DCMedical News: Monday, May 20, 2019
DCMedical News-DCMN
Washington, D.C.
Monday, May 20, 2019
DCMedical News is published every day both the House and the Senate are in session. Subscription information below.
THE BIG STORY IN HEALTH CARE
Congress Back in Town
Both houses of Congress are in session this week, today through Thursday, then gone until June 5.
DOCTORS, NURSES AND OTHER HEALTH PROFESSIONALS
Editor Slams EHR Use in Clinical Research
The editor of JAMA Cardiology has published a scathing critique (here) of electronic medical record coding and use in cardiac research. She writes that attempts to record information concerning “type2MI” [myocardial infarction] have run afoul of timing, coding and clinical issues, rendering it possible that “misclassification occurs across the United States” with major implications for both disease surveillance and health care reimbursement. “The present example is one of many that show how far we remain from being able to use EHR data alone to conduct reliable, in-depth, and accurate observational research.”
MEDICARE, MEDICAID, COMMERCIAL HEALTH INSURANCE
The Future is . . . in Payments
JPMorgan has announced (here) that is has spent $500 million to buy a health care bill payments firm (InstaMed) and that the Amazon-Berkshire Hathaway-JPMorgan sponsored “Haven” has a (relatively) modest charge: “The acquisition comes as JPMorgan works with technology behemoth Amazon and Warren Buffett-backed investment conglomerate Berkshire Hathaway on a new healthcare venture called Haven that it hopes will reduce the bank’s annual healthcare costs.”
DRUGS AND DEVICES
IQVIA Publishes Profile of New Drug R&D and Approval Activity
IQVIA has published (here) a summary of new drug activity in 2018. Highlights: “Fifty-nine new active substances (NAS) were launched in 2018, higher than in any of the past five years . . . Oncology had the most launches for a therapy area with 16 launches, including supportive care, 12 of which were orphan drugs, followed by infectious disease with 12 launches . . . Of the NASs launched in 2018, 46% were approved based on data from trials with fewer than 500 subjects in total, and the average number of years that subjects collectively spend in trials cited for their approval declined. The development of new drugs remains a slow process, with the 2018 U.S. NASs taking a median of 13.6 years to launch from the time of their first patent filing – about two years faster than drugs launched in the prior two years . . .Over 70% of new drugs came through the regulatory process under one of several tracks (priority review, accelerated approval, fast track or breakthrough status) intended to accelerate development and review . . . Of the 59 new drug launches in 2018, 38 were patented by emerging biopharma [EBP] companies, and 74% of those were also registered by these companies. Although the importance of large pharma in originating molecules is decreasing, they remain important partners for EBP companies even as EBP are increasingly able to commercialize alone.”
Nearly Half of NDA Approvals Rely on a Single Study
One aspect of the IQVIA study is sure to be controversial, namely the finding that one half all new drug approvals in 2018 relied on a single clinical study. A report (here) from the Regulatory Professionals Society (RPS), recounts the history of single versus multiple trials to establish drug effectiveness. “Back in the 1970s and 1980s, the US Food and Drug Administration (FDA) made clear that at least two adequate and well-controlled studies were necessary to establish a new drug’s effectiveness, except in only the rarest of circumstances. Then in 1997, the Food and Drug Administration Modernization Act was passed, and Congress clarified that FDA may consider data from one adequate and well-controlled clinical investigation and confirmatory evidence to approve a new drug.” In 1998 guidance (here) the FDA said that its reliance on only a single study “will generally be limited to situations in which a trial has demonstrated a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease with potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.” The RPS article continues, “Most recently, IQVIA released a report finding that 25 of 59 (42%) novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials. But as in previous years, a large portion of the drugs relying on only one trial were new orphan and cancer drugs.”
READINGS AND REFERENCES
The United Hospital Fund’s estimable Greg Burke, veering toward retirement, has produced a report (here) on New York’s 32 Accountable Care Organizations (ACOs), demonstrating why CMS is changing the ACO program. Notwithstanding rhetoric concerning value, quality and coordination of care, CMS was seeking (in the ACO program) to pay less than retail rates for medical care. The New York ACOs lost $60 million in each of the first two program years, but produced “savings” of $11.5 million in 2017. Still, after counting and distributing $52 million in shared savings to 13 NY ACOs, CMS lost $40 million. CMS has already announced that it will be abandoning the “shared savings only” model ACO for one involving “shared savings or losses.” Providers sound dubious (e.g., here), as interest groups position themselves.
Medicare-for-America Act, here.
U.S. House of Representatives:
Members at https://www.house.gov/representatives.
Committees and Members at https://www.house.gov/committees.
U. S. Senate:
Members at https://www.senate.gov/general/contact_information/senators_cfm.cfm.
Committees and Members at https://www.senate.gov/committees/membership_assignments.htm.
House and Senate 2019 Calendar of Regularly Scheduled Sessions, here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
May publication dates: 21, 22, 23
June publication dates: 5, 6, 7, 8, 11, 12, 13, 14, 25, 26, 27, 28
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.