In my last update, I described the great news from February’s budget agreement that fixed Medicare’s payment adjustments so MIPS penalties would not include Part B drug costs, ensuring stabilization of the Medicare Part B drug system, among other successes. (Read the ACR’s press release on this topic.) I also described the Trump administration’s preliminary ideas about reducing drug prices in the U.S. Since then, the Trump administration has proposed major changes in the various drug distribution systems and requested input from stakeholders. Before I get into the drug price issue, though, here’s an update from D.C.
As you know, 2018 is an election year. All of you will have the chance to elect new members of the House of Representatives, and some of you will be able to vote for Senators. In U.S. midterm election history, the president’s party loses an average of 32 House seats and two Senate seats, so regardless of whether the Democrats or the Republicans control the next Congress, two things are nearly certain: House and Senate majorities will be slim, and there will be dozens of new leaders in Washington. The point: The ACR will need RheumPAC investments from you and your colleagues to meet these leaders, so please invest and spread the word now.
With a divided Congress and the looming hyper-partisan spectre of a possible presidential impeachment, legislation will be much less likely to pass for the foreseeable future. In this context, Congress is considering changing from annual to biennial budgets. What does this mean for rheumatology? We’ll need to work even harder to move our issues (especially funding requests) through the legislative branch via the relationships we have developed—thanks in large part to RheumPAC investments and other methods, such as coalitions, press interviews, letters to the editor, social media—all hands on deck! Also, we’ll continue to strengthen our efforts for regulatory reform. These reforms are the changes the executive branch makes through rulemaking and regulation—without Congress—relying on stakeholder input; the ACR has more than doubled its efforts on this input in the past year on your behalf.
ACR/ARHP Goes to Washington
ACR and ARHP leaders recently visited Congress and held more than 100 meetings with lawmakers and staff. (Check out the details and pictures.) We pressed Congress to act on four issues for our patients and our profession:
- Boosting the rheumatology workforce and research;
- Passing common-sense reform of step therapy;
- Rooting out PBMs; and
- Streamlining the prior authorization headache.
Our efforts have already been successful in moving the ball downfield: Senators we met with introduced a bill that requires Medicare to allow electronic prior authorizations; we’re also closer to getting a bill to limit step therapy in the Senate and possibly a $20 million rheumatology research fund at the Pentagon. I urge you to take 90 seconds right now to email a prewritten, editable note to your members of Congress through the ACR website—remember, we’ll copy your local newspapers, and about 50 of these letters get published each year, magnifying our voices. Do it now.
The Elephant in the Room: Drug Prices
Have you noticed that everyone’s finally talking about drug prices? In May, President Trump and Health and Human Services (HHS) Secretary Alex Azar released several plans, ideas and a 39-page “blueprint” with more than 100 questions about how to lower U.S. drug prices. The government identified four problems and four kinds of solutions. There are some good ideas here, and some possibly bad, but you can be sure that in some way, rheumatology will be changed by this process.
The four central problems (per the Trump administration):
- High list prices;
- Government programs overpaying due to lack of negotiation tools (Secretary Azar says he’s not interested in price fixing or restricting access to particular drugs);
- High out-of-pocket costs; and
- Foreign free-riding.
The four solutions:
- Improved competition;
- Better negotiation;
- Incentives for lower list prices; and
- Lowering out-of-pocket costs.
The ACR began responding to these questions in advance of the release of the blueprint and request for information (RFI). The ACR’s coalition letter to the administration in March was co-signed by several other medical groups. The College has published a set of principles for drug price reform that support ways to improve patient access to high-quality medicines. By mid-July, the ACR will respond formally to the administration’s RFI. Here’s an initial analysis of what’s good, possibly bad, and what’s new about Trump’s proposals:
- The good: Forcing payers to pass negotiated drug cost savings on to patients; prohibiting plans from gagging pharmacists to prevent them from telling patients when it’s cheaper to pay cash than use insurance; promoting transparency with pharmacy benefit manager (PBM) middlemen and reducing their market consolidation; and promoting biosimilar development through REMS and other reforms.
- The possibly bad: Inserting step therapy and other utilization management techniques into Medicare Part B by moving some Part B (physician-administered) drugs into the Part D system, restricting Medicare drug formularies by allowing payers to approve one drug (instead of two) per class and recreating a competitive acquisition program for Part B drugs that was previously unworkable.
- What’s new: The Trump administration seems to be getting serious here. If you don’t think rheumatology will be affected by this administration’s plans, well, are you sitting down? Read this tweet string, in which I highlighted and responded to a talk radio transcript of Trump’s top health official, Secretary Azar, promoting transparency reform by describing misleading scenarios in which rheumatologists profit by secretly prescribing more expensive, less effective drugs. Our mission is clear: clarify how valuable the rheumatology profession and its medicines are to our patients, and promote reforms that improve, not reduce, Americans’ access to high-quality drugs. We’re already communicating this message to top policymakers at the HHS, we’re banding together with other groups, and we’ll need your input. Stay tuned.
Are you prescribing biosimilars yet? Biosimilars are the No. 1 issue of our profession right now. The best way to reduce drug prices for rheumatology biologics may well be to spur safe, effective biosimilars into the U.S. market ASAP. I would humbly submit that the one thing we and our patients can do right now about drug prices is to become more comfortable with biosimilars. (Read the ACR’s educational white paper.) Still, the largest hurdle for biosimilars may be the middlemen in the drug distribution system. FDA Commissioner Scott Gottlieb, MD, worries the PBM business model will prevent biosimilars from getting on formularies, because less expensive drugs might not provide PBMs with high enough rebates, and thus, fewer biosimilars would get to market to compete on price.
Also: The Affiliate Society Council met at the D.C. fly-in last month. The ASC, chaired by Chris Adams, MD, and staffed by ACR Senior Manager of State Affairs Joseph Cantrell, JD, is the ACR’s forum for state rheumatology societies to come together for updates and to share what they’re doing among themselves and the ACR. This year, U.S. states introduced over 30 bills aiming to reform pharmacy benefits manager practices, 11 bills about step therapy reform, 10 bills about non-medical switching and eight bills to streamline prior authorization. Forty states have passed biosimilars substitution laws (most requiring provider notification within five days). Note that the FDA still has not finalized a pathway for interchangeable biosimilars.
That’s all for now from D.C. Thanks for reading and sharing this.
Angus Worthing, MD, FACP, FACR, chair, Government Affairs Committee, is a practicing rheumatologist in the Washington, D.C., metro area and clinical assistant professor of medicine at Georgetown University.