What does a split congress mean for healthcare reform?

What can we conclude from the election of Democrats to the House while Republican’s increased their majority in the Senate? The simple answer is that nothing will get done in the next two year. I’ve long held that a congressional fix for healthcare is an unlikely outcome; however, I now believe that there are some interesting things that can happen. The focus should be on the (progessive/trifecta blue) states.

#1) Create durable protections under law for pre-existing conditions

IF the Democrats are clever…The Democrats should take Republican claims of support for pre-existing conditions seriously. Even Ted Cruz supported pre-existing conditions down the stretch. Democrats should put pressure on Reps by passing legislation in the House carving out and creating a long-term, legal protection for pre-existing conditions. Even though this is technically unnecessary, given the prominence of pre-existing conditions in ACA, it’s possible that the Republicans may suddenly ‘forget’ their support for this policy. It is unlikely to pass in the Senate – but that’s not the point. Election stump talk is cheap, legislation is more expensive.

Allowing Republicans to u-turn on pre-existing conditions and not holding their feet to the fire would be a mistake. (but count on Democrats to miss a good opportunity whenever they can)

 

#2) Stop focusing on prescription drugs – start focusing on the medical benefit

Last night Nancy Pelosi gave a truly cringeworthy speech that touched on the need to reduce the cost of prescription drugs as a primary way to make healthcare affordable. As I’ve written many times, we could eliminate our spending on drugs, crippling both the branded and generic drug manufacturers at the expense of thousands of jobs, and ONLY reduce healthcare spending by >10%.

In politics cutting healthcare spending means ‘cutting drug spending’ because drug out-of-pocket costs are highly visible to consumers. But until politicians see the forest (medical benefits) for the trees (drug spending) we aren’t going to see healthcare costs come down. Having a single payer system isn’t going to solve this problem, despite what progressives wish to be true.

 

#3) The cauldron of innovation is now the States

One lightly reported change is the democratic pickup of 5 ‘trifectas’. With the slow/no rate of healthcare change at the National level, these states are the most likely to try something creative. Rumors abound that California will resurface it’s $400B single payer legislation that went nowhere in 2017. Without the balance of a meaningful opposition party, Democrats in these 13 states will want to demonstrate to their constituents that they can deliver on healthcare. IF they take a serious look at BOTH pharmacy and medical benefits (see #2!) it will be interesting to follow the outcome. Reducing spend by eliminating overbilling, unnecessary care, prioritizing less expensive treatments, etc. sounds much easier than it is. However, I will applaud their efforts and we should all watch with open-minded interest. After all, almost every other advanced economy has managed to provide (good/better) healthcare at lower costs.

Not today! Q&A on ‘Value-based Contracts’ in the U.S.A.

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I recently took issue with a well written, but incomplete article called Value-based Contracting: New, Necessary, but Not Easy from Simi Mathew in the online version of Managed Care Magazine.

Please stop and think of these questions, every time you see one of these articles – as the authors often don’t have the inside view from a pharma company or major payer.

  • Are the contracts tied, precisely and exactly, to the clinical trials that were performed by the manufacturer?
  • If they aren’t straight out of the label, do they rely on FDAMA 114 data including HEOR Studies?
  • Do they include, or must they include to make the financials make sense, product for zero dollars or a nominal value?
  • Would the payer be better off if the contract included another product that’s co-administered with the product in question, but manufactured by another company?

In they article Ms. (in fairness soon-to-be Dr.) Mathew correctly states:

Value-based contracting also creates a whole new set of logistical problems. Developing the infrastructure for an auditing method introduces a new upfront cost. To track outcomes, all parties require access to data that are typically siloed in individual health systems. Regulatory pitfalls must be anticipated. Discounts could trigger Medicaid best-price rules, 340B ceiling prices, or anti-kickback laws.

But merely pointing out that something doesn’t or can’t work isn’t enough. I’ll address the points one-by-one, and demonstrate how non-trivial these problems are.

  1. Developing infrastructure

What this point says is, ‘we’ve now entered into potentially adversarial relationships between payers and pharma, we need systems to handle this’. Some might argue that Pharma/Payer contracts have ALWAYS agreements between frenemies. ‘Value-based’ contracts take the adversarial relationship to a new level. The payers have all the data – and like any pharmacoeconomic study, success or failure will boil down to how small or large one defines the population – so it’s in their best interest to ONLY provide the data that tells the best story for them. And contracting in advance to get exactly the data you’ll need at the end of a multi-year study isn’t easy.

  1. Tracking outcomes

Here’s one that I don’t think anyone has thought of properly, outside the rooms where these deals are being discussed – and to give credit to folks I’ve seen on the Pharma side in Managed Markets teams.

Let’s contrast clinical trials with the real world. In clinical trials patients meet with their doctors, often weekly, and have HUGE incentives to stay on therapy. In the real world…unfortunately this isn’t the case. Here’s the problem, manufacturers are being held to task for something that’s the Doctor’s, Patient’s, and Plans’ responsibility, namely keeping the patient on therapy. Medical Possession ratio is a nice metric, but what if the medication doesn’t work because it’s sitting in a bottle on the medicine cabinet? Why should Pharma discount the drug there?

  1. Discounts and Federal Programs

No ‘money back guarantee’ under the current system, especially not for drugs with any Medicaid business. Simply put, until these programs are excluded from best price calculations pharma pricers will not have enough flexibility to make them meaningful. Not to mention the concomitant use of drugs from multiple manufacturers, often in high dollar therapies like oncology, make the most attractive discount scheme (discounting somebody else’s medication and not yours) the most attractive. Who’s going to do that to enable a competitor’s profits?

I’m not a regulatory or compliance expert so I’m not going to address the nightmare that is arguing that you’re not ‘promoting’ the use of these products through these contracts…I’ll leave that for others to outline.

So what can we do about it?

  1. Let’s stop pretending that Value-Based contracts are the future
  2. …Until we see meaningful regulatory changes at the FEDERAL level it will be difficult for payers and manufacturers to craft these agreements in ways that will enable their broad acceptance
    1. Change best price to exclude these kinds of contracts
    2. Loosen promotional activities directly related to FDAMA 114 and provide clear direction that HEOR teams can and should sit, not with medical but with Managed Care (silo them if that makes sense)
    3. Provide mechanisms for various companies to come together to provide appropriate discounts on bundles of products including MULTIPLE manufactures (weighted average value approach)
  3. Assume that highly publicized ‘Value-based’ contracts look and feel a lot like every day managed care contracts (because you don’t and can’t know what they say unless they’re made public)
  4. Invest in a trusted, objective third party systems to collect ALL the data and publicly report the results (I support a For Profit technology-based approach)

Until we see ALL these points addressed we won’t see the dawn of the age of the Value-Based contract. Another time I’ll write about how such adoption might continue to DRIVE UP the WAC prices for products in the United States…