September 23, 2013
Legends Of The Fall: Health Care Stories For A Season’s Change
By Michael D. Shaw
The magical season of autumn is upon us. The days grow shorter, the leaves turn color, and yarns from the world of health care continue to spin…
1. Back-Alley Redux
The Golden State of California prides itself on being in the forefront, and with Assembly Bill 154 soon to be signed into law, the state legislature has done it again. AB 154 will relax medical standards that currently require surgical abortions to be performed by a physician, and would instead allow first trimester abortions to be performed by physician assistants, nurse practitioners, and nurse midwives.
Wherever you stand on the abortion issue, the notion of permitting so-called mid-level providers to perform this procedure (via medication or aspiration) should give you pause–even if they are required to take an eight-week course. It is noted that this training is to be conducted by the Board of Registered Nursing, not by physicians, and the protocols for defining physician supervision have not been specified. In fact, there is nothing in the legislation requiring a physician to be present or on-site during an abortion.
As an additional affront, the bill would reclassify abortion by aspiration (vacuum) as non-surgical. I guess since it’s not surgery anymore, such far-from-rare complications including torn cervix or perforated uterus will simply disappear. But if they don’t, one wonders what our mid-level providers will do.
Here’s my prediction: The women will be rushed to the nearest emergency department, minus what used to be called “continuity of care.” And, despite the Orwellian use of electronic health records, keeping track of such complications will disappear into the vapor. Given the State’s position on the matter, expect a massive increase in Medi-Cal and Medicaid funded abortions.
This is nothing less than a radical lowering of the standard of care. Or, to put it another way, a government-mandated return to the infamous pre-Roe v. Wade “back alley.” For what it’s worth, public opinion was strongly against the law. Think some palms were greased?
Let’s segue to lowering the standard of regulation.
2. FDA drops the ball. Lawsuits to follow
On matters related to health IT, the FDA relies on its Health IT Policy Committee Workgroup for recommendations. On September 4, draft recommendations were issued, which included a big surprise: Health IT should generally not be subject to FDA premarket testing and validation requirements, with a few exceptions–medical device accessories, high-risk clinical decision support, and higher risk software use cases.
Bear in mind that a study released earlier this year tallied 171 health IT-related incidents in just nine weeks from 36 member Patient Safety Organization hospitals, resulting in eight injuries and three possible deaths–all reported voluntarily. And note that all (physical) medical devices and drugs require some sort of premarket approval or clearance.
Health IT guru Scot Silverstein, MD minces no words in his open letter to Workgroup Chair David Bates, MD…
I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee’s recommendations that health IT including typical commercial EHR/CPOE [Electronic Health Record/Computerized Physician Order Entry] systems not be subjected to a premarket testing and validation process. I believe this recommendation is, quite frankly, negligent.
It is my expert opinion the issues that cause these outcomes [referring to the study cited above] would never have made it into production systems, had a reasonable, competent, unbiased premarket testing and validation process been in place.
Silverstein offers up this zinger: “I am also making recommendations that in any torts, individual or class, regarding EHR problems that would likely have been averted with competent premarket testing and validation, that the FDASIA HIT Policy Committee members who agreed with the recommendation be considered possible defendants. I am sorry it has come to this.”
Need I mention that both of these health care stories emerge as a direct result of the Affordable Care Act (Obamacare)?