November 20, 2020
Trump Administration Announces Prescription Drug Payment Model to Put American Patients First
In support of President Trump's historic commitment to lowering drug prices for American patients, HHS Secretary Alex Azar announced a drug payment model through the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services that will lower Medicare Part B payments for certain drugs to the lowest price for similar countries and save American taxpayers and beneficiaries more than $85 billion over seven years.
Starting in January, the model, known as the Most Favored Nation (MFN) Model, will test an innovative way for Medicare to pay no more for high cost, physician-administered Medicare Part B drugs than the lowest price charged in other similar countries. Following the President's recent Executive Orders to lower drug prices and improve access to life-saving medications, the MFN Model will protect current beneficiary access to Medicare Part B drugs, make them more affordable, and address the disparity of drug costs between the U.S. and other countries.
"The way we pay for some of the most costly drugs in Medicare today puts American patients last; the President's Most Favored Nation Model will put American patients first," said HHS Secretary Alex Azar. "By dramatically lowering prices and potentially delivering more than $28 billion in out-of-pocket savings for patients, the Most Favored Nation Model will be the most significant single action any administration has ever taken to lower American drug costs."
"President Trump has proven time and again that he is unafraid of taking on the entrenched special interests that have stymied patient-centered reforms in Washington for generations," said CMS Administrator Seema Verma. "The current system creates incentives for drug manufacturers to price Medicare Part B drugs as high as they can in the U.S. system because the program pays doctors more when they prescribe more expensive drugs, even when a lower cost, clinically-equivalent alternative is available. The Most Favored Nation Model will lead to lower drug prices for seniors."
The rule tackles a number of issues identified in the American Patients First drug pricing blueprint, released by President Trump in May 2018 and developed by HHS under Secretary Azar's leadership, including high out-of-pocket costs, foreign freeriding, and the need for more biosimilar competition.
Over the last five years, Medicare Part B percent drug costs have grown at an annual rate of 11.5 percent. The 2020 Medicare Trustees report noted that Medicare Part B drugs have consistently been a major contributor to overall Medicare Part B spending trends, accounting for 37 percent of the change in Medicare Fee-for-Service Part B benefit spending from 2015 to 2019. Medicare Part B drug spending of $30 billion in 2019 made up 14 percent of total Medicare Fee-for-Service Part B spending, up from 11 percent in 2015.
Medicare Part B drug spending is growing faster than drug spending in Medicare Part D and the U.S. as a whole. In a new report released today, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) found that between 2006 and 2017, Medicare Part B Fee-For-Service drug spending per enrollee grew at 8.1 percent, more than twice as high as per capita spending on Medicare Part D (3.4 percent) and nearly three times as high as overall retail prescription per capita drug spending (2.9 percent). Moreover, spending and enrollment projections by the CMS Office of the Actuary for the 2021 President's Budget suggest that per capita spending on Medicare Part B physician-administered drugs and separately payable hospital outpatient drugs will grow at a similar annual rate of 8 percent between 2020 and 2027, before consideration of any COVID-19 pandemic impacts.
While state Medicaid programs and Medicare Advantage plans have tools to reduce certain drug costs through price negotiations, current law requires the Medicare Part B program to pay for most drugs administered by physicians at the average sales price in the United States, plus a percentage-based add-on payment. As manufacturers largely have the ability to set these prices independent of market forces, the result is that Americans pay more than twice as much as individuals in other higher-income countries for Medicare Part B drugs, according to a new ASPE study. This anti-competitive system leaves taxpayers and American seniors on the hook for paying the highest drug costs in the world.
For example, the top-selling Part B drug—a common eye drug (Eylea)—was approximately two times as expensive in Medicare Part B as in comparison countries. Because many seniors pay their 20 percent coinsurance obligation out of pocket, this difference costs them thousands of dollars in additional medical expenses a year. These high costs have a real impact: Medicare beneficiaries are often on fixed incomes and paying more for these drugs can hurt them financially, prompt them to take fewer doses of their medications, or lead them to abandon treatment altogether.
The Most Favored Nation Model will operate for seven years. Under the model, CMS will test paying based on the MFN Price for 50 Medicare Part B drugs and biologicals with the highest Medicare Part B spending. These 50 drugs and biologicals encompass approximately 73 percent of Medicare Part B drug spending, despite accounting for fewer than 10 percent of Medicare Part B drugs. All Medicare-participating physicians, hospitals and ambulatory surgical centers in the United States and territories will be paid the model payment for these 50 drugs and biologicals, rather than the current average sales price plus 6 percent add-on. The model payment will include two parts: a drug payment amount that will phase in the lowest price in other similar countries by blending it with the average sales price, and a flat add-on amount per dose that will be the same for each model drug. The model will accelerate the phase-in of the MFN Price if drug manufacturers increase U.S. prices faster than inflation and the lowest price in other similar countries. The model's flat per-dose add-on will remove the incentive for participating physicians, hospitals and other providers to furnish high-cost drugs. Beneficiaries' cost sharing on this add-on payment will be waived.
The model also includes protections for beneficiaries to ensure they will see savings compared to what they would pay if the model were not tested. Additionally, the model includes financial hardship protections for certain MFN participants (physicians, hospitals, and other providers) whose revenue is significantly affected by the model.
For a fact sheet on the Most Favored Nation Model, please visit: https://www.cms.gov/newsroom/fact-sheets/fact-sheet-most-favored-nation-model-medicare-part-b-drugs-and-biologicals-interim-final-rule-0
The Most Favored Nation Model Interim Final Rule with Comment Period (CMS-5528-IFC) can be downloaded here: https://innovation.cms.gov/media/document/mfn-ifc-rule. Public comments on the rule can be submitted through www.regulations.gov and must be received no later than 60 days after publication of the IFC in the Federal Register.
The new ASPE report on rises in Medicare Part B drug spending can be found here: https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-spending-and-utilization
The ASPE report on Medicare Part B drug spending and international price comparisons can be found here: https://aspe.hhs.gov/pdf-report/medicare-ffs-part-b-and-international-drug-prices