Drug Reform - I Still Want the Regulation to Take Effect

The recently signed gun law, S. 2938: Bipartisan Safer Communities Act, contained a surprise dingleberry postponing a regulation designed to save seniors money on their pharmaceutical drugs by prohibiting kickbacks to an industry few have heard of: Pharmacy Benefit Managers (PBMs). This little-known but extremely powerful industry deserves much of the blame for ever rising prescription drugs costs in the United States. In this episode, Jen gives you the scoop on PBMs and how they make their money at the expense of Americans who are most dependent on medications. Please Support Congressional Dish – Quick Links Contribute monthly or a lump sum via Support Congressional Dish via (donations per episode) Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank’s online bill pay function to mail contributions to: Please make checks payable to Congressional Dish Thank you for supporting truly independent media! We’re Not Wrong Berlin Meetup Contact Justin at Background Sources Recommended Congressional Dish Episodes US Healthcare Landscape Jessi Jezewska Stevens. Apr 23, 2020. Bookforum. Tanza Loudenback. Mar 7, 2019. Insider. Chuck Grassley and Ron Wyden. 2019. U.S. Senate Finance Committee. Kaiser Family Foundation. Sara R. Collins and David C. Radley. Dec 7, 2018. The Commonwealth Fund. PBMs What are PBMs? JC Scott. Jun 30, 2022. The Hill. Zach Freed. Jun 22, 2022. American Economic Liberties Project. Adam J. Fein. Jun 22, 2021. Drug Channels. Nov 11, 2021. 46brooklyn. Adam J. Fein. Feb 3, 2019. The Wall Street Journal. How PBMs Make Money National Association of Chain Drug Stores. RxSafe. True North Political Solutions. Oct 25, 2017. Pharmacy Times. ACA “Vertical Integration” Loophole Peter High. Jul 8, 2019. Forbes. Angelica LaVito. Nov 28, 2018. CNBC. David Dayen. Oct 12, 2018. The American Prospect. Jeff Byers. April 12, 2018. Healthcare Dive. Susan Morse. May 10, 2017. Healthcare Finance. Lobbying Open Secrets. The Demise of Independent Pharmacies Christine Blank. Oct 17, 2019. Drug Topics. Paulina Firozi. Aug 23, 2018. The Washington Post. What Is a Formulary? Ana Gascon Ivey. May 19, 2020. GoodRx. Previous Delays in Rebate Regulation Paige Minemyer. Jan 29, 2021. Fierce Healthcare. Paige Minemyer. Jan 12, 2021. Fierce Healthcare. May 2019. Congressional Budget Office. The Gun Law Passage Process Office of the Clerk. May 18, 2022. U.S. House of Representatives. Tampa Bay Times Editorial Board. May 12, 2022. Miami Herald. Annie Karni. Apr 12, 2022. The New York Times. Background on Most Important Provisions Mary Katherine Wildeman. May 26, 2022. CT Insider. Jeffrey Pierre. May 26, 2022. NPR. The Dingleberry Erik Sherman. Jun 30, 2022. Forbes. Molly Rutherford. Jun 28, 2022. The Hill. Marty Schladen. Jun 22, 2022. Iowa Capital Dispatch. Poland Train Station Taylor Popielarz, Maureen McManus and Justin Tasolides. Mar 25, 2022. Spectrum News NY1. The Law and the Regulation U.S. Health and Human Services Department November 30, 2020 Audio Sources November 17, 2015 House Committee on the Judiciary Witnesses: Bradley J. Arthur, R.Ph., Owner, Black Rock Pharmacy David Balto, Law Offices of David A. Balto PLLC Amy Bricker, R.Ph. Vice President of Retail Contracting & Strategy, Express Scripts Natalie A. Pons, Senior Vice President and Assistant General Counsel, CVS Health Clips 53:48 Bradley Arthur: The Big Three PBMs control almost 80% of the entire market and these PBMs have the upper hand both in negotiating the contract with the payer, as well as strongly influencing the actual plan design itself. The PBM industry typically states that they can use their economic power to harness enhanced market efficiencies, but for whom? However, the staggering annual revenues that continue to grow each year of the big three suggests that these efficiencies are going directly to their corporations’ bottom lines. Small community pharmacies like mine are faced on a daily basis with the impact of the PBMs’ disproportionate market power. Community pharmacies routinely must agree to take-it-or-leave-it contracts from the PBMs just to continue to serve our long-standing patients. As if that weren't enough, the PBMs also directly set the reimbursement rates for pharmacies, the very same pharmacies that stand in direct competition of some of these PBM-owned mail-order and specialty pharmacies. Therefore, it comes as no surprise that the PBMs present employer and government payers with carefully tailored suggested plans designs that steer beneficiaries to these PBM-owned entities. January 29, 2019 Senate Committee on Finance Witnesses: Kathy Sego, Mother of a Child with Insulin-Dependent Diabetes Douglas Holtz-Eakin, Ph.D., President, American Action Forum Mark E. Miller, Ph.D., Vice President of Health Care, Laura and John Arnold Foundation Peter B. Bach, MD, MAPP, Director, Memorial Sloan Kettering Center for Health Policy and Outcomes Clips 1:57:30 Sen. John Cornyn (R - TX): Can anybody on the panel explain to me why we have a general prohibition against kickbacks — they call them rebates — under the Social Security Act, but we nevertheless allow it for prescription drug pricing? What's the sound public policy reason for excluding prescription drug pricing from the anti-kickback rule under federal law? Douglas Holtz-Eakin: I can't explain that and won’t pretend to. [laughter] Sen. Cornyn: I thought I was the only one who didn't understand the wisdom of that. Well, it's not a transparent arrangement and it does produce upward pressure on drug prices. And obviously, the negotiations between the PBM and the pharma in terms of what the net cost is, is not transparent, nor is it delivered to the consumer. Is it Dr. Miller? Dr. Bach? Peter Bach: It's delivered to the consumer indirectly through the reduction of the total cost of the benefit, but it is not delivered to the actual consumer using the drug, and that is a disassociation, that is a problem. Because it essentially reverses the structure of insurance. Lowering the total costs are people who use it the least, and raising the costs are people who use it the most, relative to if you allowed the rebate to be used at the point of sale, including all discounts. 1:59:49 Douglas Holtz-Eakin: If we had the negotiation be about the upfront price, so instead of a high list price and a rebate, you just negotiate a lower price, that would be the price that Ms. Sego would pay and insurance companies would look at that and say, okay, she's not paying as much as she used to, we're going to have to make up that money somewhere else and they might raise premiums. That means that people who don't have extreme insulin drug costs would pay a little bit more in a premium every month, and people who have extremely devastating medical conditions and high health care costs would get less costs. That's exactly what insurance is supposed to do. And so the rebate system is more than giving strange incentives on pricing. It's undercutting the purpose of insurance in general. February 26, 2019 Senate Committee on Finance Witnesses: Richard A. Gonzalez, Chairman and Chief Executive Officer, AbbVie Inc. Pascal Soriot, Executive Director and Chief Executive Officer, AstraZeneca Giovanni Caforio, M.D., Chairman of the Board and Chief Executive Officer, Bristol-Myers Squibb Co. Jennifer Taubert, Executive Vice President, Worldwide Chairman, Janssen Pharmaceuticals, Johnson & Johnson Kenneth C. Frazier, Chairman and Chief Executive Officer, Merck & Co., Inc. Albert Bourla, DVM, Ph.D., Chief Executive Office, Pfizer Olivier Brandicourt, M.D., Former Chief Executive Officer, Sanofi Clips 1:22:03 Albert Bourla: Adverse incentives that favor higher cost biologics are keeping biosimilars from reaching patients. In many cases, insurance companies declined to include lower cost biosimilars in their formularies because they would risk losing the rebates from covering higher cost medicines. I can't think of a more concerning example of a broken system and we need to do something about it. 1:33:35 Sen. Chuck Grassley (R - IA): So many of you have voiced support for the recent rebate rule proposed by the administration. Should the administration finalized this rule, will you commit to lowering your drug prices? Richard Gonzalez [CEO, AbbVie]: Mr. Chairman, we are supportive of the rule. We'd like to see it in its final form, obviously, to make a final decision, but we are supportive of taking the discount to the patient at the point of sale. Sen Grassley: Okay. AstraZeneca? **Pascal Soriot [CEO, AstraZeneca]**The same for us Senator, I would go one step further: if the rebates were removed from the commercial sector as well, we will definitely reduce our list prices. Sen Grassley: Okay. And Bristol? Giovanni Caforio [CEO, Bristol-Myers Squibb]: We have the same positions. Sen Grassley: Okay. Johnson and Johnson? Jennifer Taubert [EVP, J&J]: Yes, we're supportive, and that definitely would be my goal. We would just need to see the final legislation, provided that there aren't additional fees that are added into the system to compensate for the rebates. Sen Grassley: Merck? **Kenneth C. Frazier: I would expect that our prices would go down if we change the system. Again, on the commercial side as well as the Medicare side. Sen Grassley: Okay, Pfizer? Albert Bourla [CEO, Pfizer]: It is a very clear intention that we will not keep a single dollar from these rebates. We will try to move every single penny to the patients and we think if this goes also to the commercial plants that will be even better for more patients. Sen Grassley: Okay. Sanofi? Olivier Brandicourt [Former CEO, Sanofi]: Lowering list price has to be linked to better access and affordability at the counter for the patients. 1:35:20 Sen. Ron Wyden (D - OR): Is it correct that your company, and nobody else, sets the starting price for all drugs sold by Pfizer? Yes or no? Albert Bourla: It is a negotiation with PBMs and they are very powerful. Sen. Wyden: But you still get to set the list price? Albert Bourla: Yes, but we set this price and the rebate limit(?). 1:35:40 Sen. Ron Wyden (D - OR): Is it correct, when a hypothetical patient, let's call her Mrs. Jones, goes to pay for her drug at the pharmacy counter, her coinsurance is based on the price of the drug you set? Albert Bourla: It is correct in many cases. Sen. Wyden: Okay. I just want you all to know that the number one reason consumers are getting hammered, is because these list prices, which you have the last word with respect to where they are, are unaffordable. And the high prices are tied to what the consumer pays at the pharmacy counter. And all this other stuff you talk about, the rebates and the discounts and the coupons, all this other stuff is window dressing, all of that. And the fact is on Part D, 40% of the drugs don't even have a rebate. So I want it understood, particularly because I've asked you, Mr. Borla, I think you and others in the industry are stonewalling on the key issue, which is actually lowering list prices. And reducing those list prices are the easiest way for American consumers to pay less at the pharmacy counter. 2:12:45 Sen. Thomas Carper (D-DE): First is eliminating rebates to PBMs. That's the first one, eliminating rebates to PBMs. The second is value based arrangements. And the third is increasing transparency industry-wide on how you set your prices. 2:13:20 Richard Gonzalez: We clearly support providing the discount at the patient level, eliminating rebates essentially. 2:14:10 Pascal Soriot: If the rebates, as I said earlier, were to be removed from Part D and the commercial sector, we would actually reduce our list prices. 2:15:10 Giovanni Caforio: I would say that not only do we support all three elements that you mentioned, but I do believe those three elements together with the continued effort to develop a generic and biosimilar market would mean significant change, and would clearly alleviate the concerns that patients have today. 2:14:44 Jennifer Taubert: We are very supportive of all three elements that you outlined 2:15:52 Kenneth Frazier: We too support all three. 2:15:55 Albert Bourla: All three elements are transformational for our industry, will disrupt it. However, we do agree that these are the three things that need to be done and also I believe that will have significant meaningful results if we do. 2:16:10 Olivier Brandicourt: We support the three Senator, but we want to keep in mind at the end of the chain the patient has to benefit, so if rebates are removed it has to be to the benefit of patients. Sen. Thomas Carper (D-DE): Good, thanks. 2:18:10 Albert Bourla: 50% of the American people are in commercial plans and these rebate rules apply to Medicare. If the rules apply to all, definitely the list price will go down. 2:18:30 Albert Bourla: The list price is not irrelevant, it's very relevant for a lot of people because they have to pay list price during the deductible period. However if the rebate rule is applied, then they become irrelevant because the patients will not be paying the list price at the purchase point. 2:19:10 Sen. John Thune (R-SD): How would manufacturers respond if the rebate rule were finalized for government programs? I mean, what does that what does that mean for the commercial market? Albert Bourla: Senator, as I said before, all these proposals that they're discussing, [undistinguishable], eliminating the rebate rule, are transformational and will disrupt the way we do business. I don't know exactly how the system will evolve, and I really don't favor a bifurcated system. I would like to have a transparent single system across both parts. So we need to see how the whole thing will evolve. 2:25:26 Johnny Isakson (R-GA): Who sets the discount and who sets the rebate? 2:26:20 Richard Gonzalez: We negotiate with payers, so managed care and PBMs— Sen. Johnny Isakson (R-GA): You’re a supplier though, so you have to go negotiate with the PBMs and those people, is that right? Richard Gonzalez: Correct, and they negotiate aggressively. Sen. Isakson: Is that pretty much true with everybody, that they're the major component between the end retail consumer price and the origin of the product? Richard Gonzalez: Yes, Senator. Sen. Isakson: Well, that seems like that's someplace we ought to focus, because that's where the distorted numbers come in. Johnson & Johnson, Janssen, in your testimony, you talked about your average list price of 8.1%, up, but an average net price change of only 4.6%. So while your gross went up 8.6, your net went down 4.6 In the same pricing period. How does that happen? If you're setting the price, how does it not go up on the bottom? Jennifer Taubert: Yeah, and in fact, in 2018, our net price actually declined 8.6%, so even more than that. The intermediaries in the system are very, very effective negotiators— Sen. Isakson: Tell me who the intermediaries are. Jennifer Taubert: Those would be the PBMs and the insurers. Sen. Isakson: …and the insurance companies? Jennifer Taubert: Right, and they set the formularies for patients. Sen. Isakson: And they're not the same. They're two different people? Jennifer Taubert: Yes, correct. 2:40:45 James Lankford (R-OK): All of you have mentioned the rebate issue has been a problem and that insurance companies and PBMs are very effective negotiators. Part of the challenge of this is, health insurance companies pay their PBM based on the quality of their negotiation skills, cutting a price off the list price. And so if a list price is higher and a rebate is higher, that also gives preference to them. So the difficulty is, as you raise list price, and the rebate gets larger, the insurance company gives that preference, making it harder for biosimilars. Am I tracking this correctly? 2:43:00 Albert Bourla: Here in the US, the penetration of biosimilars is much lower than in other places, but it is disproportional to different parts of the US healthcare system. For example, in open systems, systems where the decision maker it is a PBM, the one biosimilar we have has a market share of 5% in the US. In closed systems, in systems like Kaiser, for example, integrated healthcare systems where the one who decides has the whole cost of the healthcare system in its interest, we have 73%. 5% and 73% for the same product. I agree with what Mr. Fraser said that we need to create incentives, but I would add also that we need to break this rebate trap that creates significant disincentives for providers, and the healthcare system, and insurance companies. 3:19:25 Kenneth Frazier: If you went back a few years ago, when we negotiated to get our drugs on formulary, our goal was to have the lowest copay by patients. Today the goal is to pay into the supply chain the biggest rebate, and so that actually puts the patient at a disadvantage since they're the only ones that are paying a portion of the list price. The list price is actually working against the patient. 3:19:50 Sen. Steve Daines (R-MT): Why do we have a system today? Where you all are setting, I'll just say very, very high list prices, which is the starting point for negotiation. Why? Olivier Brandicourt: Senator, we're trying to get formulary position. With those list prices. High list price, high rebates. It's a preferred position. Unfortunately the preferred position doesn't automatically ensure affordability at the end. Kenneth C. Frazier: Senator, If you bring a product to the market with a low list price in this system, you get punished financially and you get no uptake because everyone in the supply chain makes money as a result of a higher list price. April 9, 2019 Senate Committee on Finance Witnesses: Steve Miller, MD, Former Executive Vice President and Chief Clinical Officer, Cigna Corporation Derica Rice, Former Executive Vice President and President, CVS Health and CVS Caremark William Fleming, Pharm.D., Segment President, Healthcare Services, Humana Inc. John Prince, Chief Executive Officer, OptumRx Mike Kolar, JD, Interim President & CEO, Senior Vice President and General Counsel, Prime Therapeutics LLC Clips Sen. Ron Wyden (D - OR): Pharmaceutical Benefit Managers first showed up decades ago, back when prescription drugs were being utilized more extensively. The PBMs told the insurance companies, “we're the ones who know drug pricing, we will handle the negotiations for you.” But there is little evidence that the pharmaceutical benefit managers have actually held down the prices in a meaningful way. In fact, most of the evidence shows just the opposite. Pharmaceutical Benefit Managers actually make more money when they pick a higher price drug over a lower price drug. Colleagues, let's remember that all the way through this discussion, benefit managers make more money when they pick a higher price drug over a lower price drug. The logic on this isn't exactly complicated, graduate-level economics. PBM profits are based on taking their slice of the prescription-drug pie. More expensive drugs means there's a bigger pie. When there's a bigger pie, [there are] bigger slices for the pharmaceutical benefit managers. 50:24 Mike Kolar: Rebates and the role they play have been key areas of focus in the drug cost debate. In our view, rebates are a powerful tool to offset high prices, which are set by pharmaceutical companies, and pharmaceutical companies alone. The fact that rebates are not offered on many of the highest cost drugs, and that studies show no correlation between prices and rebates underscore that rebates are a key to mitigating rather than causing high drug prices. We pass rebates through fully to our plans, and we believe our plans should be able to choose how to apply these rebates in ways that best serve their members and market needs by balancing premiums and cost sharing. 56:05 Sen. Chuck Grassley (R-IA): I'd like to talk about consolidation, including the recent integration of PBMs with insurance companies. Last year I wrote to the Justice Department on the issues, it reported that the three largest PBMs who are before us today now covers 71% of Medicaid, Medicare Part D enrollees and 86% of standalone Drug Plan enrollees. 57:45 Derica Rice: This is a highly competitive space. In addition to the three that you've pointed out here, CMS has noted there are over 60 PBMs across the US. Therefore, the competition, there's many options for the employers that are out there, government entities, as well as unions to choose from given their specific needs. 1:10:35 Sen. Debbie Stabenow (D-MI): So when we look at Express Scripts has 100 million Americans covered, CVS 90 million, OptumRx 65 million, Prime Therapeutics 27 million, Humana 21 million, and yet Americans still pay the highest prices in the world. Even though you are negotiating for millions of people. The VA has its own pharmacy benefit manager service, they negotiate for 9 million veterans, and they pay, on average, 40% less for the same drugs that the rest of the healthcare system pays for. Despite greater volume, you are unable to secure these kinds of low prices. With all due respect, you guys are pretty bad negotiators. Given the fact that the VA can get 40% less. And so I'd like to know from each of you why that's the case. Dr. Miller? Steve Miller [Former EVP and Chief Clinical Officer, Cigna Corporation]: Yes. Part of the equation is giving patients choice. At the VA, they actually limit their formulary more than any of us at this table do. So oftentimes, they'll have one beta blocker, one ace inhibitor. And so if it's going to get to that level of choice, then we could get better prices also. Sen. Stabenow: Let me jump in, in the interest of time. I know you create nationwide drug formularies, you have pre-authorization, you give preferred status to certain medications. So you don't use any of those tools that the VA is using? Because you do. Steve Miller: We definitely use those tools, but we also give people choice. It's crucial for both physicians and patients to have the choice of the products they want to be able to access. Many of our plans want us to have broad formularies and when you have more products, it means you move less market share. Sen. Stabenow: So basically you’re saying a 40% premium gives them more choice. 1:24:30 Sherrod Brown (D-OH): If the administration's rebate rule were finalized as proposed, would you in some way be required to change the way you do business? Mike Kolar: Yes, Senator we would. John Prince: Yes. William Fleming: Yes. Derica Rice: Yes. Steve Miller: Yes. Sen. Brown: Thank you. 1:25:05 Sherrod Brown (D-OH): What percentage of prescriptions that you fill across Part D actually receive a rebate? Roughly what percentage? Mike Kolar: So Senator, approximately 8% of the prescriptions that we cover in Part D are associated with a rebate. Sen. Brown: Okay, Mr. Prince? John Prince: Senator, I don’t know the exact number, I know our overall business is about 7%. Sen. Brown: Okay, thank you. William Fleming: About 7-8%. Derica Rice: Senator, I do not know the exact number but we pass through 100% of all rebates and discounts. Sen. Brown: [Grunt] Steve Miller: 90% of the prescriptions will be generic. Of the 10% that are branded, about two-thirds have rebates. So it's about seven-- Sen. Brown: 7-8% like the others. Okay. To recap, PBMs do not set drug prices. Forcing you to change the way you do business -- as the administration's rule would — will not change that fact. And while the rule might impact a small percentage of drugs and Part D that receive a rebate, it does nothing to lower costs, as your answer suggests, for the other 90% of prescriptions you fill. Most importantly, absolutely nothing in the proposed rule would require Secretary Azar’s former employer or any other pharma company to lower the price of insulin or any other drug. It's important to establish that, so thank you for that. 1:41:40 Catherine Cortez Masto (D-NV): Let me ask you, Dr. Fleming, in your testimony, you say Humana’s analysis of the rebate rule -- and we're talking about the administration's rebate rule now — found that approximately 17% of beneficiaries will see savings at the pharmacy counter as a result of this rule. Can you tell me a little bit more about who these people are? And what kind of conditions do they have? William Fleming: Senator, there will be a number of members who are taking brand drugs for which we get rebates and so it could vary all the way from the common chronic conditions, things like diabetes or hypertension or high cholesterol, all the way over to occasionally, not usually, but occasionally on the specialty drug side. When you think of some medications like treatments for rheumatoid arthritis, multiple sclerosis, places where there's competition. 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