About pharma
U.S. drugmakers file lawsuit against requiring drug prices in TV ads: As previously reported, the federal government is requiring pharma companies to present their drugs’ prices in ads. On Friday, Amgen Inc, Merck & Co, Eli Lilly and Co and the Association Of National Advertisers filed a lawsuit against this requirement in the U.S. district court for the district of Columbia. The plaintiffs content the regulations are a violation of free speech. Stay tuned. The principles involved could have a profound effect on advertising and the government’s desire for transparency.
The top 20 drugs by 2018 U.S. sales: This article is more of a FYI. The top seller, by far, was Humira. It does not have to worry about a US biosimilar until 2023.
Allscripts acquires prescription drug startup ZappRx: Another example of a cross-sector purchase in health care. The IT company Allscripts purchased specialty drug prescribing startup ZappRx. The link is Allscript’s subsidiary Veradigm, described as “an integrated data systems and services company that delivers superior data-driven insights to improve the efficiency, value, and quality of healthcare delivery.” Specifically, the functionality is to get into the e-prescribing space.
Bluebird bio prices beta thalassaemia gene therapy Zynteglo at 1.575 million euros over five years: Other than being the second most expensive medication, this story is noteworthy to emphasize the continuing trend of value-based payments. Payment will be based on “a five-year installment plan… 315 000 euros ($354 000) to be paid up front and additional annual payments due only if the treatment continues to be effective, for a total of 1.575 million euros ($1.8 million).”
Aerosol chemo may treat stomach cancer: Chemotherapy has been administered through infusions or pills. This new method raises the promise of yet another route of administration.
About health insurance
Trump touts administration's expansion of HRAs as win for small business: I reported this story last week, but this article is another reminder of a plan that could disrupt the marketplace. One twist I should emphasize is that these payments can be used to pay for non-qualified plans under the ACA.
Florida ‘Patient Savings Act’ adds financial incentive to transparency tools: This article is a nice summary of some healthcare innovations in Florida (such as telemedicine). Its focus is on a new law that “directs health insurers who choose to offer such a program to develop a website outlining the range of ‘shoppable’ health care services available to clients…. When a consumer obtains a ‘shoppable’ healthcare service for less than the average listed price, the new law requires the savings [no less than 25%] to be shared by the health insurer and the insured.”
Humana asked experts to define 'value-based care.' They couldn't do it: Definitions drive actions. Humana convened a panel of healthcare experts to define some important and commonly-used terms. Although “the participants could find common ground on what ‘value-based payment’ is, they couldn't agree when it came to ‘value-based care’ or ‘population health."‘“ How do we know if we have achieved something if we can’t define it?
Trump says he will roll out new health care plan in next couple of months: While this announcement was made yesterday, President Trump previously mentioned this initiative for the 2020 campaign. No details are yet available and the broad range of possibilities make speculation fruitless at this time.
Top Trump health official warned against controversial ObamaCare changes in private memo: In a just- released confidential memo from August of 2018, CMS Administrator Verma warned the Trump administration of the disruptive consequences of changes eventually made to the ACA. So the White house either did not believe her analysis or made the changes, knowing it would make the ACA look dysfunctional. Perhaps it was to bolster the upcoming Trump proposal (see above)?
Read the story (and click the link to the memo)
About healthcare IT
AMA policy aims to ensure doctors have a role as AI gains traction: At its annual meeting last week, the AMA developed policies to help physicians deal with Artificial Intelligence (AI). Measures include educational programs on how to use and evaluate AI, a call for accreditation and licensing, and evaluations on outcomes of its use.
Variation in Physicians’ Electronic Health Record [EHR] Documentation and Potential Patient Harm from That Variation: EHRs were supposed to standardize data gathering to make analysis easier. This study, however shows that there are important, statistically significant variations in the documentation. Specifically: “Five clinical documentation categories had substantial and statistically significant (p < 0.001) variation at the physician level after accounting for state, organization, and practice levels: (1) discussing results…; (2) assessment and diagnosis…; (3) problem list…; (4) review of systems…; and (5) social history…. Drivers of variation from interviews included user preferences and EHR designs with multiple places to record similar information. Variation was perceived to create documentation inefficiencies and risk patient harm due to missed or misinterpreted information.” The article discusses mitigation strategies.
Senate privacy bill aims to set new federal standard for consumer health apps: “Sens. Amy Klobuchar (D-Minn.) and Lisa Murkowski (R-Alaska) have introduced a bill that would create new privacy regulations protecting consumer health data collected through health tracking apps, fitness wearables and direct-to-consumer DNA testing kits.” Consumer health data is not HIPAA protected so these measures are needed, especially in light of recent leaks.
OIG found cybersecurity gaps in NIH's All of Us precision medicine research project: The NIH-sponsored project, called All of Us, aims to gather very large amounts of genetic data for research purposes. The Office of the Inspector General (OIG) of HHS “reviewed information system general controls at two of the seven components of the All of Us program: the Participant Technology Systems Center (PTSC), awarded to Vibrent Health, and the Data and Research Center, awarded to Vanderbilt University Medical Center. These controls included security plans, access controls, information protection and system maintenance, audit logging, data and physical security, incident response, and disaster recovery. The PTSC did not have adequate controls to protect All of Us participants’ sensitive data. NIH did not adequately monitor the PTSC to ensure that the PTSC had implemented adequate cybersecurity controls to protect the participants’ sensitive data. Based on the results of our penetration testing at the PTSC, we identified vulnerabilities that could expose personally identifiable information, including personal health information of the All of Us participants, and allow access to their data.”