Legal Activities

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NHIA Submits Comments on Administration’s Patients Over Paperwork Initiative
On August 12th, NHIA sent a letter to CMS Administrator Seema Verma in response to the administration’s request for proposals to put “Patients over Paperwork.” In the letter, we identified several areas for administrative simplification, including the Detailed Written Order (DWO); the DME Information Form (DIF), Medicare Bill for Denial (BFD), Local Coverage Determinations (LCD), Medically Unusual Edits (MUE), and transitions of care. To read the letter, click here.

NHIA Sends Letter to CMS on PID Proposal
On August 12th, NHIA sent a letter to CMS Administrator Seema Verma expressing our concern that the Agency failed to meet its obligation to provide sufficient public notice and a 60-day comment period for any rule, requirement, or other statement of policy that changes the standard for the payment for services. Specifically, the Centers for Medicare and Medicaid Services (CMS) recently issued Change Request – 11295 which expanded coverage under the Part B benefit for immunoglobulin replacement therapy in the home setting to an additional 10 primary immune deficiency (PI). As a result, drugs that may have been previously covered under Medicare Part D will be covered under Part B beginning August 13th. To read the letter, click here.

NHIA Files Suit Against CMS Over Medicare Transitional Payment
On February 14th, NHIA filed a complaint in U.S. District Court against the Centers for Medicare and Medicaid Services (CMS) related to the agency’s Home Infusion Final Rule. Specifically, NHIA is challenging the Agency’s interpretation of “infusion drug administration calendar day,” which limits payment to only those days in which a “skilled professional is in the patient’s home.”

NHIA did not undertake this decision lightly. Since the rule was initially released, NHIA has fought tirelessly to convince CMS that their interpretation was contrary to Congress’ intent, which was to provide reimbursement for each day a patient received an infusion drug. We made legal, policy, and political arguments imploring CMS to recognize and reimburse pharmacy services that are provided remotely, in addition to the nursing services covered under the existing rule. Unfortunately, CMS’ refusal to recognize those services has left NHIA with little other choice than to pursue legal action.

NHIA has negotiated an expedited briefing schedule and expect to get the merits before the Court quickly. Our hope is that the case will be litigated and a judgement rendered by early-mid Summer.

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