Unforeseen consequences of old drug policy
April 18, 2021
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April 18, 2021
Kaiser Health News reported on a federal program known as Unapproved Drugs Initiative (launched in 2006). It appears the original intention was to give drug manufacturers of older drugs an incentive for them to apply for FDA approval. These older drugs seem to have existed before FDA had its current processes in place, and were therefore "grandfathered" in. The incentive was seven years of exclusivity -- less than the standard patent, but still potentially very valuable.
The article reports that unsurprisingly, during the seven years of exclusivity, prices of drugs skyrocketed: the example given rose from $0.10 per pill to about $4.50 per pill. The article does note that after generic competitors were approved, prices dropped, but not to the original amount. The approval process is likely so expensive that generic competitors need higher prices in order to recover their upfront investment.
Safety can come at a price, especially when the drug approval process requires volumes of data and many participants in clinical trials. Such safety measure might be deemed worthwhile, but patients might be shocked at the cost. Fortunately, people are thinking of cost-saving measures to still collect safety data without going through a traditional clinical trial.
April 11, 2021
This week, we rolled out some changes to our profile summary pages. We had been relying on a JavaScript library to dynamically render many of the charts, but we were told that using non-JavaScript renderings of the charts would make the content easier to be understood by search engines.
It is ironic that we ended up removing functionality (cosmetic features such as chart highlights), but one advantage is that users who browse without JavaScript will have an easier time understanding our page.
April 04, 2021
The Affordable Care Act, passed in 2010, has attracted the attention of several lawsuits. The Supreme Court has yet to release a decision for a case that it heard (California vs. Texas), and Kaiser Health News reported on yet another lawsuit that received clearance for the lawsuit to proceed. This lawsuit attacks the requirement that preventive services must be free. While requiring that preventive services must be free might be good policy (I am unaware how strongly the evidence supports or undermines that), the case raises some constitutional questions, including one regarding whether officials who are neither appointed by the president nor confirmed by the Senate are authorized by the constitution to make binding regulatory decisions.
This current lawsuit attacks specific provisions of the ACA, while the Supreme Court is expected to rule on the constitutionality of the entire legislation after the individual mandate was revoked. After seeing these many attacks on the ACA (whether in rhetoric or via lawsuits), it would be nice to see opponents spell out what they think would be a better plan and understand what advantages such plans would offer.
March 28, 2021
NPR published a look at one patient's surprise at being billed a facility fee that cost about ten times as much as the actual treatment. Hospitals have argued that they should be able to charge more for the same procedure performed in their facilities rather than in a clinic because they have to provide the ability to handle complications, even if those complications do not arise. On some level, the argument makes sense for some potentially risky procedures. For routine procedures (and I suspect that the steroid injection listed in the story would count as one), this argument seems to fall flat. In particular, hospitals get paid a fee for providing emergency services, and if those prices do not cover operations, perhaps those fees should be adjusted. Regardless, from a societal perspective -- and especially from the perspective of an individual patient -- it does not make sense that a simple, routine, and relatively safe procedure should cost the patient ten times as much as it did when not much else has meaningfully changed.
The current model gives hospitals a strong incentive to acquire physician practices and tack on a facility fee in order to boost revenue. Those acquisitions make independent doctor practices less and less common, driving up the overall price of health care. Fortunately, the Centers for Medicare & Medicaid Services has tried to stop this practice, but the story points out that the American Hospital Association has sued to have this practice continue.
March 21, 2021
Kaiser Health News published an article noting that the governor of California awarded a no-bid contract to Blue Shield and recounting a number of donations that the insurer has given to the governor's campaigns. While the contract is only $15 million (the insurer had $21 billion in revenue in 2019), the contract represents a marketing opportunity that could be valuable for the company.
With only a quick review, the optics do not look good: Blue Shield has a history of donating to the governor's campaigns (including some special interests). Vaccines are generally administered through providers, although one can imagine that having a strong retail presence (like drug stores) could be very helpful. Blue Shield, a health insurer, controls neither a provider network nor a strong retail presence. What the insurer does have is a history of financial contributions.
The optics would look much better if the contract had a bidding process. What the administrator would likely reasonably respond with is that the current circumstances call for speed and agility, not for perfection. While that might be true, it seems that the state could have put forth a bidding process with an accelerated review schedule.