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January 28, 2021

DHPA Urges CMS to Rescind Ill-Conceived MFN Interim Final Rule

In a comment letter to the U.S. Centers for Medicare and Medicaid (CMS) regarding the Most Favored Nation (MFN) Interim Final Rule, DHPA wrote that the procedurally, statutorily and constitutionally flawed policy will severely restrict access to life-saving drug treatments and have adverse economic consequences for the Medicare program by shifting care from the more cost-efficient medical office setting into the higher-cost hospital setting.

In the letter, DHPA writes, “In the first performance year alone, nine percent of Medicare beneficiaries who rely on non-340B providers such as independent gastroenterology (and other specialty) practices to administer Part B drugs in the medical office setting will no longer have access to their treatment. And it only gets worse from there as the policy phases out the time-tested Average Sales Price reimbursement formula and replaces it with the untested MFN Model price, with the CMS Office of the Actuary (OACT) projecting that nearly one-in-five Medicare beneficiaries (19%) will have no access to their life-saving Part B drugs in the third through seventh years of the Model.”

Further complicating the policy, the MFN rule could threaten the viability of medical practices, especially smaller practices and those in rural or underserved areas. There will be a two-quarter lag between when the MFN adjusted price is identified and when providers acquire and provide drug treatment to their patients. This lag would force physician practices into a constant, unrelenting scramble to acquire medications without building too much inventory due to the risk that the new reimbursement rate will drop below the market price at which they acquired the product.

If private practices can no longer afford to administer these drugs, this policy is likely to force patients to seek care in the more expensive hospital setting where Medicare and patients pay dramatically more for drug administration. Such a result runs counter to policymakers’ desire to keep care out of the more expensive outpatient hospital setting.

In urging CMS to rescind the policy, the letter states, “The Trump Administration IFC, if implemented, will unlawfully deprive Medicare beneficiaries of life-saving care. Changes to Medicare drug pricing policy should not come at the expense of independent gastroenterology (and other specialty) practices and the patients they serve.”

Click here to read the full comment letter.

Filed Under: Advocacy, Letters to Policymakers, Newsroom, Press Releases, Protecting Patient Access to Integrated GI Care in the Independent Setting

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