Today's News and Commentary

About pharma

ICER [Institute for Clinical and Economic Review] Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence: “In 2017 and 2018, out of nine identified drugs that had substantial price increases on top of already high current spending, seven drugs had no new important evidence to support their price increases. The net price increases on these seven drugs alone cost American insurers and patients an additional $5.1 billion over two years.” The top 3 on the list are Humira® (adalimumab, AbbVie); Rituxan® (rituximab, Genentech); and Lyrica® (pregabalin, Pfizer). The other drugs and contributions of all to the excess costs are included in a table. Will Congress use this list to lower drug costs?

2020 Democrats embrace aggressive step on drug prices: Continuing the theme of high drug costs, “Democratic presidential candidates are threatening to take a drastic step that even the Obama administration rejected to lower drug prices without congressional approval.

 The move involves invoking an obscure section of a 1980 law to break the patent on a drug when it is priced too high. The idea, known as ‘march-in rights,’ would allow the government to ‘march in’ and break a patent to allow a cheaper version of a drug to be made by another company.”

J&J emerges unscathed in retried California talcum powder suit: This article is a nice summary of the status of the lawsuits against J&J for alleged contamination of baby powder with asbestos.

Jury smacks J&J with $8B Risperdal verdict, but will it stand up in appeals?: “Plaintiff Nicholas Murray sued the company in 2013 alleging his off-label use of Risperdal caused him to develop breasts. Risperdal was approved in 1993 to treat schizophrenia and bipolar mania in adults, but Murray alleged the drugmaker marketed its drug for unapproved uses [in his case, autism spectrum disorder] and didn't adequately warn about its risks.” J&J is appealing the jury award of $8 billion.

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: This guidance was prepared by the Office of New Drugs (Center for Drug Evaluation and Research (CDER)), in cooperation with the Center for Biologics Evaluation and Research(CBER),at the FDA. It is “the second in a series of four methodological patient-focused drug development (PFDD) guidance documents that the FDA is developing to describe in a stepwise manner how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.” In other words, the FDA is interested in gathering input from users of medical products, not just safety and efficacy data.  

AbbVie, Bristol-Myers Among Patient Advocacy Groups’ Big Backers: Abbvie, Bristol-Myers Squibb, Pfizer, Merck, AstraZeneca and J&J contributed more than $680 million to hundreds of nonprofit organizations last year. Many of those organizations are now lobbying against federal legislation to lower pharmaceutical costs. This article is a good analysis of this backdoor politics. See the graphic for how much each firm is contributing.

Priority Review Voucher Fees Cut for Fiscal Year 2020: “Effective Oct. 1, drugmakers will have to pay $2,167,116 million to redeem a priority review voucher for a newly approved drug or biologic for treatment of a rare pediatric disease, a tropical disease or for a medical countermeasure.” This change is part of the update in the FDA’s Medical Countermeasures Initiative.

About healthcare quality and safety

HHS Proposes Stark Law and Anti-Kickback Statute Reforms to Support Value-Based and Coordinated Care: So-called “Stark laws” were passed to prevent conflicts of interest in healthcare transactions. But recent trends in value-based care have required combinations of organizations and changes in payment incentives that would conflict with those laws. HHS has recognized these problems and is proposing changes explained in this statement. Links to OIG and CMS proposed rules are also at this website.

CMS launching tool on nursing home website to warn of abuse violations: “Later this month, the Trump administration will add an alert to its Nursing Home Compare website to warn consumers about homes that have been flagged for violations including abuse and neglect.
The Centers for Medicare & Medicaid Services (CMS) said the addition of the consumer alert icon is part of a larger approach to boost nursing home safety and quality.”

Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database: Post-marketing surveillance for product problems is an important FDA function. As previously reported in March, a Kaiser Health News report revealed that “the FDA had allowed device manufacturers to file reports of malfunctions in a hidden database.” That data base was closed in June. However, another reporting miscategorization is occurring through the Manufacturer and User Facility Device Experience (MAUDE) database. The authors of this report “found a substantial misclassification of patient deaths in the FDA’s MAUDE database for the Sapien 3 and MitraClip devices, which resulted in the underreporting of deaths…[which] raise concerns about the accuracy of adverse-event reports for high-risk devices.” Clearly the FDA needs to improve the process to ensure the public’s safety.

Hospitals and health systems

Commonspirit Health reports losses of $582M in first financial report since merger: “Chicago-based CommonSpirit Health posted a $582 million loss last year in the wake of the merger that created the Catholic health giant, officials reported this week.
The new health system—the largest nonprofit health system in the country by revenue—was created in February through a merger between Catholic Health Initiatives and Dignity Health.” The article provides more details about the loss and future plans for the organization.

About the public’s health

How PG&E’s historic blackouts will put California’s medical emergency planning to the test: Pacific Gas & Electric is shutting down power to hundreds of thousand of residents in northmen California, including in the San Francisco Bay area. The utility states that the measure is needed to prevent a recurrence of sparks that caused recent wildfires. Those who depend on electricity for medical devices and refrigeration for medications will be in trouble unless special emergency measures can be implemented.

About healthcare professionals

Changes and Variation in Medicare Graduate Medical Education Payments: “Graduate medical education (GME), the training of resident physicians, is funded by GME payments to hospitals and health systems, largely from Medicare and Medicaid…Medicare provides 2 types of GME payments to hospitals: direct medical education, based on the proportional Medicare patient load and the number of resident physicians; and indirect medical education, an add-on to Inpatient Prospective Payment System reimbursements based on a resident-to-bed ratio, such that hospitals with higher Medicare patient loads, resident physician-to-bed ratio, and Medicare reimbursements get paid more…. Medicare GME payments per resident FTE grew nearly 20% from 2000 to 2015, largely driven by increasing inpatient reimbursements. This raises the question of whether linking GME payments mechanically to inpatient reimbursements without assessing the association with teaching costs is sensible policy. The variation between hospital GME rates suggests some hospitals could support GME at lower payment rates. If Medicare GME were capped at the $150 000 rate of the Teaching Health Centers program, $1.28 billion would have been available for redistribution to address other US health workforce needs. Wide rate variation also suggests the need for caution and pacing in GME payment reform, with attention to how payment reductions may affect hospitals receiving lower payments.”

About healthcare IT

UnitedHealthcare launches new app with on-demand telemedicine: “UnitedHealthcare has launched a new app for its members that will make it far easier for them to access virtual visits around the clock. 
The app, which will be available for free on both Apple and Android devices, will allow UnitedHealthcare’s 27 million employer plan members to access on-demand telemedicine 24/7 alongside tools that allow them to track their benefits and compare pricing…” The article has a screenshot of the menu of quick links.

NLM [National Library of Medicine]taps EHRs, FHIR to improve sharing of medical research data: “The National Library of Medicine is developing analysis tools to mine electronic health records to help discover adverse drug reactions, identify promising drug targets and detect transplant rejection earlier.”

1.5 million patients' data exposed in September-reported healthcare breaches (Modern Healthcare- subscription may be required fro this article): ”Nearly 1.5 million people had data exposed in healthcare breaches reported to the federal government last month.
That's more than double the roughly 730,000 people who had data compromised in healthcare breaches reported the month prior.” The “top 10” are included.

About health insurance

Colorado proposes running public health care option through private insurers: As previously reported, some states are planning to implement their own public insurance options. Under Colorado’s plan (details of which have now been issued), insurers will administer the the state-designed insurance. “The plan, which the agencies are calling the ‘state option,’ will be available to Colorado residents who purchase their own insurance…
Under the proposal, the state will create a reimbursement fee schedule, basically setting rates for how much hospitals can receive in return for treating individuals on the public option plan. The state intends to set the rates between 175% to 225% of what Medicare charges for services, which is below the current average on the individual market.” Now that they have the prices checked, what are they going to do to control the volume and intensity of services?