Congressman Brett Guthrie | Official U.S. House headshot
Congressman Brett Guthrie | Official U.S. House headshot
Congressman Brett Guthrie (KY-02) and Rep. Buddy Carter (GA-01) have sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to withdraw a recently proposed rule related to the Medicaid Drug Rebate Program. More than twenty Republicans on the Energy & Commerce committee have joined Guthrie in expressing their concerns with the proposed rule, specifically how it will impact patient access to life-saving drugs, including curative cell and gene therapies.
In the letter, Guthrie and Carter highlight their concerns with the proposed changes to the definition of "covered outpatient drugs" (COD). They argue that CMS is diverging from the original text of the statute, which excludes bundled drugs from the definition, and instead moving towards an inclusion of all drugs identified on an invoice, regardless of whether they are bundled. This redefinition of CODs could have significant implications for rebates and payment arrangements, potentially disrupting the healthcare system and limiting access to innovative treatments.
"We are also troubled by other significant overreaches by the agency in rewriting several statutory definitions in the proposed rule that will curtail innovation and undercut patients’ access to essential care," the letter states.
The proposed rule would also require manufacturers to "stack discounts" offered in the commercial markets, which exceeds the current statutory authority. Additionally, it would impose costly reporting burdens on manufacturers by requiring them to report proprietary pricing information to CMS.
Another concerning provision of the proposed rule is the classification of inpatient administered drugs as "Covered Outpatient Drugs." This would subject classes of drugs that have not otherwise been subject to Medicaid's mandatory 23.1% rebate to these high rebates. Hospitals, which are paid through bundled payments for drugs administered to Medicaid patients, could receive less reimbursement for these drugs, potentially cutting access to care for vulnerable patients.
Guthrie and Carter's letter emphasizes the need for CMS to withdraw the proposed rule in order to protect patient access to essential care and maintain innovation in the healthcare industry.
The full letter can be accessed here.
For additional details, please follow this link: https://guthrie.house.gov/news/documentsingle.aspx?DocumentID=388116
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