Drug Costs

Despite Restraints, Democrats’ Drug Pricing Plan Could Still Aid Consumers

The Medicare prescription drug pricing plan Democrats unveiled this week is not nearly as ambitious as many lawmakers sought, but they and drug policy experts say the provisions crack open the door to reforms that could have dramatic effects. 

Tamping down drug expenses has been a longtime rallying cry for consumers beset by rapidly rising prices. Although people in private plans had some protections, those on Medicare often did not. They had no out-of-pocket caps and frequently complained that federal law kept them from using drugmakers’ coupons or other cost-cutting strategies.

A plan offered earlier this year by House Democrats — which included robust negotiation over drug prices in Medicare — was blocked by a handful of moderates who argued that the price curbs would stifle innovation. The legislation also was on a course to hit roadblocks among senators.

The moderates favored more limited negotiation over drugs only in Medicare Part B — those administered in doctors’ offices and hospitals. Most people in Medicare get their drugs through Part D, which covers medicine dispensed at a pharmacy.

When it appeared that the bill to fund President Joe Biden’s social agenda would move forward without a drug pricing proposal, the pressure built, intense negotiations were held, and a hybrid proposal was unveiled. It includes identifying 100 of the most expensive drugs and targeting 10 of them for negotiations to bring those costs down beginning in 2025. It will also place inflation caps on prescription drug prices for all insurance plans, restrict copays for insulin to no more than $35, and limit Medicare beneficiaries’ annual out-of-pocket drug costs to $2,000.

“There was a sense that the government had its hands tied behind its back. Now a precedent is being set,” said Senate Finance Committee Chairman Ron Wyden (D-Ore.), who led the talks for the senators. “There’s going to be negotiation on the most expensive drugs: cancer drugs, arthritis drugs or the anticoagulants. And that’s a precedent, and once you set a precedent that you can actually negotiate, you are really turning an important corner.”

Drugmakers say the changes could stymie consumers’ options. “Under the guise of ‘negotiation,’ it gives the government the power to dictate how much a medicine is worth,” Stephen Ubl, CEO of the trade group PhRMA, said in a statement, “and leaves many patients facing a future with less access to medicines and fewer new treatments.”

But how, exactly, will the changes be felt by most Americans, and who will be helped?

The answers vary, and many details would still have to be worked out by government agencies if the legislation passes. House members warned some minor changes were still being made Thursday night, and it all has to pass both chambers.

Controlling Insulin Costs

One of the most obvious benefits will go to those who need insulin, the lifesaving drug for people with Type 1 diabetes and some with Type 2 diabetes. Although the drug has been around for decades, prices have risen rapidly in recent years. Lawmakers have been galvanized by nightmarish accounts of people dying because they couldn’t afford insulin or driving to Canada or Mexico to get it cheaper.

Under the bill, starting in 2023, the maximum out-of-pocket cost for a 30-day supply of insulin would be $35. The benefit would not be limited to Medicare beneficiaries.

That cap is the same as one that was set in a five-year model program in Medicare. In it, the Centers for Medicare & Medicaid Services estimated that the average patient would save about $466 a year.

Detailed analyses of the proposals were not yet available, so it is unclear what the fiscal impact or savings would be for patients outside of Medicare.

Limiting Out-of-Pocket Spending

Another obvious benefit for Medicare beneficiaries is the $2,000 cap on out-of-pocket costs for prescription drugs. Currently, drug costs for people in the Part D prescription drug plans are calculated with a complicated formula that features the infamous “doughnut hole,” but there is no limit to how much they might spend.

That has led to consumers with serious diseases such as cancer or multiple sclerosis paying thousands of dollars to cover their medication, a recent KFF analysis found. Under current law, when an individual beneficiary and her plan spend $4,130 this year on drugs, the beneficiary enters the doughnut hole coverage gap and pays up to 25% of the price of the drug. Once she has spent $6,500 on drugs, she is responsible for 5% of the cost through the end of the year.

Limiting that expense is an especially big deal for people who get little low-income assistance and have expensive illnesses, said Dr. Jing Luo, an assistant professor of medicine at the University of Pittsburgh’s Center for Research on Health Care. “The patient pays 5% of all drug costs, and 5% of $160,000 is still a lot of money,” he said.

The legislation would alleviate that fear for consumers. “Rather than having a bill at the end of the year, like over $10,000, maybe their bill at the end of that year for that very expensive multiple myeloma treatment is $2,000,” he said.

Negotiating Drug Prices

Medicare price negotiation is probably the highest-profile provision in the legislation — and the most controversial. According to the bill, the Department of Health and Human Services would be responsible for identifying the 100 high-cost drugs and choosing the 10 for price negotiations. That effort wouldn’t start until 2023, but the new prices would go into effect in 2025. Another 10 drugs could be added by 2028. No drugs have been identified yet.

To meet the concerns of some lawmakers, the legislation lays out specific provisions for how HHS would select the drugs to be included. Only drugs identified as one of a kind or the only remedy for a specific health problem would be included.

The list would also be limited to drugs that have been on the market beyond the period of exclusivity the government grants them to be free from competition and recoup costs. For most regular drugs, the exclusivity can last nine years. For the more complicated biologic drugs, the period would be 13 years. Using the exclusivity timing allowed lawmakers to skirt the issue of whether the drugs were still under patent protection.

The measure allows for prices to be negotiated to a lower level for older drugs chosen for the program. So, for example, the negotiated price for a non-biologic drug that has been available for less than 12 years would be 75% of the average manufacturer price. That would fall to 65% for drugs that are 12 to 16 years past their initial exclusivity, and 40% for drugs more than 16 years past the initial exclusivity.

Drugs from smaller companies with sales under $200 million are excluded because lawmakers were afraid tamping down their prices would harm innovation.

Some experts questioned whether the negotiated prices would be directly felt by consumers.

“It helps Medicare, without question, to reduce their expenditures,” said William Comanor, a professor of health policy and management at the UCLA Fielding School of Public Health. “But how does that affect consumers? I bet Medicare doesn’t change the copay.”

Yet, he added, the copayment is less of an issue if a consumer’s prescription expenses are capped at $2,000.

Linking Prices to Inflation

Under the bill, manufacturers would have to report their prices to the HHS secretary, and if the prices increase faster than inflation, the drugmakers would have to pay a rebate to the government. Manufacturers that don’t pay the rebate would face a civil penalty of 125% of the value of the rebate.

The provisions would apply to drugs purchased through Medicare and non-Medicare plans.

Over the long term, the idea is to slow the overall inflation of drug prices, which has exceeded general inflation for decades.

Drug prices would be pegged to what they were in March, and the system would go into effect in 2023, so there would be little immediate impact. (Some lawmakers had hoped to peg the program to prices from several years ago — which might produce a bigger effect — but that was changed in the negotiations over the weekend.) The long-term impact is also hard to judge, because under the current complicated system, many people who pay for drugs get assistance from the drug companies, and most generics in the U.S. are relatively inexpensive, Comanor said.

Over the long haul, though, savings are expected to be substantial for the government, as well as for consumers who don’t qualify for other programs to help pay drug expenses and need high-end medication.

At the very least, the legislation would move the U.S. in the direction of the rest of the world.

“The longer the drug is on the market, the lower the price,” said Gerard Anderson, a professor of health policy at Johns Hopkins’ medical school. “In every other country, the price goes down over time, while in the United States, it is common for prices to increase.”

Update: This story was updated at 3:15 p.m. ET on Nov. 5, 2021, to reflect new language added to the measure that would changed the exclusivity period for negotiating the price of biologic drugs from 12 to 13 years.

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The Public Backs Medicare Rx Price Negotiation Even After Hearing Both Sides’ Views

As Congress debates cutting prescription drug costs, a poll released Tuesday found the vast majority of adults — regardless of their political party or age — support letting the federal government negotiate drug prices for Medicare beneficiaries and those in private health insurance plans.

The argument that pharmaceutical companies need to charge high prices to invest in research and develop new drugs does little to change that sentiment, according to the new KFF poll. Most respondents agreed the negotiation strategy is needed because Americans pay more than people in other countries and because companies’ profits are too high.

Various polls, in addition to KFF’s, have found the plan to allow Medicare to negotiate prescription drug prices to be very popular. (KHN is an editorially independent program of KFF.) The policy has polled favorably for at least the past six years, according to Ashley Kirzinger, associate director of public opinion and survey research at KFF.

Still, congressional lawmakers have yet to reach a consensus on whether to include such a provision in the major reconciliation bill aimed at funding President Joe Biden’s domestic policy agenda and enhancing social programs. Republican lawmakers generally oppose efforts to impose price restraints on prescription drugs. Democrats in the House are pushing a bill that would allow changes in Medicare drug policies, including negotiations of prices for some medications. The bill passed the House last year but has run into opposition this fall. A few moderate Democrats have introduced a narrower approach.

The KFF poll found 83% of the public — including 91% of Democrats, 85% of Independents, 76% of Republicans and 84% of seniors — initially favored the federal government negotiating lower drug prices for both Medicare and private insurance. These opinions were relatively unchanged by the arguments in favor or against the policy, the poll found. Even Republican support remained relatively steady, at 71%, after hearing concerns about how negotiations could upend the pharmaceutical industry. However, the share of Republicans who “strongly” favored the plan dipped from 44% to 28%.

For example, large majorities regardless of party identification and age found the following argument convincing: “Those in favor say negotiation is needed because Americans pay higher prices than people in other countries, many can’t afford their prescriptions, and drug company profits are too high.”

A third, including a slight majority of Republicans 65 or older, found the following argument convincing: “Those opposed say it would have the government too involved and will lead to fewer new drugs being available in the future.”

In addition, 93% — including 90% of Republicans — said that even if prescription prices were lower “drug companies would still make enough money to invest in the research needed to develop new drugs,” while just 6% said “drug companies need to charge high prices in order to fund the innovative research necessary for developing new drugs.”

These findings represent a change from a June KFF poll, which found attitudes changed after hearing assertions that allowing the federal government to negotiate Medicare prescription drug prices could lead to less research and development or limited access to newer prescriptions.

“This [latest] poll did a better job of representing what’s happening in the debate,” said Kirzinger. “The public is hearing both sides of the argument.”

Pharmaceutical companies have spent a lot of money on messaging. PhRMA, the industry’s trade group, launched a seven-figure ad campaign against legislation to lower drug prices through negotiation. Pharmaceutical companies have spent the most of any single industry on federal lobbying this year and donated sizable sums to House Democrats opposed to the plan, according to Open Secrets.

But the Medicare drug-pricing negotiation plan outlined in H.R. 3 (or the “Elijah E. Cummings Lower Drug Costs Now Act”) is estimated to save roughly $500 billion in federal spending for Medicare drugs over 10 years, according to a Congressional Budget Office estimate. Many Democrats hope to use the savings to expand coverage in Medicare and Medicaid as they piece together their larger spending plan.

The KFF poll also found most people have little or no confidence that Biden or Congress will “recommend the right thing” for the country on prescription drug prices. The vast majority expressed the same about drug companies. A slight majority reported confidence in what AARP recommends — and the advocacy group backs the negotiated Medicare prices.

The KFF Health Tracking Poll was conducted from Sept. 23 to Oct. 4 among a nationally representative sample of 1,146 adults, including an oversample of adults 65 and older. The margin of sampling error is plus or minus 4 percentage points for the full sample.

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An Ad’s Charge That Price Haggling Would ‘Swipe $500 Billion From Medicare’ Is Incorrect

The advertisement opens with a doctor sitting across from his patient and holding a prescription drug pill bottle. “You want to continue with this medication?” the doctor asks while an older patient nods.

The doctor then explains that he can no longer provide the medicine to her because insurance companies and Washington bureaucrats “are working together to swipe $500 billion from Medicare to pay for [House Speaker Nancy] Pelosi and [Senate Majority Leader Chuck] Schumer’s out-of-control spending spree.”

“They’re calling it Medicare negotiation, but, really, it’s just a way to cut your benefits and no longer pay for lifesaving medicines,” the doctor says.

Medicare negotiation refers to the federal government bargaining directly with pharmaceutical companies on the price of prescription drugs. Currently, Medicare is prohibited from using its vast market-share muscle to set prices. But supporters of Medicare drug negotiations eye the Democratic-backed budget reconciliation bill now being discussed in Congress as a means to reverse the policy.

This ad, seen on television and online, is part of a multiplatform campaign by the 60 Plus American Association of Senior Citizens, a conservative group that lobbies on senior issues and brands itself as the “right alternative to AARP.” It’s one example of a swath of ads that have popped up in the past month about Medicare drug price negotiations.

Since drug pricing is a hot topic and a critical piece of the broad, politically charged debate in Congress, we thought it was important to dig into the ad’s messages.

The $500 Billion Number

First, the ad claims that Medicare drug price negotiation will take “$500 billion from Medicare.”

All five of the Medicare and drug pricing experts we consulted said that was a misleading way to frame this policy.

The reference to $500 billion most likely comes from a Congressional Budget Office estimate of a provision in H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. It’s an estimate of how much the government would save over 10 years if drug price negotiations were enacted.

That is, the government would be paying pharmaceutical companies $500 billion less for prescription drugs.

And, in that bill, $300 billion to $400 billion of the savings were to be used to expand benefits to include dental, hearing and vision coverage, said Juliette Cubanski, deputy director of the program on Medicare policy at KFF. Right now, Medicare doesn’t provide that coverage to seniors.

If this policy were to make it into the pending budget reconciliation, some of the savings would also likely address other Democratic health care priorities, such as permanently closing the Medicaid coverage gap and improving Affordable Care Act coverage and subsidies.

So the ad’s charged language — that Pelosi and Schumer are planning to “swipe” this money from Medicare — is incorrect. That $500 billion in savings would be slated for reinvestment in the program. And some experts said the changes to drug pricing could also translate into lower premiums and out-of-pocket costs for seniors.

The point of negotiations is “to spend less on the drugs we’re already buying and put the money back into the health system,” said Rachel Sachs, a law professor and expert on drug policy at Washington University in St. Louis.

But what about the ad’s other main point — that Medicare negotiation will result in seniors no longer being able to get their medications?

Since 60 Plus did not return requests for comment, it’s hard to know exactly what it is asserting will come between seniors and their medication.

It’s possible the ad is implying that drugmakers may walk away from the negotiating table if they don’t like the prices the government promotes. But experts said it’s likely a financial penalty would be in place to motivate the companies to work with the government. H.R. 3 proposed an escalating excise tax.

The U.S. has the world’s largest prescription market, so it seems unlikely companies would stop selling drugs here completely, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University.

And the number of drugs subject to negotiation would probably be a small subset of all drugs on the market, based on the negotiation method that was proposed in H.R. 3.

In real life, the scenario shown in the ad is unlikely to happen, said Joseph Antos, senior fellow in health care policy at the American Enterprise Institute.

“The question of whether a drug would be taken off the market — it’s always a little hard to say and, clearly, that is a possibility,” said Antos. “But it’s much more plausible to say this is the kind of policy that would lead to some new drugs not coming out to the market.”

That’s an argument often wielded by the pharmaceutical industry.

Evidence suggests there’s a grain of truth in the assessment that lower industry profits results in less research and development, said Paul Van de Water, a senior fellow in health care policy at the Center on Budget and Policy Priorities. But only a grain. For the most part, the drug industry overstates the effect of lost profits.

“A lot of these drugs are what’s known as ‘me-too’ medicines, which means the drugmakers are making small innovations on existing drugs,” said Van de Water. “The loss to Medicare beneficiaries of those types of drugs would be relatively small.”

In a separate analysis, the CBO examined to what extent negotiated drug prices could squeeze the pharmaceutical industry’s R&D capacity. The agency, using a 30-year window, estimated that 59 drugs wouldn’t come to market. That’s against a baseline of about 900 drugs being released per year, said Sachs, which means it would stymie only a tiny fraction of otherwise expected drugs.

Still, some experts say the CBO report can’t precisely predict the future and a loss in profits would have a larger effect on smaller, start-up pharmaceutical companies.

“At the small operations, a scientist thinks they have an insight into some biological process and they attract venture capitalists to develop a drug,” said Antos. “But drug development is a complicated business, and the drug might not make it to market. With less funds for that type of research, that is the part of the drug business most directly affected by the drug pricing policy.”

Why It Matters

The political stakes surrounding the Medicare drug price negotiations are high.

Currently, the idea is seen as a way to help pay for the Democratic-backed health initiatives being discussed as part of the reconciliation bill.

And, a recent poll from KFF shows that almost 90% of the public supports the government’s ability to negotiate for lower drug prices.

But allowing Medicare to bargain on drugs is controversial, even among Democrats, some of whom say they don’t want to stifle drug companies’ innovation, especially if it’s a big industry in the area of the country they represent.

Meanwhile, PhRMA, the powerful pharmaceutical industry trade group, announced Sept. 15 it would be launching a seven-figure ad campaign against the drug pricing proposals, according to The Hill.

Our Rating

The 60 Plus Association ran an advertisement that claimed Medicare drug price negotiations were “swiping” $500 billion from Medicare and going to be used as a way to “cut benefits and no longer pay for lifesaving medicines.”

While the $500 billion number is based on facts, everything else this ad says is misleading.

If Congress approves a plan to let Medicare negotiate drug prices, Democrats are calling for most of the savings to be funneled directly back into the Medicare program to provide vision, dental and hearing benefits. So, it’s not true that the plan for the money is to steal from Medicare. Experts also agreed it is specious to say seniors could no longer get the medications they’re currently taking.

We rate this claim False.

Sources

60 Plus American Association of Senior Citizens, “Our Mission,” accessed Sept. 22, 2021

60 Plus American Association of Senior Citizens, “Protecting Medicare,” accessed Sept. 22, 2021

Center on Budget and Policy Priorities, Build Back Better Legislation Would Close the Medicaid Coverage Gap, Sept. 13, 2021

Congressional Budget Office, CBO’s Simulation Model of New Drug Development, August 2021

Congressional Budget Office, H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act Cost Estimate, Dec. 10, 2019

Congress.gov, H.R.3 — Elijah E. Cummings Lower Drug Costs Now Act — 116th Congress (2019-2020), accessed Sept. 22, 2021

Email interview with Stacie Dusetzina, associate professor of health policy at Vanderbilt University, Sept. 21, 2021

Fierce Pharma, “Advocates Roll Pricey Ad Campaigns as Biden, Congress Push for Medicare Drug Negotiations,” Aug. 17, 2021

The Hill, “PhRMA Launches 7-Figure Ad Campaign Against Democrats’ Drug Pricing Measures,” Sept. 15, 2021

KFF, What’s the Latest on Medicare Drug Price Negotiations?, July 23, 2021

KFF, Public Opinion on Prescription Drugs and Their Prices, June 15, 2021

KHN/PolitiFact, “Pharma’s Take on the Pelosi Drug-Pricing Bill: Fair Warning or Fearmongering?” Dec. 5, 2019

KHN/PolitiFact, “Biden Promise Tracker — Promise: Lower Cost of Prescription Drugs,” updated July 15, 2021

Open Secrets, “Pharmaceutical Industry Backs Democratic Holdouts on Drug Pricing Plan,” Sept. 17, 2021

Politico, “House Leadership Looks to Jam Holdouts on Drug Pricing,” Sept. 21, 2021

Phone interview with Juliette Cubanski, deputy director of the program on Medicare policy at KFF, Sept. 21, 2021

Phone interview with Joseph Antos, senior fellow and Wilson H. Taylor Scholar in health care and retirement policy at the American Enterprise Institute, Sept. 21, 2021

Phone interview with Paul N. Van de Water, senior fellow at the Center on Budget and Policy Priorities, Sept. 21, 2021

Phone interview with Rachel Sachs, Treiman professor of law at Washington University in St. Louis School of Law, Sept. 21, 2021

The Washington Post, “Three Democrats Say They’ll Oppose Party’s Drug-Price Plan, Creating Roadblock for Larger Package,” Sept. 14, 2021

YouTube, 60 Plus Association Official Account, “Doctor’s Visit,” Sept. 10, 2021

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