”
—Composite success rates for clinical development varied widely by therapeutic class, ranging from 26% for rare diseases to 6% for vaccines.

Read the report

Today's News and Commentary

About health insurance

Prior Authorization Bill Expected in Congress This Summer: Prior authorizations for services, tests and pharmaceuticals add a large time and cost burden to practitioners and inconvenience for patients. This forthcoming bill has bipartisan support and is expected out this summer.

Read the article

Next Generation ACO participants for 2019 drop to 41: Since March 2018 the number of these ACO participants dropped from 58 to 41. Some may have shifted to the less risky shared savings program, but will be required to eventually assume more risk.

Read the announcement (Modern Healthcare, so there is some limited access)

CBO changes how it estimates insurance coverage: The Congressional Budget office will change its methodology for determining the impact of such insurance changes as repeal of the ACA.
“The updated insurance model changes how individuals and families are projected to choose among coverage options and how an employer is projected to take a worker's preference into account when deciding whether to offer employment-based coverage.”

Read the article (Modern Healthcare, so there is some limited access)

US Emergency Department Visits and Hospital Discharges Among Uninsured Patients Before and After Implementation of the Affordable Care Act: We still have a long way to go covering the uninsured, who use the ED for much of their care. “Proportions of ED visits and hospital discharges by uninsured patients decreased considerably after the implementation of the 2014 ACA insurance provisions. Despite these changes, approximately 1 in 10 ED visits and 1 in 20 hospital discharges were made by uninsured individuals in 2014 to 2016.”

Read the research

The Return of Churn:State Paperwork Barriers Caused More Than 1.5 Million Low-Income People to Lose Their Medicaid Coverage in 2018: This paper looks into the reason for the huge drop in Medicaid coverage in 2018. Reasons were not previously clear. For example, one could speculate that the country’s increased employment took many off the roles. This study claims that the vast majority of the loss was due to “enrollment churn”- or eligibility redetermination enrollment losses. The losses varied dramatically among the states. We need more uniform criteria, processes and enforcement; if for no other reason then 744,000 of the 1.5million loss were children

Read the research.


About healthcare IT

Senators move to ramp up oversight of VA's $16B EHR project: Integration of VA and Department of Defense IT systems was announced in 2017. It still has a long way to go. Because of the cost and slow pace, bipartisan action in the senate will “ramp up oversight” of this project.

Read the article

About pharma

Innovative drug delivery improves effectiveness of cancer immunotherapy: “…a new method has been developed that targets collagen to deliver immunotherapies directly to tumours, helping to both reduce side effects and make the therapies more effective in treating cancer.” The collagen complex sees blood leakage in cancers as a breach in blood vessels and seals them up, delivering the immunotherapy.

Read the article

Almost Half of Young Asthma Patients Misuse Inhalers: This article highlights the difference between efficacy (ideal circumstance use) and effectiveness (use in real world conditions). Asthma treatments are mostly efficacious but more needs to be done to make them effective.

Read the article

On-chip drug screening for identifying antibiotic interactions in eight hours: A problem using antibiotics in a timely fashion is the long time it takes to assess the the sensitivity of the bacteria. This technology speeds up the process and will also help reduce resistance by “getting it right” sooner.

Read the article