Just the stories I'm paying attention to. My completely subjective opinions on the healthcare news that matters. I could be wrong. Both in opinion and whether it matters.
Took a week off to celebrate our nation's birthday, but I'm back at it this week. Besides NOT blowing anything up or even seeing any fireworks myself, I also spent a little time in Napa wine country, where a supposedly Michelin-starred restaurant gave me a plate with a crouton, 3 dots of sauce and a dandelion green for the inflation-driven price of $75. Anyway, on to the news...
Pharmacists win the dubious honor of prescribing privileges for Paxlovid.
I'm going deep on this one, the main topic for this week. This really is a perplexing sequence of decisions, lobbying and excuse making all around. To orient you on the history, COVID vaccine and monoclonal antibodies had no specific prescriber related restrictions in their Emergency Use Authorization (EUA). The EUA for Paxlovid, on the other hand, was very specific as to who may prescribe. As I've said a thousand times, go read the source material, not just the opinion of some journalist, or worse, pharmacist smart-alec wanna-be healthcare blogger narcissist.
This restriction on prescribing isn't typical. Ordinarily, prescriptive authority lies within a state's practice act and FDA defers to the states to manage that part. So for Paxlovid, one must wonder why they felt compelled to specify physicians, NPs and PAs. It's pretty transparent if you read the statements coming out of the American Medical Association, available on their press page. How about this doozy (full statement here):
"prescribing [Paxlovid] requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care...requirements far beyond a pharmacist’s scope and training."
Uh huh. Clearly you aren't aware of a pharmacist's scope and training. In many states, such practice is very clearly in-scope for a pharmacist, as codified by their practice act. Check out Oregon's language in our practice act--scroll down to ORS 689.005(30) for the definition of clinical pharmacy. Nevermind that the majority of your membership, particularly newer practitioners that came up in academic medical centers with collaborative models including pharmacists, don't agree with this stupidity. Yet again you are fighting for primary care turf to the exclusion of allied healthcare professionals, while at the same time acknowledging (in other statements) that there is a serious lack of access to primary care. Interesting.
My take on what this all means:
1. Lobbyists are ALWAYS involved in these sorts of laws, rules, and regulatory guidance statements. Clearly the AMA steered the original EUA one way for frankly stupid reasons that aren't in the best interest of public health. Pharmacy organizations such as APhA and ASHP pushed back and are declaring victory.
2. The EUA was updated to allow pharmacists to prescribe, but the way they did it was more complicated than necessary. The first condition could be interpreted to mean that the pharmacist must always be in consult with someone else. The "such as" language leaves some room for interpretation though. The second condition around obtaining a comprehensive med list leaves room for patient reporting, so that's a little better.
This is all pretty clearly geared towards creating guard rails in the retail pharmacy setting, which is what most people think of when bringing pharmacists into the prescribing mix. The way this unfolded is unfortunate for clinical pharmacists working in non-dispensing settings. Many states have pharmacists working in clinical environments prescribing under collaborative practice agreements and protocols, and the overly restrictive way this rolled out ignored those advanced pharmacy practice environments that already have the right processes and controls baked in.
3. Not addressed by the EUA (nor is it their role) is national provider status for pharmacists, which would make payment for the clinical encounter reimbursable by CMS. Depending on your state, you may not get paid at all, or in a progressive state like here in Oregon, it really depends on the payor. I estimate that pharmacists get paid via a medical billing pathway for clinical encounters similar to this a little more than half the time here in Oregon, depending on the setting and payor mix.
4. The reimbursement model for dispensing Paxlovid is still broken. As part of the EUA, the government has purchased Paxlovid and is making it available to patients at no cost. So although there is no drug cost in the pharmacy encounter, there's still cost for the pharmacist to do their part, which gets billed to a PBM most commonly. Pharmacies rely on making a margin on the product itself, but that's not an option here so the pharmacy only gets a standard dispense fee--and with most PBM's, that ranges from $0 to $1. The pharmacy can't do all the work involved and only make $1, period full stop. So many pharmacies are simply saying thanks but no thanks.
I don't mean to rain on the parade. This is a win, and recognizing the importance of pharmacy practice in addressing a variety of public health challenges is indeed a good thing. This corrects a strange restriction that should never have been there in the first place, but in my mind the win still has an asterisk. Let's hope this leads toward national provider status and a broader inclusion of pharmacists in the future.
Other small bits of news I'm paying attention to:
Florida Governor Ron DeSantis has jumped into the PBM cage-fight with a pretty aggressive executive order. An audit showed spread pricing and other fees cost Florida more than $113M in 2020. Despite other drug cost tactics in Florida that aren't going to work like Canadian re-importation, this is a good move. Time will tell if it works, the PBMs have proven to be slippery to say the least. Pretty good article here. The executive order aims to do the following:
Prohibits spread pricing and clawbacks in any state contracts
Managed Medicaid and State Group Insurance audit over the last 5 years
Expeditious implementation of price negotiation by the state, which was part of a previous piece of legislation
Emergency Medical Treatment and Labor Act (EMTALA) may ensure emergency abortions are allowed, even in states that have otherwise outlawed them. Frankly, it's about time the administration responded with something tangible on this issue. They seem to have been caught flat-footed with no coherent response at all when the SCOTUS opinion came out, despite it having been leaked weeks ahead of time.
Politicians still want to talk about drug price negotiation, but they keep watering it down. This strategy will work, if they make it applicable to all drugs. There is room for debate as to whether this is truly drug price negotiation or just price setting on behalf of the government, which I am against. Not that the drug industry needs or deserves me to defend them.