Medicare Blog

where is law that keeps medicare from negotiating drug prices

by Trinity Hirthe Published 2 years ago Updated 1 year ago
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Should Medicare be allowed to negotiate drug prices?

According to Senator Wyden’s principles document, allowing Medicare to negotiate drug prices could address circumstances of market failure around drug prices, such as when there is inadequate or no competition or when drugs launch at high prices that may not be justified based on their clinical value.

Should HHS have the authority to negotiate drug prices?

Proponents of this approach believe that giving the HHS Secretary the authority to negotiate drug prices would provide the leverage needed to lower drug costs, particularly for high-priced drugs for which there are no competitors, where private plans may be less able to negotiate lower prices.

Does Medicare have the power to control drug prices?

Medicare, which insures more than 60 million beneficiaries, doesn't have that power, mostly because Congress stopped it from getting the best drug prices years ago. But that could change. The anti-consumer poison pill was embedded in a law ironically called the Medicare Modernization Act.

Will drug negotiations deny Medicare beneficiaries access to prescriptions?

In TV ads, the pharmaceutical industry claims congressional plans to allow the federal government to negotiate drug prices in Medicare would deny beneficiaries’ access to medicines their doctors prescribe. Experts say that’s unlikely, and an inaccurate portrayal of recent legislation.

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Who introduced the Medicare price negotiations bill?

Rep. Lloyd Doggett introduced a bill in March that would require Medicare drug price negotiations and actually establish a formulary for what drugs would be covered, or require the private Part D plans’ formularies to incorporate the negotiated prices. The bill was referred to committee; CBO has not analyzed it.

Who pays the negotiated prices?

Both Medicare and private insurers, if they chose to, would pay the negotiated prices.

What is the non-interference clause?

The relevant provision of the law is called the noninterference clause. It says the secretary of the Department of Health and Human Services “may not interfere with the negotiations between drug manufacturers and pharmacies and PDP [prescription drug plan] sponsors” and “may not require a particular formulary or institute a price structure for the reimbursement of covered part D drugs.”

What is the H.R. 3 bill?

H.R. 3, “Elijah E. Cummings Lower Drug Costs Now Act,” would require the HHS secretary to negotiate prices for at least 25 brand-name drugs in 2024 and at least 50 in 2025 and later years – specifically drugs that don’t have generic or similar competitors. The drugs selected would come from a list of 125 drugs that account for the greatest national spending or Medicare spending, and the secretary must negotiate the price of insulin products.

How much would H.R. 3 decrease in drugs?

In an August paper on its simulation model, CBO said a policy like H.R. 3 would cause a 0.5% decrease in new drugs in the first decade, a 5% decrease in the second decade and 8% in the third decade. The admittedly “uncertain” estimate from CBO would amount to 59 fewer new drugs over 30 years.

When was H.R. 3 passed?

The leading legislative proposal now — H.R. 3 — passed the House in December 2019, but went nowhere in the Senate. It was reintroduced in April. It’s unclear if Democrats will include that proposal — or a different one on Medicare drug negotiation — in the broad reconciliation bill they are crafting. The Biden administration has backed the policy idea, though a proposal it released on Sept. 9 included very few specifics on how this should be done.

Should Medicare premiums go down?

The CBO says Medicare premiums and cost-sharing in Part D should go down, and drug prices in other countries should increase.

When did Medicare stop negotiating prices?

When lawmakers created Medicare's Part D outpatient prescription drug program in 2003, they barred Medicare from negotiating prices. Republicans who controlled Congress at the time wanted insurers that administer drug plans to do the haggling. Medicare was sidelined, despite decades of experience setting prices for hospitals, doctors and nursing homes.

Who is pressing for Medicare negotiations?

Amid a furious lobbying and advertising campaign, the AARP, consumer groups, and health insurers are pressing for Medicare negotiations.

What does PhRMA oppose?

PhRMA opposes constraints on launch prices for new drugs, as well as limitations on price increases for existing medicines. It says the government has other ways to shield Medicare recipients from high out-of-pocket costs and blames insurers for not passing manufacturer rebates directly to patients.

What are the biggest industry objections to the House bill?

One of the biggest industry objections is that the House bill would use lower prices in other advanced counties as a yardstick for Medicare. The Trump administration tried a similar idea with a different set of Medicare medications. Drugmakers say U.S. patients may have to wait longer than they're used to for new medications if that goes through.

Who was the former administrator of Medicare?

Former Medicare administrator Andy Slavitt recalls proposing a “modest experiment” on pricing. “You would have thought we had pressed the nuclear button and the country was going to blow up,” he said.

Who has supported Medicare?

Politicians including former President Donald Trump and House Speaker Nancy Pelosi, D-Calif., have supported Medicare negotiations. But it's Biden, with Pelosi doing much of the lifting, who's come closest to getting it done.

Will drug development shrivel?

Others say it's unlikely that drug development would shrivel. Valuable medicines would go forward, but ones with fewer benefits would have a harder path, said biotethicist said Dr. Steven Pearson, head of the nonprofit Institute for Clinical and Economic Review, or ICER, in Boston. The research organization recommends prices based on effectiveness.

What is Medicare drug price negotiation?

In a nutshell, it would allow the Medicare program to directly negotiate pharmaceutical prices with drugmakers. Negotiations could apply to either all Medicare-covered drugs or just the costliest ones.

How much would the drug pricing negotiation reduce federal spending?

As proposed in H.R. 3, drug pricing negotiation would reduce federal spending by $456 billion and increase revenues by $45 billion over 10 years. This would include: an increase in government revenue from employers using savings from reduced premiums to fund taxable wage increases for their workers.

How would price negotiation affect patients?

Negotiation that uses an upper limit based on international prices, such as the one proposed in H.R. 3, is expected to reduce costs for patients in Medicare Part D and the commercial market through lower beneficiary premiums and cost-sharing (cost-sharing for specialty drugs is generally based on a percentage of the list price). CBO estimates that H.R. 3 would reduce prices on these drugs between 57 percent and 75 percent.

How does H.R. 3 affect Medicare?

Negotiation that uses an upper limit based on international prices, such as the one proposed in H.R. 3, is expected to reduce costs for patients in Medicare Part D and the commercial market through lower beneficiary premiums and cost-sharing (cost-sharing for specialty drugs is generally based on a percentage of the list price). CBO estimates that H.R. 3 would reduce prices on these drugs between 57 percent and 75 percent.

How many drugs are eligible for negotiation?

Each year, the HHS secretary would select at least 50 drugs from among the up to 250 drugs eligible for negotiation. Drugs that are new to market may be eligible for negotiation if the wholesale acquisition cost, also called the list price, is equal to or greater than the U.S. median household income ($78,500 in 2020).

What percentage of drug sales are taxed?

If a drug is selected for negotiation and the manufacturer either does not participate in negotiations with the HHS secretary or does not reach agreement on a price, an excise tax of up to 95 percent of the drug’s sales, as reported by the manufacturer, would be imposed on the manufacturer.

Who would negotiate with drugmakers in Medicare?

Under H.R. 3, the Secretary of Health and Human Services (HHS) would be authorized to negotiate directly with drugmakers in the Medicare program for lower prices for up to 250 prescription drugs each year, including the 125 most costly drugs offered by Medicare Part D plans or sold anywhere in the commercial market.

What are the prospects for Medicare drug price negotiation?

Congressional Democrats are generally supportive of government negotiations on drug prices, as is the public, based on concerns about high and rising drug prices, particularly for new drugs with little or no competition. Many supporters would also like to apply budgetary savings from this proposal to pay for other health care priorities. But even among Democrats, support for this proposal is not universal, and it is not clear that current legislative proposals have sufficient votes to pass the House this Congressional session, given a narrower majority, and concerns about preserving incentives for innovation raised by some centrist Democratic lawmakers.

How would Medicare negotiate drug prices under H.R. 3?

The negotiation process applies to at least 25 (in 2024) and 50 (in 2025 and subsequent years) single-source brand-name drugs lacking generic or biosimilar competitors, selected from among the 125 drugs with the highest net Medicare Part D spending and the 125 drugs with the highest net spending in the U.S., which could include physician-administered drugs covered under Medicare Part B, along with all insulin products. Drugs that are new to market could also be subject to negotiation if their list price is greater than median household income and their projected spending would place them among the list of drugs with the highest spending under Medicare or the U.S. overall.

What has CBO said about the potential for savings from Medicare drug price negotiation under H.R. 3?

CBO estimated over $450 billion in 10-year (2020-2029) savings from the Medicare drug price negotiation provision in the version of H.R. 3 in the 116 th Congress, including $448 billion in savings to Medicare and $12 billion in savings for subsidized plans in the ACA marketplace and the Federal Employees Health Benefits Program. CBO also estimated an increase in revenues of about $45 billion over 10 years resulting from lower drug prices available to employers, which would reduce premiums for employer-sponsored insurance, leading to higher compensation in the form of taxable wages.

What is Medicare Part D?

Under the Medicare Part D program, which covers retail prescription drugs, Medicare contracts with private plan sponsors to provide a prescription drug benefit and gives plan sponsors authority to negotiate drug prices with pharmaceutical companies. The law that established the Medicare Part D benefit, which covers retail prescription drugs, ...

How long does it take for the HHS to lower drug prices?

The executive order, which also endorsed other proposals to lower drug prices, such as inflation caps, called for HHS to develop more specific proposals to lower drug prices within 45 days of the order’s issue date. In Congress, proposals to authorize the federal government to negotiate drug prices for Medicare and other payers appear ...

What are the principles of price negotiation?

The principles call for a policy that establishes clear criteria for which drugs to include in price negotiation , gives the HHS Secretary the requisite tools to negotiate a “fair” price, and creates incentives for manufacturers to participate in the negotiation process.

What is the effect of H.R. 3 on Medicare?

In an October 2019 letter to Chairman Pallone, CBO provided a preliminary estimate of the effects of the drug price negotiation provisions of H.R. 3 on Medicare spending. In prior analyses of drug price negotiation, CBO has said that repealing the non-interference clause and allowing price negotiations between the Secretary and drug manufacturers would yield negligible savings, primarily because the Secretary would have insufficient leverage to secure price concessions. In its analysis of H.R 3, however, CBO indicates that the provision to levy an excise tax on drug companies that do not enter into negotiations or agree to the maximum fair price provides the Secretary with needed leverage to achieve lower drug prices and federal savings.

How much would the US save if Medicare negotiated the same prices for drugs as people in Denmark pay?

According to the Center for Economic and Policy Research, the U.S. government could save $976 billion over ten years if Medicare negotiated the same prices for drugs as people in Denmark pay. A senior citizen relying on Medicare for their prescription drugs will pay on average two to six times more than the rest of the world. One of the main reasons for that, is that other countries not only negotiate price, but negotiate whether the drug will make it into that market at all. Many governments incorporate drug review boards that determine whether a drug provides a need in the current market relative to its cost and other drugs currently in the marketplace. Being barred access from an entire country can go a long way towards a negotiation.

Does Medicare negotiate drug prices?

Did you know that Medicare does not negotiate drug prices? - Senior Security Alliance

Does Medicare pay more for prescription drugs?

Did you know that although Medicare is the largest provider of prescription drugs in the US, they are not allowed to negotiate for better pricing? Under the law passed in 2003, The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Secretary of Health and Human Services is not allowed to negotiate for lower drug prices on behalf of Medicare Part D recipients. This law does not prohibit Medicaid or the Veterans Administration from negotiating, and as a result, they pay far less for the exact same medication. They pay on average between 70-80% more! Yes, you read this correctly, the largest provider of drugs in the United States pays on average 75% more for the same drugs than do other U.S. government programs.

October 20 Update

In our post below, we discussed the political and empirical obstacles to a congressional repeal of the ban on Medicare’s negotiating on prescription drugs. As an example of a pilot project that could generate data and be initiated without congressional action, we referenced CMS’s proposed pilot on value-based drug purchasing in Medicare Part B.

Original Post

Despite this election season’s divisiveness, both major parties’ presidential candidates have embraced the idea of authorizing Medicare Part D to negotiate directly with drug companies to set prescription drug prices. The Medicare Modernization Act of 2003 (MMA), which established Medicare Part D, included a ban on such negotiation.

The Political and Legal History Behind the Ban on Negotiating Drug Prices

Allowing Part D to negotiate drug prices is not a new idea: President Obama supported the repeal during his 2008 campaign and has included versions of the proposal in multiple budgets. Meanwhile, other government programs that purchase drugs have been able to lower drug costs through a variety of tactics.

The Contested Merits of Repealing the Ban on Price Negotiation

Rarely have we seen a health policy issue on which there is so much apparent consensus that is backed by so little research. Although it seems intuitive that allowing Medicare to negotiate will produce savings, under both Presidents Obama and George W.

Practical Politics: Incremental Steps and Pilots in Value-Based Pricing

Some of the most important major policy changes in health care began with pilot programs or experiments in the states. The ACA was inspired by Massachusetts’ health reform law, passed in 2006. The ACA embraces this philosophy of incremental, tested reform.

What is the Medicare Negotiation and Competitive Licensing Act?

The recently introduced Medicare Negotiation and Competitive Licensing Act would put Medicare directly in charge of demanding the lowest drug prices.

Why doesn't Medicare have power?

Medicare, which insures more than 60 million beneficiaries, doesn't have that power, mostly because Congress stopped it from getting the best drug prices years ago. But that could change.

Can pharma companies lock in profits?

Pharma companies can lock in some of the highest profits of any industry -- for years. Countries with national or single-payer healthcare, it should be noted, offer drugs to citizens at a fraction of what U.S. consumers pay.

Do drug companies compete against other companies?

Although free market advocates counter that drug companies compete against other to provide low prices, the industry is protected by patent laws and consistently fights low-cost, generic competition. Pharma companies can lock in some of the highest profits of any industry -- for years.

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